Drug · FAERS side-effect profile with label screen

Promethazine and Dextromethorphan Hydrobromide side effects: what 597 FDA adverse event reports show

Promethazine Hydrochloride And Dextromethorphan Hydrobromide · 13 reaction terms · 80 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

597 reports · 52% serious · 30 with death outcome · 70% 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 8 strongest signals

Likely indication confounding 1Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 4

What the badges mean

Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
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.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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. 5 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
Economic problem	9	20.5 10.7–39.2ROR 20.8 · χ² 148 / p 2e-34	19.0 EB05 9.6 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 22.0	no trial data cached
Anhedonia	14	18.5 11.0–31.1ROR 19.0 · χ² 215 / p 5e-49	17.8 EB05 10.8 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 21.1	no trial data cached
Infusion site pain	6	16.5 7.4–36.5ROR 16.6 · χ² 72 / p 8e-18	13.0 EB05 4.8 · IC025 +1.5 3/3 methods agree	Likely indication confounding term in indications	serious n=5	no trial data cached
Respiratory tract congestion	7	15.4 7.4–32.2ROR 15.6 · χ² 81 / p 1e-19	12.6 EB05 5.2 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 11.3	no trial data cached
Impaired quality of life	6	14.6 6.6–32.4ROR 14.8 · χ² 63 / p 1e-15	11.0 EB05 4.2 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.0	no trial data cached
Product use complaint	6	13.6 6.1–30.1ROR 13.7 · χ² 58 / p 1e-14	10.0 EB05 3.9 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious n=4	no trial data cached
Bone density decreased	9	10.0 5.2–19.1ROR 10.1 · χ² 64 / p 6e-16	7.7 EB05 4.0 · IC025 +1.6 3/3 methods agree	Lab value / disease marker	serious PRR 12.2	no trial data cached
Dermatitis atopic	5	3.5 1.5–8.4ROR 3.5 · χ² 7 / p 0.005	2.8 EB05 1.4 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Not in label — unassessed	–	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
Anhedonia	14	18.5 11.0–31.1ROR 19.0 · χ² 215 / p 5e-49	17.8 EB05 10.8 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 21.1	no trial data cached
Bone density decreased	9	10.0 5.2–19.1ROR 10.1 · χ² 64 / p 6e-16	7.7 EB05 4.0 · IC025 +1.6 3/3 methods agree	Lab value / disease marker	serious PRR 12.2	no trial data cached
Economic problem	9	20.5 10.7–39.2ROR 20.8 · χ² 148 / p 2e-34	19.0 EB05 9.6 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 22.0	no trial data cached
Respiratory tract congestion	7	15.4 7.4–32.2ROR 15.6 · χ² 81 / p 1e-19	12.6 EB05 5.2 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 11.3	no trial data cached
Product use complaint	6	13.6 6.1–30.1ROR 13.7 · χ² 58 / p 1e-14	10.0 EB05 3.9 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious n=4	no trial data cached
Impaired quality of life	6	14.6 6.6–32.4ROR 14.8 · χ² 63 / p 1e-15	11.0 EB05 4.2 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.0	no trial data cached
Infusion site pain	6	16.5 7.4–36.5ROR 16.6 · χ² 72 / p 8e-18	13.0 EB05 4.8 · IC025 +1.5 3/3 methods agree	Likely indication confounding term in indications	serious n=5	no trial data cached
Dermatitis atopic	5	3.5 1.5–8.4ROR 3.5 · χ² 7 / p 0.005	2.8 EB05 1.4 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Not in label — unassessed	–	no trial data cached
Multiple fractures	4	8.5 3.2–22.5ROR 8.5 · χ² 19 / p 5e-6	5.0 EB05 2.0 · IC025 +0.4 3/3 methods agree	Not in label — unassessed	serious PRR 10.0	no trial data cached
Madarosis	4	12.0 4.5–31.8ROR 12.1 · χ² 30 / p 2e-8	7.0 EB05 2.5 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Deformity	4	15.0 5.6–39.8ROR 15.1 · χ² 39 / p 2e-10	9.3 EB05 3.0 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 19.0	no trial data cached
Hair texture abnormal	3	7.8 2.5–24.1ROR 7.8 · χ² 12 / p 3e-4	4.2 EB05 1.6 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious n=1	no trial data cached
Hair colour changes	3	8.4 2.7–25.9ROR 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 n=1	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.

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?

In FDA FAERS, the most frequently co-reported reaction terms for Promethazine are anhedonia, bone density decreased, respiratory tract congestion, impaired quality of life, infusion site pain, dermatitis atopic. 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 have an FDA boxed warning?

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

Do FAERS signals prove that Promethazine 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, 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.