Drug Safety Information for FLEXERIL (Cyclobenzaprine hydrochloride)

Adverse Drug Reactions for FLEXERIL* (Cyclobenzaprine hydrochloride)

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 FLEXERIL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain2256
2Nausea1821
3Fatigue*1479
4Drug ineffective*1453
5Dyspnoea1425
6Headache1414
7Depression*1336
8Anxiety*1283
9Back pain1189
10Dizziness*1159
11Arthralgia1088
12Vomiting1086
13Fall1080
14Completed suicide1075
15Pain in extremity1071
16Chest pain976
17Diarrhoea976
18Insomnia907
19Asthenia881
20Toxicity to various agents866

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

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

Reason # of FDA Reports
1Product used for unknown indication17217
2Muscle spasms*8851
3Muscle relaxant therapy4280
4Pain*3534
5Back pain*2622
6Fibromyalgia*1524
7Myalgia810
8Neck pain*542
9Rheumatoid arthritis435
10Suicide attempt431

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


Types of Adverse Events for FLEXERIL

Total Reports Filed with FDA: 149266


Number of FDA Adverse Event Reports by Patient Age for FLEXERIL

Total Reports Filed with FDA: 149266*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Cyclobenzaprine hydrochloride (Cyclobenzaprine, Flexiban, Fexmid, Ciclobenzaprina, Amrix, Flexeril)

Charts are based on 149266 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 FLEXERIL 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.