Drug Safety Information for ROBAXISAL (Aspirin; methocarbamol)

Adverse Drug Reactions for ROBAXISAL* (Aspirin; 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 ROBAXISAL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Chills1
2Hepatitis1
3Muscle rigidity1
4Anaemia1
5Mycobacterium avium complex infection1
6Electrolyte imbalance1
7Somnolence1
8Pain1
9Arthralgia1
10Swelling face1
11Meniscus lesion1
12Renal failure chronic1
13Acquired claw toe1
14Malaise1
15Suicide attempt1
16Muscle spasms1
17Hyperglycaemia1
18Erythema nodosum1
19Dehydration1
20Joint fluid drainage1

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

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

Reason # of FDA Reports
1Back pain12
2Product used for unknown indication8
3Pain6
4Migraine2
5Rhinitis allergic1

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


Types of Adverse Events for ROBAXISAL

Total Reports Filed with FDA: 49


Number of FDA Adverse Event Reports by Patient Age for ROBAXISAL

Total Reports Filed with FDA: 49*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Aspirin; methocarbamol (Robaxisal)

Charts are based on 49 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 ROBAXISAL 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.