Quetiapine
Tablet, Film Coated · Oral
Uses
Quetiapine is an atypical antipsychotic indicated for the treatment of: Schizophrenia ( 1.1 ) Bipolar I disorder manic episodes ( 1.2 ) Bipolar disorder, depressive episodes ( 1.2 ) 1.1 Schizophrenia Quetiapine is indicated for the treatment of schizophrenia. The efficacy of quetiapine in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [ see Clinical Studies (14.1) ]. 1.2 Bipolar Disorder Quetiapine is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [ see Clinical Studies (14.2) ]. Quetiapine is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [ see Clinical Studies (14.2) ]. Quetiapine is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [ see Clinical Studies (14.2) ]. 1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.
Dosage and administration
2 DOSAGE & ADMINISTRATION · Quetiapine tablets, USP can be taken with or without food ( 2.1 ) Indication Initial Dose Recommended Dose Maximum Dose Schizophrenia-Adults (2.2) 25 mg twice daily 150 to 750 mg/day 750 mg/day Schizophrenia-Adolescents (13 to 17 years) (2.2) 25 mg twice daily 400 to 800 mg/day 800 mg/day Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex (2.2) 50 mg twice daily 400 to 800 mg/day 800 mg/day Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy (2.2) 25 mg twice daily 400 to 600 mg/day 600 mg/day Bipolar Depression-Adults (2.2) 50 mg once daily at bedtime 300 mg/day 300 mg/day Geriatric Use: Consider a lower starting dose (50 mg/day), slower titration and careful monitoring during the initial dosing period in the elderly ( 2.3 , 8.5 ) Hepatic Impairment: Lower starting dose (25 mg/day) and slower titration may be needed ( 2.4 , 8.7 , 12.3 ) 2.1 Important Administration Instructions Quetiapine tablets, USP can be taken with or without food. 2.2 Recommended Dosing The recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [ see Clinical Studies ( 14.1 and 14.2 ) ]. Table 1: Recommended Dosing for quetiapine Indication Initial Dose and Titration Recommended Dose Maximum Dose Schizophrenia-Adults Day 1: 25 mg twice daily. Increase in increments of 25 mg-50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4. Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days. 150 to 750 mg/day 750 mg/day Schizophrenia- Adolescents (13 to 17 years) Day 1: 25 mg twice daily. Day 2: Twice daily dosing totaling 100 mg. Day 3: Twice daily dosing totaling 200 mg. Day 4: Twice daily dosing totaling 300 mg. Day 5: Twice daily dosing totaling 400 mg. Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400-800 mg/day. Based on response and tolerability, may be administered three times daily. 400 to 800 mg/day 800 mg/day Schizophrenia-Maintenance Not applicable. 400 to 800 mg/day 800 mg/day Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex Day 1: Twice daily dosing totaling 100 mg. Day 2: Twice daily dosing totaling 200 mg. Day 3: Twice daily dosing totaling 300 mg. Day 4: Twice daily dosing totaling 400 mg. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. 400 to 800 mg/day 800 mg/day Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy Day 1: 25 mg twice daily. Day 2: Twice daily dosing totaling 100 mg. Day 3: Twice daily dosing totaling 200 mg. Day 4: Twice daily dosing totaling 300 mg. Day 5: Twice daily dosing totaling 400 mg. Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400-600 mg/day. Based on response and tolerability, may be administered three times daily. 400 to 600 mg/day 600 mg/day Bipolar Depression- Adults Administer once daily at bedtime. Day 1: 50 mg Day 2: 100 mg Day 3: 200 mg Day 4: 300 mg 300 mg/day 300 mg/day Bipolar I Disorder Maintenance Therapy- Adults Administer twice daily totaling 400-800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized. 400 to 800 mg/day 800 mg/day Maintenance Treatment for Schizophrenia and Bipolar I Disorder Maintenance Treatment– Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2) ] . 2.3 Dose Modifications in Elderly Patients Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3) ] . When indicated, dose escalation should be performed with caution in these patients. Elderly patients should be started on quetiapine 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient. 2.4 Dose Modifications in Hepatically Impaired Patients Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day - 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient. 2.5 Dose Modifications when used with CYP3A4 Inhibitors Quetiapine dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine should be increased by 6-fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1) ] . 2.6 Dose Modifications when used with CYP3A4 Inducers Quetiapine dose should be increased up to 5-fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine should be reduced to the original level within 7-14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1) ] .
