Drug · FAERS side-effect profile with label screen

Promethazine and Codeine side effects: what 3,559 FDA adverse event reports show

Promethazine Hydrochloride And Codeine Phosphate · 42 reaction terms · 5,734 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Promethazine (Promethazine)

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

Who reports

3,559 reports · 100% serious · 165 with death outcome · 47% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Promethazine hydrochloride tablets, USP are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism.

FDA label, Indications and Usage

What it is

DESCRIPTION Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride.

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 29 strongest signals

Reporting / coding artifact 4Not in label — unassessed 25

What the badges mean

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. 13 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
Dependence	3,495	395.8 392.0–399.7ROR 21,956.3 · χ² 1,291,696 / p <1e-300	369.9 EB05 359.7 · IC025 +8.4 3/3 methods agree	Not in label — unassessed	serious PRR 215.4 · 100% consumer	no trial data cached
Back injury	238	132.4 117.0–149.9ROR 141.8 · χ² 30,238 / p <1e-300	128.2 EB05 115.1 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious PRR 99.0 · 100% consumer	no trial data cached
Spinal operation	77	37.7 30.2–47.1ROR 38.5 · χ² 2,699 / p <1e-300	37.2 EB05 30.7 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 23.6 · 100% consumer	no trial data cached
Knee operation	34	20.7 14.8–28.9ROR 20.9 · χ² 616 / p 3e-136	20.4 EB05 15.2 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 13.2 · 100% consumer	no trial data cached
Overdose	680	18.6 17.3–19.9ROR 22.7 · χ² 11,355 / p <1e-300	18.5 EB05 17.3 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 13.5 · 100% consumer	no trial data cached
Intervertebral disc degeneration	27	17.1 11.8–25.0ROR 17.3 · χ² 393 / p 8e-88	16.8 EB05 12.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 11.3 · 100% consumer	no trial data cached
Joint injury	48	13.3 10.0–17.6ROR 13.4 · χ² 531 / p 9e-118	13.0 EB05 10.1 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.9 · 100% consumer	no trial data cached
Intervertebral disc protrusion	48	12.9 9.8–17.1ROR 13.1 · χ² 516 / p 2e-114	12.7 EB05 9.8 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.7 · 100% consumer	no trial data cached
Road traffic accident	84	11.8 9.6–14.6ROR 12.1 · χ² 823 / p 2e-181	11.7 EB05 9.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.0 · 100% consumer	no trial data cached
Back pain	420	10.7 9.7–11.7ROR 12.0 · χ² 3,702 / p <1e-300	10.6 EB05 9.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.3 · 100% consumer	no trial data cached
Drug withdrawal syndrome neonatal	24	9.5 6.4–14.1ROR 9.5 · χ² 173 / p 7e-40	8.6 EB05 5.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 5.5 · 100% consumer	no trial data cached
Ill-defined disorder	78	7.6 6.1–9.4ROR 7.7 · χ² 439 / p 1e-97	7.3 EB05 6.0 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 6.6 · 100% consumer	no trial data cached
Limb injury	34	7.4 5.3–10.3ROR 7.5 · χ² 182 / p 9e-42	6.8 EB05 5.1 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 5.8 · 100% consumer	no trial data cached
Neck pain	65	6.9 5.4–8.7ROR 7.0 · χ² 319 / p 1e-71	6.6 EB05 5.3 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 6.3 · 100% consumer	no trial data cached
Withdrawal syndrome	46	6.4 4.8–8.6ROR 6.5 · χ² 205 / p 7e-47	6.1 EB05 4.7 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 5.3 · 100% consumer	no trial data cached
Fibromyalgia	26	6.3 4.3–9.3ROR 6.4 · χ² 111 / p 3e-26	5.7 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 4.8 · ♀ 88% (drug 47%) · 100% consumer	no trial data cached
Spinal fracture	21	6.2 4.1–9.5ROR 6.2 · χ² 87 / p 6e-21	5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 3.7 · 100% consumer	no trial data cached
Rotator cuff syndrome	13	5.9 3.5–10.2ROR 6.0 · χ² 49 / p 2e-12	5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.0	no trial data cached
Toothache	17	5.5 3.4–8.9ROR 5.6 · χ² 59 / p 9e-15	4.9 EB05 3.2 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 6.0	no trial data cached
Caesarean section	11	5.5 3.1–10.0ROR 5.5 · χ² 36 / p 9e-10	4.6 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 3.3	no trial data cached
Knee arthroplasty	15	4.2 2.6–7.0ROR 4.3 · χ² 34 / p 3e-9	3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 2.5	no trial data cached
Ankle fracture	11	4.2 2.3–7.5ROR 4.2 · χ² 24 / p 6e-7	3.6 EB05 2.2 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.7	no trial data cached
Hip arthroplasty	10	3.9 2.1–7.2ROR 3.9 · χ² 19 / p 8e-6	3.4 EB05 2.0 · IC025 +0.7	Not in label — unassessed	serious PRR 2.3	no trial data cached
