Drug · FAERS side-effect profile with label screen
Ibupfrofen side effects: what 198,213 FDA adverse event reports show
Drug class
Nonsteroidal Anti-inflammatory Drug
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Ibuprofen
openFDA label
Who reports
198,213 reports · 73% serious · 16,220 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
temporarily relieves minor aches and pains due to: o headache o toothache o backache o menstrual cramps o the common cold o muscular aches o minor pain of arthritis temporarily reduces fever
FDA label, Indications and Usage
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Lab value / disease marker 7No label text to screen 33
What the badges mean
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,134 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Nsaid exacerbated respiratory disease | 172 | 99.9 81.0–123.1ROR 99.9 · calibrated p 2e-7 ✓ | 51.0 EB05 44.9 · IC025 +5.2 3/3 methods agree vs other NSAIDs: PRR 15.4 (13.0–18.3) | No label text to screen label has no adverse-reaction text | serious n=169 · ♀ 0% (drug 65%) · 100% clinician | no trial arm names this drug |
| Anti-cyclic citrullinated peptide antibody | 287 | 79.7 68.4–93.0ROR 79.8 · calibrated p 7e-7 ✓ | 45.3 EB05 41.1 · IC025 +5.2 3/3 methods agree vs other NSAIDs: PRR 5.7 (5.0–6.4) | Lab value / disease marker | serious n=287 · ♀ 100% (drug 65%) · 100% clinician | no trial arm names this drug |
| Deep vein thrombosis postoperative | 797 | 72.3 66.1–79.2ROR 72.6 · calibrated p 1e-6 ✓ | 42.9 EB05 40.5 · IC025 +5.3 3/3 methods agree vs other NSAIDs: PRR 5.1 (4.7–5.5) | No label text to screen label has no adverse-reaction text | serious n=797 · ♀ 100% (drug 65%) · 91% clinician | no trial arm names this drug |
| Duodenal ulcer perforation | 2,892 | 68.6 65.5–71.9ROR 69.6 · calibrated p 2e-6 ✓ | 41.6 EB05 40.4 · IC025 +5.3 3/3 methods agree vs other NSAIDs: PRR 5.9 (5.7–6.2) | No label text to screen label has no adverse-reaction text | serious PRR 32.8 · ♀ 96% (drug 65%) · 93% clinician | no trial arm names this drug |
| C-reactive protein | 347 | 65.3 57.1–74.7ROR 65.4 · calibrated p 3e-6 ✓ | 40.3 EB05 36.9 · IC025 +5.1 3/3 methods agree vs other NSAIDs: PRR 4.8 (4.3–5.3) | Lab value / disease marker | serious n=347 · ♀ 100% (drug 65%) · 100% clinician | no trial arm names this drug |
| Anti-cyclic citrullinated peptide antibody positive | 2,632 | 62.1 59.1–65.1ROR 62.9 · calibrated p 3e-6 ✓ | 39.1 EB05 37.9 · IC025 +5.2 3/3 methods agree vs other NSAIDs: PRR 5.8 (5.6–6.0) | Lab value / disease marker | serious PRR 31.0 · ♀ 100% (drug 65%) · 94% clinician | no trial arm names this drug |
| Lupus vulgaris | 431 | 59.9 53.2–67.4ROR 60.0 · calibrated p 4e-6 ✓ | 38.2 EB05 35.3 · IC025 +5.0 3/3 methods agree vs other NSAIDs: PRR 4.8 (4.3–5.3) | No label text to screen label has no adverse-reaction text | serious n=431 · ♀ 100% (drug 65%) · 100% clinician | no trial arm names this drug |
