Mirtazapine
Tablet, Film Coated · Oral
Uses
Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )] . Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults. ( 1 )
Dosage and administration
• Starting dose: 15 mg once daily; may increase up to maximum recommended dose of 45 mg once daily. ( 2.1 )
• Administer orally once daily, preferably in the evening prior to sleep. ( 2.1 )
• Reduce dose gradually when discontinuing mirtazapine tablets. ( 2.6 , 5.14 ) 2.1 Recommended Dosage The recommended starting dose of mirtazapine tablets is 15 mg once daily, administered orally, preferably in the evening prior to sleep. If patients do not have an adequate response to the initial 15 mg dose, increase the dose up to a maximum of 45 mg per day. Dose changes should not be made in intervals of less than 1 to 2 weeks to allow sufficient time for evaluation of response to a given dose [see Clinical Pharmacology ( 12.3 )] . 2.3 Screen for Bipolar Disorder Prior to Starting Mirtazapine Tablets Prior to initiating treatment with mirtazapine tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.9 )]. 2.4 Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of mirtazapine tablets. In addition, at least 14 days must elapse after stopping mirtazapine tablets before starting an MAOI antidepressant [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] . 2.5 Dosage Modifications Due to Drug Interactions Strong CYP3A Inducers An increase in dosage of mirtazapine tablets may be needed with concomitant strong CYP3A inducer (e.g., carbamazepine, phenytoin, rifampin) use. Conversely, a decrease in dosage of mirtazapine tablets may be needed if the CYP3A inducer is discontinued [see Drug Interactions ( 7 )]. Strong CYP3A Inhibitors A decrease in dosage of mirtazapine tablets may be needed with concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin). Conversely, an increase in dosage of mirtazapine tablets may be needed if the CYP3A4 inhibitor is discontinued [see Drug Interactions ( 7 )]. Cimetidine A decrease in dosage of mirtazapine tablets may be needed with concomitant use of cimetidine. Conversely, an increase in dosage of mirtazapine tablets may be needed if cimetidine is discontinued [see Drug Interactions ( 7 )]. 2.6 Discontinuation of Mirtazapine Tablets Treatment Adverse reactions may occur upon discontinuation or dose reduction of mirtazapine tablets [see Warnings and Precautions ( 5.14 )] . Gradually reduce the dosage of mirtazapine tablets rather than stopping abruptly whenever possible.
Dosage forms and strengths
Mirtazapine tablets are supplied as:
• 7.5 mg tablets: White, round biconvex tablets debossed with 'E14' on one side, plain on the other side.
• 15 mg tablets: Yellow colored, oval shape biconvex tablets debossed with 'E' and' 15' separated with functionally scored line on one side, plain on the other side.
• 30 mg tablets: Red-brown colored, oval shape biconvex tablets debossed with 'E' and '16' separated with functionally scored line on one side, plain on the other side.
• 45 mg tablets: White, oval shape biconvex tablets debossed with 'El7' on one side, plain on the other side. Tablets: 7.5 mg, 15 mg functionally scored, 30 mg functionally scored and 45 mg. ( 3 )
Contraindications
Mirtazapine tablets are contraindicated in patients:
• Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )] .
• With a known hypersensitivity to mirtazapine or to any of the excipients in mirtazapine tablets . Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme and toxic epidermal necrolysis have been reported following the use of mirtazapine tablets [see Warnings and Precautions (5.6) , Adverse Reactions ( 6.2 )].
• Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of stopping MAOIs. ( 2.4 , 4 , 7 )
• Known hypersensitivity to mirtazapine or any of the excipients in mirtazapine tablets. ( 4 )
Warnings and precautions
• Agranulocytosis : If sore throat, fever, stomatitis or signs of infection occur, along with a low white blood cell count, treatment with mirtazapine tablets should be discontinued and the patient should be closely monitored. ( 5.2 )
• Serotonin Syndrome : Increased risk when co-administered with other serotonergic drugs (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue mirtazapine tablets and initiate supportive treatment. ( 2.4 , 4 , 5.3 , 7 )
• Angle-Closure Glaucoma : Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.4 )
• QT Prolongation : Use mirtazapine tablets with caution in patients with risk factors for QT prolongation. ( 5.5 , 7 )
• Drug Reaction with Eosinophilia and System Symptoms (DRESS) : Discontinue mirtazapine tablets if DRESS is suspected. ( 5.6 )
• Increased Appetite/Weight Gain : Mirtazapine tablets have been associated with increased appetite and weight gain. ( 5.7 )
• Somnolence : May impair judgment, thinking and/or motor skills. Use with caution when engaging in activities requiring alertness, such as driving or operating machinery. ( 5.8 , 7 )
• Activation of Mania/Hypomania : Screen patients for bipolar disorder prior to initiating treatment. ( 2.3 , 5.9 )
• Seizures : Use with caution in patients with a seizure disorder. ( 5.10 )
• Elevated Cholesterol/Triglycerides : Has been reported with mirtazapine tablets use. ( 5.11 )
• Hyponatremia : May occur as a result of treatment with serotonergic antidepressants, including mirtazapine tablets. ( 5.12 )