Product prescribing issue	11	3.2 1.8–5.7ROR 3.2 · χ² 14 / p 7e-5	2.9 EB05 1.8 · IC025 +0.5	Reporting / coding artifact	serious PRR 4.8	no trial data cached
Tooth disorder	12	3.2 1.8–5.6ROR 3.2 · χ² 16 / p 4e-5	2.9 EB05 1.8 · IC025 +0.6	Not in label — unassessed	serious PRR 3.2	no trial data cached
Fracture	10	3.1 1.7–5.8ROR 3.1 · χ² 12 / p 2e-4	2.8 EB05 1.7 · IC025 +0.4	Not in label — unassessed	serious PRR 2.0	no trial data cached
Lower limb fracture	10	3.1 1.7–5.7ROR 3.1 · χ² 12 / p 3e-4	2.8 EB05 1.7 · IC025 +0.4	Not in label — unassessed	serious PRR 2.0	no trial data cached
Arthritis	37	2.8 2.0–3.8ROR 2.8 · χ² 40 / p 1e-10	2.7 EB05 2.1 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.5 · 100% consumer	no trial data cached
Injury	29	2.4 1.7–3.5ROR 2.4 · χ² 23 / p 9e-7	2.4 EB05 1.7 · IC025 +0.6	Not in label — unassessed	serious PRR 1.7 · 100% consumer	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
Dependence	3,495	395.8 392.0–399.7ROR 21,956.3 · χ² 1,291,696 / p <1e-300	369.9 EB05 359.7 · IC025 +8.4 3/3 methods agree	Not in label — unassessed	serious PRR 215.4 · 100% consumer	no trial data cached
Overdose	680	18.6 17.3–19.9ROR 22.7 · χ² 11,355 / p <1e-300	18.5 EB05 17.3 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 13.5 · 100% consumer	no trial data cached
Back pain	420	10.7 9.7–11.7ROR 12.0 · χ² 3,702 / p <1e-300	10.6 EB05 9.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.3 · 100% consumer	no trial data cached
Back injury	238	132.4 117.0–149.9ROR 141.8 · χ² 30,238 / p <1e-300	128.2 EB05 115.1 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious PRR 99.0 · 100% consumer	no trial data cached
Road traffic accident	84	11.8 9.6–14.6ROR 12.1 · χ² 823 / p 2e-181	11.7 EB05 9.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.0 · 100% consumer	no trial data cached
Ill-defined disorder	78	7.6 6.1–9.4ROR 7.7 · χ² 439 / p 1e-97	7.3 EB05 6.0 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 6.6 · 100% consumer	no trial data cached
Spinal operation	77	37.7 30.2–47.1ROR 38.5 · χ² 2,699 / p <1e-300	37.2 EB05 30.7 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 23.6 · 100% consumer	no trial data cached
Neck pain	65	6.9 5.4–8.7ROR 7.0 · χ² 319 / p 1e-71	6.6 EB05 5.3 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 6.3 · 100% consumer	no trial data cached
Intervertebral disc protrusion	48	12.9 9.8–17.1ROR 13.1 · χ² 516 / p 2e-114	12.7 EB05 9.8 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.7 · 100% consumer	no trial data cached
Joint injury	48	13.3 10.0–17.6ROR 13.4 · χ² 531 / p 9e-118	13.0 EB05 10.1 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.9 · 100% consumer	no trial data cached
Withdrawal syndrome	46	6.4 4.8–8.6ROR 6.5 · χ² 205 / p 7e-47	6.1 EB05 4.7 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 5.3 · 100% consumer	no trial data cached
Arthritis	37	2.8 2.0–3.8ROR 2.8 · χ² 40 / p 1e-10	2.7 EB05 2.1 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.5 · 100% consumer	no trial data cached
Limb injury	34	7.4 5.3–10.3ROR 7.5 · χ² 182 / p 9e-42	6.8 EB05 5.1 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 5.8 · 100% consumer	no trial data cached
Knee operation	34	20.7 14.8–28.9ROR 20.9 · χ² 616 / p 3e-136	20.4 EB05 15.2 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 13.2 · 100% consumer	no trial data cached
Injury	29	2.4 1.7–3.5ROR 2.4 · χ² 23 / p 9e-7	2.4 EB05 1.7 · IC025 +0.6	Not in label — unassessed	serious PRR 1.7 · 100% consumer	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.

Dependence — n=3,495, PRR 395.8
Back injury — n=238, PRR 132.4
Intervertebral disc degeneration — n=27, PRR 17.1
Joint injury — n=48, PRR 13.3
Intervertebral disc protrusion — n=48, PRR 12.9
Road traffic accident — n=84, PRR 11.8
Back pain — n=420, PRR 10.7
Drug withdrawal syndrome neonatal — n=24, PRR 9.5
Ill-defined disorder — n=78, PRR 7.6
Limb injury — n=34, PRR 7.4

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 Promethazine and Codeine?

In FDA FAERS, the most frequently co-reported reaction terms for Promethazine and Codeine are dependence, back pain, back injury, road traffic accident, ill-defined disorder, neck pain. 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 Promethazine and Codeine have an FDA boxed warning?

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

Do FAERS signals prove that Promethazine and Codeine 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 4f681538-7ac4-484c-9e6d-b571d73b9e0b, effective 20221008; matched on openfda.generic_name.exact:"PROMETHAZINE")
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, 42 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.