Hydrocodone Bitartrate and Ibuprofen side effects: what 467 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Hydrocodone Bitartrate (Hydrocodone Bitartrate)
Who reports
467 reports · 82% serious · 82 with death outcome · 46% female
Used for
Hydrocodone bitartrate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limita.
What it is
Hydrocodone bitartrate extended-release tablets are supplied in 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg film-coated tablets for oral administration. The tablet strengths describe the amount of hydrocodone per tablet as the bitartrate salt. Hydrocodone bitartrate is an opioid agonist.
Boxed warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDROCODONE BITARTRATE EXTENDED-RELEASE TABLETS Addiction, Abuse, and Misuse Because the use of hydrocodone bitartrate extended-release tablets exposes patients and othe.
Causality screen of the 11 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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.
- 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.
- 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. 1 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 |
|---|---|---|---|---|---|---|
| Dependence | 269 | 218.5 202.0–236.3ROR 513.9 · χ² 57,884 / p <1e-300 | 214.1 EB05 193.5 · IC025 +7.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 153.7 · 99% consumer | no trial data cached |
| Product prescribing issue | 18 | 39.7 25.3–62.5ROR 41.3 · χ² 642 / p 7e-142 | 38.2 EB05 25.6 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 73.3 | no trial data cached |
| Overdose | 166 | 34.4 30.5–38.9ROR 52.9 · χ² 5,407 / p <1e-300 | 34.3 EB05 30.1 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 30.5 · 99% consumer | no trial data cached |
| Ill-defined disorder | 33 | 24.4 17.5–33.9ROR 26.2 · χ² 719 / p 1e-158 | 24.1 EB05 17.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 25.8 · 100% consumer | no trial data cached |
| Withdrawal syndrome | 19 | 20.2 13.0–31.4ROR 21.0 · χ² 329 / p 1e-73 | 19.8 EB05 13.2 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 20.4 | no trial data cached |
| Drug withdrawal syndrome neonatal | 5 | 15.0 6.3–35.9ROR 15.2 · χ² 52 / p 3e-13 | 10.5 EB05 3.7 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.6 | no trial data cached |
| Tooth loss | 6 | 12.9 5.8–28.6ROR 13.1 · χ² 55 / p 8e-14 | 9.3 EB05 3.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Drug dependence | 33 | 9.1 6.6–12.7ROR 9.7 · χ² 232 / p 1e-52 | 8.5 EB05 6.2 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 · 90% consumer | no trial data cached |
| Drug withdrawal syndrome | 10 | 5.1 2.7–9.3ROR 5.2 · χ² 29 / p 4e-8 | 4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Drug abuse | 8 | 4.3 2.2–8.5ROR 4.4 · χ² 17 / p 2e-5 | 3.6 EB05 2.0 · IC025 +0.6 | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Completed suicide (death by suicide) | 8 | 4.3 2.1–8.5ROR 4.3 · χ² 17 / p 2e-5 | 3.5 EB05 2.0 · IC025 +0.6 | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 3.0 | 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 |
|---|---|---|---|---|---|---|
| Dependence | 269 | 218.5 202.0–236.3ROR 513.9 · χ² 57,884 / p <1e-300 | 214.1 EB05 193.5 · IC025 +7.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 153.7 · 99% consumer | no trial data cached |
| Overdose | 166 | 34.4 30.5–38.9ROR 52.9 · χ² 5,407 / p <1e-300 | 34.3 EB05 30.1 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 30.5 · 99% consumer | no trial data cached |
| Drug dependence | 33 | 9.1 6.6–12.7ROR 9.7 · χ² 232 / p 1e-52 | 8.5 EB05 6.2 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 · 90% consumer | no trial data cached |
| Ill-defined disorder | 33 | 24.4 17.5–33.9ROR 26.2 · χ² 719 / p 1e-158 | 24.1 EB05 17.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 25.8 · 100% consumer | no trial data cached |
| Withdrawal syndrome | 19 | 20.2 13.0–31.4ROR 21.0 · χ² 329 / p 1e-73 | 19.8 EB05 13.2 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 20.4 | no trial data cached |
| Product prescribing issue | 18 | 39.7 25.3–62.5ROR 41.3 · χ² 642 / p 7e-142 | 38.2 EB05 25.6 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 73.3 | no trial data cached |
| Drug withdrawal syndrome | 10 | 5.1 2.7–9.3ROR 5.2 · χ² 29 / p 4e-8 | 4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Completed suicide (death by suicide) | 8 | 4.3 2.1–8.5ROR 4.3 · χ² 17 / p 2e-5 | 3.5 EB05 2.0 · IC025 +0.6 | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 3.0 | no trial data cached |
| Drug abuse | 8 | 4.3 2.2–8.5ROR 4.4 · χ² 17 / p 2e-5 | 3.6 EB05 2.0 · IC025 +0.6 | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Tooth loss | 6 | 12.9 5.8–28.6ROR 13.1 · χ² 55 / p 8e-14 | 9.3 EB05 3.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Drug withdrawal syndrome neonatal | 5 | 15.0 6.3–35.9ROR 15.2 · χ² 52 / p 3e-13 | 10.5 EB05 3.7 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.6 | no trial data cached |
| Intentional drug misuse | 3 | 6.4 2.1–19.6ROR 6.4 · χ² 9 / p 0.002 | 3.7 EB05 1.4 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 8.0 | no trial data cached |
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.
- Ill-defined disorder — n=33, PRR 24.4
✓ 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 Hydrocodone Bitartrate and Ibuprofen?
In FDA FAERS, the most frequently co-reported reaction terms for Hydrocodone Bitartrate and Ibuprofen are dependence, ill-defined disorder, withdrawal syndrome, drug withdrawal syndrome, tooth loss, drug withdrawal syndrome neonatal. 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 Hydrocodone Bitartrate and Ibuprofen have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDROCODONE BITARTRATE EXTENDED-RELEASE TABLETS Addiction, Abuse, and Misuse Because the use of hydrocodone bitartrate extended-release tablets exposes patients and othe.
Do FAERS signals prove that Hydrocodone Bitartrate and Ibuprofen 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 f7b55d14-0980-b680-8ceb-7489ff65455e, effective 20251007; matched on
openfda.generic_name.exact:"HYDROCODONE BITARTRATE") - 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, 12 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.