• Transaminase Elevations : Clinically significant elevations have occurred. Use with caution in patients with impaired hepatic function. ( 5.13 ) 5.1 Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 1. Table 1: Risk Differences of the Number of Patients with Suicidal Thoughts and Behavior in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range Drug-Placebo Difference in Number of Patients with Suicidal Thoughts or Behaviors per 1000 Patients Treated Increases Compared to Placebo <18 years old 14 additional patients 18 to 24 years old 5 additional patients Decreases Compared to Placebo 25 to 64 years old 1 fewer patient ≥65 years old 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors. Monitor all antidepressant-treated patients for any indication of clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing mirtazapine tablets, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors. 5.2 Agranulocytosis In premarketing clinical trials, 2 (1 with Sjögren’s Syndrome) out of 2796 patients treated with mirtazapine tablets developed agranulocytosis [absolute neutrophil count (ANC) <500/mm 3 with associated signs and symptoms, e.g., fever, infection, etc.] and a third patient developed severe neutropenia (ANC <500/mm 3 without any associated symptoms). For these 3 patients, onset of severe neutropenia was detected on days 61, 9, and 14 of treatment, respectively. All 3 patients recovered after mirtazapine tablets was stopped. If a patient develops a sore throat, fever, stomatitis, or other signs of infection, along with a low white blood cell (WBC) count, treatment with mirtazapine tablets should be discontinued and the patient should be closely monitored. 5.3 Serotonin Syndrome Serotonergic antidepressants, including mirtazapine tablets, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see Contraindications ( 4 ), Drug Interactions ( 7 )] . Serotonin syndrome can also occur when these drugs are used alone. Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The concomitant use of mirtazapine tablets with MAOIs is contraindicated.
Side effects
The following adverse reactions are described in more detail in other sections of the prescribing information:
• Hypersensitivity [see Contraindications (4) ]
• Suicidal Thoughts and Behaviors [see Warnings and Precautions (5.1)]
• Agranulocytosis [see Warnings and Precautions (5.2)]
• Serotonin Syndrome [see Contraindications (4) , Warnings and Precautions (5.3), Drug Interactions (7)]
• Angle-Closure Glaucoma [see Warnings and Precautions (5.4)]
• QT Prolongation and Torsades de Pointes [see Warnings and Precautions (5.5)]
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.6)]
• Increased Appetite and Weight Gain [see Warnings and Precautions (5.7)]
• Somnolence [see Warnings and Precautions (5.8)]
• Activation of Mania or Hypomania [see Warnings and Precautions (5.9) ]
• Seizures [see Warnings and Precautions (5.10)]
• Elevated Cholesterol and Triglycerides [see Warnings and Precautions (5.11) ]
• Hyponatremia [see Warnings and Precautions ( 5.12) ]
• Transaminase Elevations [see Warnings and Precautions (5.13)]
• Discontinuation Syndrome [see Warnings and Precautions (5.14) ]
• Use in Patients with Concomitant Illness [see Warnings and Precautions (5.15)] Most common adverse reactions(>5% or greater and twice placebo) were somnolence, incresed appetite, weight gain,and dizziness. 6.1 To report SUSPECTED ADVERSE REACTIONS, contact XL Care Pharmaceticals,Inc.at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below are from clinical trials in which mirtazapine tablets were administered to 2796 patients in phase 2 and 3 clinical studies. The trials consisted of double-blind controlled and open-label studies, inpatient and outpatient studies, fixed dose, and titration studies. Adverse Reactions Leading to Discontinuation of Treatment Approximately 16% of the 453 patients who received mirtazapine tablets in U.S. 6-week placebo-controlled clinical trials discontinued treatment due to an adverse reaction, compared to 7% of the 361 placebo-treated patients in those studies. The most common reactions leading to discontinuation (≥1% and at a rate at least twice that of placebo) are included in Table 2. Table 2: Adverse Reactions (≥1% and at least twice placebo) Leading to Discontinuation of Mirtazapine Tablets in 6-Week Clinical Trials in Patients with MDD Mirtazapine Tablets (n=453) Placebo (n=361) Somnolence 10.4% 2.2% Nausea 1.5% 0% Common Adverse Reactions The most common adverse reactions (≥5% and twice placebo) associated with the use of mirtazapine tablets are listed in Table 3. Table 3: Adverse Reactions (≥5% and twice placebo) in 6-Week U.S. Clinical Trials of Mirtazapine Tablets in Patients with MDD Mirtazapine Tablets (n=453) Placebo (n=361) Somnolence 54% 18% Increased Appetite 17% 2% Weight Gain 12% 2% Dizziness 7% 3% Table 4 enumerates adverse reactions that occurred in ≥1% of mirtazapine-treated patients, and were more frequent than the placebo-treated patients, who participated in 6-week, U.S. placebo-controlled trials in which patients were dosed in a range of 5 to 60 mg/day. This table shows the percentage of patients in each group who had at least 1 episode of an adverse reaction at some time during their treatment. Table 4: Adverse Reactions (≥1% and greater than placebo) in 6-Week U.S. Clinical Studies of Mirtazapine Tablets in Patients with MDD Mirtazapine Tablets (n=453) Placebo (n=361) Body as a Whole Asthenia 8% 5% Flu Syndrome 5% 3% Back Pain 2% 1% Digestive System