Dosage forms and strengths
Quetiapine Tablets, USP 25 mg are Peach coloured, film coated, round shape, biconvex tablets, debossed with "262" on one side and plain on other side Quetiapine Tablets, USP50 mg are White coloured, film coated, round shape, biconvex tablets, debossed with"337" on one side and plain on other side Quetiapine Tablets, USP100 mg are Yellow coloured film coated, round shape, biconvex tablets, debossed with "261" on one side and plain on other side Quetiapine Tablets, USP150 mg are Off white to light yellow coloured, film coated, round shape, biconvex tablets, debossed with "353" on one side and plain on other side Quetiapine Tablets, USP200 mg are White coloured, film coated, round shape, biconvex tablets, debossed with "260" on one side and plain on other side Quetiapine Tablets, USP300 mg are White coloured, film coated, capsule shaped, biconvex tablets, debossed with "259" on one side and plain on other side Quetiapine Tablets, USP400 mg are Yellow coloured, film coated, capsuleshaped, biconvex tablets, debossed with ''336'' on one side and plain on other side Tablets: 25 mg, 50 mg, 100 mg, 150mg, 200 mg, 300 mg, and 400 mg ( 3 )
Contraindications
Hypersensitivity to quetiapine or to any excipients in the quetiapine formulation. Anaphylactic reactions have been reported in patients treated with quetiapine. Known hypersensitivity to quetiapine or any components in the formulation. ( 4 )
Warnings and precautions
5 WARNINGS AND PRECAUTIONS · Cerebrovascular Adverse Reactions: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack) has been seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs ( 5.3 ) · Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring ( 5.4 ) · Metabolic Changes: Atypical antipsychotics have been associated with metabolic changes. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain ( 5.5 ) · Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes · Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically, during treatment · Weight Gain: Gain in body weight has been observed; clinical monitoring of weight is recommended · Tardive Dyskinesia: Discontinue if clinically appropriate ( 5.6 ) · Hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease ( 5.7 ) · Increased Blood Pressure in Children and Adolescents: Monitor blood pressure at the beginning of, and periodically during treatment in children and adolescents ( 5.9 ) · Leukopenia, Neutropenia and Agranulocytosis: Monitor complete blood count frequently during the first few months of treatment in patients with a pre-existing low white cell count or a history of leukopenia/neutropenia and discontinue quetiapine at the first sign of a decline in WBC in absence of other causative factors ( 5.10 ) · Cataracts: Lens changes have been observed in patients during long-term quetiapine treatment. Lens examination is recommended when starting treatment and at 6-month intervals during chronic treatment ( 5.11 ) · Anticholinergic (antimuscarinic) Effects: Use with caution with other anticholinergic drugs and in patients with urinary retention, prostatic hypertrophy, or constipation ( 5.20 ) 5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analysis of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. quetiapine is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning ] . 5.2 Suicidal Thoughts and Behaviors in Adolescents and Young Adults Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 2.
Side effects
The following adverse reactions are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions (5.2) ] Cerebrovascular adverse reactions, including stroke in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.3 )] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4 )] Metabolic changes (hyperglycemia, dyslipidemia, weight gain) [see Warnings and Precautions (5.5 )] Tardive dyskinesia [see Warnings and Precautions (5.6 )] Hypotension [see Warnings and Precautions (5.7 )] Falls [ see Warnings and Precautions (5.8) ] Increases in blood pressure (children and adolescents) [see Warnings and Precautions ( 5.9 )] Leukopenia, neutropenia and agranulocytosis [see Warnings and Precautions ( 5.10 )] Cataracts [see Warnings and Precautions ( 5.11 )] QT Prolongation [see Warnings and Precautions ( 5.12 )] Seizures [see Warnings and Precautions ( 5.13 )] Hypothyroidism [see Warnings and Precautions ( 5.14 )] Hyperprolactinemia [see Warnings and Precautions ( 5.15 )] Potential for cognitive and motor impairment [see Warnings and Precautions ( 5.16 )] Body temperature regulation [see Warnings and Precautions ( 5.17 )] Dysphagia [see Warnings and Precautions ( 5.18 )] Discontinuation Syndrome [see Warnings and Precautions ( 5.19 )] Anticholinergic (antimuscarinic) Effects [see Warnings and Precautions ( 5.20 )]
• Most common adverse reactions (incidence ≥ 5% and twice placebo): Adults: somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain, postural hypotension, pharyngitis, weight gain, lethargy, ALT increased, dyspepsia ( 6.1 )
• Children and Adolescents: somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increased ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Study Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adults: The information below is derived from a clinical trial database for quetiapine consisting of over 4,300 patients. This database includes 698 patients exposed to quetiapine for the treatment of bipolar depression, 405 patients exposed to quetiapine for the treatment of acute bipolar mania (monotherapy and adjunct therapy), 646 patients exposed to quetiapine for the maintenance treatment of bipolar I disorder as adjunct therapy, and approximately 2600 patients and/or normal subjects exposed to 1 or more doses of quetiapine for the treatment of schizophrenia. Of these approximately 4,300 subjects, approximately 4,000 (2,300 in schizophrenia, 405 in acute bipolar mania, 698 in bipolar depression, and 646 for the maintenance treatment of bipolar I disorder) were patients who participated in multiple dose effectiveness trials, and their experience corresponded to approximately 2,400 patient-years. The conditions and duration of treatment with quetiapine varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, fixed-dose and dose-titration studies, and short-term or longer-term exposure. Adverse reactions were assessed by collecting adverse reactions, results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, an adverse reaction of the type listed. Adverse Reactions Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials Schizophrenia: Overall, there was little difference in the incidence of discontinuation due to adverse reactions (4% for quetiapine vs. 3% for placebo) in a pool of controlled trials. However, discontinuations due to somnolence (0.8% quetiapine vs. 0% placebo) and hypotension (0.4% quetiapine vs. 0% placebo) were considered to be drug related [see Warnings and Precautions ( 5.7 and5.19)]. Bipolar Disorder: Mania: Overall, discontinuations due to adverse reactions were 5.7% for quetiapine vs. 5.1% for placebo in monotherapy and 3.6% for quetiapine vs. 5.9% for placebo in adjunct therapy. Depression: Overall, discontinuations due to adverse reactions were 12.3% for quetiapine 300 mg vs. 19.0% for quetiapine 600 mg and 5.2% for placebo. Commonly Observed Adverse Reactions in Short-Term, Placebo-Controlled Trials: In the acute therapy of schizophrenia (up to 6 weeks) and bipolar mania (up to 12 weeks) trials, the most commonly observed adverse reactions associated with the use of quetiapine monotherapy (incidence of 5% or greater) and observed at a rate on quetiapine at least twice that of placebo were somnolence (18%), dizziness (11%), dry mouth (9%), constipation (8%), ALT increased (5%), weight gain (5%), and dyspepsia (5%). Adverse Reactions Occurring at an Incidence of 2% or More Among quetiapine Treated Patients in Short-Term, Placebo-Controlled Trials: The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators.
