Ibuprofen and Film-Coated side effects: what 198,211 FDA adverse event reports show
Drug class
Nonsteroidal Anti-inflammatory Drug
Label matched
Ibuprofen (Ibuprofen)
Who reports
198,211 reports · 73% serious · 16,220 with death outcome · 65% female
Used for
Carefully consider the potential benefits and risks of Ibuprofen Tablets and other treatment options before deciding to use Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . Ibuprofen Tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
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.
Boxed warning
Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see WARNINGS and PRECAUTIONS ].
Causality screen of the 40 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- 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). 956 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| 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 | Not in label — unassessed | serious PRR 27.0 · ♀ 100% (drug 65%) · 93% clinician | not reported in cached trials |
| 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 | Not in label — unassessed | serious PRR 24.3 · ♀ 100% (drug 65%) · 93% clinician | not reported in cached trials |
| 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 | Not in label — unassessed | serious PRR 19.4 · ♀ 100% (drug 65%) · 94% clinician | not reported in cached trials |
| 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 | Not in label — unassessed | serious PRR 19.3 · ♀ 100% (drug 65%) · 92% clinician | not reported in cached trials |
| 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 | Not in label — unassessed | serious PRR 15.7 · ♀ 95% (drug 65%) · 92% clinician | NCT00346216: 1/7,992 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| 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 | Not in label — unassessed | serious PRR 15.0 · ♀ 95% (drug 65%) · 92% clinician | NCT00346216: 1/8,030 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| 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 | Not in label — unassessed | serious PRR 15.4 · ♀ 98% (drug 65%) | NCT00346216: 1/8,030 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| 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 | Labeled (related wording) related wording | serious PRR 15.1 · ♀ 98% (drug 65%) | not reported in cached trials |
| Wound | 2,830 | 11.9 11.4–12.4ROR 12.0 · calibrated p 0.017 ✓ | 10.8 EB05 10.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | age-adj. PRR 10.5 · serious PRR 10.0 · ♀ 96% (drug 65%) | NCT00346216: 2/7,992 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| Impaired healing | 3,289 | 11.7 11.3–12.1ROR 11.9 · calibrated p 0.018 ✓ | 10.6 EB05 10.3 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 9.2 · serious PRR 10.0 · ♀ 96% (drug 65%) | NCT00346216: 1/7,992 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| Contraindicated product administered | 2,851 | 10.9 10.5–11.4ROR 11.1 · calibrated p 0.022 ✓ | 10.0 EB05 9.7 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 9.7 · serious PRR 9.4 · ♀ 93% (drug 65%) | not reported in cached trials |
| Autoimmune disorder | 900 | 10.9 10.2–11.7ROR 10.9 · calibrated p 0.024 ✓ | 9.9 EB05 9.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · ♀ 100% (drug 65%) | NCT00346216: 1/8,030 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| Bursitis | 1,130 | 10.8 10.2–11.5ROR 10.9 · calibrated p 0.024 ✓ | 9.9 EB05 9.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · ♀ 92% (drug 65%) | NCT00346216: 2/8,030 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| Joint range of motion decreased | 1,207 | 10.4 9.8–11.0ROR 10.5 · calibrated p 0.028 ✓ | 9.5 EB05 9.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · ♀ 93% (drug 65%) | not reported in cached trials |
| Hypercholesterolaemia | 855 | 10.3 9.6–11.0ROR 10.3 · calibrated p 0.029 ✓ | 9.4 EB05 8.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · ♀ 92% (drug 65%) · 90% clinician | not reported in cached trials |
| Lower respiratory tract infection | 3,985 | 10.1 9.8–10.4ROR 10.3 · calibrated p 0.029 ✓ | 9.3 EB05 9.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | age-adj. PRR 8.4 · serious PRR 7.7 · ♀ 95% (drug 65%) | NCT00346216: 1/7,992 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| Systemic lupus erythematosus | 3,001 | 9.7 9.4–10.1ROR 9.9 · calibrated p 0.034 ✓ | 9.0 EB05 8.7 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 9.5 · serious PRR 7.3 · ♀ 100% (drug 65%) · 91% clinician | not reported in cached trials |
| Wound infection | 909 | 9.6 8.9–10.2ROR 9.6 · calibrated p 0.037 ✓ | 8.8 EB05 8.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · ♀ 94% (drug 65%) · 91% clinician | NCT00346216: 2/7,992 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| Fibromyalgia | 1,962 | 9.2 8.8–9.6ROR 9.3 · calibrated p 0.041 ✓ | 8.5 EB05 8.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · ♀ 95% (drug 65%) | not reported in cached trials |