| Muscle injury | 2,935 | 58.7 56.1–61.4ROR 59.6 · calibrated p 4e-6 ✓ | 37.8 EB05 36.7 · IC025 +5.2 3/3 methods agree vs other NSAIDs: PRR 6.6 (6.3–6.8) | No label text to screen label has no adverse-reaction text | serious PRR 32.2 · ♀ 100% (drug 65%) · 92% clinician | no trial arm names this drug |
| Subcutaneous drug absorption impaired | 193 | 57.8 48.5–68.9ROR 57.9 · calibrated p 6e-6 ✓ | 37.3 EB05 33.1 · IC025 +4.9 3/3 methods agree vs other NSAIDs: PRR 6.2 (5.4–7.3) | No label text to screen label has no adverse-reaction text | serious n=192 · ♀ 100% (drug 65%) · 100% clinician | no trial arm names this drug |
| Sleep disorder due to general medical condition, insomnia type | 2,217 | 55.4 52.6–58.3ROR 56.0 · calibrated p 7e-6 ✓ | 36.4 EB05 35.1 · IC025 +5.1 3/3 methods agree vs other NSAIDs: PRR 6.9 (6.6–7.2) | No label text to screen label has no adverse-reaction text | serious n=2,210 · ♀ 100% (drug 65%) · 93% clinician | no trial arm names this drug |
| Adjustment disorder with depressed mood | 689 | 54.7 49.9–60.0ROR 54.9 · calibrated p 8e-6 ✓ | 36.1 EB05 33.9 · IC025 +5.0 3/3 methods agree vs other NSAIDs: PRR 5.4 (5.0–5.9) | No label text to screen label has no adverse-reaction text | serious n=684 · ♀ 100% (drug 65%) · 93% clinician | no trial arm names this drug |
| Swollen joint count increased | 1,011 | 50.5 46.9–54.5ROR 50.8 · calibrated p 1e-5 ✓ | 34.2 EB05 32.5 · IC025 +5.0 3/3 methods agree vs other NSAIDs: PRR 4.8 (4.5–5.1) | Lab value / disease marker | serious n=1,010 · ♀ 100% (drug 65%) · 95% clinician | no trial arm names this drug |
| Aspirin-exacerbated respiratory disease | 196 | 48.1 40.6–57.0ROR 48.2 · calibrated p 2e-5 ✓ | 33.1 EB05 29.3 · IC025 +4.7 3/3 methods agree vs other NSAIDs: PRR 11.6 (9.9–13.5) | No label text to screen label has no adverse-reaction text | serious n=191 · 100% clinician | no trial arm names this drug |
| Rheumatic fever | 1,258 | 42.6 39.9–45.5ROR 42.8 · calibrated p 4e-5 ✓ | 30.4 EB05 29.0 · IC025 +4.8 3/3 methods agree vs other NSAIDs: PRR 4.4 (4.2–4.7) | No label text to screen label has no adverse-reaction text | serious n=1,258 · ♀ 100% (drug 65%) · 94% clinician | no trial arm names this drug |
| X-ray abnormal | 510 | 42.1 38.0–46.7ROR 42.2 · calibrated p 4e-5 ✓ | 30.2 EB05 28.0 · IC025 +4.7 3/3 methods agree vs other NSAIDs: PRR 5.2 (4.8–5.7) | Lab value / disease marker | serious n=510 · ♀ 100% (drug 65%) · 100% clinician | no trial arm names this drug |
| Dislocation of vertebra | 619 | 40.6 37.0–44.5ROR 40.7 · calibrated p 5e-5 ✓ | 29.4 EB05 27.5 · IC025 +4.7 3/3 methods agree vs other NSAIDs: PRR 5.0 (4.6–5.4) | No label text to screen label has no adverse-reaction text | serious n=619 · ♀ 100% (drug 65%) · 92% clinician | no trial arm names this drug |
| Folliculitis | 2,860 | 40.3 38.6–42.1ROR 40.9 · calibrated p 5e-5 ✓ | 29.3 EB05 28.4 · IC025 +4.8 3/3 methods agree vs other NSAIDs: PRR 5.9 (5.6–6.1) | No label text to screen label has no adverse-reaction text | serious PRR 27.0 · ♀ 100% (drug 65%) · 93% clinician | no trial arm names this drug |
