Drug Safety Information for LESCOL XL (Fluvastatin sodium)

Safety-related Labeling Changes for LESCOL (FLUVASTATIN SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for LESCOL XL (FLUVASTATIN SODIUM) Rx Drug: FDA Link

Adverse Drug Reactions for LESCOL XL* (Fluvastatin sodium)

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 LESCOL XL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Myalgia*313
2Nausea287
3Dyspnoea222
4Asthenia215
5Fatigue215
6Dizziness214
7Diarrhoea208
8Vomiting195
9Pain*178
10Myocardial infarction169
11Arthralgia*168
12Pyrexia162
13Blood creatine phosphokinase increased162
14Chest pain161
15Alanine aminotransferase increased159
16Aspartate aminotransferase increased158
17Drug ineffective154
18Drug interaction154
19Headache149
20Renal failure acute149

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

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

Reason # of FDA Reports
1Hypercholesterolaemia2254
2Product used for unknown indication1298
3Blood cholesterol increased*1277
4Hyperlipidaemia*1106
5Dyslipidaemia535
6Blood cholesterol*349
7Coronary artery disease194
8Blood cholesterol abnormal138
9Ill-defined disorder81
10Renal transplant81

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


Types of Adverse Events for LESCOL XL

Total Reports Filed with FDA: 24945


Number of FDA Adverse Event Reports by Patient Age for LESCOL XL

Total Reports Filed with FDA: 24945*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Fluvastatin sodium (Fluvastatin, Lescol, Lescol xl, Fluvastatin sodium)

Charts are based on 24945 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 LESCOL XL Reviews and Review Summary .

Historical 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.