Drug · FAERS side-effect profile with label screen
Ibuprofen 200Mg side effects: what 198,390 FDA adverse event reports show
Drug class
Nonsteroidal Anti-inflammatory Drug
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Redicare Ibuprofen 200Mg
openFDA label
Who reports
198,390 reports · 73% serious · 16,227 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
temporarily relieves minor aches and pains due to: ■ headache ■ toothache ■ backache ■ menstrual cramps ■ the common cold ■ muscular aches ■ minor pain of arthritis ■ temporarily reduces fever
FDA label, Indications and Usage
What it is
Ibuprofen is a monocarboxylic acid that is propionic acid in which one of the hydrogens at position 2 is substituted by a 4-(2-methylpropyl)phenyl group.
PubChem CID 3672 (ChEBI)
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
Likely indication confounding 1Lab value / disease marker 7Not in label — unassessed 32
What the badges mean
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
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). 1,133 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 | 99.8 80.9–123.0ROR 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) | Not in label — unassessed | serious n=169 · ♀ 0% (drug 65%) · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 287 | 79.7 68.3–92.9ROR 79.8 · calibrated p 7e-7 ✓ | 45.3 EB05 41.0 · 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 | not reported in cached trials |
| Deep vein thrombosis postoperative | 797 | 72.3 66.0–79.1ROR 72.5 · calibrated p 1e-6 ✓ | 42.9 EB05 40.4 · IC025 +5.3 3/3 methods agree vs other NSAIDs: PRR 5.1 (4.7–5.5) | Not in label — unassessed | serious n=797 · ♀ 100% (drug 65%) · 91% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 2,892 | 68.6 65.4–71.9ROR 69.6 · calibrated p 2e-6 ✓ | 41.6 EB05 40.3 · IC025 +5.3 3/3 methods agree vs other NSAIDs: PRR 5.9 (5.7–6.2) | Not in label — unassessed | serious PRR 32.8 · ♀ 96% (drug 65%) · 93% clinician | not reported in cached trials |
| C-reactive protein | 347 | 65.3 57.1–74.6ROR 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 | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 2,632 | 62.0 59.1–65.1ROR 62.8 · 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 | not reported in cached trials |
| Lupus vulgaris | 431 | 59.8 53.1–67.3ROR 59.9 · 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) | Not in label — unassessed | serious n=431 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| Muscle injury | 2,935 | 58.7 56.1–61.4ROR 59.5 · calibrated p 4e-6 ✓ | 37.8 EB05 36.6 · IC025 +5.2 3/3 methods agree vs other NSAIDs: PRR 6.6 (6.3–6.8) | Not in label — unassessed | serious PRR 32.2 · ♀ 100% (drug 65%) · 92% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 193 | 57.8 48.4–68.9ROR 57.8 · 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) | Not in label — unassessed | serious n=192 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 2,217 | 55.3 52.5–58.2ROR 55.9 · 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) | Not in label — unassessed | serious n=2,210 · ♀ 100% (drug 65%) · 93% clinician | not reported in cached trials |
| 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) | Not in label — unassessed | serious n=684 · ♀ 100% (drug 65%) · 93% clinician | not reported in cached trials |
| Swollen joint count increased | 1,011 | 50.5 46.8–54.4ROR 50.7 · 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 | not reported in cached trials |
| Aspirin-exacerbated respiratory disease | 196 | 48.1 40.6–56.9ROR 48.1 · calibrated p 2e-5 ✓ | 33.0 EB05 29.3 · IC025 +4.7 3/3 methods agree vs other NSAIDs: PRR 11.6 (9.9–13.5) | Not in label — unassessed | serious n=191 · 100% clinician | not reported in cached trials |
| Rheumatic fever | 1,258 | 42.5 39.8–45.4ROR 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) | Not in label — unassessed | serious n=1,258 · ♀ 100% (drug 65%) · 94% clinician | not reported in cached trials |
