Drug · FAERS side-effect profile with label screen

Ibuprofen 200 side effects: what 198,333 FDA adverse event reports show

Ibuprofen 200 Mg · 1,174 reaction terms · 991,076 drug–reaction co-reports · data 2026-09-14

Drug class

Nonsteroidal Anti-inflammatory Drug

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Ibuprofen 200 Mg (Ibuprofen Fast Relief Medicine For Pain)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

198,333 reports · 73% serious · 16,224 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). 1,134 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

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 80.9–123.1ROR 99.9 · calibrated p 2e-7 ✓	51.0 EB05 44.9 · IC025 +5.2 3/3 methods agree	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 41.1 · IC025 +5.2 3/3 methods agree	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 72.6 · calibrated p 1e-6 ✓	42.9 EB05 40.4 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=797 · ♀ 100% (drug 65%) · 91% clinician	not reported in cached trials
Duodenal ulcer perforation	2,892	68.6 65.5–71.9ROR 69.6 · calibrated p 2e-6 ✓	41.6 EB05 40.4 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 32.8 · ♀ 96% (drug 65%) · 93% clinician	NCT00346216: 2/7,933 (0.0%) on Ibuprofen 200 (serious AE)
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	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	Lab value / disease marker	serious PRR 31.0 · ♀ 100% (drug 65%) · 94% clinician	not reported in cached trials
Lupus vulgaris	431	59.8 53.1–67.4ROR 60.0 · calibrated p 4e-6 ✓	38.2 EB05 35.3 · IC025 +5.0 3/3 methods agree	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	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	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 52.6–58.3ROR 55.9 · calibrated p 7e-6 ✓	36.4 EB05 35.1 · IC025 +5.1 3/3 methods agree	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	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	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 40.6–57.0ROR 48.1 · calibrated p 2e-5 ✓	33.0 EB05 29.3 · IC025 +4.7 3/3 methods agree	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	Not in label — unassessed	serious n=1,258 · ♀ 100% (drug 65%) · 94% clinician	not reported in cached trials
X-ray abnormal	510	42.1 38.0–46.6ROR 42.2 · calibrated p 4e-5 ✓	30.2 EB05 28.0 · IC025 +4.7 3/3 methods agree	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	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	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	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	Not in label — unassessed	serious n=238 · 100% clinician	not reported in cached trials
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	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 32.5 · calibrated p 2e-4 ✓	24.9 EB05 23.4 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=742 · ♀ 100% (drug 65%) · 92% clinician	NCT00346216: 1/7,933 (0.0%) on Ibuprofen 200 (serious AE)
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	Not in label — unassessed	serious PRR 19.3 · ♀ 100% (drug 65%) · 94% clinician	not reported in cached trials
Hand deformity	2,789	28.5 27.3–29.7ROR 28.8 · 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
Retinitis	335	26.4 23.4–29.7ROR 26.4 · calibrated p 5e-4 ✓	21.2 EB05 19.3 · IC025 +4.2 3/3 methods agree	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	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	Not in label — unassessed	serious PRR 15.7 · ♀ 95% (drug 65%) · 92% clinician	NCT00346216: 1/7,992 (0.0%) on Ibuprofen 200 (serious AE)
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	Not in label — unassessed	serious n=282	not reported in cached trials
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	Not in label — unassessed	serious n=699 · ♀ 100% (drug 65%) · 92% clinician	NCT00346216: 1/7,992 (0.0%) on Ibuprofen 200 (serious AE)
Synovitis	3,101	21.8 20.9–22.6ROR 22.1 · calibrated p 0.001 ✓	18.2 EB05 17.6 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 14.9 · ♀ 95% (drug 65%) · 92% clinician	NCT00346216: 1/8,030 (0.0%) on Ibuprofen 200 (serious AE)
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	Not in label — unassessed	serious n=138 · ♀ 100% (drug 65%) · 100% clinician	not reported in cached trials
Gastric ulcer perforation	200	19.6 16.9–22.8ROR 19.7 · calibrated p 0.002 ✓	16.6 EB05 14.8 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=200 · 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	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 14.2 · IC025 +3.7 3/3 methods agree	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	Not in label — unassessed	serious PRR 15.4 · ♀ 98% (drug 65%)	NCT00346216: 1/8,030 (0.0%) on Ibuprofen 200 (serious AE)
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	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	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	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	Not in label — unassessed	serious n=189 · ♀ 0% (drug 65%) · 100% clinician	not reported in cached trials
Obstructive sleep apnoea syndrome	164	14.0 11.9–16.4ROR 14.0 · calibrated p 0.010 ✓	12.3 EB05 10.8 · IC025 +3.3 3/3 methods agree	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	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	4,843	4.24.1–4.3	signal
Severe cutaneous reaction	2,767	4.03.9–4.2	signal
Gi bleeding	5,628	3.33.2–3.4	signal
Suicidality	7,531	3.33.2–3.4	signal
Liver injury	8,920	3.23.1–3.3	signal
Tendon disorder	1,067	3.02.8–3.2	signal
Kidney injury	11,980	2.82.8–2.9	signal
Depression	5,735	2.22.1–2.2	signal
Venous thromboembolism	3,759	1.81.8–1.9	raised
Pancreatitis	1,305	1.71.6–1.8	raised
Serious infection	12,400	1.71.7–1.7	raised
Hyponatraemia	1,200	1.61.5–1.7	raised
Rhabdomyolysis / myopathy	1,193	1.61.5–1.7	raised
Interstitial lung disease	1,372	1.51.4–1.6	raised
Anaemia	4,275	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 200 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 (6 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)
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)