| Helicobacter infection | 2,811 | 40.1 38.4–41.8ROR 40.6 · calibrated p 5e-5 ✓ | 29.1 EB05 28.3 · IC025 +4.8 3/3 methods agree vs other NSAIDs: PRR 5.6 (5.4–5.8) | No label text to screen label has no adverse-reaction text | serious PRR 24.3 · ♀ 100% (drug 65%) · 93% clinician | no trial arm names this drug |
| Cross sensitivity reaction | 239 | 34.7 30.0–40.2ROR 34.7 · calibrated p 1e-4 ✓ | 26.2 EB05 23.5 · IC025 +4.4 3/3 methods agree vs other NSAIDs: PRR 11.4 (9.9–13.2) | No label text to screen label has no adverse-reaction text | serious n=238 · 100% clinician | no trial arm names this drug |
| Rheumatoid factor positive | 1,431 | 34.7 32.7–36.8ROR 34.9 · calibrated p 1e-4 ✓ | 26.2 EB05 25.1 · IC025 +4.6 3/3 methods agree vs other NSAIDs: PRR 5.0 (4.7–5.3) | Lab value / disease marker | serious n=1,431 · ♀ 100% (drug 65%) · 95% clinician | no trial arm names this drug |
| Facet joint syndrome | 742 | 32.4 29.8–35.1ROR 32.5 · calibrated p 2e-4 ✓ | 24.9 EB05 23.4 · IC025 +4.5 3/3 methods agree vs other NSAIDs: PRR 3.8 (3.5–4.1) | No label text to screen label has no adverse-reaction text | serious n=742 · ♀ 100% (drug 65%) · 92% clinician | no trial arm names this drug |
| Pemphigus | 2,876 | 31.6 30.4–33.0ROR 32.1 · calibrated p 2e-4 ✓ | 24.5 EB05 23.7 · IC025 +4.5 3/3 methods agree vs other NSAIDs: PRR 5.5 (5.3–5.7) | No label text to screen label has no adverse-reaction text | serious PRR 19.4 · ♀ 100% (drug 65%) · 94% clinician | no trial arm names this drug |
| Hand deformity | 2,789 | 28.5 27.3–29.7ROR 28.9 · calibrated p 3e-4 ✓ | 22.5 EB05 21.8 · IC025 +4.4 3/3 methods agree vs other NSAIDs: PRR 5.2 (5.1–5.4) | No label text to screen label has no adverse-reaction text | serious PRR 19.3 · ♀ 100% (drug 65%) · 92% clinician | no trial arm names this drug |
| Retinitis | 335 | 26.4 23.4–29.7ROR 26.4 · calibrated p 5e-4 ✓ | 21.2 EB05 19.4 · IC025 +4.2 3/3 methods agree vs other NSAIDs: PRR 5.0 (4.5–5.6) | No label text to screen label has no adverse-reaction text | serious n=335 · ♀ 100% (drug 65%) · 100% clinician | no trial arm names this drug |
| C-reactive protein abnormal | 1,230 | 25.0 23.5–26.6ROR 25.1 · calibrated p 7e-4 ✓ | 20.3 EB05 19.4 · IC025 +4.2 3/3 methods agree vs other NSAIDs: PRR 4.4 (4.1–4.6) | Lab value / disease marker | serious n=1,228 · ♀ 93% (drug 65%) · 94% clinician | no trial arm names this drug |
| Pericarditis | 3,109 | 24.1 23.2–25.0ROR 24.5 · calibrated p 8e-4 ✓ | 19.7 EB05 19.1 · IC025 +4.2 3/3 methods agree vs other NSAIDs: PRR 5.6 (5.4–5.8) | No label text to screen label has no adverse-reaction text | serious PRR 15.7 · ♀ 95% (drug 65%) · 92% clinician | no trial arm names this drug |
| Enthesopathy | 286 | 23.3 20.5–26.4ROR 23.3 · calibrated p 1e-3 ✓ | 19.1 EB05 17.4 · IC025 +4.0 3/3 methods agree vs other NSAIDs: PRR 6.7 (5.9–7.5) | No label text to screen label has no adverse-reaction text | serious n=282 | no trial arm names this drug |
| Peripheral venous disease | 702 | 22.4 20.6–24.3ROR 22.5 · calibrated p 0.001 ✓ | 18.6 EB05 17.4 · IC025 +4.1 3/3 methods agree vs other NSAIDs: PRR 4.3 (4.0–4.7) | No label text to screen label has no adverse-reaction text | serious n=699 · ♀ 100% (drug 65%) · 92% clinician | no trial arm names this drug |