| X-ray abnormal | 510 | 42.1 37.9–46.6ROR 42.2 · calibrated p 4e-5 ✓ | 30.1 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 | not reported in cached trials |
| Dislocation of vertebra | 619 | 40.5 36.9–44.5ROR 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) | Not in label — unassessed | serious n=619 · ♀ 100% (drug 65%) · 92% clinician | not reported in cached trials |
| Folliculitis | 2,860 | 40.3 38.6–42.0ROR 40.8 · calibrated p 5e-5 ✓ | 29.2 EB05 28.4 · IC025 +4.8 3/3 methods agree vs other NSAIDs: PRR 5.9 (5.6–6.1) | Not in label — unassessed | serious PRR 27.0 · ♀ 100% (drug 65%) · 93% clinician | not reported in cached trials |
| Helicobacter infection | 2,811 | 40.0 38.3–41.8ROR 40.6 · calibrated p 5e-5 ✓ | 29.1 EB05 28.2 · IC025 +4.8 3/3 methods agree vs other NSAIDs: PRR 5.6 (5.4–5.8) | Not in label — unassessed | serious PRR 24.2 · ♀ 100% (drug 65%) · 93% clinician | not reported in cached trials |
| Cross sensitivity reaction | 239 | 34.7 29.9–40.1ROR 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) | Not in label — unassessed | serious n=238 · 100% clinician | not reported in cached trials |
| Rheumatoid factor positive | 1,431 | 34.7 32.6–36.8ROR 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 | not reported in cached trials |
| Facet joint syndrome | 742 | 32.3 29.8–35.1ROR 32.4 · calibrated p 2e-4 ✓ | 24.8 EB05 23.4 · IC025 +4.5 3/3 methods agree vs other NSAIDs: PRR 3.8 (3.5–4.1) | Not in label — unassessed | serious n=742 · ♀ 100% (drug 65%) · 92% clinician | not reported in cached trials |
| Pemphigus | 2,876 | 31.6 30.3–33.0ROR 32.1 · calibrated p 2e-4 ✓ | 24.4 EB05 23.7 · IC025 +4.5 3/3 methods agree vs other NSAIDs: PRR 5.5 (5.3–5.7) | Not in label — unassessed | serious PRR 19.3 · ♀ 100% (drug 65%) · 94% clinician | not reported in cached trials |
| Hand deformity | 2,789 | 28.4 27.3–29.7ROR 28.8 · 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) | Not in label — unassessed | serious PRR 19.3 · ♀ 100% (drug 65%) · 92% clinician | not reported in cached trials |
| Retinitis | 335 | 26.3 23.4–29.7ROR 26.4 · calibrated p 5e-4 ✓ | 21.2 EB05 19.3 · IC025 +4.2 3/3 methods agree vs other NSAIDs: PRR 5.0 (4.5–5.6) | Not in label — unassessed | serious n=335 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| C-reactive protein abnormal | 1,230 | 24.9 23.4–26.5ROR 25.1 · calibrated p 7e-4 ✓ | 20.3 EB05 19.3 · 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 | not reported in cached trials |
| Pericarditis | 3,109 | 24.1 23.2–25.0ROR 24.4 · 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) | Not in label — unassessed | serious PRR 15.7 · ♀ 95% (drug 65%) · 92% clinician | not reported in cached trials |
| Enthesopathy | 286 | 23.2 20.4–26.4ROR 23.3 · calibrated p 0.001 ✓ | 19.1 EB05 17.3 · IC025 +4.0 3/3 methods agree vs other NSAIDs: PRR 6.7 (5.9–7.5) | Not in label — unassessed | serious n=282 | not reported in cached trials |
| Peripheral venous disease | 702 | 22.4 20.6–24.3ROR 22.4 · 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) | Not in label — unassessed | serious n=699 · ♀ 100% (drug 65%) · 92% clinician | not reported in cached trials |
| Synovitis | 3,101 | 21.8 20.9–22.6ROR 22.1 · calibrated p 0.001 ✓ | 18.1 EB05 17.6 · IC025 +4.1 3/3 methods agree vs other NSAIDs: PRR 4.8 (4.6–4.9) | Not in label — unassessed | serious PRR 14.9 · ♀ 95% (drug 65%) · 92% clinician | not reported in cached trials |
| Granuloma skin | 138 | 21.0 17.5–25.2ROR 21.0 · calibrated p 0.002 ✓ | 17.5 EB05 15.2 · IC025 +3.8 3/3 methods agree vs other NSAIDs: PRR 7.0 (5.9–8.4) | Not in label — unassessed | serious n=138 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| Gastric ulcer perforation | 199 | 19.5 16.8–22.7ROR 19.5 · calibrated p 0.002 ✓ | 16.5 EB05 14.7 · IC025 +3.8 3/3 methods agree vs other NSAIDs: PRR 11.3 (9.7–13.2) | Not in label — unassessed | serious n=199 · 100% clinician | not reported in cached trials |