Drug interactions
Concomitant use of strong CYP3A4 inhibitors: Reduce quetiapine dose to one sixth when coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) ( 2.5 , 7.1 , 12.3 ) Concomitant use of strong CYP3A4 inducers: Increase quetiapine dose up to 5 fold when used in combination with a chronic treatment (more than 7-14 days) of potent CYP3A4 inducers (e.g., phenytoin, rifampin, St. John’s wort) ( 2.6 , 7.1 , 12.3 ) Discontinuation of strong CYP3A4 inducers: Reduce quetiapine dose by 5-fold within 7-14 days of discontinuation of CYP3A4 inducers ( 2.6 , 7.1 , 12.3 ) 7.1 Effect of Other Drugs on Quetiapine The risks of using quetiapine in combination with other drugs have not been extensively evaluated in systematic studies. Given the primary CNS effects of quetiapine, caution should be used when it is taken in combination with other centrally acting drugs. Quetiapine potentiated the cognitive and motor effects of alcohol in a clinical trial in subjects with selected psychotic disorders, and alcoholic beverages should be limited while taking quetiapine. Quetiapine exposure is increased by the prototype CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.) and decreased by the prototype CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). Dose adjustment of quetiapine will be necessary if it is co-administered with potent CYP3A4 inducers or inhibitors. CYP3A4 inhibitors: Coadministration of ketoconazole, a potent inhibitor of cytochrome CYP3A4, resulted in significant increase in quetiapine exposure. The dose of quetiapine should be reduced to one sixth of the original dose if co-administered with a strong CYP3A4 inhibitor [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3)] . CYP3A4 inducers: Coadministration of quetiapine and phenytoin, a CYP3A4 inducer increased the mean oral clearance of quetiapine by 5- fold. Increased doses of quetiapine up to 5 fold may be required to maintain control of symptoms of schizophrenia in patients receiving quetiapine and phenytoin, or other known potent CYP3A4 inducers [see Dosage and Administration (2.6) and Clinical Pharmacology (12.3)] . When the CYP3A4 inducer is discontinued, the dose of quetiapine should be reduced to the original level within 7-14 days [see Dosage and Administration (2.6)] . Anticholinergic Drugs: Concomitant treatment with quetiapine and other drugs with anticholinergic activity can increase the risk for severe gastrointestinal adverse reactions related to hypomotility. Quetiapine should be used with caution in patients receiving medications having anticholinergic (antimuscarinic) effects [see Warnings and Precautions (5.20)]. The potential effects of several concomitant medications on quetiapine pharmacokinetics were studied [see Clinical Pharmacology (12.3)] . 7.2 Effect of Quetiapine on Other Drugs Because of its potential for inducing hypotension, Quetiapine may enhance the effects of certain antihypertensive agents. Quetiapine may antagonize the effects of levodopa and dopamine agonists. There are no clinically relevant pharmacokinetic interactions of quetiapine on other drugs based on the CYP pathway. Quetiapine and its metabolites are non-inhibitors of major metabolizing CYP’s (1A2, 2C9, 2C19, 2D6, and 3A4).
Use in specific populations
8 USE IN SPECIFIC POPULATIONS · Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. ( 8.1 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including quetiapine tablets, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ Risk Summary Neonates exposed to antipsychotic drugs (including quetiapine tablet) during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations). Overall available data from published epidemiologic studies of pregnant women exposed to quetiapine have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). There are risks to the mother associated with untreated schizophrenia, bipolar I, or major depressive disorder, and with exposure to antipsychotics, including quetiapine tablet, during pregnancy (see Clinical Considerations) . In animal studies, embryo-fetal toxicity occurred including delays in skeletal ossification at approximately 1 and 2 times the maximum recommended human dose (MRHD) of 800 mg/day in both rats and rabbits, and an increased incidence of carpal/tarsal flexure (minor soft tissue anomaly) in rabbit fetuses at approximately 2 times the MRHD. In addition, fetal weights were decreased in both species. Maternal toxicity (observed as decreased body weights and/or death) occurred at 2 times the MRHD in rats and approximately 1-2 times the MRHD in rabbits. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or fetal risk There is a risk to the mother from untreated schizophrenia, or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide. Schizophrenia and bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth. It is not known if this is a direct result of the illness or other comorbid factors. A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Fetal/neonatal adverse reactions Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs, including quetiapine tablets, during the third trimester of pregnancy. These symptoms varied in severity. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Data Human Data Published data from observational studies, birth registries, and case reports on the use of atypical antipsychotics during pregnancy do not report a clear association with antipsychotics and major birth defects. A retrospective cohort study from a Medicaid database of 9258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk of major birth defects. Animal Data When pregnant rats and rabbits were exposed to quetiapine during organogenesis, there was no teratogenic effect in fetuses. Doses were 25, 50 and 200 mg/kg in rats and 25, 50 and 100 mg/kg in rabbits which are approximately 0.3, 0.6 and 2-times (rats) and 0.6, 1 and 2-times (rabbits) the MRHD for schizophrenia of 800 mg/day based on mg/m 2 body surface area. However, there was evidence of embryo-fetal toxicity including delays in skeletal ossification at approximately 1 and 2 times the MRHD of 800 mg/day in both rats and rabbits, and an increased incidence of carpal/tarsal flexure (minor soft tissue anomaly) in rabbit fetuses at approximately 2 times the MRHD. In addition, fetal weights were decreased in both species. Maternal toxicity (observed as decreased body weights and/or death) occurred at 2 times the MRHD in rats and approximately 1-2 times the MRHD (all doses tested) in rabbits. In a peri/postnatal reproductive study in rats, no drug-related effects were observed when pregnant dams were treated with quetiapine at doses 0.01, 0.1, and 0.2 times the MRHD of 800 mg/day based on mg/m 2 body surface area. However, in a preliminary peri/postnatal study, there were increases in fetal and pup death, and decreases in mean litter weight at 3 times the MRHD. 8.2 Lactation Risk Summary Limited data from published literature report the presence of quetiapine in human breast milk at relative infant dose of <1% of the maternal weight-adjusted dosage. There are no consistent adverse events that have been reported in infants exposed to quetiapine through breast milk. There is no information on the effects of quetiapine on milk production.
