Rosuvastatin
Tablet, Film Coated · Oral
Uses
Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): in adults with hypercholesterolemia. and slow the progression of atherosclerosis in adults. in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia. Rosuvastatin tablets are an HMG Co-A reductase inhibitor (statin) indicated: ( 1 ) To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): in adults with primary hypercholesterolemia. and slow the progression of atherosclerosis in adults. in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.
Dosage and administration
Take orally with or without food, at any time of day. ( 2.1 ) Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin tablets, and adjust dosage if necessary. ( 2.1 ) Adults: Recommended dosage range is 5 mg to 40 mg once daily. ( 2.2 ) Pediatric Patients with HeFH: Recommended dosage range is 5 mg to 10 mg once daily for patients aged 8 to less than 10 years of age, and 5 mg to 20 mg once daily for patients aged 10 years and older. ( 2.3 ) Pediatric Patients with HoFH: Recommended dosage is 20 mg once daily for patients aged 7 years and older. ( 2.3 ) Asian Patients: Initiate at 5 mg once daily. Consider risks and benefits of treatment if not adequately controlled at dosages up to 20 mg once daily. ( 2.4 ) Patients with Severe Renal Impairment (not on hemodialysis): Initiate at 5 mg once daily; do not exceed 10 mg once daily. ( 2.5 ) See full prescribing information for rosuvastatin tablets dosage and administration modifications due to drug interactions. ( 2.6 ) 2.1 General Dosage and Administration Information Administer rosuvastatin tablets orally as a single dose at any time of day, with or without food. Swallow the tablets whole. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin tablets and adjust the dosage if necessary. If a dose is missed, advise patients not to take an extra dose. Resume treatment with the next dose. When taking rosuvastatin tablets with an aluminum and magnesium hydroxide combination antacid, administer rosuvastatin tablets at least 2 hours before the antacid [see Drug Interactions (7.2) ] . 2.2 Recommended Dosage in Adult Patients The dosage range for rosuvastatin tablets is 5 mg to 40 mg orally once daily. The recommended dosage of rosuvastatin tablets depends on a patient’s indication for usage, LDL-C, and individual risk for CV events. 2.3 Recommended Dosage in Pediatric Patients Dosage in Pediatric Patients 8 Years of Age and Older with HeFH The recommended dosage range is 5 mg to 10 mg orally once daily in patients aged 8 years to less than 10 years and 5 mg to 20 mg orally once daily in patients aged 10 years and older. Dosage in Pediatric Patients 7 Years of Age and Older with HoFH The recommended dosage is 20 mg orally once daily. 2.4 Recommended Dosage in Asian Patients Initiate rosuvastatin tablets at 5 mg orally once daily due to increased rosuvastatin plasma concentrations. Consider the risks and benefits of rosuvastatin tablets when treating Asian patients not adequately controlled at dosages up to 20 mg orally once daily [see Warnings and Precautions (5.1) , Use in Specific Populations (8.8) , and Clinical Pharmacology (12.3) ]. 2.5 Recommended Dosage in Patients with Renal Impairment In patients with severe renal impairment (CL cr less than 30 mL/min/1.73 m 2 ) not on hemodialysis, the recommended starting dosage is 5 mg orally once daily and should not exceed 10 mg orally once daily [see Warnings and Precautions (5.1) and Use in Specific Populations (8.6) ] . There are no dosage adjustment recommendations for patients with mild and moderate renal impairment. 2.6 Dosage Modifications Due to Drug Interactions Table 1 displays dosage modifications for rosuvastatin tablets due to drug interactions [see Warnings and Precautions (5.1) and Drug Interactions (7.1) ]. Table 1: Rosuvastatin tablets Dosage Modifications Due to Drug Interactions Concomitantly Used Drug Rosuvastatin tablets Dosage Modifications Sofosbuvir/velpatasvir/voxilaprevir or Ledipasvir/sofosbuvir Avoid concomitant use. Gemfibrozil Avoid concomitant use. If use is unavoidable, initiate at 5 mg once daily and do not exceed 10 mg once daily. Tafamidis Avoid concomitant use. If use is unavoidable, initiate at 5 mg once daily and do not exceed 20 mg once daily. Belumosudil Do not exceed 5 mg once daily. Cyclosporine Do not exceed 5 mg once daily. Darolutamide Do not exceed 5 mg once daily. Additional Antiviral Medications Simeprevir Dasabuvir/ombitasvir/paritaprevir/ritonavir Elbasvir/Grazoprevir Sofosbuvir/Velpatasvir Glecaprevir/Pibrentasvir Atazanavir/Ritonavir Lopinavir/Ritonavir Initiate at 5 mg once daily. Do not exceed 10 mg once daily. Capmatinib Do not exceed 10 mg once daily. Enasidenib Do not exceed 10 mg once daily. Momelotinib Do not exceed 10 mg once daily. Regorafenib Do not exceed 10 mg once daily. Teriflunomide Do not exceed 10 mg once daily. Ticagrelor Do not exceed 20 mg once daily. In patients at increased risk for rhabdomyolysis [see Warnings and Precautions (5.1) ] , consider dosages less than 20 mg per day. Febuxostat Do not exceed 20 mg once daily. Fostamatinib Do not exceed 20 mg once daily.
Dosage forms and strengths
Rosuvastatin tablets, USP: 5 mg of rosuvastatin: pink colored, oval shaped, biconvex, film coated tablets, debossed with SG on one side and 116 other side. 10 mg of rosuvastatin: pink colored, round, biconvex, film coated tablets, debossed with SG on one side and 117 other side. 20 mg of rosuvastatin: pink colored, round, biconvex, film coated tablets, debossed with SG on one side and 118 other side. 40 mg of rosuvastatin: pink colored, oval shaped, biconvex, film coated tablets debossed with SG on one side and 119 other side. Tablets: 5 mg, 10 mg, 20 mg, and 40 mg of rosuvastatin. ( 3 )
Contraindications
Rosuvastatin tablets are contraindicated in patients with: Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ] . Hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin tablets [see Adverse Reactions (6.1) ] . Acute liver failure or decompensated cirrhosis. ( 4 ) Hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets. ( 4 )
Warnings and precautions
Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher rosuvastatin tablets dosage. Asian patients may be at higher risk for myopathy. Discontinue rosuvastatin tablets if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue rosuvastatin tablets in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing rosuvastatin tablets dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. ( 5.1 ) Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use. Discontinue rosuvastatin tablets if IMNM is suspected. ( 5.2 ) Hepatic Dysfunction: Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue rosuvastatin tablets. ( 5.3 ) 5.1 Myopathy and Rhabdomyolysis Rosuvastatin may cause myopathy [muscle pain, tenderness, or weakness associated with elevated creatine kinase (CK)] and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis with statins, including rosuvastatin. Risk Factors for Myopathy Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs (including other lipid-lowering therapies), and higher rosuvastatin dosage. Asian patients on rosuvastatin may be at higher risk for myopathy [see Drug Interactions (7.1) and Use in Specific Populations (8.8) ] . The myopathy risk is greater in patients taking rosuvastatin 40 mg daily compared with lower rosuvastatin dosages. Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis The concomitant use of rosuvastatin with cyclosporine or gemfibrozil is not recommended. Rosuvastatin dosage modifications are recommended for patients taking certain antiviral medications, darolutamide, and regorafenib [see Dosage and Administration (2.6) ] . Niacin, fibrates, and colchicine may also increase the risk of myopathy and rhabdomyolysis [see Drug Interactions (7.1) ] . Discontinue rosuvastatin if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Muscle symptoms and CK elevations may resolve if rosuvastatin is discontinued. Temporarily discontinue rosuvastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis (e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy). Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the rosuvastatin dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. 5.2 Immune-Mediated Necrotizing Myopathy There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use, including reports of recurrence when the same or a different statin was administered. IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase that persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. Additional neuromuscular and serologic testing may be necessary. Treatment with immunosuppressive agents may be required. Discontinue rosuvastatin if IMNM is suspected. 5.3 Hepatic Dysfunction Increases in serum transaminases have been reported with use of rosuvastatin [see Adverse Reactions (6.1) ] . In most cases, these changes appeared soon after initiation, were transient, were not accompanied by symptoms, and resolved or improved on continued therapy or after a brief interruption in therapy. In a pooled analysis of placebo-controlled trials, increases in serum transaminases to more than three times the ULN occurred in 1.1% of patients taking rosuvastatin versus 0.5% of patients treated with placebo. Marked persistent increases of hepatic transaminases have also occurred with rosuvastatin. There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including rosuvastatin. Patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury [see Use in Specific Populations (8.7) ] . Consider liver enzyme testing before rosuvastatin initiation and when clinically indicated thereafter. Rosuvastatin is contraindicated in patients with acute liver failure or decompensated cirrhosis [see Contraindications (4) ] . If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue rosuvastatin. 5.4 Proteinuria and Hematuria In the rosuvastatin tablets clinical trial program, dipstick-positive proteinuria and microscopic hematuria were observed among rosuvastatin treated patients. These findings were more frequent in patients taking rosuvastatin 40 mg, when compared to lower doses of rosuvastatin or comparator statins, though it was generally transient and was not associated with worsening renal function.
Side effects
The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] Hepatic Dysfunction [see Warnings and Precautions (5.3) ] Proteinuria and Hematuria [see Warnings and Precautions (5.4) ] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.5) ] Most frequent adverse reactions (rate ≥ 2%) are headache, nausea, myalgia, asthenia, and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals, Inc., at 1-855-724-3436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials 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 clinical practice. Adverse reactions reported in ≥2% of patients in placebo-controlled clinical studies and at a rate greater than placebo are shown in Table 2. These studies had a treatment duration of up to 12 weeks. Table 2: Adverse Reactions Reported in ≥2% of Patients Treated with Rosuvastatin and > Placebo in Placebo-Controlled Trials Adverse Reactions Placebo N=382% Rosuvastatin 5 mg N=291% Rosuvastatin 10 mg N=283% Rosuvastatin 20 mg N=64% Rosuvastatin 40 mg N=106% Total Rosuvastatin 5 mg to 40 mg N=744% Headache 5.0 5.5 4.9 3.1 8.5 5.5 Nausea 3.1 3.8 3.5 6.3 0 3.4 Myalgia 1.3 3.1 2.1 6.3 1.9 2.8 Asthenia 2.6 2.4 3.2 4.7 0.9 2.7 Constipation 2.4 2.1 2.1 4.7 2.8 2.4 Other adverse reactions reported in clinical studies were abdominal pain, dizziness, hypersensitivity (including rash, pruritus, urticaria, and angioedema) and pancreatitis. The following laboratory abnormalities have also been reported: dipstick-positive proteinuria and microscopic hematuria; elevated creatine phosphokinase, transaminases, glucose, glutamyl transpeptidase, alkaline phosphatase, and bilirubin; and thyroid function abnormalities. In the METEOR study, patients were treated with rosuvastatin 40 mg (n=700) or placebo (n=281) with a mean treatment duration of 1.7 years. Adverse reactions reported in ≥2% of patients and at a rate greater than placebo are shown in Table 3. Table 3: Adverse Reactions Reported in ≥ 2% of Patients Treated with Rosuvastatin and > Placebo in the METEOR Trial Adverse Reactions Placebo N=281% Rosuvastatin 40 mg N=700% 1 Frequency recorded as abnormal laboratory value. Myalgia 12.1 12.7 Arthralgia 7.1 10.1 Headache 5.3 6.4 Dizziness 2.8 4.0 Increased CPK 0.7 2.6 Abdominal pain 1.8 2.4 ALT greater than 3x ULN 1 0.7 2.2 In the JUPITER study, patients were treated with rosuvastatin 20 mg (n=8901) or placebo (n=8901) for a mean duration of 2 years. In JUPITER, there was a significantly higher frequency of diabetes mellitus reported in patients taking rosuvastatin (2.8%) versus patients taking placebo (2.3%). Mean HbA1c was significantly increased by 0.1% in rosuvastatin-treated patients compared to placebo-treated patients. The number of patients with a HbA1c >6.5% at the end of the trial was significantly higher in rosuvastatin-treated versus placebo-treated patients [see Clinical Studies (14) ]. Adverse reactions reported in ≥ 2% of patients and at a rate greater than placebo are shown in Table 4. Table 4: Adverse Reactions Reported in ≥ 2% of Patients Treated with Rosuvastatin and > Placebo in the JUPITER Trial Adverse Reactions Placebo N=8901% Rosuvastatin 20 mg N=8901% Myalgia 6.6 7.6 Arthralgia 3.2 3.8 Constipation 3.0 3.3 Diabetes mellitus 2.3 2.8 Nausea 2.3 2.4 Pediatric Patients with HeFH In a 12-week controlled study in pediatric patients 10 to 17 years of age with HeFH with rosuvastatin 5 mg to 20 mg daily [see Use in Specific Populations (8.4) and Clinical Studies (14) ] , elevations in serum CK greater than 10 x ULN were observed more frequently in rosuvastatin treated patients compared with patients receiving placebo. Four of 130 (3%) patients treated with Rosuvastatin (2 treated with 10 mg and 2 treated with 20 mg) had increased CK greater than 10 x ULN, compared to 0 of 46 patients on placebo. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of rosuvastatin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood Disorders: thrombocytopenia Hepatobiliary Disorders: hepatitis, jaundice, fatal and non-fatal hepatic failure Musculoskeletal Disorders: arthralgia, rare reports of immune-mediated necrotizing myopathy associated with statin use Nervous System Disorders: peripheral neuropathy, rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, and confusion) associated with the use of all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks). There have been rare reports of new-onset or exacerbation of myasthenia gravis, including ocular myasthenia, and reports of recurrence when the same or a different statin was administered. Psychiatric Disorders: depression, sleep disorders (including insomnia and nightmares) Reproductive System and Breast Disorders: gynecomastia Respiratory Disorders: interstitial lung disease Skin and Subcutaneous Tissue Disorders: drug reaction with eosinophilia and systemic symptoms (DRESS), lichenoid drug eruption
Drug interactions
See full prescribing information for details regarding concomitant use of rosuvastatin tablets with other drugs that increase the risk of myopathy and rhabdomyolysis. ( 7.1 ) Aluminum and Magnesium Hydroxide Combination Antacids: Administer rosuvastatin tablets at least 2 hours before the antacid. ( 7.2 ) Warfarin: Obtain INR prior to starting rosuvastatin tablets. Monitor INR frequently until stable upon initiation, dosage titration or discontinuation. ( 7.3 ) 7.1 Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin Rosuvastatin is a substrate of CYP2C9 and transporters (such as OATP1B1, BCRP). Rosuvastatin plasma levels can be significantly increased with concomitant administration of inhibitors of CYP2C9 and transporters. Table 5 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when used concomitantly with rosuvastatin and instructions for preventing or managing them [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ] . Table 5: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin Tablets Sofosbuvir/velpatasvir/voxilaprevir or Ledipasvir/sofosbuvir Prevention or Management: Avoid concomitant use with rosuvastatin. Mechanism and Clinical Effect(s): Rosuvastatin plasma levels were significantly increased with concomitant administration of many anti-viral drugs, which increases the risk of myopathy and rhabdomyolysis. Gemfibrozil Prevention or Management: Avoid concomitant use of gemfibrozil with rosuvastatin. If use is unavoidable, initiate rosuvastatin at 5 mg once daily and do not exceed a dosage of rosuvastatin 10 mg once daily. Mechanism and Clinical Effect(s): Gemfibrozil significantly increased rosuvastatin exposure and gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Tafamidis Prevention or Management: Avoid concomitant use of tafamidis with rosuvastatin. If use is unavoidable, initiate rosuvastatin at 5 mg once daily and do not exceed a dosage of rosuvastatin 20 mg once daily. Monitor for signs of myopathy and rhabdomyolysis if used concomitantly with rosuvastatin. Mechanism and Clinical Effect(s): Tafamidis significantly increased rosuvastatin exposure and tafamidis may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Belumosudil Prevention or Management: In patients taking belumosudil, do not exceed a dosage of rosuvastatin 5 mg once daily. Mechanism and Clinical Effect(s): Belumosudil increased rosuvastatin exposure more than 4.6-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Cyclosporine Prevention or Management: In patients taking cyclosporine, do not exceed a dosage of rosuvastatin 5 mg once daily. Mechanism and Clinical Effect(s): Cyclosporine increased rosuvastatin exposure 7-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Darolutamide Prevention or Management: In patients taking darolutamide, do not exceed a dosage of rosuvastatin 5 mg once daily. Mechanism and Clinical Effect(s): Darolutamide increased rosuvastatin exposure more than 5-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Additional Anti-Viral Medications Prevention or Management: Simeprevir Dasabuvir/ombitasvir/paritaprevir/ritonavir Elbasvir/grazoprevir Sofosbuvir/velpatasvir Glecaprevir/pibrentasvir Atazanavir/ritonavir Lopinavir/ritonavir Initiate with rosuvastatin 5 mg once daily, and do not exceed a dosage of rosuvastatin 10 mg once daily. Mechanism and Clinical Effect(s): Rosuvastatin plasma levels were significantly increased with concomitant administration of many anti-viral drugs, which increases the risk of myopathy and rhabdomyolysis. Capmatinib Prevention or Management: In patients taking capmatinib, do not exceed a dosage of rosuvastatin 10 mg once daily. Mechanism and Clinical Effect(s): Capmatinib increased rosuvastatin exposure more than 2.1-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Enasidenib Prevention or Management: In patients taking enasidenib, do not exceed a dosage of rosuvastatin 10 mg once daily. Mechanism and Clinical Effect(s): Enasidenib increased rosuvastatin exposure more than 3.4-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Momelotinib Prevention or Management: In patients taking momelotinib, do not exceed a dosage of rosuvastatin 10 mg once daily. Mechanism and Clinical Effect(s): Momelotinib increased rosuvastatin exposure by 2.7-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use.. Regorafenib Prevention or Management: In patients taking regorafenib, do not exceed a dosage of rosuvastatin 10 mg once daily. Mechanism and Clinical Effect(s): Regorafenib increased rosuvastatin exposure and may increase the risk of myopathy and rhabdomyolysis. Teriflunomide Prevention or Management: In patients taking teriflunomide, do not exceed a dosage of rosuvastatin 10 mg once daily. Mechanism and Clinical Effect(s): Teriflunomide increased rosuvastatin exposure more than 2.5-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Ticagrelor Prevention or Management: In patients taking ticagrelor, do not exceed a dosage of rosuvastatin 20 mg once daily. Inpatients at increased risk for rhabdomyolysis [see Warnings and Precautions (5.1) ] , consider dosages less than 20 mg per day. Mechanism and Clinical Effect(s): Ticagrelor increased rosuvastatin exposure by 2.3-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Febuxostat Prevention or Management: In patients taking febuxostat, do not exceed a dosage of rosuvastatin 20 mg once daily. Mechanism and Clinical Effect(s): Febuxostat increased rosuvastatin exposure more than 1.9-fold.
Use in specific populations
Pregnancy: May cause fetal harm. ( 8.1 ) Lactation: Breastfeeding not recommended during treatment with rosuvastatin tablets. ( 8.2 ) 8.1 Pregnancy Risk Summary Discontinue rosuvastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Rosuvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1) ] . In addition, treatment of hypercholesterolemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations. Published data from prospective and retrospective observational cohort studies with rosuvastatin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data ) . In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered rosuvastatin during the period of organogenesis at doses that resulted in systemic exposures equivalent to human exposures at the maximum recommended human dose (MRHD) of 40 mg/day, based on AUC and body surface area (mg/m 2 ), respectively (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. Data Human Data A Medicaid cohort linkage study of 1,152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity scorebased methods. The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births. Animal Data In female rats given 5 mg/kg/day, 15 mg/kg/day and 50 mg/kg/day before mating and continuing through to gestation day 7 resulted in decreased fetal body weight (female pups) and delayed ossification at 50 mg/kg/day (10 times the human exposure at the MRHD of 40 mg/day based on AUC). In pregnant rats given 2 mg/kg/day, 10 mg/kg/day and 50 mg/kg/day of rosuvastatin from gestation day 7 through lactation day 21 (weaning), decreased pup survival occurred at 50 mg/kg/day (dose equivalent to 12 times the MRHD of 40 mg/day based body surface area). In pregnant rabbits given 0.3 mg/kg/day, 1 mg/kg/day, and 3 mg/kg/day of rosuvastatin from gestation day 6 to day 18, decreased fetal viability and maternal mortality was observed at 3 mg/kg/day (dose equivalent to the MRHD of 40 mg/day based on body surface area). Rosuvastatin crosses the placenta in rats and rabbits and is found in fetal tissue and amniotic fluid at 3% and 20%, respectively, of the maternal plasma concentration following a single 25 mg/kg oral gavage dose on gestation day 16 in rats. In rabbits, fetal tissue distribution was 25% of maternal plasma concentration after a single oral gavage dose of 1 mg/kg on gestation day 18. 8.2 Lactation Risk Summary Limited data from case reports in published literature indicate that rosuvastatin is present in human milk. There is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. Statins, including rosuvastatin, decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant. Because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with rosuvastatin [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.1) ] . 8.4 Pediatric Use The safety and effectiveness of rosuvastatin as an adjunct to diet to reduce LDL-C have been established in pediatric patients 8 years of age and older with HeFH. Use of rosuvastatin for this indication is based on one 12-week controlled trial with a 40-week open-label extension period in 176 pediatric patients 10 years of age and older with HeFH and one 2-year open-label, uncontrolled trial in 175 pediatric patients 8 years of age and older with HeFH [see Clinical Studies (14) ] . In the 1-year trial with a 12-week controlled phase, there was no detectable effect of rosuvastatin on growth, weight, BMI (body mass index), or sexual maturation in patients aged 10 to 17 years.
Pregnancy
8.1 Pregnancy Risk Summary Discontinue rosuvastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Rosuvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1) ] . In addition, treatment of hypercholesterolemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations. Published data from prospective and retrospective observational cohort studies with rosuvastatin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data ) . In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered rosuvastatin during the period of organogenesis at doses that resulted in systemic exposures equivalent to human exposures at the maximum recommended human dose (MRHD) of 40 mg/day, based on AUC and body surface area (mg/m 2 ), respectively (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. Data Human Data A Medicaid cohort linkage study of 1,152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity scorebased methods. The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births. Animal Data In female rats given 5 mg/kg/day, 15 mg/kg/day and 50 mg/kg/day before mating and continuing through to gestation day 7 resulted in decreased fetal body weight (female pups) and delayed ossification at 50 mg/kg/day (10 times the human exposure at the MRHD of 40 mg/day based on AUC). In pregnant rats given 2 mg/kg/day, 10 mg/kg/day and 50 mg/kg/day of rosuvastatin from gestation day 7 through lactation day 21 (weaning), decreased pup survival occurred at 50 mg/kg/day (dose equivalent to 12 times the MRHD of 40 mg/day based body surface area). In pregnant rabbits given 0.3 mg/kg/day, 1 mg/kg/day, and 3 mg/kg/day of rosuvastatin from gestation day 6 to day 18, decreased fetal viability and maternal mortality was observed at 3 mg/kg/day (dose equivalent to the MRHD of 40 mg/day based on body surface area). Rosuvastatin crosses the placenta in rats and rabbits and is found in fetal tissue and amniotic fluid at 3% and 20%, respectively, of the maternal plasma concentration following a single 25 mg/kg oral gavage dose on gestation day 16 in rats. In rabbits, fetal tissue distribution was 25% of maternal plasma concentration after a single oral gavage dose of 1 mg/kg on gestation day 18.
Pediatric use
8.4 Pediatric Use The safety and effectiveness of rosuvastatin as an adjunct to diet to reduce LDL-C have been established in pediatric patients 8 years of age and older with HeFH. Use of rosuvastatin for this indication is based on one 12-week controlled trial with a 40-week open-label extension period in 176 pediatric patients 10 years of age and older with HeFH and one 2-year open-label, uncontrolled trial in 175 pediatric patients 8 years of age and older with HeFH [see Clinical Studies (14) ] . In the 1-year trial with a 12-week controlled phase, there was no detectable effect of rosuvastatin on growth, weight, BMI (body mass index), or sexual maturation in patients aged 10 to 17 years. The safety and effectiveness of rosuvastatin as an adjunct to other LDL-C-lowering therapies to reduce LDL-C have been established in pediatric patients 7 years of age and older with HoFH. Use of rosuvastatin for this indication is based on a randomized, placebo-controlled, cross-over study in 14 pediatric patients 7 years of age and older with HoFH [see Clinical Studies (14) ] . The safety and effectiveness of rosuvastatin have not been established in pediatric patients younger than 8 years of age with HeFH, younger than 7 years of age with HoFH, or in pediatric patients with other types of hypercholesterolemia (other than HeFH or HoFH).
Geriatric use
8.5 Geriatric Use Of the 10,275 patients in clinical studies with rosuvastatin, 3,159 (31%) were 65 years and older, and 698 (6.8%) were 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Advanced age (≥65 years) is a risk factor for rosuvastatin-associated myopathy and rhabdomyolysis. Dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. Monitor geriatric patients receiving rosuvastatin for the increased risk of myopathy [see Warnings and Precautions (5.1) ] .
Overdosage
No specific antidotes for rosuvastatin are known. Hemodialysis does not significantly enhance clearance of rosuvastatin. In the event of overdose, consider contacting the Poison Help Line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.
Description
Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium, USP is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2 [methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The empirical formula for rosuvastatin calcium is (C 22 H 27 FN 3 O 6 S) 2 Ca and the molecular weight is 1001.14. Rosuvastatin calcium, USP is a white to almost white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 1.4 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium, USP) and the following inactive ingredients: Each tablet contains: crospovidone, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, red ferric oxide, triacetin and titanium dioxide. structural formula
Mechanism of action
12.1 Mechanism of Action Rosuvastatin is an inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol.
How supplied
Rosuvastatin tablets, USP are supplied as: Strength How Supplied NDC Tablet Description 5 mg bottles of 30 tablets 50228-116-30 Pink colored, oval shaped, biconvex, film coated tablets, debossed with SG on one side and 116 other side bottles of 90 tablets 50228-116-90 bottles of 500 tablets 50228-116-05 bottles of 1,000 tablets 50228-116-10 10 mg bottles of 30 tablets 50228-117-30 Pink colored, round, biconvex, film coated tablets, debossed with SG on one side and 117 other side bottles of 90 tablets 50228-117-90 bottles of 500 tablets 50228-117-05 bottles of 1,000 tablets 50228-117-10 20 mg bottles of 30 tablets 50228-118-30 Pink colored, round, biconvex, film coated tablets, debossed with SG on one side and 118 other side bottles of 90 tablets 50228-118-90 bottles of 500 tablets 50228-118-05 bottles of 1,000 tablets 50228-118-10 40 mg bottles of 30 tablets 50228-119-30 Pink colored, oval shaped, biconvex, film coated tablets debossed with SG on one side and 119 other side bottles of 90 tablets 50228-119-90 bottles of 500 tablets 50228-119-05 bottles of 1,000 tablets 50228-119-10 Storage Store at controlled room temperature, 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
Patient information
Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Myopathy and Rhabdomyolysis Advise patients that rosuvastatin tablets may cause myopathy and rhabdomyolysis. Inform patients that the risk is also increased when taking certain types of medication and they should discuss all medication, both prescription and over-the-counter, with their healthcare provider. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions (5.1) , and Drug Interactions (7.1) ]. Hepatic Dysfunction Inform patients that rosuvastatin tablets may cause liver enzyme elevations and possibly liver failure. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice [see Warnings and Precautions (5.3) ] . Increases in HbA1c and Fasting Serum Glucose Levels Inform patients that increases in HbA1c and fasting serum glucose levels may occur with rosuvastatin tablets. Encourage patients to optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices [see Warnings and Precautions (5.5) ] . Pregnancy Advise pregnant patients and patients who can become pregnant of the potential risk to a fetus. Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if rosuvastatin tablets should be discontinued [see Use in Specific Populations (8.1) ] . Lactation Advise patients that breastfeeding during treatment with rosuvastatin tablets is not recommended [see Use in Specific Populations (8.2) ]. Concomitant Use of Antacids When taking rosuvastatin tablets with an aluminum and magnesium hydroxide combination antacid, administer rosuvastatin tablets at least 2 hours before the antacid [see Drug Interactions (7.2) ] . Missed Doses If a dose is missed, advise patients no to take an extra dose. Just resume the usual schedule [see Dosage and Administration (2.1) ] . CRESTOR is a trademark of the AstraZeneca group of companies. Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 USA Revised: 7/2026
Label text from the FDA structured product label by ScieGen Pharmaceuticals, Inc. (revised Sep 4, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Rosuvastatin in 33 products
- Rosuvastatin Calcium in 32 products
Rosuvastatin NDC products (65)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7793 | Rosuvastatin 20 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7730 | Rosuvastatin 20 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7483 | Rosuvastatin 40 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7482 | Rosuvastatin 40 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7431 | Rosuvastatin 10 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7430 | Rosuvastatin 10 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7241 | Rosuvastatin 5 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7240 | Rosuvastatin 5 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 16729-284 | Rosuvastatin Calcium 5 mg/1 Tablet, Film Coated | Accord Healthcare Inc. | ANDA |
| 16729-285 | Rosuvastatin Calcium 10 mg/1 Tablet, Film Coated | Accord Healthcare Inc. | ANDA |
| 16729-286 | Rosuvastatin Calcium 20 mg/1 Tablet, Film Coated | Accord Healthcare Inc. | ANDA |
| 16729-287 | Rosuvastatin Calcium 40 mg/1 Tablet, Film Coated | Accord Healthcare Inc. | ANDA |
| 11788-131 | Rosuvastatin Calcium 10 mg/1 Tablet, Coated | AiPing Pharmaceutical, Inc. | ANDA |
| 11788-130 | Rosuvastatin Calcium 5 mg/1 Tablet, Coated | AiPing Pharmaceutical, Inc. | ANDA |
| 11788-133 | Rosuvastatin Calcium 40 mg/1 Tablet, Coated | AiPing Pharmaceutical, Inc. | ANDA |
| 11788-132 | Rosuvastatin Calcium 20 mg/1 Tablet, Coated | AiPing Pharmaceutical, Inc. | ANDA |
| 71610-797 | Rosuvastatin 10 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-922 | Rosuvastatin 20 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-798 | Rosuvastatin 40 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-796 | Rosuvastatin 20 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 50268-711 | Rosuvastatin Calcium 40 mg/1 Tablet, Film Coated | AvPAK | ANDA |
| 50268-710 | Rosuvastatin Calcium 20 mg/1 Tablet, Film Coated | AvPAK | ANDA |
| 50268-709 | Rosuvastatin Calcium 10 mg/1 Tablet, Film Coated | AvPAK | ANDA |
| 71335-0606 | Rosuvastatin Calcium 10 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-0749 | Rosuvastatin Calcium 5 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2406 | Rosuvastatin 20 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2440 | Rosuvastatin 5 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2498 | Rosuvastatin 40 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2539 | Rosuvastatin 10 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-9669 | Rosuvastatin Calcium 20 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 31722-882 | Rosuvastatin Calcium 5 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-883 | Rosuvastatin Calcium 10 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-884 | Rosuvastatin Calcium 20 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-885 | Rosuvastatin Calcium 40 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 55154-0158 | Rosuvastatin Calcium 10 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-0159 | Rosuvastatin Calcium 20 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 67046-1627 | Rosuvastatin 10 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 72189-065 | Rosuvastatin Calcium 5 mg/1 Tablet, Film Coated | DIRECT RX | ANDA |
| 51407-849 | Rosuvastatin 10 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 51407-848 | Rosuvastatin 5 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 51407-850 | Rosuvastatin 20 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 51407-851 | Rosuvastatin 40 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 33342-261 | Rosuvastatin Calcium 5 mg/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-262 | Rosuvastatin Calcium 10 mg/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-263 | Rosuvastatin Calcium 20 mg/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-264 | Rosuvastatin Calcium 40 mg/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 68071-3847 | Rosuvastatin 20 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals, Inc. | ANDA |
| 68788-4161 | Rosuvastatin 5 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-4057 | Rosuvastatin 10 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8533 | Rosuvastatin Calcium 20 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8649 | Rosuvastatin Calcium 40 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8698 | Rosuvastatin 20 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 71205-044 | Rosuvastatin Calcium 20 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 82009-191 | Rosuvastatin Calcium 40 mg/1 Tablet, Film Coated | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-190 | Rosuvastatin Calcium 20 mg/1 Tablet, Film Coated | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-189 | Rosuvastatin Calcium 10 mg/1 Tablet, Film Coated | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-188 | Rosuvastatin Calcium 5 mg/1 Tablet, Film Coated | Quallent Pharmaceuticals Health LLC | ANDA |
| 70518-4314 | Rosuvastatin 40 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4098 | Rosuvastatin 5 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4296 | Rosuvastatin 20 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4303 | Rosuvastatin 10 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 50228-116 | Rosuvastatin 5 mg/1 Tablet, Film Coated | ScieGen Pharmaceuticals, Inc. | ANDA |
| 50228-117 | Rosuvastatin 10 mg/1 Tablet, Film Coated | ScieGen Pharmaceuticals, Inc. | ANDA |
| 50228-118 | Rosuvastatin 20 mg/1 Tablet, Film Coated | ScieGen Pharmaceuticals, Inc. | ANDA |
| 50228-119 | Rosuvastatin 40 mg/1 Tablet, Film Coated | ScieGen Pharmaceuticals, Inc. | ANDA |
Rosuvastatin recalls
- D-0292-2026 Jan 14, 2026 · Class II · Ongoing
Out of specification for dissolution. - D-0404-2023 Mar 8, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection. - D-0405-2023 Mar 8, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection. - D-0406-2023 Mar 8, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection. - D-0407-2023 Mar 8, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Frequently asked questions
What is Rosuvastatin used for?
Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): in adults with hypercholesterolemia. and slow the progression…
What are the side effects of Rosuvastatin?
The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] Hepatic Dysfunction [see Warnings and Precautions (5.3) ] Proteinuria and Hematuria [see Warnings and Precautions (5.4) ] Increases in HbA1c and Fasting Serum… See the full label for the complete list.
Who makes Rosuvastatin?
Rosuvastatin is listed by 18 labelers in the FDA NDC directory, including A-S Medication Solutions, Accord Healthcare Inc., AiPing Pharmaceutical, Inc., Aphena Pharma Solutions - Tennessee, LLC.
Has Rosuvastatin been recalled?
The FDA enforcement database lists 5 recalls for Rosuvastatin, most recently D-0292-2026 (class ii): Out of specification for dissolution.