OpenClaim

Ibuprofen Side Effects

The most commonly reported side effects of ibuprofen include pain, fatigue, and nausea, based on 345,963 FDA adverse event reports from 2004 to 2025. 8.2% of reports found the drug to be ineffective.

Ibuprofen side effects

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

1
Drug Ineffective8.2%28,474
2
Pain5.8%20,001
3
Fatigue5.7%19,872
4
Nausea5.3%18,177
5
Headache4.8%16,584
6
Arthralgia4.0%13,868
7
Diarrhoea3.9%13,342
8
Dyspnoea3.7%12,853
9
Off Label Use3.7%12,630
10
Vomiting3.6%12,502
11
Dizziness3.3%11,275
12
Rash3.2%11,130
13
Pruritus2.9%9,868
14
Drug Hypersensitivity2.7%9,305
15
Pyrexia2.6%9,135

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

Report severity

64.1%Serious221,721 reports
29.5%Hospitalizations102,001 reports
8.8%Fatal30,482 reports

Seriousness is determined by the reporter, not by OpenClaim.

Ibuprofen drug interactions

Other drugs that appear in adverse event reports alongside ibuprofen. 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
Acetaminophen9.0%30,974
2
Hydrocodone5.1%17,761
3
Oxycodone4.8%16,775
4
Adalimumab4.5%15,614
5
Aspirin3.9%13,653
6
Etanercept3.3%11,456
7
Methotrexate3.0%10,302
8
Fentanyl2.8%9,569
9
Diclofenac2.8%9,540
10
Naproxen2.6%9,165
11
Hydromorphone-hydrochloride2.6%8,972
12
Morphine-sulfate2.5%8,710
13
Buprenorphine2.4%8,205
14
Diphenhydramine2.4%8,194
15
Sodium-oxybate2.4%8,147

Taken alongside

1
Acetaminophen19.6%67,646
2
Hydrocodone14.2%49,019
3
Ergocalciferol9.9%34,193
4
Aspirin9.0%31,180
5
Omeprazole7.6%26,188
6
Albuterol7.4%25,655
7
Gabapentin7.1%24,658
8
Levothyroxine-sodium7.1%24,617
9
Prednisone6.2%21,463
10
Lisinopril6.0%20,870
11
Atorvastatin-calcium5.4%18,738
12
Pantoprazole-sodium5.3%18,441
13
Fluticasone5.0%17,349
14
Amlodipine4.9%17,092
15
Oxycodone4.8%16,474

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 ibuprofen side effects

57.2% of ibuprofen adverse event reports involve female patients and 30.2% involve male patients. The largest age group is adult at 66%. These figures reflect who reports side effects, not underlying risk.

Sex

Female57.2%
Male30.2%
Unknown12.7%

Age group

< 21.9%
2–113.8%
12–173.9%
18–6465.5%
65+25.0%

What is ibuprofen used for

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

AbasiaAbdominal DiscomfortAbdominal DistensionAbdominal HerniaAbdominal InjuryAbdominal PainAbdominal Pain LowerAbdominal Pain UpperAbdominal TendernessAbnormal BehaviourAbortionAbortion CompleteAbortion InducedAbortion Induced ComplicatedAbscess

Showing 15 of 2,779 indications

Ibuprofen brand names and reporting trend

Ibuprofen is sold under brand names including Reprexain, Ibuprofen Sodium, Neoprofen.

Brand names

Reprexain226,830
Ibuprofen Sodium370
Neoprofen198

Quarterly reports (20042025)

20052010201520202025

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

Taking ibuprofen with another medication?

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