| Synovitis | 3,101 | 21.8 21.0–22.6ROR 22.1 · calibrated p 0.001 ✓ | 18.2 EB05 17.6 · IC025 +4.1 3/3 methods agree vs other NSAIDs: PRR 4.8 (4.6–4.9) | No label text to screen label has no adverse-reaction text | serious PRR 15.0 · ♀ 95% (drug 65%) · 92% clinician | no trial arm names this drug |
| Granuloma skin | 138 | 21.0 17.5–25.2ROR 21.0 · calibrated p 0.002 ✓ | 17.6 EB05 15.2 · IC025 +3.8 3/3 methods agree vs other NSAIDs: PRR 7.0 (5.9–8.4) | No label text to screen label has no adverse-reaction text | serious n=138 · ♀ 100% (drug 65%) · 100% clinician | no trial arm names this drug |
| Gastric ulcer perforation | 199 | 19.5 16.8–22.7ROR 19.5 · calibrated p 0.002 ✓ | 16.6 EB05 14.7 · IC025 +3.8 3/3 methods agree vs other NSAIDs: PRR 11.3 (9.7–13.2) | No label text to screen label has no adverse-reaction text | serious n=199 · 100% clinician | no trial arm names this drug |
| Chronic kidney disease-mineral and bone disorder | 167 | 19.3 16.3–22.7ROR 19.3 · calibrated p 0.002 ✓ | 16.4 EB05 14.4 · IC025 +3.7 3/3 methods agree vs other NSAIDs: PRR 6.9 (5.8–8.1) | No label text to screen label has no adverse-reaction text | serious n=167 | no trial arm names this drug |
| Porphyria acute | 208 | 18.6 16.1–21.6ROR 18.6 · calibrated p 0.003 ✓ | 15.9 EB05 14.2 · IC025 +3.7 3/3 methods agree vs other NSAIDs: PRR 4.9 (4.2–5.6) | No label text to screen label has no adverse-reaction text | serious n=206 · ♀ 100% (drug 65%) · 100% clinician | no trial arm names this drug |
| Irritable bowel syndrome | 3,158 | 18.2 17.5–18.9ROR 18.5 · calibrated p 0.003 ✓ | 15.6 EB05 15.2 · IC025 +3.9 3/3 methods agree vs other NSAIDs: PRR 5.8 (5.6–6.0) | No label text to screen label has no adverse-reaction text | serious PRR 15.4 · ♀ 98% (drug 65%) | no trial arm names this drug |
| Seronegative arthritis | 160 | 17.4 14.8–20.6ROR 17.5 · calibrated p 0.004 ✓ | 15.0 EB05 13.2 · IC025 +3.6 3/3 methods agree vs other NSAIDs: PRR 4.9 (4.1–5.7) | No label text to screen label has no adverse-reaction text | serious n=160 · ♀ 100% (drug 65%) · 100% clinician | no trial arm names this drug |
| Renal tubular acidosis | 290 | 16.0 14.2–18.1ROR 16.1 · calibrated p 0.005 ✓ | 14.0 EB05 12.7 · IC025 +3.6 3/3 methods agree vs other NSAIDs: PRR 11.8 (10.3–13.4) | No label text to screen label has no adverse-reaction text | serious n=288 · 100% clinician | no trial arm names this drug |
| Glossodynia (burning tongue/mouth pain) | 2,865 | 15.4 14.8–16.0ROR 15.6 · calibrated p 0.006 ✓ | 13.5 EB05 13.1 · IC025 +3.7 3/3 methods agree vs other NSAIDs: PRR 5.2 (5.0–5.4) | No label text to screen label has no adverse-reaction text | serious PRR 15.1 · ♀ 98% (drug 65%) | no trial arm names this drug |
| Fixed eruption | 214 | 15.2 13.1–17.5ROR 15.2 · calibrated p 0.007 ✓ | 13.3 EB05 11.9 · IC025 +3.5 3/3 methods agree vs other NSAIDs: PRR 11.4 (9.8–13.2) | No label text to screen label has no adverse-reaction text | serious n=189 · ♀ 0% (drug 65%) · 100% clinician | no trial arm names this drug |
