Drug Safety Information for RELAFEN (Nabumetone)

Adverse Drug Reactions for RELAFEN* (Nabumetone)

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 RELAFEN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain398
2Drug ineffective*337
3Nausea307
4Dyspnoea283
5Arthralgia259
6Headache*243
7Anxiety232
8Fatigue220
9Depression209
10Pain in extremity207
11Dizziness*199
12Diarrhoea*199
13Chest pain181
14Back pain173
15Asthenia171
16Oedema peripheral157
17Vomiting157
18Hypertension154
19Fall153
20Rash148

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

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

Reason # of FDA Reports
1Product used for unknown indication2082
2Rheumatoid arthritis*1038
3Arthritis*919
4Pain852
5Osteoarthritis*388
6Arthralgia*351
7Back pain*243
8Inflammation*236
9Antiinflammatory therapy160
10Pain in extremity122

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


Types of Adverse Events for RELAFEN

Total Reports Filed with FDA: 27334


Number of FDA Adverse Event Reports by Patient Age for RELAFEN

Total Reports Filed with FDA: 27334*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Nabumetone (Mebutan, Relifex, Nabumetone, Relif, Nabucox, Relafen)

Charts are based on 27334 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 RELAFEN 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.