| 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) | Not in label — unassessed | serious n=167 | not reported in cached trials |
| Porphyria acute | 208 | 18.6 16.0–21.6ROR 18.6 · calibrated p 0.003 ✓ | 15.9 EB05 14.1 · IC025 +3.7 3/3 methods agree vs other NSAIDs: PRR 4.9 (4.2–5.6) | Not in label — unassessed | serious n=206 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| 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) | Not in label — unassessed | serious PRR 15.4 · ♀ 98% (drug 65%) | not reported in cached trials |
| Seronegative arthritis | 160 | 17.4 14.7–20.6ROR 17.4 · 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) | Likely indication confounding shares a disease stem with the indications wording | serious n=160 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| Renal tubular acidosis | 290 | 16.0 14.2–18.1ROR 16.0 · 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) | Not in label — unassessed | serious n=288 · 100% clinician | not reported in cached trials |
| 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) | Not in label — unassessed | serious PRR 15.1 · ♀ 98% (drug 65%) | not reported in cached trials |
| 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) | Not in label — unassessed | serious n=189 · ♀ 0% (drug 65%) · 100% clinician | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 164 | 13.9 11.9–16.4ROR 14.0 · calibrated p 0.010 ✓ | 12.3 EB05 10.8 · IC025 +3.3 3/3 methods agree vs other NSAIDs: PRR 14.3 (12.0–17.0) | Not in label — unassessed | serious n=161 · ♀ 0% (drug 65%) | not reported in cached trials |
| 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) | Not in label — unassessed | serious n=314 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
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 | 4,848 | 4.24.1–4.3 | signal |
| Severe cutaneous reaction | 2,765 | 4.03.9–4.2 | signal |
| Gi bleeding | 5,627 | 3.33.2–3.4 | signal |
| Suicidality | 7,530 | 3.33.2–3.4 | signal |
| Liver injury | 8,921 | 3.23.1–3.3 | signal |
| Tendon disorder | 1,066 | 3.02.8–3.2 | signal |
| Kidney injury | 11,983 | 2.82.8–2.9 | signal |
| Depression | 5,736 | 2.22.1–2.2 | signal |
| Venous thromboembolism | 3,760 | 1.81.8–1.9 | raised |
| Pancreatitis | 1,305 | 1.71.6–1.8 | raised |
| Serious infection | 12,397 | 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 | 4,278 | 1.51.5–1.6 | raised |
| Fall / fracture | 4,878 | 1.41.3–1.4 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Ibuprofen 200Mg as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT01229449 — Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study (N=678, PHASE3; 6 AE terms posted; arms: Ibuprofen 200mg + Paracetamol 500mg (Low; Ibuprofen 400mg + Paracetamol 1000mg (Hi; Nurofen Plus®; Panadeine® Extra)
- NCT01238120 — The Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients (N=110, PHASE2; 23 AE terms posted; arms: Placebo and Home-Based Exercise; Placebo; Ibuprofen 200mg BID, Home-Based Exercise; Ibuprofen 200 mg BID)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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) | 15,707 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.498 | 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 | not reported in cached trials |
| Pain | 15,063 | 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) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 2.7 · serious PRR 2.7 | NCT01238120: 1/25 (4.0%) control (serious AE) |
| Fatigue (tiredness) | 14,481 | 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) | Not in label — unassessed | age-adj. PRR 1.8 · serious PRR 2.2 | not reported in cached trials |
| Nausea | 13,513 | 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) | Not in label — unassessed | age-adj. PRR 1.7 · serious PRR 2.0 | NCT01229449: 33/168 (19.6%) on Ibuprofen 200Mg; 18/55 (32.7%) control |
