Ibuprofen and Pseudoephedrine side effects: what 1,249 FDA adverse event reports show
Drug class
Nonsteroidal Anti-inflammatory Drug
Label matched
Ibuprofen (Ibuprofen)
Who reports
1,249 reports · 25% serious · 12 with death outcome · 69% female
Used for
Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
What it is
DESCRIPTION Ibuprofen tablets USP contain the active ingredient ibuprofen, which is (±) - 2 - ( p - isobutylphenyl) propionic acid. Ibuprofen is a white to off-white, crystalline powder with 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 ].
Causality screen of the 14 strongest signals
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 7 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 |
|---|---|---|---|---|---|---|
| Drug effective for unapproved indication | 26 | 14.9 10.2–21.9ROR 15.2 · χ² 325 / p 7e-73 | 14.5 EB05 10.2 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | 100% consumer | no trial data cached |
| Product complaint | 20 | 13.5 8.7–20.8ROR 13.7 · χ² 218 / p 1e-49 | 12.7 EB05 8.2 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious n=2 · 100% consumer | no trial data cached |
| Feeling jittery | 15 | 13.2 8.0–21.8ROR 13.3 · χ² 157 / p 3e-36 | 12.1 EB05 7.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Drug effect incomplete | 27 | 12.3 8.5–17.9ROR 12.5 · χ² 269 / p 8e-61 | 11.7 EB05 8.1 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Choking | 13 | 11.2 6.5–19.3ROR 11.3 · χ² 111 / p 3e-26 | 9.7 EB05 5.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 25.5 | no trial data cached |
| Skin laceration | 7 | 10.9 5.2–22.8ROR 10.9 · χ² 53 / p 1e-13 | 7.9 EB05 3.6 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Product packaging issue | 6 | 10.9 4.9–24.1ROR 10.9 · χ² 44 / p 1e-11 | 7.5 EB05 3.3 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious n=1 | no trial data cached |
| Therapeutic response unexpected | 29 | 10.8 7.5–15.5ROR 11.0 · χ² 249 / p 2e-56 | 10.2 EB05 7.2 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 6.6 · 96% consumer | no trial data cached |
| Lip swelling | 15 | 7.6 4.6–12.5ROR 7.7 · χ² 79 / p 3e-19 | 6.4 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.2 | no trial data cached |
| Eye swelling | 15 | 6.8 4.1–11.3ROR 6.9 · χ² 69 / p 6e-17 | 5.8 EB05 3.7 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.9 | no trial data cached |
| Product taste abnormal | 5 | 6.2 2.6–15.0ROR 6.3 · χ² 17 / p 2e-5 | 4.2 EB05 2.0 · IC025 +0.5 | Reporting / coding artifact | serious n=1 | no trial data cached |
| Expired product administered | 12 | 6.1 3.5–10.7ROR 6.1 · χ² 46 / p 6e-12 | 5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Product physical issue | 6 | 5.1 2.3–11.2ROR 5.1 · χ² 16 / p 4e-5 | 3.8 EB05 1.9 · IC025 +0.5 | Reporting / coding artifact | – | no trial data cached |
| Drug effect decreased | 11 | 3.4 1.9–6.1ROR 3.4 · χ² 16 / p 3e-5 | 3.0 EB05 1.8 · IC025 +0.6 | Reporting / coding artifact | serious PRR 2.4 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Therapeutic response unexpected | 29 | 10.8 7.5–15.5ROR 11.0 · χ² 249 / p 2e-56 | 10.2 EB05 7.2 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 6.6 · 96% consumer | no trial data cached |
| Drug effect incomplete | 27 | 12.3 8.5–17.9ROR 12.5 · χ² 269 / p 8e-61 | 11.7 EB05 8.1 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Drug effective for unapproved indication | 26 | 14.9 10.2–21.9ROR 15.2 · χ² 325 / p 7e-73 | 14.5 EB05 10.2 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | 100% consumer | no trial data cached |
| Product complaint | 20 | 13.5 8.7–20.8ROR 13.7 · χ² 218 / p 1e-49 | 12.7 EB05 8.2 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious n=2 · 100% consumer | no trial data cached |
| Eye swelling | 15 | 6.8 4.1–11.3ROR 6.9 · χ² 69 / p 6e-17 | 5.8 EB05 3.7 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.9 | no trial data cached |
| Lip swelling | 15 | 7.6 4.6–12.5ROR 7.7 · χ² 79 / p 3e-19 | 6.4 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.2 | no trial data cached |
| Feeling jittery | 15 | 13.2 8.0–21.8ROR 13.3 · χ² 157 / p 3e-36 | 12.1 EB05 7.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Choking | 13 | 11.2 6.5–19.3ROR 11.3 · χ² 111 / p 3e-26 | 9.7 EB05 5.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 25.5 | no trial data cached |
| Expired product administered | 12 | 6.1 3.5–10.7ROR 6.1 · χ² 46 / p 6e-12 | 5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Drug effect decreased | 11 | 3.4 1.9–6.1ROR 3.4 · χ² 16 / p 3e-5 | 3.0 EB05 1.8 · IC025 +0.6 | Reporting / coding artifact | serious PRR 2.4 | no trial data cached |
| Drug dependence | 10 | 1.0 0.6–1.9ROR 1.0 · χ² 0 / p 0.475 | 1.1 EB05 0.6 · IC025 -1.0 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 2.4 | no trial data cached |
| Skin laceration | 7 | 10.9 5.2–22.8ROR 10.9 · χ² 53 / p 1e-13 | 7.9 EB05 3.6 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Product physical issue | 6 | 5.1 2.3–11.2ROR 5.1 · χ² 16 / p 4e-5 | 3.8 EB05 1.9 · IC025 +0.5 | Reporting / coding artifact | – | no trial data cached |
| Product packaging issue | 6 | 10.9 4.9–24.1ROR 10.9 · χ² 44 / p 1e-11 | 7.5 EB05 3.3 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious n=1 | no trial data cached |
| Dependence | 5 | 1.5 0.6–3.6ROR 1.5 · χ² 0 / p 0.257 | 1.5 EB05 0.7 · IC025 -1.0 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
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.
✓ 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 Pseudoephedrine?
In FDA FAERS, the most frequently co-reported reaction terms for Ibuprofen and Pseudoephedrine are drug effective for unapproved indication, eye swelling, lip swelling, feeling jittery, choking, skin laceration. 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 Pseudoephedrine 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 Pseudoephedrine 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 00872852-680a-41b3-901b-b991b12a176d, effective 20250214; matched on
openfda.generic_name.exact:"IBUPROFEN") - 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, 21 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
Page generated 2026-10-08. 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.