Drug Safety Information for ARTHROTEC (Diclofenac sodium; misoprostol)

Safety-related Labeling Changes for ARTHROTEC (DICLOFENAC SODIUM; MISOPROSTOL) Rx Drug: FDA Link

Adverse Drug Reactions for ARTHROTEC* (Diclofenac sodium; misoprostol)

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 ARTHROTEC
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain239
2Drug ineffective235
3Diarrhoea*217
4Nausea*214
5Arthralgia212
6Fall156
7Dyspnoea149
8Fatigue141
9Dizziness*135
10Headache*130
11Pain in extremity129
12Vomiting122
13Back pain118
14Malaise114
15Abdominal pain upper*113
16Asthenia111
17Weight decreased110
18Oedema peripheral104
19Myocardial infarction100
20Chest pain99

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

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

Reason # of FDA Reports
1Product used for unknown indication1556
2Arthritis*1478
3Osteoarthritis*709
4Rheumatoid arthritis*583
5Pain408
6Arthralgia*406
7Back pain214
8Ill-defined disorder151
9Psoriatic arthropathy112
10Neck pain*87

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


Types of Adverse Events for ARTHROTEC

Total Reports Filed with FDA: 17540


Number of FDA Adverse Event Reports by Patient Age for ARTHROTEC

Total Reports Filed with FDA: 17540*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Diclofenac sodium; misoprostol (Arthrotec)

Charts are based on 17540 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 ARTHROTEC 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.