| Headache | 12,100 | 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) | Likely indication confounding term in indications | age-adj. PRR 1.7 · serious PRR 2.3 | NCT01229449: 19/168 (11.3%) on Ibuprofen 200Mg; 10/55 (18.2%) control |
| Arthralgia (joint pain) | 10,923 | 2.8 2.8–2.9ROR 2.9 · calibrated p 0.646 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other NSAIDs: PRR 4.5 (4.4–4.5) | Not in label — unassessed | age-adj. PRR 2.4 · serious PRR 3.3 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 10,537 | 2.0 1.9–2.0ROR 2.0 · calibrated p 0.967 | 2.0 EB05 1.9 · IC025 +0.9 vs other NSAIDs: PRR 4.3 (4.3–4.4) | Not in label — unassessed | age-adj. PRR 1.8 · serious PRR 1.9 | not reported in cached trials |
| Vomiting | 9,981 | 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) | Labeled (related wording) related wording | age-adj. PRR 2.0 · serious PRR 2.2 | NCT01229449: 30/168 (17.9%) on Ibuprofen 200Mg; 13/55 (23.6%) control |
| Diarrhoea (diarrhea) | 9,708 | 1.6 1.6–1.6ROR 1.6 · calibrated p 0.728 | 1.6 EB05 1.6 · IC025 +0.6 vs other NSAIDs: PRR 4.0 (3.9–4.1) | Not in label — unassessed | age-adj. PRR 1.5 · serious PRR 1.7 | not reported in cached trials |
| Rash | 9,038 | 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) | Labeled adverse reaction exact term | age-adj. PRR 2.0 · serious PRR 3.1 | NCT01238120: 2/24 (8.3%) on Ibuprofen 200Mg |
| Off label use (used outside approved label) | 8,567 | 1.0 1.0–1.1ROR 1.0 · calibrated p 0.336 | 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 | not reported in cached trials |
| Dizziness | 8,178 | 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) | Not in label — unassessed | age-adj. PRR 1.7 · serious PRR 1.8 | NCT01229449: 15/168 (8.9%) on Ibuprofen 200Mg; 3/55 (5.5%) control |
| Pruritus (itching) | 7,917 | 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) | Not in label — unassessed | age-adj. PRR 1.8 · serious PRR 3.3 | not reported in cached trials |
| Pyrexia (fever) | 7,891 | 2.4 2.4–2.5ROR 2.5 · calibrated p 0.813 | 2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other NSAIDs: PRR 4.9 (4.8–5.0) | Labeled (related wording) related wording | age-adj. PRR 1.9 · serious PRR 2.1 | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 6,629 | 4.8 4.7–4.9ROR 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) | Not in label — unassessed | age-adj. PRR 3.9 · serious PRR 3.6 | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Nsaid exacerbated respiratory disease — n=172, PRR 99.8
- Deep vein thrombosis postoperative — n=797, PRR 72.3
- Duodenal ulcer perforation — n=2,892, PRR 68.6
- Lupus vulgaris — n=431, PRR 59.8
- Muscle injury — n=2,935, PRR 58.7
- Subcutaneous drug absorption impaired — n=193, PRR 57.8
- Sleep disorder due to general medical condition, insomnia type — n=2,217, PRR 55.3
- Adjustment disorder with depressed mood — n=689, PRR 54.7
- Aspirin-exacerbated respiratory disease — n=196, PRR 48.1
- Rheumatic fever — n=1,258, PRR 42.5
✓ A hand-written Bradford Hill causality assessment exists for this drug: Ibuprofen (NSAIDs) ↔ Gastrointestinal bleeding.
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 Ibuprofen 200Mg?
In FDA FAERS, the most frequently co-reported reaction terms for Ibuprofen 200Mg 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 Ibuprofen 200Mg have an FDA boxed warning?
No. The FDA label retrieved for Ibuprofen 200Mg has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ibuprofen 200Mg 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 2f0db953-33e2-1729-e063-6294a90af074, effective 20250304; matched on
openfda.generic_name.exact:"IBUPROFEN 200MG") - PubChem CID 3672 description (ChEBI)
- 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, 1,173 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
IBUPROFEN 200MG, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.