Drug Safety Information for DICLOFENAC SODIUM (Diclofenac sodium)

Safety-related Labeling Changes for VOLTAREN (DICLOFENAC SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for VOLTAREN-XR (DICLOFENAC SODIUM) Brand name discontinued; available as generic: FDA Link

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

Safety-related Labeling Changes for PENNSAID (DICLOFENAC SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for SOLARAZE (DICLOFENAC SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for DYLOJECT (DICLOFENAC SODIUM) Discontinued Drug: FDA Link

Adverse Drug Reactions for DICLOFENAC SODIUM* (Diclofenac sodium)

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 DICLOFENAC SODIUM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*1576
2Pain1519
3Dyspnoea1354
4Vomiting*1333
5Pyrexia1315
6Diarrhoea*1301
7Drug ineffective1232
8Arthralgia1183
9Renal failure acute1135
10Headache*1062
11Malaise1057
12Fatigue1034
13Dizziness*1009
14Drug interaction968
15Pain in extremity930
16Anaemia914
17Fall898
18Rash889
19Asthenia839
20Abdominal pain827

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

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

Reason # of FDA Reports
1Product used for unknown indication15616
2Pain9560
3Rheumatoid arthritis*7466
4Back pain*5644
5Arthritis*4344
6Arthralgia*4329
7Osteoarthritis*3108
8Pyrexia2053
9Analgesic therapy1782
10Inflammation1158

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


Types of Adverse Events for DICLOFENAC SODIUM

Total Reports Filed with FDA: 156176


Number of FDA Adverse Event Reports by Patient Age for DICLOFENAC SODIUM

Total Reports Filed with FDA: 156176*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Diclofenac sodium (Voltaren, Diclophenac, Diclofenac sodium , Solaraze, Diclofenac, Dicrofenac, Pennsaid, Voltaren-xr, Dyloject, Diclofenac sodium)

Charts are based on 156176 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 DICLOFENAC SODIUM 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.