| Obstructive sleep apnoea syndrome | 164 | 14.0 11.9–16.4ROR 14.0 · calibrated p 0.010 ✓ | 12.4 EB05 10.8 · IC025 +3.3 3/3 methods agree vs other NSAIDs: PRR 14.3 (12.0–17.0) | No label text to screen label has no adverse-reaction text | serious n=161 · ♀ 0% (drug 65%) | no trial arm names this drug |
| Drug tolerance decreased | 324 | 13.7 12.2–15.4ROR 13.7 · calibrated p 0.010 ✓ | 12.2 EB05 11.1 · IC025 +3.4 3/3 methods agree vs other NSAIDs: PRR 4.8 (4.3–5.4) | No label text to screen label has no adverse-reaction text | serious n=314 · ♀ 100% (drug 65%) · 100% clinician | no trial arm names this drug |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Anaphylaxis / angioedema | 4,841 | 4.24.1–4.3 | signal |
| Severe cutaneous reaction | 2,764 | 4.03.9–4.2 | signal |
| Gi bleeding | 5,625 | 3.33.2–3.4 | signal |
| Suicidality | 7,527 | 3.33.2–3.4 | signal |
| Liver injury | 8,914 | 3.23.1–3.3 | signal |
| Tendon disorder | 1,066 | 3.02.8–3.2 | signal |
| Kidney injury | 11,973 | 2.82.8–2.9 | signal |
| Depression | 5,733 | 2.22.1–2.2 | signal |
| Venous thromboembolism | 3,759 | 1.91.8–1.9 | raised |
| Pancreatitis | 1,303 | 1.71.6–1.8 | raised |
| Serious infection | 12,396 | 1.71.7–1.7 | raised |
| Hyponatraemia | 1,198 | 1.61.5–1.7 | raised |
| Rhabdomyolysis / myopathy | 1,193 | 1.61.5–1.7 | raised |
| Interstitial lung disease | 1,371 | 1.51.4–1.6 | raised |
| Anaemia | 4,272 | 1.51.5–1.6 | raised |
| Fall / fracture | 4,876 | 1.41.3–1.4 | raised |
Trial evidence (ClinicalTrials.gov)
No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Ibupfrofen (searched IBUPFROFEN).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 15,699 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.499 | 1.3 EB05 1.2 · IC025 +0.3 vs other NSAIDs: PRR 4.0 (3.9–4.0) | Reporting / coding artifact | age-adj. PRR 1.3 · serious PRR 1.8 | no trial arm names this drug |
| Pain | 15,060 | 2.6 2.6–2.7ROR 2.8 · calibrated p 0.709 | 2.6 EB05 2.6 · IC025 +1.3 3/3 methods agree vs other NSAIDs: PRR 4.8 (4.7–4.8) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.7 · serious PRR 2.7 | no trial arm names this drug |
| Fatigue (tiredness) | 14,474 | 2.0 2.0–2.0ROR 2.1 · calibrated p 0.980 | 2.0 EB05 1.9 · IC025 +1.0 vs other NSAIDs: PRR 4.3 (4.3–4.4) | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.8 · serious PRR 2.2 | no trial arm names this drug |
| Nausea | 13,506 | 1.8 1.8–1.9ROR 1.9 · calibrated p 0.879 | 1.8 EB05 1.8 · IC025 +0.8 vs other NSAIDs: PRR 4.4 (4.4–4.5) | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.7 · serious PRR 2.0 | no trial arm names this drug |
| Headache | 12,090 | 2.1 2.0–2.1ROR 2.1 · calibrated p 0.986 | 2.0 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other NSAIDs: PRR 4.6 (4.5–4.6) | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.7 · serious PRR 2.3 | no trial arm names this drug |
| Arthralgia (joint pain) | 10,921 | 2.8 2.8–2.9ROR 2.9 · calibrated p 0.645 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other NSAIDs: PRR 4.5 (4.4–4.5) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.4 · serious PRR 3.3 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 10,529 | 2.0 2.0–2.0ROR 2.0 · calibrated p 0.967 | 2.0 EB05 1.9 · IC025 +0.9 vs other NSAIDs: PRR 4.3 (4.3–4.4) | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.8 · serious PRR 1.9 | no trial arm names this drug |