Dry Mouth 25% 15% Increased Appetite 17% 2% Constipation 13% 7% Metabolic and Nutritional Disorders Weight Gain 12% 2% Peripheral Edema 2% 1% Edema 1% 0% Musculoskeletal System Myalgia 2% 1% Nervous System Somnolence 54% 18% Dizziness 7% 3% Abnormal Dreams 4% 1% Thinking Abnormal 3% 1% Tremor 2% 1% Confusion 2% 0% Respiratory System Dyspnea 1% 0% Urogenital System Urinary Frequency 2% 1% ECG Changes The electrocardiograms for 338 patients who received mirtazapine tablets and 261 patients who received placebo in 6-week, placebo-controlled trials were analyzed. Mirtazapine tablets was associated with a mean increase in heart rate of 3.4 bpm, compared to 0.8 bpm for placebo. The clinical significance of these changes is unknown. Other Adverse Reactions Observed During the Premarketing Evaluation of Mirtazapine Tablets The following list does not include reactions: 1) already listed in previous tables or elsewhere in labeling, 2) for which a drug cause was remote, 3) which were so general or excessively specific so as to be uninformative, 4) which were not considered to have significant clinical implications, or 5) which occurred at a rate equal to or less than placebo. Adverse reactions are categorized by body system according to the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare adverse reactions are those occurring in fewer than 1/1000 patients. Body as a Whole: frequent: malaise, abdominal pain, abdominal syndrome acute; infrequent : chills, fever, face edema, ulcer, photosensitivity reaction, neck rigidity, neck pain, abdomen enlarged; rare : cellulitis, chest pain substernal. Cardiovascular System : frequent: hypertension, vasodilatation; infrequent : angina pectoris, myocardial infarction, bradycardia, ventricular extrasystoles, syncope, migraine, hypotension; rare : atrial arrhythmia, bigeminy, vascular headache, pulmonary embolus, cerebral ischemia, cardiomegaly, phlebitis, left heart failure.
Drug interactions
Table 5 includes clinically important drug interactions with mirtazapine tablets [see Clinical Pharmacology ( 12.3 )]. Table 5: Clinically Important Drug Interactions with Mirtazapine Tablets Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of serotonergic drugs, including mirtazapine tablets, and MAOIs increases the risk of serotonin syndrome. Intervention Mirtazapine tablets are contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration ( 2.4 ), Contraindications (4), Warnings and Precautions ( 5.3 )]. Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact The concomitant use of serotonergic drugs with mirtazapine tablets increases the risk of serotonin syndrome. Intervention Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of mirtazapine tablets and/or concomitant serotonergic drugs [see Warnings and Precautions ( 5.3 )]. Examples SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, amphetamines, St. John’s Wort, tramadol, tryptophan, buspirone Strong CYP3A Inducers Clinical Impact The concomitant use of strong CYP3A inducers with mirtazapine tablets decreases the plasma concentration of mirtazapine [see Clinical Pharmacology ( 12.3 )] . Intervention Increase the dose of mirtazapine tablets if needed with concomitant CYP3A inducer use. Conversely, a decrease in dosage of mirtazapine tablets may be needed if the CYP3A inducer is discontinued [see Dosage and Administration ( 2.5 )]. Examples phenytoin, carbamazepine, rifampin Strong CYP3A Inhibitors Clinical Impact The concomitant use of strong CYP3A inhibitors with mirtazapine tablets may increase the plasma concentration of mirtazapine [see Clinical Pharmacology ( 12.3 )] . Intervention Decrease the dose of mirtazapine tablets if needed with concomitant strong CYP3A inhibitor use. Conversely, an increase in dosage of mirtazapine tablets may be needed if the CYP3A inhibitor is discontinued [see Dosage and Administration ( 2.5 )]. Examples itraconazole, ritonavir, nefazodone Cimetidine Clinical Impact The concomitant use of cimetidine, a CYP1A2, CYP2D6, and CYP3A inhibitor, with mirtazapine tablets may increase the plasma concentration of mirtazapine [see Clinical Pharmacology ( 12.3 )]. Intervention Decrease the dose of mirtazapine tablets if needed with concomitant cimetidine use. Conversely, an increase in dosage of mirtazapine tablets may be needed if cimetidine is discontinued [see Dosage and Administration ( 2.5 )] . Benzodiazepines and Alcohol Clinical Impact The concomitant use of benzodiazepines or alcohol with mirtazapine tablets increases the impairment of cognitive and motor skills produced by mirtazapine tablets alone. Intervention Avoid concomitant use of benzodiazepines and alcohol with mirtazapine tablets [see Warnings and Precautions ( 5.8 ), Clinical Pharmacology ( 12.3 )] . Examples diazepam, alprazolam, alcohol Drugs that Prolong QTc Interval Clinical Impact The concomitant use of other drugs which prolong the QTc interval with mirtazapine tablets, increase the risk of QT prolongation and/or ventricular arrhythmias (e.g., Torsades de Pointes). Intervention Use caution when using mirtazapine tablets concomitantly with drugs that prolong the QTc interval [see Warnings and Precautions ( 5.5 ), Clinical Pharmacology ( 12.3 )]. Warfarin Clinical Impact The concomitant use of warfarin with mirtazapine tablets may result in an increase in INR [see Clinical Pharmacology ( 12.3 )] . Intervention Monitor INR during concomitant use of warfarin with mirtazapine tablets.
