Hydrocodone Polistirex side effects: what 976 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Hydrocodone Polistirex And Chlorpheniramine Polistirex (Hydrocodone Polistirex And Chlorpheniramine Polistirex Extended-Release)
Who reports
976 reports · 94% serious · 196 with death outcome · 41% female
Used for
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use : • Not indicated for pediatric patients under 18 years of age [ see Use in Specific Populations (8.4 ) ].
What it is
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension contains hydrocodone, an opioid agonist; and chlorpheniramine, a histamine-1 (H 1 ) receptor antagonist. Each.
Boxed warning
ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACT.
Causality screen of the 13 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.
- 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. 0 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 | 826 | 324.3 315.3–333.5ROR 2,104.6 · χ² 262,585 / p <1e-300 | 317.1 EB05 299.3 · IC025 +8.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 196.2 · 100% consumer | no trial data cached |
| Overdose | 463 | 46.0 43.1–49.2ROR 86.6 · χ² 20,513 / p <1e-300 | 45.8 EB05 42.4 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 35.3 · 100% consumer | no trial data cached |
| Withdrawal syndrome | 35 | 17.8 12.9–24.7ROR 18.4 · χ² 540 / p 1e-119 | 17.6 EB05 13.2 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 15.7 · 100% consumer | no trial data cached |
| Product prescribing issue | 15 | 15.8 9.6–26.2ROR 16.1 · χ² 194 / p 2e-44 | 15.0 EB05 9.0 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 23.7 | no trial data cached |
| Ill-defined disorder | 41 | 14.5 10.7–19.6ROR 15.1 · χ² 503 / p 1e-111 | 14.3 EB05 10.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 · 100% consumer | no trial data cached |
| Brain injury | 6 | 12.9 5.8–28.5ROR 12.9 · χ² 54 / p 9e-14 | 9.2 EB05 3.7 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 | no trial data cached |
| Hepatitis c | 6 | 10.6 4.8–23.4ROR 10.6 · χ² 43 / p 3e-11 | 7.2 EB05 3.2 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Drug withdrawal syndrome neonatal | 7 | 10.1 4.8–21.0ROR 10.1 · χ² 48 / p 2e-12 | 7.2 EB05 3.4 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.1 | no trial data cached |
| Respiratory depression | 5 | 8.8 3.7–21.0ROR 8.8 · χ² 27 / p 1e-7 | 5.6 EB05 2.5 · IC025 +0.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.5 | no trial data cached |
| Disability | 8 | 8.7 4.4–17.3ROR 8.8 · χ² 47 / p 3e-12 | 6.4 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Product taste abnormal | 5 | 8.0 3.3–19.2ROR 8.0 · χ² 24 / p 5e-7 | 5.1 EB05 2.3 · IC025 +0.7 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Tooth loss | 6 | 6.2 2.8–13.7ROR 6.2 · χ² 21 / p 2e-6 | 4.4 EB05 2.2 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Suicide attempt | 17 | 6.0 3.8–9.6ROR 6.1 · χ² 66 / p 2e-16 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | 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 | 826 | 324.3 315.3–333.5ROR 2,104.6 · χ² 262,585 / p <1e-300 | 317.1 EB05 299.3 · IC025 +8.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 196.2 · 100% consumer | no trial data cached |
| Overdose | 463 | 46.0 43.1–49.2ROR 86.6 · χ² 20,513 / p <1e-300 | 45.8 EB05 42.4 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 35.3 · 100% consumer | no trial data cached |
| Ill-defined disorder | 41 | 14.5 10.7–19.6ROR 15.1 · χ² 503 / p 1e-111 | 14.3 EB05 10.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 · 100% consumer | no trial data cached |
| Withdrawal syndrome | 35 | 17.8 12.9–24.7ROR 18.4 · χ² 540 / p 1e-119 | 17.6 EB05 13.2 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 15.7 · 100% consumer | no trial data cached |
| Suicide attempt | 17 | 6.0 3.8–9.6ROR 6.1 · χ² 66 / p 2e-16 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Product prescribing issue | 15 | 15.8 9.6–26.2ROR 16.1 · χ² 194 / p 2e-44 | 15.0 EB05 9.0 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 23.7 | no trial data cached |
| Disability | 8 | 8.7 4.4–17.3ROR 8.8 · χ² 47 / p 3e-12 | 6.4 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Drug withdrawal syndrome neonatal | 7 | 10.1 4.8–21.0ROR 10.1 · χ² 48 / p 2e-12 | 7.2 EB05 3.4 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.1 | no trial data cached |
| Tooth loss | 6 | 6.2 2.8–13.7ROR 6.2 · χ² 21 / p 2e-6 | 4.4 EB05 2.2 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Hepatitis c | 6 | 10.6 4.8–23.4ROR 10.6 · χ² 43 / p 3e-11 | 7.2 EB05 3.2 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Brain injury | 6 | 12.9 5.8–28.5ROR 12.9 · χ² 54 / p 9e-14 | 9.2 EB05 3.7 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 | no trial data cached |
| Product taste abnormal | 5 | 8.0 3.3–19.2ROR 8.0 · χ² 24 / p 5e-7 | 5.1 EB05 2.3 · IC025 +0.7 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Respiratory depression | 5 | 8.8 3.7–21.0ROR 8.8 · χ² 27 / p 1e-7 | 5.6 EB05 2.5 · IC025 +0.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.5 | 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=41, PRR 14.5
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 Polistirex?
In FDA FAERS, the most frequently co-reported reaction terms for Hydrocodone Polistirex are dependence, ill-defined disorder, withdrawal syndrome, suicide attempt, disability, 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 Polistirex have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACT.
Do FAERS signals prove that Hydrocodone Polistirex 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 25f400d9-1d6e-4d38-8f0d-98d471eba73b, effective 20240730; matched on
openfda.generic_name.exact:"HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX") - 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, 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.