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including quetiapine tablets, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ Risk Summary Neonates exposed to antipsychotic drugs (including quetiapine tablet) during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations). Overall available data from published epidemiologic studies of pregnant women exposed to quetiapine have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). There are risks to the mother associated with untreated schizophrenia, bipolar I, or major depressive disorder, and with exposure to antipsychotics, including quetiapine tablet, during pregnancy (see Clinical Considerations) . In animal studies, embryo-fetal toxicity occurred including delays in skeletal ossification at approximately 1 and 2 times the maximum recommended human dose (MRHD) of 800 mg/day in both rats and rabbits, and an increased incidence of carpal/tarsal flexure (minor soft tissue anomaly) in rabbit fetuses at approximately 2 times the MRHD. In addition, fetal weights were decreased in both species. Maternal toxicity (observed as decreased body weights and/or death) occurred at 2 times the MRHD in rats and approximately 1-2 times the MRHD in rabbits. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or fetal risk There is a risk to the mother from untreated schizophrenia, or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide. Schizophrenia and bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth. It is not known if this is a direct result of the illness or other comorbid factors. A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Fetal/neonatal adverse reactions Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs, including quetiapine tablets, during the third trimester of pregnancy. These symptoms varied in severity. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Data Human Data Published data from observational studies, birth registries, and case reports on the use of atypical antipsychotics during pregnancy do not report a clear association with antipsychotics and major birth defects. A retrospective cohort study from a Medicaid database of 9258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk of major birth defects. Animal Data When pregnant rats and rabbits were exposed to quetiapine during organogenesis, there was no teratogenic effect in fetuses. Doses were 25, 50 and 200 mg/kg in rats and 25, 50 and 100 mg/kg in rabbits which are approximately 0.3, 0.6 and 2-times (rats) and 0.6, 1 and 2-times (rabbits) the MRHD for schizophrenia of 800 mg/day based on mg/m 2 body surface area. However, there was evidence of embryo-fetal toxicity including delays in skeletal ossification at approximately 1 and 2 times the MRHD of 800 mg/day in both rats and rabbits, and an increased incidence of carpal/tarsal flexure (minor soft tissue anomaly) in rabbit fetuses at approximately 2 times the MRHD. In addition, fetal weights were decreased in both species. Maternal toxicity (observed as decreased body weights and/or death) occurred at 2 times the MRHD in rats and approximately 1-2 times the MRHD (all doses tested) in rabbits. In a peri/postnatal reproductive study in rats, no drug-related effects were observed when pregnant dams were treated with quetiapine at doses 0.01, 0.1, and 0.2 times the MRHD of 800 mg/day based on mg/m 2 body surface area. However, in a preliminary peri/postnatal study, there were increases in fetal and pup death, and decreases in mean litter weight at 3 times the MRHD.
Pediatric use
8.4 Pediatric Use In general, the adverse reactions observed in children and adolescents during the clinical trials were similar to those in the adult population with few exceptions. Increases in systolic and diastolic blood pressure occurred in children and adolescents and did not occur in adults. Orthostatic hypotension occurred more frequently in adults (4-7%) compared to children and adolescents (< 1%) [see Warnings and Precautions ( 5.7 ) and Adverse Reactions ( 6.1 )]. Schizophrenia The efficacy and safety of quetiapine in the treatment of schizophrenia in adolescents aged 13 to 17 years were demonstrated in one 6-week, double-blind, placebo-controlled trial [see Indications and Usage ( 1.1 ), Dosage and Administration ( 2.2 ), Adverse Reactions ( 6.1 ), and Clinical Studies ( 14.1 )]. Safety and effectiveness of quetiapine in pediatric patients less than 13 years of age with schizophrenia have not been established. Maintenance The safety and effectiveness of quetiapine in the maintenance treatment of bipolar disorder has not been established in pediatric patients less than 18 years of age. The safety and effectiveness of quetiapine in the maintenance treatment of schizophrenia has not been established in any patient population, including pediatric patients. Bipolar Mania The efficacy and safety of quetiapine in the treatment of mania in children and adolescents ages 10 to 17 years with bipolar I disorder was demonstrated in a 3-week, double-blind, placebo-controlled, multicenter trial [see Indications and Usage ( 1.2 ), Dosage and Administration ( 2.3 ), Adverse Reactions ( 6.1 ), and Clinical Studies ( 14.2 )] . Safety and effectiveness of quetiapine in pediatric patients less than 10 years of age with bipolar mania have not been established. Bipolar Depression Safety and effectiveness of Quetiapine in pediatric patients less than 18 years of age with bipolar depression have not been established. A clinical trial with SEROQUEL XR was conducted in children and adolescents (10 to 17 years of age) with bipolar depression, efficacy was not established. Some differences in the pharmacokinetics of quetiapine were noted between children/adolescents (10 to 17 years of age) and adults. When adjusted for weight, the AUC and Cmax of quetiapine were 41% and 39% lower, respectively, in children and adolescents compared to adults. The pharmacokinetics of the active metabolite, norquetiapine, were similar between children/adolescents and adults after adjusting for weight [see Clinical Pharmacology ( 12.3 )] .
