Drug Safety Information for SKELAXIN (Metaxalone)

Safety-related Labeling Changes for SKELAXIN (METAXALONE) Rx Drug: FDA Link

Adverse Drug Reactions for SKELAXIN* (Metaxalone)

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 SKELAXIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain444
2Nausea*383
3Drug ineffective*303
4Headache*294
5Anxiety*288
6Depression*287
7Dyspnoea277
8Fatigue*271
9Dizziness*259
10Back pain256
11Pain in extremity241
12Insomnia*224
13Hypertension223
14Vomiting223
15Chest pain215
16Fall213
17Arthralgia209
18Completed suicide204
19Muscle spasms201
20Asthenia190

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

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

Reason # of FDA Reports
1Product used for unknown indication1990
2Muscle spasms*1264
3Muscle relaxant therapy955
4Pain687
5Back pain*530
6Fibromyalgia*394
7Myalgia*185
8Neck pain*167
9Back injury*123
10Intervertebral disc degeneration117

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


Types of Adverse Events for SKELAXIN

Total Reports Filed with FDA: 32592


Number of FDA Adverse Event Reports by Patient Age for SKELAXIN

Total Reports Filed with FDA: 32592*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Metaxalone (Metaxalone, Skelaxin)

Charts are based on 32592 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 SKELAXIN 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.