| Liver injury | 1,852 | 8.7 8.3–9.1ROR 8.8 · calibrated p 0.050 ✓ | 8.1 EB05 7.8 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 7.0 · serious PRR 6.6 · ♀ 88% (drug 65%) · 92% clinician | NCT00346216: 1/7,992 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| Tubulointerstitial nephritis | 1,414 | 8.6 8.1–9.0ROR 8.6 · calibrated p 0.053 | 8.0 EB05 7.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | age-adj. PRR 7.4 · serious PRR 6.3 · 94% clinician | NCT00346216: 1/7,992 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| Muscle spasticity | 904 | 8.2 7.7–8.8ROR 8.3 · calibrated p 0.060 | 7.7 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · ♀ 92% (drug 65%) | not reported in cached trials |
| Blister | 3,892 | 7.8 7.6–8.1ROR 8.0 · calibrated p 0.067 | 7.3 EB05 7.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | age-adj. PRR 6.0 · serious PRR 9.1 · ♀ 93% (drug 65%) | not reported in cached trials |
| Arthropathy | 3,808 | 7.7 7.4–7.9ROR 7.8 · calibrated p 0.072 | 7.2 EB05 7.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | age-adj. PRR 7.2 · serious PRR 6.8 · ♀ 93% (drug 65%) | NCT00346216: 2/7,992 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| Obesity | 1,079 | 7.6 7.1–8.1ROR 7.6 · calibrated p 0.077 | 7.1 EB05 6.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 · ♀ 88% (drug 65%) | NCT00346216: 5/7,992 (0.1%) on Ibuprofen and Film-Coated (serious AE) |
| Psoriatic arthropathy | 2,670 | 7.5 7.2–7.8ROR 7.5 · calibrated p 0.079 | 7.0 EB05 6.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | not reported in cached trials |
| Therapeutic product effect decreased | 2,921 | 7.4 7.1–7.7ROR 7.5 · calibrated p 0.081 | 7.0 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 7.6 · serious PRR 10.4 · ♀ 94% (drug 65%) | not reported in cached trials |
| Red blood cell sedimentation rate increased | 717 | 7.2 6.7–7.8ROR 7.3 · calibrated p 0.089 | 6.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | age-adj. PRR 6.5 · serious PRR 6.0 · ♀ 90% (drug 65%) | not reported in cached trials |
| Ear pain | 1,229 | 7.1 6.7–7.5ROR 7.1 · calibrated p 0.095 | 6.7 EB05 6.4 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | age-adj. PRR 5.4 · serious PRR 7.9 · ♀ 92% (drug 65%) | NCT00346216: 7/7,992 (0.1%) on Ibuprofen and Film-Coated (serious AE) |
| Angioedema (deep swelling of face/throat) | 2,783 | 7.1 6.8–7.3ROR 7.1 · calibrated p 0.093 | 6.7 EB05 6.5 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 5.8 · serious PRR 5.5 · 94% clinician | NCT00346216: 4/7,992 (0.1%) on Ibuprofen and Film-Coated (serious AE) |
| Sciatica | 1,000 | 7.1 6.6–7.5ROR 7.1 · calibrated p 0.096 | 6.6 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · ♀ 90% (drug 65%) | NCT00346216: 2/7,992 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| End stage renal disease | 1,155 | 7.0 6.6–7.4ROR 7.0 · calibrated p 0.097 | 6.6 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | not reported in cached trials |
| Night sweats | 2,008 | 7.0 6.7–7.3ROR 7.0 · calibrated p 0.097 | 6.6 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · ♀ 89% (drug 65%) | not reported in cached trials |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 935 | 6.9 6.5–7.4ROR 7.0 · calibrated p 0.101 | 6.5 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 5.7 · serious PRR 5.2 · 95% clinician | not reported in cached trials |
| Discomfort | 3,743 | 6.9 6.7–7.1ROR 7.0 · calibrated p 0.098 | 6.5 EB05 6.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | age-adj. PRR 6.2 · serious PRR 8.4 · ♀ 91% (drug 65%) | NCT00346216: 1/7,933 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| Renal tubular necrosis | 606 | 6.9 6.3–7.5ROR 6.9 · calibrated p 0.103 | 6.5 EB05 6.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | age-adj. PRR 4.9 · serious PRR 5.2 · 100% clinician | not reported in cached trials |
| Stomatitis (mouth sores) | 3,614 | 6.6 6.4–6.9ROR 6.7 · calibrated p 0.110 | 6.3 EB05 6.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | age-adj. PRR 5.3 · serious PRR 7.1 · ♀ 94% (drug 65%) | not reported in cached trials |
| Chronic kidney disease | 4,452 | 6.5 6.3–6.7ROR 6.6 · calibrated p 0.117 | 6.1 EB05 6.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | age-adj. PRR 5.3 · serious PRR 4.9 | NCT00346216: 2/7,992 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| Type 2 diabetes mellitus | 1,942 | 6.4 6.1–6.7ROR 6.4 · calibrated p 0.124 | 6.1 EB05 5.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · ♀ 91% (drug 65%) | NCT00346216: 1/7,992 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| Intentional overdose | 3,640 | 6.3 6.1–6.6ROR 6.4 · calibrated p 0.124 | 6.0 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 4.9 · serious PRR 4.9 · 94% clinician | NCT00346216: 1/7,933 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
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)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Ibuprofen and Film-Coated 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 (20 of 40 signal terms matched).