Geriatric use
8.5 Geriatric Use Of the approximately 3700 patients in clinical studies with quetiapine, 7% (232) were 65 years of age or over. In general, there was no indication of any different tolerability of quetiapine in the elderly compared to younger adults. Nevertheless, the presence of factors that might decrease pharmacokinetic clearance, increase the pharmacodynamic response to quetiapine, or cause poorer tolerance or orthostasis, should lead to consideration of a lower starting dose, slower titration, and careful monitoring during the initial dosing period in the elderly. The mean plasma clearance of quetiapine was reduced by 30% to 50% in elderly patients when compared to younger patients [ see Clinical Pharmacology (12.3) and Dosage and Administration (2.3 ) ] .
Overdosage
10.1 Human Experience In clinical trials, survival has been reported in acute overdoses of up to 30 grams of quetiapine. Most patients who overdosed experienced no adverse reactions or recovered fully from the reported reactions. Death has been reported in a clinical trial following an overdose of 13.6 grams of quetiapine alone. In general, reported signs and symptoms were those resulting from an exaggeration of the drug’s known pharmacological effects, i.e., drowsiness, sedation, tachycardia, hypotension, and anticholinergic toxicity including coma and delirium. Patients with pre-existing severe cardiovascular disease may be at an increased risk of the effects of overdose [see Warnings and Precautions ( 5.12 )]. One case, involving an estimated overdose of 9,600 mg, was associated with hypokalemia and first- degree heart block. In post-marketing experience, there were cases reported of QT prolongation with overdose. 10.2 Management of Overdosage Establish and maintain an airway and ensure adequate oxygenation and ventilation. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias. Appropriate supportive measures are the mainstay of management. For the most up-to-date information on the management of quetiapine overdosage, contact a certified Regional Poison Control Center (1-800-222-1222).
Description
Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b,f ] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42 H 50 N 6 O 4 S 2
• C 4 H 4 O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine. Structure
Mechanism of action
12.1 Mechanism of Action The mechanism of action of quetiapine in the listed indications is unclear. However, the efficacy of quetiapine in these indications could be mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2 (5HT 2 ) antagonism. The active metabolite, N-desalkyl quetiapine (norquetiapine), has similar activity at D 2 , but greater activity at 5HT2A receptors, than the parent drug (quetiapine).
How supplied
Quetiapine tablets, USP 25 mg Peach coloured, film coated, round shape, biconvex tablets, debossed with "262 ” on one side and plain on other side. Bottles of 100 tablets NDC 67877-242-01 Bottles of 1000 tablets NDC 67877-242-10 Carton pack of 100 tablets (10 x 10’s blister pack) NDC 67877-242-38 Carton pack of 10 tablets (1 x 10’s blister pack) NDC 67877-242-33 Quetiapine tablets, USP 50 mg White coloured, film coated, round shape, biconvex tablets, debossed with"337" on one side and plain on other side. Bottles of 100 tablets NDC 67877-249-01 Bottles of 1000 tablets NDC 67877-249-10 Carton pack of 100 tablets (10 x 10’s blister pack) NDC 67877-249-38 Carton pack of 10 tablets (1 x 10’s blister pack) NDC 67877-249-33 Quetiapine tablets, USP 100 mg Yellow coloured, film coated, round shape, biconvex tablets, debossed with "261" on one side and plain on other side. Bottles of 100 tablets NDC 67877-250-01 Bottles of 1000 tablets NDC 67877-250-10 Carton pack of 100 tablets (10 x 10’s blister pack) NDC 67877-250-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-250-33 Quetiapine tablets, USP 150 mg Off white to light yellow coloured, film coated, round shape, biconvex tablets, debossed with "353" on one side and plain on other side. Bottles of 100 tablets NDC 67877-245- 01 Carton pack of 100 tablets (10 x 10's blister pack) NDC 67877-245-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-245-33 Quetiapine tablets, USP 200 mg White coloured, film coated, round shape, biconvex tablets, debossed with "260" on one side and plain on other side. Bottles of 100 tablets NDC 67877-246- 01 Bottles of 1000 tablets NDC 67877-246-10 Carton pack of 100 tablets (10 x 10's blister pack) NDC 67877-246-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-246-33 Quetiapine tablets, USP 300 mg White coloured, film coated, capsule shaped, biconvex tablets, debossed with "259" on one side and plain on other side. Bottles of 60 tablets NDC 67877-247- 60 Bottles of 1000 tablets NDC 67877-247-10 Carton pack of 100 tablets (10 x 10's blister pack) NDC 67877-247-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-247-33 Quetiapine tablets, USP 400 mg Yellow coloured, film coated, capsule shaped, biconvex tablets, debossed with "336" on one side and plain on other side. Bottles of 100 tablets NDC 67877-248- 01 Bottles of 1000 tablets NDC 67877-248-10 Carton pack of 100 tablets (10 x 10's blister pack) NDC 67877-248-38 Carton pack of 10 tablets (1 x 10's blister pack) NDC 67877-248-33 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Patient information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking quetiapine. Increased Mortality in Elderly Patients with Dementia-Related Psychosis Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at increased risk of death compared with placebo. Quetiapine is not approved for elderly patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )] . Suicidal Thoughts and Behaviors Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Warnings and Precautions ( 5.2 )]. Neuroleptic Malignant Syndrome (NMS) Patients should be advised to report to their physician any signs or symptoms that may be related to NMS. These may include muscle stiffness and high fever [see Warnings and Precautions ( 5.4 )]. Hyperglycemia and Diabetes Mellitus Patients should be aware of the symptoms of hyperglycemia (high blood sugar) and diabetes mellitus. Patients who are diagnosed with diabetes, those with risk factors for diabetes, or those that develop these symptoms during treatment should have their blood glucose monitored at the beginning of and periodically during treatment [see Warnings and Precautions ( 5.5 )]. Hyperlipidemia Patients should be advised that elevations in total cholesterol, LDL-cholesterol and triglycerides and decreases in HDL- cholesterol may occur. Patients should have their lipid profile monitored at the beginning of and periodically during treatment [see Warnings and Precautions ( 5.5 )] . Weight Gain Patients should be advised that they may experience weight gain. Patients should have their weight monitored regularly [see Warnings and Precautions ( 5.5 )]. Orthostatic Hypotension Patients should be advised of the risk of orthostatic hypotension (symptoms include feeling dizzy or lightheaded upon standing, which may lead to falls), especially during the period of initial dose titration, and also at times of re-initiating treatment or increases in dose [see Warnings and Precautions ( 5.7 )] . Increased Blood Pressure in Children and Adolescents Children and adolescent patients should have their blood pressure measured at the beginning of, and periodically during, treatment [ see Warnings and Precautions ( 5.9 ) ]. Leukopenia/Neutropenia Patients with a pre-existing low WBC or a history of drug induced leukopenia/neutropenia should be advised that they should have their CBC monitored while taking quetiapine. Patients should be advised to talk to their doctor as soon as possible if they have a fever, flu-like symptoms, sore throat, or any other infection as this could be a result of a very low WBC, which may require quetiapine to be stopped and/or treatment to be given [ see Warnings and Precautions ( 5.10 ) ]. Interference with Cognitive and Motor Performance Patients should be advised of the risk of somnolence or sedation (which may lead to falls), especially during the period of initial dose titration. Patients should be cautioned about performing any activity requiring mental alertness, such as operating a motor vehicle (including automobiles) or operating machinery, until they are reasonably certain quetiapine therapy does not affect them adversely [ see Warnings and Precautions ( 5.16 ) ]. Heat Exposure and Dehydration Patients should be advised regarding appropriate care in avoiding overheating and dehydration [ see Warnings and Precautions (5 .17 ) ]. Concomitant Medication As with other medications, patients should be advised to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs [ see Drug Interactions ( 7.1 ) ]. Pregnancy Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with quetiapine. Advise patients that quetiapine may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to quetiapine during pregnancy [see Use in Specific Populations ( 8.1 )]. Infertility Advise females of reproductive potential that quetiapine may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible [see Use in Specific Populations ( 8.3 )]. Need for Comprehensive Treatment Program Quetiapine is indicated as an integral part of a total treatment program for adolescents with schizophrenia and pediatric bipolar disorder that may include other measures (psychological, educational, and social). Effectiveness and safety of quetiapine have not been established in pediatric patients less than 13 years of age for schizophrenia or less than 10 years of age for bipolar mania. Appropriate educational placement is essential and psychosocial intervention is often helpful.
Label text from the FDA structured product label by Ascend Laboratories, LLC (revised Aug 6, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Quetiapine Fumarate in 102 products
- Quetiapine in 5 products
Quetiapine NDC products (107)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 16729-149 | Quetiapine Fumarate 300 mg/1 Tablet, Film Coated | Accord Healthcare Inc. | ANDA |
| 16729-148 | Quetiapine Fumarate 200 mg/1 Tablet, Film Coated | Accord Healthcare Inc. | ANDA |
| 16729-147 | Quetiapine Fumarate 100 mg/1 Tablet, Film Coated | Accord Healthcare Inc. | ANDA |
| 16729-146 | Quetiapine Fumarate 50 mg/1 Tablet, Film Coated | Accord Healthcare Inc. | ANDA |
| 16729-145 | Quetiapine Fumarate 25 mg/1 Tablet, Film Coated | Accord Healthcare Inc. | ANDA |
| 16729-150 | Quetiapine Fumarate 400 mg/1 Tablet, Film Coated | Accord Healthcare Inc. | ANDA |
| 71093-139 | Quetiapine Fumarate 400 mg/1 Tablet, Film Coated, Extended Release | ACI Healthcare USA, Inc. | ANDA |
| 71093-135 | Quetiapine Fumarate 50 mg/1 Tablet, Film Coated, Extended Release | ACI Healthcare USA, Inc. | ANDA |
| 71093-136 | Quetiapine Fumarate 150 mg/1 Tablet, Film Coated, Extended Release | ACI Healthcare USA, Inc. | ANDA |
| 71093-137 | Quetiapine Fumarate 200 mg/1 Tablet, Film Coated, Extended Release | ACI Healthcare USA, Inc. | ANDA |
| 71093-138 | Quetiapine Fumarate 300 mg/1 Tablet, Film Coated, Extended Release | ACI Healthcare USA, Inc. | ANDA |
| 69948-002 | Quetiapine Fumarate 150 mg/1 Tablet, Film Coated, Extended Release | AlignScience Pharma Inc. | ANDA |
