Drug Safety Information for ROBAXIN (Methocarbamol)

Adverse Drug Reactions for ROBAXIN* (Methocarbamol)

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 ROBAXIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain*396
2Nausea357
3Dyspnoea287
4Anxiety*285
5Drug ineffective*282
6Depression272
7Headache*269
8Back pain256
9Fatigue*250
10Pain in extremity249
11Dizziness*231
12Fall227
13Diarrhoea225
14Arthralgia219
15Hypertension215
16Asthenia213
17Chest pain210
18Vomiting205
19Insomnia181
20Muscle spasms170

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

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

Reason # of FDA Reports
1Product used for unknown indication2264
2Muscle spasms*1524
3Muscle relaxant therapy1036
4Pain933
5Back pain*542
6Myalgia304
7Headache191
8Fibromyalgia*187
9Neck pain181
10Migraine154

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


Types of Adverse Events for ROBAXIN

Total Reports Filed with FDA: 30638


Number of FDA Adverse Event Reports by Patient Age for ROBAXIN

Total Reports Filed with FDA: 30638*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Methocarbamol (Forbaxin, Delaxin, Methocarbamol, Relaxin, Ortoton, Lumirelax, Skelex, Robaxin-750, Robaxin)

Charts are based on 30638 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 ROBAXIN 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.