• Strong CYP3A inducers: Dosage increase may be needed for mirtazapine tablets with concomitant use of strong CYP3A inducers. ( 2.5 , 7 )
• Strong CYP3A inhibitors : Dosage decrease may be needed when mirtazapine tablets are coadministered with strong CYP3A inhibitors. ( 2.5 , 7 )
• Cimetidine : Dosage decrease may be needed when mirtazapine tablets are coadministered with cimetidine. ( 2.5 , 7 )
• Warfarin : Monitor INR during concomitant use. ( 7 )
Use in specific populations
• Geriatric Use : Use with caution in elderly patients. ( 5.12 , 5.15 , 8.5 )
• Renal impairment: Dosage decrease may be needed in patients with moderate to severe renal impairment. ( 8.6 )
• Hepatic impairment: Dosage decrease may be needed in patients with hepatic impairment. ( 8.6 ) 8.1 Pregnancy Risk Summary Prolonged experience with mirtazapine in pregnant women, based on published observational studies and postmarketing reports, has not reliably identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks associated with untreated depression in pregnancy (see Clinical Considerations). In animal reproduction studies, oral administration of mirtazapine to pregnant rats and rabbits during the period of organogenesis revealed no evidence of teratogenic effects up to 20 and 17 times the maximum recommended human dose (MRHD) of 45 mg, respectively, based on mg/m 2 body surface area. However, in rats, there was an increase in postimplantation loss at 20 times the MRHD based on mg/m 2 body surface area. Oral administration of mirtazapine to pregnant rats during pregnancy and lactation resulted in an increase in pup deaths and a decrease in pup birth weights at doses 20 times the MRHD based on mg/m 2 body surface area (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population 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 Embryo/Fetal Risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Data Animal Data Mirtazapine was administered orally to pregnant rats and rabbits during the period of organogenesis at doses of 2.5, 15, and 100 mg/kg/day and 2.5, 10, and 40 mg/kg/day, respectively, which are up to 20 and 17 times the maximum recommended human dose (MRHD) of 45 mg based on mg/m 2 body surface area, respectively. No evidence of teratogenic effects was observed. However, in rats, there was an increase in postimplantation loss in dams treated with mirtazapine at 100 mg/kg/day which is 20 times the MRHD based on mg/m 2 body surface area. Oral administration of mirtazapine at doses of 2.5, 15, and 100 mg/kg/day to pregnant rats during pregnancy and lactation resulted in an increase in pup deaths during the first 3 days of lactation and a decrease in pup birth weights at 20 times the MRHD based on mg/m 2 body surface area. The cause of these deaths is not known. The no effect dose level is 3 times the MRHD based on mg/m 2 body surface area. 8.2 Lactation Risk Summary Data from published literature report the presence of mirtazapine in human milk at low levels with relative infant doses for mirtazapine ranging between 0.6 and 2.8% of the maternal weight-adjusted dose (see Data) . No adverse effects on the breastfed infant have been reported in most cases of maternal use of mirtazapine. There are no data on the effects of mirtazapine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mirtazapine and any potential adverse effects on the breastfed infant from mirtazapine or from the underlying maternal condition. Data In a published pooled analysis of 8 breastfeeding mother-infant pairs, the mean (min, max) total relative infant doses for mirtazapine and its desmethyl metabolite were 1.5% (0.6%, 2.8%) and 0.4% (0.1%, 0.7%) of the maternal weight-adjusted dose (median (min, max) dose of 38 mg (30 mg, 120 mg), respectively). No adverse drug effects were reported for any of the infants. 8.4 Pediatric Use The safety and effectiveness of mirtazapine tablets have not been established in pediatric patients with MDD. Two placebo-controlled trials in 258 pediatric patients with MDD have been conducted with mirtazapine tablets, and the data were insufficient to establish the safety and effectiveness of mirtazapine tablets in pediatric patients with MDD. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning and Warnings and Precautions ( 5.1 )] . In an 8-week-long clinical trial in pediatric patients receiving doses between 15 to 45 mg per day, 49% of mirtazapine-treated patients had a weight gain of at least 7%, compared to 5.7% of placebo-treated patients. The mean increase in weight was 4 kg (2 kg SD) for mirtazapine-treated patients versus 1 kg (2 kg SD) for placebo-treated patients [see Warnings and Precautions ( 5.7 )] . 8.5 Geriatric Use Approximately 190 patients ≥65 years of age participated in clinical studies with mirtazapine tablets. Mirtazapine tablets are known to be substantially excreted by the kidney (75%), and the risk of decreased clearance of this drug is greater in patients with impaired renal function. Pharmacokinetic studies revealed a decreased clearance of mirtazapine in the elderly [see Clinical Pharmacology ( 12.3 )] . Sedating drugs, including mirtazapine tablets, may cause confusion and over-sedation in the elderly. Elderly patients may be at greater risk of developing hyponatremia. Caution is indicated when administering mirtazapine tablets to elderly patients [see Warnings and Precautions ( 5.12 ), ( 5.15 ) and Clinical Pharmacology ( 12.3 )] .
