Ibuprofen Lysine side effects: what 564 FDA adverse event reports show

Ibuprofen Lysine · 13 reaction terms · 140 drug–reaction co-reports · data 2026-09-14

Drug class

Nonsteroidal anti-inflammatory drug

FDA label, Indications wording

Who reports

564 reports · 97% serious · 94 with death outcome · 50% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Ibuprofen Lysine Injection is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The clinical trial was conducted among infants with an asymptomatic PDA.

FDA label, Indications and Usage

What it is

Ibuprofen Lysine Injection is a clear sterile preservative-free solution of the L-lysine salt of (±)-ibuprofen which is the active ingredient. (±)-Ibuprofen is a nonsteroidal anti-inflammatory agent (NSAID). L-lysine is used to create a water-soluble drug product salt suitable for intravenous administration.

FDA label, Description section

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 9 strongest signals

Labeled adverse reaction 3Labeled (related wording) 1Outcome field, not a reaction 1Not in label — unassessed 4

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.
Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
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. 4 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
Intestinal perforation	25	82.9 56.5–121.7ROR 86.7 · χ² 1,938 / p <1e-300	78.0 EB05 55.5 · IC025 +4.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 47.2 · 100% clinician	no trial data cached
Haemorrhage intracranial	14	34.7 20.7–58.3ROR 35.6 · χ² 425 / p 9e-95	33.3 EB05 21.0 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 20.6	no trial data cached
Poisoning deliberate	8	32.0 16.1–63.7ROR 32.4 · χ² 210 / p 7e-48	29.7 EB05 15.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 18.9	no trial data cached
Pulmonary hypertension	17	30.2 18.9–48.3ROR 31.2 · χ² 452 / p 1e-100	29.3 EB05 19.4 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.1	no trial data cached
Pneumothorax	9	21.1 11.0–40.4ROR 21.4 · χ² 153 / p 2e-35	19.7 EB05 10.1 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.6	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	11	18.4 10.2–33.0ROR 18.7 · χ² 164 / p 9e-38	17.2 EB05 9.4 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.0	no trial data cached
Pancreatitis acute	10	16.7 9.0–30.8ROR 17.0 · χ² 132 / p 7e-31	15.2 EB05 7.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.9	no trial data cached
Gastric haemorrhage	5	16.1 6.7–38.4ROR 16.2 · χ² 56 / p 3e-14	11.6 EB05 3.9 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 7.9	no trial data cached
Completed suicide (death by suicide)	27	11.9 8.3–17.2ROR 12.5 · χ² 261 / p 6e-59	11.3 EB05 7.9 · IC025 +2.7 3/3 methods agree	Outcome field, not a reaction	serious PRR 7.1	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Completed suicide (death by suicide)	27	11.9 8.3–17.2ROR 12.5 · χ² 261 / p 6e-59	11.3 EB05 7.9 · IC025 +2.7 3/3 methods agree	Outcome field, not a reaction	serious PRR 7.1	no trial data cached
Intestinal perforation	25	82.9 56.5–121.7ROR 86.7 · χ² 1,938 / p <1e-300	78.0 EB05 55.5 · IC025 +4.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 47.2 · 100% clinician	no trial data cached
Pulmonary hypertension	17	30.2 18.9–48.3ROR 31.2 · χ² 452 / p 1e-100	29.3 EB05 19.4 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.1	no trial data cached
Haemorrhage intracranial	14	34.7 20.7–58.3ROR 35.6 · χ² 425 / p 9e-95	33.3 EB05 21.0 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 20.6	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	11	18.4 10.2–33.0ROR 18.7 · χ² 164 / p 9e-38	17.2 EB05 9.4 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.0	no trial data cached
Pancreatitis acute	10	16.7 9.0–30.8ROR 17.0 · χ² 132 / p 7e-31	15.2 EB05 7.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.9	no trial data cached
Pneumothorax	9	21.1 11.0–40.4ROR 21.4 · χ² 153 / p 2e-35	19.7 EB05 10.1 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.6	no trial data cached
Poisoning deliberate	8	32.0 16.1–63.7ROR 32.4 · χ² 210 / p 7e-48	29.7 EB05 15.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 18.9	no trial data cached
Gastric haemorrhage	5	16.1 6.7–38.4ROR 16.2 · χ² 56 / p 3e-14	11.6 EB05 3.9 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 7.9	no trial data cached
Intentional self-injury	4	7.4 2.8–19.6ROR 7.4 · χ² 16 / p 3e-5	4.5 EB05 1.9 · IC025 +0.3	Reporting / coding artifact	serious PRR 4.4	no trial data cached
Initial insomnia	4	14.6 5.5–38.7ROR 14.7 · χ² 38 / p 4e-10	9.0 EB05 2.9 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Sopor	3	8.3 2.7–25.8ROR 8.4 · χ² 13 / p 2e-4	4.4 EB05 1.6 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 4.9	no trial data cached
Abnormal weight gain	3	8.9 2.9–27.6ROR 9.0 · χ² 14 / p 9e-5	4.7 EB05 1.7 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious n=3	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 Lysine?

In FDA FAERS, the most frequently co-reported reaction terms for Ibuprofen Lysine are intestinal perforation, pulmonary hypertension, haemorrhage intracranial, stevens-johnson syndrome, pancreatitis acute, pneumothorax. 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 Lysine have an FDA boxed warning?

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

Do FAERS signals prove that Ibuprofen Lysine 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 6cfdec66-9483-4abe-98d3-3a7d389cc952, effective 20240101; matched on openfda.generic_name.exact:"IBUPROFEN LYSINE")
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, 13 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.