OpenClaim

Diclofenac Side Effects

The most commonly reported side effects of diclofenac include pain, off label use, and fatigue, based on 177,625 FDA adverse event reports from 2004 to 2025. 18.0% of reports found the drug to be ineffective.

Diclofenac side effects

Percentages show how often each reaction appears relative to total reports for diclofenac.

1
Drug Ineffective18.0%31,988
2
Pain8.9%15,830
3
Off Label Use8.4%14,886
4
Fatigue7.8%13,875
5
Product Use In Unapproved Indication7.8%13,794
6
Arthralgia6.4%11,306
7
Rash6.1%10,865
8
Rheumatoid Arthritis6.0%10,668
9
Abdominal Discomfort5.5%9,791
10
Product Use Issue5.4%9,657
11
Nausea5.2%9,245
12
Joint Swelling5.0%8,951
13
Alopecia4.9%8,766
14
Headache4.9%8,674
15
Systemic Lupus Erythematosus4.6%8,147

These are voluntary reports and do not establish that diclofenac caused these reactions.

Report severity

60.3%Serious107,176 reports
27.1%Hospitalizations48,166 reports
8.0%Fatal14,175 reports

Seriousness is determined by the reporter, not by OpenClaim.

Diclofenac drug interactions

Other drugs that appear in adverse event reports alongside diclofenac. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Adalimumab10.5%18,686
2
Methotrexate9.7%17,181
3
Etanercept9.4%16,626
4
Leflunomide7.3%12,933
5
Abatacept7.3%12,900
6
Rituximab7.1%12,635
7
Tocilizumab7.1%12,601
8
Infliximab7.1%12,595
9
Prednisone6.6%11,806
10
Hydroxychloroquine-sulfate6.5%11,531
11
Acetaminophen6.4%11,426
12
Certolizumab-pegol6.2%10,953
13
Folic-acid6.0%10,737
14
Sulfasalazine6.0%10,583
15
Cetirizine-hydrochloride5.9%10,563

Taken alongside

1
Acetaminophen13.9%24,633
2
Ergocalciferol8.5%15,130
3
Omeprazole7.0%12,490
4
Aspirin7.0%12,404
5
Pantoprazole-sodium6.8%12,134
6
Ibuprofen6.8%12,118
7
Prednisone6.6%11,791
8
Levothyroxine-sodium6.4%11,366
9
Gabapentin6.2%11,063
10
Albuterol5.8%10,377
11
Folic-acid5.4%9,669
12
Atorvastatin-calcium5.4%9,555
13
Methotrexate5.2%9,212
14
Tramadol-hydrochloride5.1%8,981
15
Lisinopril4.9%8,768

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports diclofenac side effects

54.2% of diclofenac adverse event reports involve female patients and 25.7% involve male patients. The largest age group is adult at 58%. These figures reflect who reports side effects, not underlying risk.

Sex

Female54.2%
Male25.7%
Unknown20.0%

Age group

< 20.6%
2–110.5%
12–171.3%
18–6458.1%
65+39.6%

What is diclofenac used for

Conditions and purposes for which patients were taking diclofenac when the adverse event was reported.

Abdominal AdhesionsAbdominal DiscomfortAbdominal DistensionAbdominal PainAbdominal Pain LowerAbdominal Pain UpperAbortionAbortion InducedAbortion SpontaneousAbscessAbscess DrainageAbscess NeckAccident At WorkAccidental ExposureAccidental Exposure To Product

Showing 15 of 2,015 indications

Diclofenac brand names and reporting trend

Diclofenac is sold under several brand names including Zorvolex, Pennsaid, Diclofenac Potassium.

Brand names

Zorvolex74,723
Pennsaid55,012
Diclofenac Potassium12,739
Licart732

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking diclofenac with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.