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)	15,701	1.3 1.2–1.3ROR 1.3 · calibrated p 0.498	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	15,065	2.6 2.6–2.7ROR 2.8 · calibrated p 0.709	2.6 EB05 2.6 · IC025 +1.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	age-adj. PRR 2.7 · serious PRR 2.7	NCT00346216: 7/7,992 (0.1%) on Ibuprofen 200 (serious AE)
Fatigue (tiredness)	14,484	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 200 (serious AE)
Nausea	13,511	1.8 1.8–1.9ROR 1.9 · calibrated p 0.879	1.8 EB05 1.8 · IC025 +0.8	Not in label — unassessed	age-adj. PRR 1.7 · serious PRR 2.0	NCT00346216: 3/7,992 (0.0%) on Ibuprofen 200 (serious AE)
Headache	12,098	2.1 2.0–2.1ROR 2.1 · calibrated p 0.986	2.0 EB05 2.0 · IC025 +1.0 3/3 methods agree	Likely indication confounding term in indications	age-adj. PRR 1.7 · serious PRR 2.3	NCT00346216: 6/7,992 (0.1%) on Ibuprofen 200 (serious AE)
Arthralgia (joint pain)	10,926	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 200 (serious AE)
Dyspnoea (shortness of breath)	10,540	2.0 2.0–2.0ROR 2.0 · calibrated p 0.968	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 200 (serious AE)
Vomiting	9,986	2.3 2.2–2.3ROR 2.3 · calibrated p 0.881	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 2.0 · serious PRR 2.2	NCT00346216: 7/7,992 (0.1%) on Ibuprofen 200 (serious AE)
Diarrhoea (diarrhea)	9,705	1.6 1.6–1.6ROR 1.6 · calibrated p 0.728	1.6 EB05 1.6 · IC025 +0.6	Not in label — unassessed	age-adj. PRR 1.5 · serious PRR 1.7	NCT00346216: 8/7,992 (0.1%) on Ibuprofen 200 (serious AE)
Rash	9,033	2.2 2.2–2.3ROR 2.3 · calibrated p 0.910	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 200 (serious AE)
Off label use (used outside approved label)	8,569	1.0 1.0–1.1ROR 1.0 · calibrated p 0.336	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	8,183	1.7 1.7–1.8ROR 1.8 · calibrated p 0.819	1.7 EB05 1.7 · IC025 +0.8	Not in label — unassessed	age-adj. PRR 1.7 · serious PRR 1.8	NCT00346216: 5/7,992 (0.1%) on Ibuprofen 200 (serious AE)
Pruritus (itching)	7,914	2.2 2.2–2.3ROR 2.3 · calibrated p 0.907	2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	age-adj. PRR 1.8 · serious PRR 3.3	NCT00346216: 1/7,933 (0.0%) on Ibuprofen 200 (serious AE)
Pyrexia (fever)	7,891	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 200 (serious AE)
Acute kidney injury (sudden kidney damage)	6,628	4.8 4.7–4.9ROR 4.9 · calibrated p 0.246	4.6 EB05 4.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	age-adj. PRR 3.9 · serious PRR 3.6	NCT00346216: 39/7,992 (0.5%) on Ibuprofen 200 (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.

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 (also seen in trial arm)
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 200?

In FDA FAERS, the most frequently co-reported reaction terms for Ibuprofen 200 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 200 have an FDA boxed warning?

No. The FDA label retrieved for Ibuprofen 200 has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Ibuprofen 200 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 dd63b011-0573-4374-9669-8d29146e5fc9, effective 20171117; matched on openfda.generic_name.exact:"IBUPROFEN 200 MG")
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, field patient.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 IBUPROFEN 200, 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.