- NCT00346216 — Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen (N=24081, PHASE4; 1238 AE terms posted; arms: Celecoxib; Ibuprofen; Naproxen)
- NCT01789606 — Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet (N=1083, PHASE3; 60 AE terms posted; arms: Compliance Arm)
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) | 15,699 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.499 | 1.3 EB05 1.2 · IC025 +0.3 | Reporting / coding artifact | age-adj. PRR 1.3 · serious PRR 1.8 | not reported in cached trials |
| 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 | Labeled — boxed warning exact term | age-adj. PRR 2.7 · serious PRR 2.7 | NCT00346216: 7/7,992 (0.1%) on Ibuprofen and Film-Coated (serious AE) |
| Fatigue (tiredness) | 14,474 | 2.0 2.0–2.0ROR 2.1 · calibrated p 0.980 | 2.0 EB05 1.9 · IC025 +1.0 | Not in label — unassessed | age-adj. PRR 1.8 · serious PRR 2.2 | NCT00346216: 2/7,992 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| Nausea | 13,506 | 1.8 1.8–1.9ROR 1.9 · calibrated p 0.879 | 1.8 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 2.0 | NCT00346216: 3/7,992 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| Headache | 12,089 | 2.1 2.0–2.1ROR 2.1 · calibrated p 0.986 | 2.0 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 2.3 | NCT00346216: 6/7,992 (0.1%) on Ibuprofen and Film-Coated (serious AE) |
| 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 | Not in label — unassessed | age-adj. PRR 2.4 · serious PRR 3.3 | NCT00346216: 33/7,992 (0.4%) on Ibuprofen and Film-Coated (serious AE) |
| 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 | Not in label — unassessed | age-adj. PRR 1.8 · serious PRR 1.9 | NCT00346216: 24/7,992 (0.3%) on Ibuprofen and Film-Coated (serious AE) |
| 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 | Labeled adverse reaction exact term | age-adj. PRR 2.0 · serious PRR 2.2 | NCT00346216: 7/7,992 (0.1%) on Ibuprofen and Film-Coated (serious AE) |
| Diarrhoea (diarrhea) | 9,701 | 1.6 1.6–1.6ROR 1.6 · calibrated p 0.729 | 1.6 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.7 | NCT00346216: 8/7,992 (0.1%) on Ibuprofen and Film-Coated (serious AE) |
| 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 | Labeled adverse reaction exact term | age-adj. PRR 2.0 · serious PRR 3.1 | NCT00346216: 1/8,030 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| 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 | Reporting / coding artifact | age-adj. PRR 0.9 · serious PRR 1.2 | not reported in cached trials |
| Dizziness | 8,172 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.818 | 1.7 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 1.8 | NCT00346216: 5/7,992 (0.1%) on Ibuprofen and Film-Coated (serious AE) |
| 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 | Labeled adverse reaction exact term | age-adj. PRR 1.8 · serious PRR 3.3 | NCT00346216: 1/7,933 (0.0%) on Ibuprofen and Film-Coated (serious AE) |
| 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 | Labeled (related wording) related wording | age-adj. PRR 1.9 · serious PRR 2.1 | NCT00346216: 4/7,992 (0.1%) on Ibuprofen and Film-Coated (serious AE) |
| 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 | Labeled (related wording) related wording | age-adj. PRR 3.9 · serious PRR 3.6 | NCT00346216: 39/7,992 (0.5%) on Ibuprofen and Film-Coated (serious AE) |
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.
- Folliculitis — n=2,860, PRR 40.3
- Helicobacter infection — n=2,811, PRR 40.1
- Pemphigus — n=2,876, PRR 31.6
- Hand deformity — n=2,789, PRR 28.5
- Pericarditis — n=3,109, PRR 24.1 (also seen in trial arm)
- Synovitis — n=3,101, PRR 21.8 (also seen in trial arm)
- Irritable bowel syndrome — n=3,158, PRR 18.2 (also seen in trial arm)
- Wound — n=2,830, PRR 11.9 (also seen in trial arm)
- Autoimmune disorder — n=900, PRR 10.9 (also seen in trial arm)
- Bursitis — n=1,130, PRR 10.8 (also seen in trial arm)
✓ 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 and Film-Coated?
In FDA FAERS, the most frequently co-reported reaction terms for Ibuprofen and Film-Coated 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 and Film-Coated have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see WARNINGS and PRECAUTIONS ].
Do FAERS signals prove that Ibuprofen and Film-Coated 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 0387bfaa-daca-48ec-b718-0216a848c16a, effective 20260710; matched on
openfda.generic_name.exact:"IBUPROFEN" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 996 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, 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.