Pregnancy
8.1 Pregnancy Risk Summary Prolonged experience with mirtazapine in pregnant women, based on published observational studies and postmarketing reports, has not reliably identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks associated with untreated depression in pregnancy (see Clinical Considerations). In animal reproduction studies, oral administration of mirtazapine to pregnant rats and rabbits during the period of organogenesis revealed no evidence of teratogenic effects up to 20 and 17 times the maximum recommended human dose (MRHD) of 45 mg, respectively, based on mg/m 2 body surface area. However, in rats, there was an increase in postimplantation loss at 20 times the MRHD based on mg/m 2 body surface area. Oral administration of mirtazapine to pregnant rats during pregnancy and lactation resulted in an increase in pup deaths and a decrease in pup birth weights at doses 20 times the MRHD based on mg/m 2 body surface area (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population 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 Embryo/Fetal Risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Data Animal Data Mirtazapine was administered orally to pregnant rats and rabbits during the period of organogenesis at doses of 2.5, 15, and 100 mg/kg/day and 2.5, 10, and 40 mg/kg/day, respectively, which are up to 20 and 17 times the maximum recommended human dose (MRHD) of 45 mg based on mg/m 2 body surface area, respectively. No evidence of teratogenic effects was observed. However, in rats, there was an increase in postimplantation loss in dams treated with mirtazapine at 100 mg/kg/day which is 20 times the MRHD based on mg/m 2 body surface area. Oral administration of mirtazapine at doses of 2.5, 15, and 100 mg/kg/day to pregnant rats during pregnancy and lactation resulted in an increase in pup deaths during the first 3 days of lactation and a decrease in pup birth weights at 20 times the MRHD based on mg/m 2 body surface area. The cause of these deaths is not known. The no effect dose level is 3 times the MRHD based on mg/m 2 body surface area.
Pediatric use
8.4 Pediatric Use The safety and effectiveness of mirtazapine tablets have not been established in pediatric patients with MDD. Two placebo-controlled trials in 258 pediatric patients with MDD have been conducted with mirtazapine tablets, and the data were insufficient to establish the safety and effectiveness of mirtazapine tablets in pediatric patients with MDD. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning and Warnings and Precautions ( 5.1 )] . In an 8-week-long clinical trial in pediatric patients receiving doses between 15 to 45 mg per day, 49% of mirtazapine-treated patients had a weight gain of at least 7%, compared to 5.7% of placebo-treated patients. The mean increase in weight was 4 kg (2 kg SD) for mirtazapine-treated patients versus 1 kg (2 kg SD) for placebo-treated patients [see Warnings and Precautions ( 5.7 )] .
Geriatric use
8.5 Geriatric Use Approximately 190 patients ≥65 years of age participated in clinical studies with mirtazapine tablets. Mirtazapine tablets are known to be substantially excreted by the kidney (75%), and the risk of decreased clearance of this drug is greater in patients with impaired renal function. Pharmacokinetic studies revealed a decreased clearance of mirtazapine in the elderly [see Clinical Pharmacology ( 12.3 )] . Sedating drugs, including mirtazapine tablets, may cause confusion and over-sedation in the elderly. Elderly patients may be at greater risk of developing hyponatremia. Caution is indicated when administering mirtazapine tablets to elderly patients [see Warnings and Precautions ( 5.12 ), ( 5.15 ) and Clinical Pharmacology ( 12.3 )] . In general, dose selection for an elderly patient should be conservative, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Overdosage
Human Experience In premarketing clinical studies, there were reports of mirtazapine tablets overdose alone or in combination with other pharmacological agents. Signs and symptoms reported in association with overdose included disorientation, drowsiness, impaired memory, and tachycardia. Based on postmarketing reports, serious outcomes (including fatalities) may occur at dosages higher than the recommended doses, especially with mixed overdoses. In these cases, QT prolongation and Torsades de Pointes have also been reported [see Warnings and Precautions ( 5.5 ), Adverse Reactions ( 6.2 ), and Drug Interactions ( 7 )]. Overdose Management No specific antidotes for mirtazapine are known. Contact Poison Control (1-800-222-1222) for the latest recommendations.
Description
Mirtazapine tablets, USP contain mirtazapine, USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2]-benzazepine and has the molecular formula of C 17 H 19 N 3 . Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture: Mirtazapine is a white or almost white powder which is practically insoluble in water, freely soluble in anhydrous ethanol. Mirtazapine tablets, USP are available for oral administration as functionally scored film-coated tablets containing 15 mg or 30 mg of mirtazapine, USP and unscored film-coated tablets containing 7.5 mg or 45 mg of mirtazapine, USP. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl methyl cellulose, iron oxide red (for 30 mg only), iron oxide yellow (for 15 mg and 30 mg only), lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide. FDA approved dissolution test specifications differ from USP. structure-of-mitrazapine
Mechanism of action
12.1 Mechanism of Action The mechanism of action of mirtazapine for the treatment of major depressive disorder, is unclear. However, its efficacy could be mediated through its activity as an antagonist at central presynaptic α 2 -adrenergic inhibitory autoreceptors and heteroreceptors and enhancing central noradrenergic and serotonergic activity.
