Drug · FAERS side-effect profile with label screen

Doxylamine and Pyridoxine side effects: what 522 FDA adverse event reports show

Doxylamine Succinate And Pyridoxine Hydrochloride · 17 reaction terms · 295 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Doxylamine Succinate And Pyridoxine Hydrochloride (Doxylamine Succinate And Pyridoxine Hydrochloride)

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

Who reports

522 reports · 48% serious · 11 with death outcome · 94% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets have not been studied in women with hyperemesis gravidarum.

FDA label, Indications and Usage

What it is

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are round, white, film-coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman.

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 13 strongest signals

Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 4Not in label — unassessed 7

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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.
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
Premature delivery	47	118.4 90.1–155.5ROR 130.0 · χ² 5,340 / p <1e-300	112.7 EB05 88.2 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 141.7	no trial data cached
Exposure during pregnancy	45	29.1 22.0–38.5ROR 31.7 · χ² 1,195 / p 3e-262	28.8 EB05 22.4 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 31.4	no trial data cached
Maternal exposure during pregnancy	61	27.8 22.0–35.2ROR 31.3 · χ² 1,555 / p <1e-300	27.6 EB05 22.2 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 28.5	no trial data cached
Caesarean section	8	27.3 13.7–54.4ROR 27.8 · χ² 178 / p 8e-41	25.5 EB05 13.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 33.7	no trial data cached
Abortion spontaneous	25	25.0 17.0–36.6ROR 26.2 · χ² 552 / p 2e-122	24.5 EB05 17.5 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 30.1	no trial data cached
Rebound effect	6	21.3 9.6–47.1ROR 21.5 · χ² 96 / p 5e-23	18.2 EB05 6.8 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 34.1	no trial data cached
Serotonin syndrome	10	21.0 11.4–38.8ROR 21.4 · χ² 171 / p 2e-39	19.8 EB05 10.7 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 25.4	no trial data cached
Foetal exposure during pregnancy	39	19.3 14.3–26.1ROR 20.8 · χ² 660 / p 6e-146	19.1 EB05 14.5 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 23.0 · ♀ 45% (drug 94%)	no trial data cached
Pregnancy	9	17.9 9.4–34.2ROR 18.2 · χ² 127 / p 9e-30	16.2 EB05 7.8 · IC025 +2.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 13.9	no trial data cached
Akathisia (inner restlessness)	5	14.7 6.2–35.2ROR 14.9 · χ² 51 / p 5e-13	10.3 EB05 3.6 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 25.1	no trial data cached
Premature baby	10	13.3 7.2–24.6ROR 13.5 · χ² 102 / p 3e-24	11.4 EB05 5.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 16.2	no trial data cached
Vaginal haemorrhage	7	6.6 3.2–13.8ROR 6.7 · χ² 28 / p 6e-8	4.8 EB05 2.5 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 16.7	no trial data cached
Drug dependence	10	2.5 1.3–4.6ROR 2.5 · χ² 7 / p 0.003	2.3 EB05 1.4 · IC025 +0.1	Reporting / coding artifact	serious PRR 3.0	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
Maternal exposure during pregnancy	61	27.8 22.0–35.2ROR 31.3 · χ² 1,555 / p <1e-300	27.6 EB05 22.2 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 28.5	no trial data cached
Premature delivery	47	118.4 90.1–155.5ROR 130.0 · χ² 5,340 / p <1e-300	112.7 EB05 88.2 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 141.7	no trial data cached
Exposure during pregnancy	45	29.1 22.0–38.5ROR 31.7 · χ² 1,195 / p 3e-262	28.8 EB05 22.4 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 31.4	no trial data cached
Foetal exposure during pregnancy	39	19.3 14.3–26.1ROR 20.8 · χ² 660 / p 6e-146	19.1 EB05 14.5 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 23.0 · ♀ 45% (drug 94%)	no trial data cached
Abortion spontaneous	25	25.0 17.0–36.6ROR 26.2 · χ² 552 / p 2e-122	24.5 EB05 17.5 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 30.1	no trial data cached
Drug dependence	10	2.5 1.3–4.6ROR 2.5 · χ² 7 / p 0.003	2.3 EB05 1.4 · IC025 +0.1	Reporting / coding artifact	serious PRR 3.0	no trial data cached
Premature baby	10	13.3 7.2–24.6ROR 13.5 · χ² 102 / p 3e-24	11.4 EB05 5.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 16.2	no trial data cached
Serotonin syndrome	10	21.0 11.4–38.8ROR 21.4 · χ² 171 / p 2e-39	19.8 EB05 10.7 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 25.4	no trial data cached
Pregnancy	9	17.9 9.4–34.2ROR 18.2 · χ² 127 / p 9e-30	16.2 EB05 7.8 · IC025 +2.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 13.9	no trial data cached
Caesarean section	8	27.3 13.7–54.4ROR 27.8 · χ² 178 / p 8e-41	25.5 EB05 13.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 33.7	no trial data cached
Vaginal haemorrhage	7	6.6 3.2–13.8ROR 6.7 · χ² 28 / p 6e-8	4.8 EB05 2.5 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 16.7	no trial data cached
Rebound effect	6	21.3 9.6–47.1ROR 21.5 · χ² 96 / p 5e-23	18.2 EB05 6.8 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 34.1	no trial data cached
Akathisia (inner restlessness)	5	14.7 6.2–35.2ROR 14.9 · χ² 51 / p 5e-13	10.3 EB05 3.6 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 25.1	no trial data cached
Pharyngeal swelling	4	16.8 6.3–44.6ROR 16.9 · χ² 45 / p 1e-11	10.9 EB05 3.2 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Drug dispensing error	3	7.8 2.5–24.0ROR 7.8 · χ² 12 / p 3e-4	4.2 EB05 1.6 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious n=1	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.

Premature delivery — n=47, PRR 118.4

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 Doxylamine and Pyridoxine?

In FDA FAERS, the most frequently co-reported reaction terms for Doxylamine and Pyridoxine are premature delivery, abortion spontaneous, premature baby, serotonin syndrome, pregnancy, caesarean section. 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 Doxylamine and Pyridoxine have an FDA boxed warning?

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

Do FAERS signals prove that Doxylamine and Pyridoxine 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 76d10d65-0279-4e86-8104-cade4343f839, effective 20251203; matched on openfda.generic_name.exact:"DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE")
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, 17 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.