| Vomiting | 9,974 | 2.3 2.2–2.3ROR 2.3 · calibrated p 0.882 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other NSAIDs: PRR 4.7 (4.7–4.8) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.0 · serious PRR 2.2 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 9,701 | 1.6 1.6–1.6ROR 1.6 · calibrated p 0.729 | 1.6 EB05 1.6 · IC025 +0.6 vs other NSAIDs: PRR 4.0 (3.9–4.1) | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.5 · serious PRR 1.7 | no trial arm names this drug |
| Rash | 9,031 | 2.2 2.2–2.3ROR 2.3 · calibrated p 0.909 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other NSAIDs: PRR 4.8 (4.7–4.9) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.0 · serious PRR 3.1 | no trial arm names this drug |
| Off label use (used outside approved label) | 8,567 | 1.0 1.0–1.1ROR 1.0 · calibrated p 0.337 | 1.0 EB05 1.0 · IC025 +0.0 vs other NSAIDs: PRR 3.6 (3.6–3.7) | Reporting / coding artifact | age-adj. PRR 0.9 · serious PRR 1.2 | no trial arm names this drug |
| Dizziness | 8,172 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.818 | 1.7 EB05 1.7 · IC025 +0.8 vs other NSAIDs: PRR 4.0 (3.9–4.1) | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.7 · serious PRR 1.8 | no trial arm names this drug |
| Pruritus (itching) | 7,913 | 2.2 2.2–2.3ROR 2.3 · calibrated p 0.907 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other NSAIDs: PRR 4.9 (4.8–5.0) | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.8 · serious PRR 3.3 | no trial arm names this drug |
| Pyrexia (fever) | 7,886 | 2.4 2.4–2.5ROR 2.5 · calibrated p 0.812 | 2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other NSAIDs: PRR 4.9 (4.8–5.0) | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.9 · serious PRR 2.1 | no trial arm names this drug |
| Acute kidney injury (sudden kidney damage) | 6,622 | 4.8 4.6–4.9ROR 4.9 · calibrated p 0.246 | 4.6 EB05 4.5 · IC025 +2.2 3/3 methods agree vs other NSAIDs: PRR 5.6 (5.4–5.7) | No label text to screen label has no adverse-reaction text | age-adj. PRR 3.9 · serious PRR 3.6 | no trial arm names this drug |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Ibupfrofen?
In FDA FAERS, the most frequently co-reported reaction terms for Ibupfrofen are pain, fatigue, nausea, headache, arthralgia, dyspnoea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Ibupfrofen have an FDA boxed warning?
No. The FDA label retrieved for Ibupfrofen has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ibupfrofen causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID f58d35f9-e44b-417b-98ce-0766b537cd2f, effective 20250612; matched on
openfda.generic_name.exact:"IBUPFROFEN") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,174 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
IBUPFROFEN, results-bearing studies sorted by enrollment)
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