How supplied
Mirtazapine tablets, USP are supplied as: 7.5 mg Tablets – White, round biconvex tablets debossed with ‘E14’ on one side, plain on the other side. Bottles of 30 NDC 72865-368-30 Bottles of 500 NDC 72865-368-05 15 mg Tablets – Yellow colored, oval shape biconvex tablets debossed with 'E' and '15' separated with functionally scored line on one side, plain on the other side. Bottles of 30 NDC 72865-369-30 Bottles of 500 NDC 72865-369-05 Bottles of 1000 NDC 72865-369-10 30 mg Tablets – Red-brown colored, oval shape biconvex tablets debossed with ‘E’ and ‘16’ separated with functionally scored line on one side, plain on the other side. Bottles of 30 NDC 72865-370-30 Bottles of 500 NDC 72865-370-05 45 mg Tablets – White, oval shape biconvex tablets debossed with 'El7' on one side, plain on the other side. Bottles of 30 NDC 72865-371-30 Bottles of 500 NDC 72865-371-05 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture.
Patient information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning and Warnings and Precautions ( 5.1 )]. Agranulocytosis Advise patients to contact their physician if they experience fever, chills, sore throat, mucous membrane ulceration, flu-like complaints, or other symptoms that might suggest infection [see Warnings and Precautions ( 5.2 )]. Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of mirtazapine tablets with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Dosage and Administration ( 2.4 ), Contraindications ( 4 ), Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )]. QT Prolongation and Torsades de Pointes Inform patients to consult their physician immediately if they feel faint, lose consciousness, or have heart palpitations [see Warnings and Precautions ( 5.5 ), Drug Interactions ( 7 ), Overdosage ( 10 )]. Advise patients to inform physicians that they are taking mirtazapine tablets before any new drug is taken. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Advise patients to report to their healthcare provider at the earliest onset of fever, rash, swollen lymph nodes, or other signs and symptoms suggestive of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Contraindications ( 4 ), Warnings and Precautions ( 5.6 )]. Somnolence Advise patients that mirtazapine tablets may impair judgment, thinking, and particularly, motor skills, because of its prominent sedative effect. Caution patients about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that mirtazapine tablets therapy does not adversely affect their ability to engage in such activities. [see Warnings and Precautions ( 5.8 )]. Alcohol Advise patients to avoid alcohol while taking mirtazapine tablets [see Warnings and Precautions ( 5.8 ), Drug Interactions ( 7 )]. Activation of Mania/Hypomania Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions ( 5.9 )] . Discontinuation Syndrome Advise patients not to abruptly discontinue mirtazapine tablets and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when mirtazapine tablets are discontinued [see Dosage and Administration ( 2.6 ), Warnings and Precautions ( 5.14 )]. Allergic Reactions Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [see Contraindications ( 4 ), Adverse Reactions ( 6.2 )] . Pregnancy
• Advise patients to notify their physician if they become pregnant or intend to become pregnant during mirtazapine tablets therapy. Lactation Advise patients to notify their physician if they are breastfeeding an infant [see Use in Specific Populations ( 8.2 )]. Angle-Closure Glaucoma Patients should be advised that taking mirtazapine tablets can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle-closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions ( 5.4 ).] Manufactured for: XLCare Pharmaceuticals, Inc. 242 South Culver Street, Suite 202, Lawrenceville, GA 30046. Manufactured by: Evaric Pharmaceuticals Inc. 155 Commerce Drive, Hauppauge, New York 11788, United States (USA) Revised: 07/26
Label text from the FDA structured product label by XLCare Pharmaceuticals Inc. (revised Jul 24, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Mirtazapine in 139 products
Mirtazapine NDC products (139)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-8019 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-2800 | Mirtazapine 15 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-2558 | Mirtazapine 30 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-2140 | Mirtazapine 15 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-1058 | Mirtazapine 30 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 80425-0305 | Mirtazapine 15 mg/1 Tablet, Film Coated | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 68084-119 | Mirtazapine 15 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 68084-120 | Mirtazapine 30 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 68084-121 | Mirtazapine 45 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 60687-584 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 70954-830 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | ANI Pharmaceuticals, Inc. | ANDA |
| 43353-378 | Mirtazapine 30 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-100 | Mirtazapine 30 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-846 | Mirtazapine 30 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-717 | Mirtazapine 15 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-713 | Mirtazapine 30 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-523 | Mirtazapine 30 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-475 | Mirtazapine 15 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-115 | Mirtazapine 15 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-853 | Mirtazapine 15 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 60505-0247 | Mirtazapine 15 mg/1 Tablet, Film Coated | Apotex Corp. | ANDA |
| 60505-0249 | Mirtazapine 45 mg/1 Tablet, Film Coated | Apotex Corp. | ANDA |
| 60505-0248 | Mirtazapine 30 mg/1 Tablet, Film Coated | Apotex Corp. | ANDA |
| 17856-0101 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | ATLANTIC BIOLOGICALS CORP. | ANDA |
| 65862-032 | Mirtazapine 45 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-031 | Mirtazapine 15 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-023 | Mirtazapine 45 mg/1 Tablet, Orally Disintegrating | Aurobindo Pharma Limited | ANDA |
| 65862-022 | Mirtazapine 30 mg/1 Tablet, Orally Disintegrating | Aurobindo Pharma Limited | ANDA |
| 65862-021 | Mirtazapine 15 mg/1 Tablet, Orally Disintegrating | Aurobindo Pharma Limited | ANDA |
| 65862-003 | Mirtazapine 30 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-001 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 13107-003 | Mirtazapine 30 mg/1 Tablet, Film Coated | Aurolife Pharma LLC | ANDA |
| 13107-001 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | Aurolife Pharma LLC | ANDA |
| 13107-031 | Mirtazapine 15 mg/1 Tablet, Film Coated | Aurolife Pharma LLC | ANDA |
| 13107-032 | Mirtazapine 45 mg/1 Tablet, Film Coated | Aurolife Pharma LLC | ANDA |
| 42291-494 | Mirtazapine 7.5 mg/1 Tablet | AvKARE | ANDA |
| 42291-952 | Mirtazapine 30 mg/1 Tablet, Film Coated | AvKARE | ANDA |
| 71335-1055 | Mirtazapine 15 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-2368 | Mirtazapine 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-2367 | Mirtazapine 15 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-2366 | Mirtazapine 15 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0286 | Mirtazapine 15 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0441 | Mirtazapine 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0664 | Mirtazapine 15 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-0964 | Mirtazapine 30 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-3346 | Mirtazapine 45 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-9255 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1332 | Mirtazapine 45 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2412 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2471 | Mirtazapine 30 mg/1 Tablet, Orally Disintegrating | Bryant Ranch Prepack | ANDA |
| 71335-2963 | Mirtazapine 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2978 | Mirtazapine 30 mg/1 Tablet, Orally Disintegrating | Bryant Ranch Prepack | ANDA |
| 71335-3038 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 72162-1639 | Mirtazapine 15 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-1640 | Mirtazapine 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-2562 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 31722-409 | Mirtazapine 30 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-408 | Mirtazapine 15 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-407 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-410 | Mirtazapine 45 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 55154-8335 | Mirtazapine 15 mg/1 Tablet, Orally Disintegrating | Cardinal Health 107, LLC | ANDA |
| 55154-0280 | Mirtazapine 15 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-5355 | Mirtazapine 15 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-7297 | Mirtazapine 15 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 67046-2024 | Mirtazapine 45 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-1590 | Mirtazapine 15 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-0625 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-0484 | Mirtazapine 30 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-0319 | Mirtazapine 15 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-0068 | Mirtazapine 30 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 61919-153 | Mirtazapine 15 mg/1 Tablet, Film Coated | Direct_Rx | ANDA |
| 72189-626 | Mirtazapine 30 mg/1 Tablet, Film Coated | Direct_Rx | ANDA |
| 51407-350 | Mirtazapine 15 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 51407-351 | Mirtazapine 30 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 51407-352 | Mirtazapine 45 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 0904-6519 | Mirtazapine 15 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 63739-099 | Mirtazapine 30 mg/1 Tablet, Film Coated | McKesson Corporation dba SKY Packaging | ANDA |
| 63739-098 | Mirtazapine 15 mg/1 Tablet, Film Coated | McKesson Corporation dba SKY Packaging | ANDA |
| 51079-086 | Mirtazapine 15 mg/1 Tablet, Film Coated | Mylan Institutional Inc. | ANDA |
| 51079-087 | Mirtazapine 30 mg/1 Tablet, Film Coated | Mylan Institutional Inc. | ANDA |
| 51079-088 | Mirtazapine 45 mg/1 Tablet, Film Coated | Mylan Institutional Inc. | ANDA |
| 0378-3530 | Mirtazapine 30 mg/1 Tablet, Film Coated | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-3545 | Mirtazapine 45 mg/1 Tablet, Film Coated | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-3515 | Mirtazapine 15 mg/1 Tablet, Film Coated | Mylan Pharmaceuticals Inc. | ANDA |
| 0615-8268 | Mirtazapine 15 mg/1 Tablet, Film Coated | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA |
| 0615-8269 | Mirtazapine 30 mg/1 Tablet, Film Coated | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA |
| 0615-8489 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8663 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 72603-558 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | NorthStar Rx LLC | ANDA |
| 68071-2635 | Mirtazapine 30 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2784 | Mirtazapine 15 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4989 | Mirtazapine 30 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 66993-609 | Mirtazapine 45 mg/1 Tablet, Film Coated | Prasco Laboratories | ANDA |