| 69948-003 | Quetiapine Fumarate 200 mg/1 Tablet, Film Coated, Extended Release | AlignScience Pharma Inc. | ANDA |
| 71610-702 | Quetiapine Fumarate 200 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 67877-250 | Quetiapine Fumarate 100 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-249 | Quetiapine Fumarate 50 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-248 | Quetiapine Fumarate 400 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-247 | Quetiapine Fumarate 300 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-246 | Quetiapine Fumarate 200 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-245 | Quetiapine Fumarate 150 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-242 | Quetiapine Fumarate 25 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 76420-522 | Quetiapine Fumarate 400 mg/1 Tablet, Film Coated | ASCLEMED USA INC. | ANDA |
| 76420-512 | Quetiapine Fumarate 25 mg/1 Tablet, Film Coated | ASCLEMED USA INC. | ANDA |
| 76420-513 | Quetiapine Fumarate 50 mg/1 Tablet, Film Coated | ASCLEMED USA INC. | ANDA |
| 76420-514 | Quetiapine Fumarate 100 mg/1 Tablet, Film Coated | ASCLEMED USA INC. | ANDA |
| 76420-516 | Quetiapine Fumarate 150 mg/1 Tablet, Film Coated | ASCLEMED USA INC. | ANDA |
| 76420-518 | Quetiapine Fumarate 200 mg/1 Tablet, Film Coated | ASCLEMED USA INC. | ANDA |
| 76420-519 | Quetiapine Fumarate 300 mg/1 Tablet, Film Coated | ASCLEMED USA INC. | ANDA |
| 68001-602 | Quetiapine Fumarate 400 mg/1 Tablet, Extended Release | BluePoint Laboratories | ANDA |
| 68001-601 | Quetiapine Fumarate 300 mg/1 Tablet, Extended Release | BluePoint Laboratories | ANDA |
| 68001-600 | Quetiapine Fumarate 200 mg/1 Tablet, Extended Release | BluePoint Laboratories | ANDA |
| 68001-599 | Quetiapine Fumarate 150 mg/1 Tablet, Extended Release | BluePoint Laboratories | ANDA |
| 68001-598 | Quetiapine Fumarate 50 mg/1 Tablet, Extended Release | BluePoint Laboratories | ANDA |
| 71335-2641 | Quetiapine Fumarate 400 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-5944 | Quetiapine Fumarate 400 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-7116 | Quetiapine Fumarate 400 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1462 | Quetiapine Fumarate 100 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 55154-3359 | Quetiapine Fumarate 200 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-8092 | Quetiapine Fumarate 50 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-7894 | Quetiapine Fumarate 100 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-7881 | Quetiapine Fumarate 25 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 67046-1623 | Quetiapine Fumarate 200 mg/1 Tablet, Extended Release | Coupler LLC | ANDA |
| 67046-0487 | Quetiapine Fumarate 100 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 51407-799 | Quetiapine Fumarate 50 mg/1 Tablet, Film Coated, Extended Release | Golden State Medical Supply, Inc. | ANDA |
| 51407-800 | Quetiapine Fumarate 150 mg/1 Tablet, Film Coated, Extended Release | Golden State Medical Supply, Inc. | ANDA |
| 51407-801 | Quetiapine Fumarate 200 mg/1 Tablet, Film Coated, Extended Release | Golden State Medical Supply, Inc. | ANDA |
| 51407-802 | Quetiapine Fumarate 300 mg/1 Tablet, Film Coated, Extended Release | Golden State Medical Supply, Inc. | ANDA |
| 51407-803 | Quetiapine Fumarate 400 mg/1 Tablet, Film Coated, Extended Release | Golden State Medical Supply, Inc. | ANDA |
| 68180-616 | Quetiapine Fumarate 400 mg/1 Tablet, Film Coated, Extended Release | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-615 | Quetiapine Fumarate 300 mg/1 Tablet, Film Coated, Extended Release | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-614 | Quetiapine Fumarate 200 mg/1 Tablet, Film Coated, Extended Release | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-613 | Quetiapine Fumarate 150 mg/1 Tablet, Film Coated, Extended Release | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-612 | Quetiapine Fumarate 50 mg/1 Tablet, Film Coated, Extended Release | Lupin Pharmaceuticals, Inc. | ANDA |
| 33342-137 | Quetiapine Fumarate 400 mg/1 Tablet, Extended Release | Macleods Pharmaceuticals Limited | ANDA |
| 33342-136 | Quetiapine Fumarate 300 mg/1 Tablet, Extended Release | Macleods Pharmaceuticals Limited | ANDA |
| 33342-135 | Quetiapine Fumarate 200 mg/1 Tablet, Extended Release | Macleods Pharmaceuticals Limited | ANDA |
| 33342-134 | Quetiapine Fumarate 150 mg/1 Tablet, Extended Release | Macleods Pharmaceuticals Limited | ANDA |
| 0904-6643 | Quetiapine Fumarate 400 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0904-6801 | Quetiapine Fumarate 50 mg/1 Tablet, Film Coated, Extended Release | Major Pharmaceuticals | ANDA |
| 0904-6802 | Quetiapine Fumarate 150 mg/1 Tablet, Film Coated, Extended Release | Major Pharmaceuticals | ANDA |
| 0904-6805 | Quetiapine Fumarate 400 mg/1 Tablet, Film Coated, Extended Release | Major Pharmaceuticals | ANDA |
| 0904-6804 | Quetiapine Fumarate 300 mg/1 Tablet, Film Coated, Extended Release | Major Pharmaceuticals | ANDA |
| 0904-6803 | Quetiapine Fumarate 200 mg/1 Tablet, Film Coated, Extended Release | Major Pharmaceuticals | ANDA |
| 0904-6638 | Quetiapine Fumarate 25 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0904-6639 | Quetiapine Fumarate 50 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0904-6642 | Quetiapine Fumarate 300 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0904-6641 | Quetiapine Fumarate 200 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0904-6640 | Quetiapine Fumarate 100 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 68071-3921 | Quetiapine Fumarate 50 mg/1 Tablet, Film Coated, Extended Release | NuCare Pharmaceuticals, Inc. | ANDA |
| 72789-266 | Quetiapine Fumarate 50 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 71205-402 | Quetiapine Fumarate 400 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-401 | Quetiapine Fumarate 200 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-026 | Quetiapine Fumarate 300 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 70518-4437 | Quetiapine Fumarate 400 mg/1 Tablet, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-4430 | Quetiapine Fumarate 50 mg/1 Tablet, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-4051 | Quetiapine Fumarate 150 mg/1 Tablet, Film Coated, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-4451 | Quetiapine Fumarate 300 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4699 | Quetiapine Fumarate 200 mg/1 Tablet, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-4700 | Quetiapine Fumarate 400 mg/1 Tablet, Extended Release | REMEDYREPACK INC. | ANDA |
| 50228-384 | Quetiapine Fumarate 400 mg/1 Tablet, Film Coated, Extended Release | ScieGen Pharmaceuticals, Inc | ANDA |
| 50228-383 | Quetiapine Fumarate 300 mg/1 Tablet, Film Coated, Extended Release | ScieGen Pharmaceuticals, Inc | ANDA |
| 50228-382 | Quetiapine Fumarate 200 mg/1 Tablet, Film Coated, Extended Release | ScieGen Pharmaceuticals, Inc | ANDA |
| 50228-381 | Quetiapine Fumarate 150 mg/1 Tablet, Film Coated, Extended Release | ScieGen Pharmaceuticals, Inc | ANDA |
| 50228-380 | Quetiapine Fumarate 50 mg/1 Tablet, Film Coated, Extended Release | ScieGen Pharmaceuticals, Inc | ANDA |
| 43547-019 | Quetiapine 50 mg/1 Tablet, Extended Release | Solco Healthcare U.S., LLC | ANDA |
| 43547-023 | Quetiapine 400 mg/1 Tablet, Extended Release | Solco Healthcare U.S., LLC | ANDA |
| 43547-022 | Quetiapine 300 mg/1 Tablet, Extended Release | Solco Healthcare U.S., LLC | ANDA |
| 43547-021 | Quetiapine 200 mg/1 Tablet, Extended Release | Solco Healthcare U.S., LLC | ANDA |
| 43547-020 | Quetiapine 150 mg/1 Tablet, Extended Release | Solco Healthcare U.S., LLC | ANDA |
| 43547-523 | Quetiapine Fumarate 400 mg/1 Tablet | Solco Healthcare US, LLC | ANDA |
| 43547-518 | Quetiapine Fumarate 25 mg/1 Tablet | Solco Healthcare US, LLC | ANDA |
| 43547-519 | Quetiapine Fumarate 50 mg/1 Tablet | Solco Healthcare US, LLC | ANDA |
| 43547-520 | Quetiapine Fumarate 100 mg/1 Tablet | Solco Healthcare US, LLC | ANDA |
| 43547-521 | Quetiapine Fumarate 200 mg/1 Tablet | Solco Healthcare US, LLC | ANDA |
| 43547-522 | Quetiapine Fumarate 300 mg/1 Tablet | Solco Healthcare US, LLC | ANDA |
| 60760-866 | Quetiapine Fumarate 200 mg/1 Tablet, Film Coated, Extended Release | ST. MARY'S MEDICAL PARK PHARMACY | ANDA |
| 0093-8162 | Quetiapine Fumarate 100 mg/1 Tablet, Film Coated | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-8163 | Quetiapine Fumarate 200 mg/1 Tablet, Film Coated | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-8164 | Quetiapine Fumarate 300 mg/1 Tablet, Film Coated | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-8165 | Quetiapine Fumarate 400 mg/1 Tablet, Film Coated | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-8166 | Quetiapine Fumarate 50 mg/1 Tablet, Film Coated | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-2063 | Quetiapine Fumarate 25 mg/1 Tablet, Film Coated | Teva Pharmaceuticals USA, Inc. | ANDA |
| 29300-312 | Quetiapine Fumarate 400 mg/1 Tablet, Extended Release | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-311 | Quetiapine Fumarate 300 mg/1 Tablet, Extended Release | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-310 | Quetiapine Fumarate 200 mg/1 Tablet, Extended Release | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-309 | Quetiapine Fumarate 150 mg/1 Tablet, Extended Release | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-308 | Quetiapine Fumarate 50 mg/1 Tablet, Extended Release | Unichem Pharmaceuticals (USA), Inc. | ANDA |
Quetiapine recalls
- D-0999-2020 Mar 18, 2020 · Class III · Terminated
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. - D-1000-2020 Mar 18, 2020 · Class III · Terminated
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. - D-1001-2020 Mar 18, 2020 · Class III · Terminated
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. - D-1002-2020 Mar 18, 2020 · Class III · Terminated
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. - D-0287-2019 Dec 5, 2018 · Class II · Terminated
Presence of Foreign Substance; metal shard found in tablet
Frequently asked questions
What is Quetiapine used for?
Quetiapine is an atypical antipsychotic indicated for the treatment of: Schizophrenia ( 1.1 ) Bipolar I disorder manic episodes ( 1.2 ) Bipolar disorder, depressive episodes ( 1.2 ) 1.1 Schizophrenia Quetiapine is indicated for the treatment of schizophrenia. The efficacy of quetiapine in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17…
What are the side effects of Quetiapine?
The following adverse reactions are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions (5.2) ] Cerebrovascular adverse reactions, including stroke in elderly patients with… See the full label for the complete list.
Who makes Quetiapine?
Quetiapine is listed by 24 labelers in the FDA NDC directory, including Accord Healthcare Inc., ACI Healthcare USA, Inc., AlignScience Pharma Inc., Aphena Pharma Solutions - Tennessee, LLC.
Has Quetiapine been recalled?
The FDA enforcement database lists 5 recalls for Quetiapine, most recently D-0999-2020 (class iii): Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate…