HMG-CoA Reductase Inhibitor · Brand: Lipitor
Atorvastatin Side Effects: Common, Serious & FDA Warnings
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FDA-Approved For
Quick answer
Based on 246,000+ FDA adverse event reports, the most-reported atorvastatin reactions include fatigue, nausea, and diarrhoea. The FDA-approved label notes statins, including atorvastatin, can raise HbA1c and fasting glucose levels: diabetes was reported as an adverse reaction in 6.1% of subjects in the atorvastatin group versus 3.8% in placebo. FDA reports 7 active Class II recalls of atorvastatin, primarily for failed dissolution specifications. The FDA-approved label does not carry a boxed warning.
For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.
Common Side Effects of Atorvastatin
The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for atorvastatin. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.
| Reaction | Reports | % of total |
|---|---|---|
| Fatigue | 14,182 | 5.7% |
| Nausea | 12,754 | 5.2% |
| Diarrhoea | 11,342 | 4.6% |
| Dyspnoea | 11,359 | 4.6% |
| Type 2 Diabetes Mellitus Reported in 6.1% of the atorvastatin group vs 3.8% placebo in the label's controlled trial. This drug is ALSO FDA-approved for cardiovascular risk reduction in patients with type 2 diabetes (see FDA-Approved Indications). | 11,272 | 4.6% |
| Pain | 10,280 | 4.2% |
| Dizziness | 10,016 | 4.1% |
| Headache | 9,952 | 4.0% |
| Myalgia | 9,961 | 4.0% |
| Asthenia | 9,052 | 3.7% |
Serious Outcomes and FDA Warnings
FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.
| Outcome flag | Reports | % of total |
|---|---|---|
| Serious reports (any flag) | — | — |
| Hospitalization | — | — |
| Death reported as outcome FAERS outcome flag, not a reaction term. The patient was on the drug when the report was filed; causation is not established. | 7,669 | 3.1% |
From the FDA-approved label, Section 5.1: Myopathy and Rhabdomyolysis
Atorvastatin calcium 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 in patients treated with statins, including atorvastatin. 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 atorvastatin dosage [see Drug Interactions (7.1) and Use in Specific Populations (8.5, 8.6 ) ].Show full Section 5.1
Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis Atorvastatin exposure may be increased by drug interactions due to inhibition of cytochrome P450 enzyme 3A4 (CYP3A4) and/or transporters (e.g., breast cancer resistant protein [BCRP], organic anion-transporting polypeptide [OATP1B1/OATP1B3] and P-glycoprotein [P-gp]), resulting in an increased risk of myopathy and rhabdomyolysis. Concomitant use of cyclosporine, gemfibrozil, tipranavir plus ritonavir, or glecaprevir plus pibrentasvir with atorvastatin is not recommended. Atorvastatin dosage modifications are recommended for patients taking certain anti-viral, azole antifungals, or macrolide antibiotic medications [see Dosage and Administration (2.5)] . Cases of myopathy/rhabdomyolysis have been reported with atorvastatin coadministered with lipid modifying doses (>1 gram/day) of niacin, fibrates, colchicine, and ledipasvir plus sofosbuvir. Consider if the benefit of use of these products outweighs the increased risk of myopathy and rhabdomyolysis [see Drug Interactions (7.1) ]. Concomitant intake of large quantities, more than 1.2 liters daily, of grapefruit juice is not recommended in patients taking atorvastatin [see Drug Interactions (7.1) ]. Discontinue atorvastatin if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Muscle symptoms and CK elevations may resolve if atorvastatin is discontinued. Temporarily discontinue atorvastatin 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 atorvastatin dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
From the FDA-approved label, Section 5.4: Increases in HbA1c and Fasting Serum Glucose Levels
Increases in HbA1c and fasting serum glucose levels have been reported with statins, including atorvastatin. Optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices.
In the controlled trial reported in the label's Adverse Reactions section, diabetes was reported as an adverse reaction in 6.1% of subjects in the atorvastatin group and 3.8% in the placebo group. This is a stronger signal than the FAERS aggregate because it is derived from a randomized controlled trial, not voluntary reports.
Atorvastatin Recalls
FDA enforcement actions matched to atorvastatin via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2025-10-22 | Failed Dissolution Specifications Ascend Laboratories, LLC | Class II | — | Ongoing |
| 2025-10-22 | Failed Dissolution Specifications Ascend Laboratories, LLC | Class II | 141,984 bottles | Ongoing |
| 2025-10-22 | Failed Dissolution Specifications Ascend Laboratories, LLC | Class II | — | Ongoing |
| 2025-10-22 | Failed Dissolution Specifications Ascend Laboratories, LLC | Class II | — | Ongoing |
| 2025-04-09 | Failed dissolution specifications: lower than specifications BIOCON PHARMA INC | Class II | 2184 bottles | Ongoing |
| 2024-10-09 | Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg. Nivagen Pharmaceuticals Inc | Class II | 2328 bottles | Ongoing |
| 2023-05-03 | CGMP Deviations Northwind Pharmaceuticals LLC | Class II | 99 bottles | Ongoing |
Show 13 closed recalls (2018 to 2023)
Includes resolved and terminated recalls matched to atorvastatin. Most recent first.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2023-03-08 | CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. | Class II | 241,585 bottles | Terminated |
| 2023-03-08 | CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. | Class II | 72,376 bottles | Terminated |
| 2023-03-08 | CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. | Class II | 147,736 bottles | Terminated |
| 2023-03-08 | CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. | Class II | 256,106 bottles | Terminated |
| 2022-04-06 | Failed Impurities/Degradation Specifications: Out of Specification results for related substance. Dr. Reddy's Laboratories, Inc. | Class III | 28,068 bottles | Terminated |
| 2021-06-23 | Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities Dr. Reddy's Laboratories, Inc. | Class III | 5984 bottles | Terminated |
| 2021-06-02 | Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities Dr. Reddy's Laboratories, Inc. | Class III | 2980 500 count -bottles | Terminated |
| 2021-03-10 | Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities Dr. Reddy's Laboratories, Inc. | Class III | 10,440 90-count and 224,710 500-count bottles | Terminated |
| 2020-03-25 | Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg. Sun Pharmaceutical Industries, Inc. | Class II | 1416 bottles | Terminated |
| 2019-11-06 | Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg. Apotex Inc. | Class III | 1968 bottles | Terminated |
| 2018-08-22 | Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets. Dr. Reddy's Laboratories, Inc. | Class III | 2280 bottles | Terminated |
| 2018-06-27 | Failed Impurities/Degradation Specifications Dr. Reddy's Laboratories, Inc. | Class III | 130,081 bottles | Terminated |
| 2018-06-27 | Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle. Dr. Reddy's Laboratories, Inc. | Class II | 6,397 bottles | Terminated |
Atorvastatin Shortages
FDA-listed shortages of atorvastatin products. Strength and dosage-form level detail.
No active or recent shortages of atorvastatin are listed. We refresh this view daily.
Is Atorvastatin Safe?
Atorvastatin is FDA-approved and the label does not carry a boxed warning. The label's Warnings and Precautions section covers myopathy and rhabdomyolysis (Section 5.1), immune-mediated necrotizing myopathy (Section 5.2), hepatic dysfunction (Section 5.3), increases in hba1c and fasting serum glucose levels (Section 5.4), increased risk of hemorrhagic stroke in patients on atorvastatin (Section 5.5).
As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.
FDA-Approved Indications
Atorvastatin is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.
Atorvastatin calcium tablets are indicated: To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Show full Indications and Usage
Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia Atorvastatin calcium tablets are an HMG-CoA reductase inhibitor (statin) indicated ( 1 ): To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia. As an adjunct to diet for the treatment of adults with: Primary dysbetaliproteinemia. Hypertriglyceridemia.
Frequently Asked Questions
What are the most-reported side effects of atorvastatin?
Fatigue, nausea, and diarrhoea are among the most-reported reactions in FDA FAERS data for atorvastatin. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.
Is atorvastatin the same as Lipitor?
Atorvastatin is the generic name; Lipitor is a brand name for the same active ingredient. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.
Has atorvastatin been recalled?
Yes. Atorvastatin has active and closed recalls on record in the FDA enforcement database. Reasons are dominated by contamination or foreign material, failed dissolution specifications, and CGMP deviations. See the recalls table on this page for current counts, firm names, dates, and lot quantities.
What are atorvastatin's current ongoing recalls about?
Active atorvastatin recalls are listed in the recalls table above with their class, reason, firm, and affected lots. The dominant reasons across these recalls are failed dissolution specifications, contamination or foreign material, and CGMP deviations. For lot numbers, distribution patterns, and the FDA enforcement record for any individual recall, follow the verify-on-FDA link from each row.
What do FDA recall classes mean?
Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.
Is type 2 diabetes a reported side effect of atorvastatin?
Yes. The FDA-approved label's Section 5.4 notes that this drug class, including atorvastatin, can increase HbA1c and fasting serum glucose levels. In the controlled trial reported in the label's Adverse Reactions section, diabetes was reported as an adverse reaction in 6.1% of subjects in the atorvastatin group and 3.8% in the placebo group. Atorvastatin is also FDA-approved for cardiovascular risk reduction in patients with type 2 diabetes, which is why "Diabetes" appears in this drug's approved-indications list above. Consult a clinician about your individual risk.
Data Sources & Methodology
How each section of this page is sourced, and how often the data is refreshed.
| Source | Endpoint | Refresh |
|---|---|---|
| FAERS reactions | openFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports. | Daily |
| Recalls | openFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here. | 6 hours |
| Shortages | FDA Drug Shortages list. | Daily |
| Boxed warnings & label sections | openFDA /drug/label.json. Labels are stable; monthly cadence is sufficient. | Monthly |
| Condition categories | Synonym-mapped from drug_labels.indications. Methodology at /methodology/. | Per-drug |
What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.