| 66993-608 | Mirtazapine 30 mg/1 Tablet, Film Coated | Prasco Laboratories | ANDA |
| 66993-607 | Mirtazapine 15 mg/1 Tablet, Film Coated | Prasco Laboratories | ANDA |
| 66993-606 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | Prasco Laboratories | ANDA |
| 68788-8459 | Mirtazapine 45 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7324 | Mirtazapine 30 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7251 | Mirtazapine 15 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 71205-481 | Mirtazapine 15 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-554 | Mirtazapine 30 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-471 | Mirtazapine 45 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-403 | Mirtazapine 30 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-206 | Mirtazapine 15 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 67296-2302 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | Redpharm Drug | ANDA |
| 70518-4548 | Mirtazapine 30 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-1838 | Mirtazapine 15 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-1397 | Mirtazapine 15 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4322 | Mirtazapine 15 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-1309 | Mirtazapine 30 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-2453 | Mirtazapine 15 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-0180 | Mirtazapine 15 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-2581 | Mirtazapine 45 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-2819 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 57237-012 | Mirtazapine 30 mg/1 Tablet, Orally Disintegrating | Rising Pharma Holdings, Inc. | ANDA |
| 57237-007 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | Rising Pharma Holdings, Inc. | ANDA |
| 57237-008 | Mirtazapine 15 mg/1 Tablet, Film Coated | Rising Pharma Holdings, Inc. | ANDA |
| 57237-009 | Mirtazapine 30 mg/1 Tablet, Film Coated | Rising Pharma Holdings, Inc. | ANDA |
| 57237-010 | Mirtazapine 45 mg/1 Tablet, Film Coated | Rising Pharma Holdings, Inc. | ANDA |
| 57237-011 | Mirtazapine 15 mg/1 Tablet, Orally Disintegrating | Rising Pharma Holdings, Inc. | ANDA |
| 57237-013 | Mirtazapine 45 mg/1 Tablet, Orally Disintegrating | Rising Pharma Holdings, Inc. | ANDA |
| 48433-078 | Mirtazapine 45 mg/1 Tablet, Film Coated | Safecor Health LLC | ANDA |
| 48433-077 | Mirtazapine 30 mg/1 Tablet, Film Coated | Safecor Health LLC | ANDA |
| 48433-076 | Mirtazapine 15 mg/1 Tablet, Film Coated | Safecor Health LLC | ANDA |
| 76483-110 | Mirtazapine 15 mg/1 Tablet, Orally Disintegrating | SQUARE PHARMACEUTICALS LIMITED | ANDA |
| 76483-111 | Mirtazapine 30 mg/1 Tablet, Orally Disintegrating | SQUARE PHARMACEUTICALS LIMITED | ANDA |
| 76483-112 | Mirtazapine 45 mg/1 Tablet, Orally Disintegrating | SQUARE PHARMACEUTICALS LIMITED | ANDA |
| 57664-499 | Mirtazapine 15 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | ANDA |
| 57664-500 | Mirtazapine 30 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | ANDA |
| 57664-501 | Mirtazapine 45 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | ANDA |
| 57664-510 | Mirtazapine 7.5 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | ANDA |
| 87441-058 | Mirtazapine 15 mg/1 Tablet, Film Coated | Unit Dose Solutions, Inc. | ANDA |
| 72578-105 | Mirtazapine 45 mg/1 Tablet, Orally Disintegrating | Viona Pharmaceuticals Inc. | ANDA |
| 72578-104 | Mirtazapine 30 mg/1 Tablet, Orally Disintegrating | Viona Pharmaceuticals Inc. | ANDA |
| 72578-103 | Mirtazapine 15 mg/1 Tablet, Orally Disintegrating | Viona Pharmaceuticals Inc. | ANDA |
| 72865-368 | Mirtazapine 7.5 mg/1 Tablet, Film Coated | XLCare Pharmaceuticals Inc. | ANDA |
| 72865-369 | Mirtazapine 15 mg/1 Tablet, Film Coated | XLCare Pharmaceuticals Inc. | ANDA |
| 72865-370 | Mirtazapine 30 mg/1 Tablet, Film Coated | XLCare Pharmaceuticals Inc. | ANDA |
| 72865-371 | Mirtazapine 45 mg/1 Tablet, Film Coated | XLCare Pharmaceuticals Inc. | ANDA |
Mirtazapine recalls
- D-1235-2020 Apr 22, 2020 · Class II · Terminated
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed - D-0636-2020 Dec 18, 2019 · Class I · Terminated
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets. - D-0637-2020 Dec 18, 2019 · Class I · Terminated
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets. - D-0492-2017 Mar 15, 2017 · Class II · Terminated
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle - D-0493-2017 Mar 15, 2017 · Class II · Terminated
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Frequently asked questions
What is Mirtazapine used for?
Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )] . Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults. ( 1 )
What are the side effects of Mirtazapine?
The following adverse reactions are described in more detail in other sections of the prescribing information: • Hypersensitivity [see Contraindications (4) ] • Suicidal Thoughts and Behaviors [see Warnings and Precautions (5.1)] • Agranulocytosis [see Warnings and Precautions (5.2)] • Serotonin Syndrome [see Contraindications (4) , Warnings and Precautions (5.3), Drug Interactions (7)] •… See the full label for the complete list.
Who makes Mirtazapine?
Mirtazapine is listed by 36 labelers in the FDA NDC directory, including A-S Medication Solutions, Advanced Rx Pharmacy of Tennessee, LLC, American Health Packaging, ANI Pharmaceuticals, Inc..
Has Mirtazapine been recalled?
The FDA enforcement database lists 5 recalls for Mirtazapine, most recently D-1235-2020 (class ii): CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed