Drug Safety Information for LIPITOR (Atorvastatin calcium)

Safety-related Labeling Changes for LIPITOR (ATORVASTATIN CALCIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for LIPTRUZET (ATORVASTATIN CALCIUM; EZETIMIBE) Discontinued Drug: FDA Link

Adverse Drug Reactions for LIPITOR* (Atorvastatin calcium)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with LIPITOR
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Type 2 diabetes mellitus7757
4Drug ineffective6759
8Myocardial infarction5538
10Pain in extremity*5145
19Muscle spasms*3709
20Chest pain3686

* This side effect also appears in "Top 10 Side Effects of LIPITOR " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking LIPITOR
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Blood cholesterol increased*82269
2Product used for unknown indication52357
5Blood cholesterol*17686
6Blood cholesterol abnormal7317
8Ill-defined disorder5558
9Low density lipoprotein increased5047
10Coronary artery disease*1960

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for LIPITOR

Total Reports Filed with FDA: 599735

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Male Patients
Female Patients
Unknown Patients

Number of FDA Adverse Event Reports by Patient Age for LIPITOR

Total Reports Filed with FDA: 599735*

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Note: * Reports include 117,470 reports of unknown age.

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Atorvastatin calcium (Caduet 10/20, Atorvastatin, Caduet 5/10, Atorvastatin calcium, Atorvastatina, Caduet 10/80, Lipitor)

Charts are based on 599735 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and LIPITOR Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

Visit   DrugInformer.com more on LIPITOR's side effects.