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|
|1||Type 2 diabetes mellitus||7757|
|10||Pain in extremity*||5145|
* 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|
|1||Blood cholesterol increased*||82269|
|2||Product used for unknown indication||52357|
|6||Blood cholesterol abnormal||7317|
|9||Low density lipoprotein increased||5047|
|10||Coronary artery disease*||1960|
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for LIPITOR
Total Reports Filed with FDA: 599735
Number of FDA Adverse Event Reports by Patient Age for LIPITOR
Total Reports Filed with FDA: 599735*
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.