Drug · FAERS side-effect profile with label screen
Doxylamine side effects: what 5,981 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Doxylamine Succinate (Zzzquil Ultra, Lil Drug Store)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
5,981 reports · 37% serious · 443 with death outcome · 66% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Use helps to reduce difficulty in falling asleep
FDA label, Indications and Usage
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 40 strongest signals
Reporting / coding artifact 13No label text to screen 27
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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 196 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Poisoning deliberate | 33 | 12.5 8.9–17.5ROR 12.5 · χ² 336 / p 3e-75 | 12.0 EB05 8.7 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.2 · 91% clinician | no trial data cached |
| Underdose | 218 | 10.5 9.2–11.9ROR 10.8 · χ² 1,861 / p <1e-300 | 10.4 EB05 9.3 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 1.1 · 99% consumer | no trial data cached |
| Disease recurrence | 140 | 10.3 8.7–12.1ROR 10.5 · χ² 1,166 / p 6e-256 | 10.2 EB05 8.8 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 88% consumer | no trial data cached |
| Drug effective for unapproved indication | 80 | 9.6 7.7–12.0ROR 9.7 · χ² 608 / p 1e-134 | 9.3 EB05 7.7 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | ♀ 93% (drug 66%) · 100% consumer | no trial data cached |
| Incorrect product administration duration | 50 | 8.7 6.6–11.4ROR 8.7 · χ² 330 / p 4e-74 | 8.2 EB05 6.4 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious n=5 · 92% consumer | no trial data cached |
| Somnolence (drowsiness) | 492 | 8.6 7.9–9.4ROR 9.3 · χ² 3,317 / p <1e-300 | 8.5 EB05 7.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 · 86% consumer | no trial data cached |
| Sinus tachycardia | 34 | 8.4 6.0–11.8ROR 8.5 · χ² 215 / p 7e-49 | 7.8 EB05 5.7 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.3 · 94% clinician | no trial data cached |
| Poor quality sleep | 49 | 8.0 6.1–10.6ROR 8.1 · χ² 295 / p 2e-66 | 7.6 EB05 5.9 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 · 94% consumer | no trial data cached |
| Therapeutic product effect decreased | 101 | 8.0 6.6–9.7ROR 8.1 · χ² 610 / p 5e-135 | 7.8 EB05 6.6 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 1.2 · 97% consumer | no trial data cached |
| Drug effect less than expected | 32 | 8.0 5.6–11.3ROR 8.0 · χ² 188 / p 5e-43 | 7.3 EB05 5.4 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious n=2 · 94% consumer | no trial data cached |
| Mydriasis | 29 | 7.9 5.5–11.4ROR 8.0 · χ² 169 / p 7e-39 | 7.2 EB05 5.2 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.4 · ♀ 32% (drug 66%) | no trial data cached |
| Maternal exposure during pregnancy | 192 | 7.6 6.6–8.8ROR 7.9 · χ² 1,104 / p 2e-242 | 7.5 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 · ♀ 97% (drug 66%) · 73% consumer | no trial data cached |
| Nightmare | 73 | 7.4 5.9–9.3ROR 7.4 · χ² 395 / p 3e-88 | 7.1 EB05 5.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 · 92% consumer | no trial data cached |
| Restless legs syndrome | 37 | 7.1 5.2–9.8ROR 7.2 · χ² 189 / p 3e-43 | 6.6 EB05 5.0 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 · ♀ 87% (drug 66%) · 100% consumer | no trial data cached |
| Exposure during pregnancy | 111 | 6.3 5.2–7.5ROR 6.4 · χ² 486 / p 5e-108 | 6.1 EB05 5.2 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 · ♀ 98% (drug 66%) | no trial data cached |
| Poisoning | 22 | 6.1 4.0–9.3ROR 6.1 · χ² 89 / p 2e-21 | 5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.7 · ♀ 29% (drug 66%) | no trial data cached |
| Product administration error | 34 | 6.0 4.3–8.4ROR 6.0 · χ² 136 / p 1e-31 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.0 · ♀ 90% (drug 66%) · 94% consumer | no trial data cached |
| Abnormal dreams | 47 | 5.9 4.5–7.9ROR 6.0 · χ² 188 / p 5e-43 | 5.6 EB05 4.4 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 · 76% consumer | no trial data cached |
| Acute hepatic failure | 22 | 5.7 3.7–8.6ROR 5.7 · χ² 80 / p 2e-19 | 5.1 EB05 3.6 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 · ♀ 36% (drug 66%) | no trial data cached |
| Intentional overdose | 98 | 5.4 4.4–6.6ROR 5.5 · χ² 347 / p 1e-77 | 5.3 EB05 4.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.1 | no trial data cached |
| Toxicity to various agents | 248 | 5.2 4.6–5.9ROR 5.4 · χ² 839 / p 1e-184 | 5.1 EB05 4.6 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.0 | no trial data cached |
| Accidental overdose | 54 | 5.2 4.0–6.8ROR 5.2 · χ² 178 / p 6e-41 | 5.0 EB05 4.0 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 10.5 | no trial data cached |
| Sluggishness | 15 | 5.2 3.1–8.6ROR 5.2 · χ² 46 / p 5e-12 | 4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=4 | no trial data cached |
| Middle insomnia | 26 | 4.9 3.3–7.2ROR 4.9 · χ² 77 / p 9e-19 | 4.5 EB05 3.3 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.3 · 92% consumer | no trial data cached |
| Serotonin syndrome | 26 | 4.8 3.2–7.0ROR 4.8 · χ² 74 / p 5e-18 | 4.4 EB05 3.2 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 · ♀ 86% (drug 66%) · 100% clinician | no trial data cached |
| Drug toxicity | 18 | 4.6 2.9–7.3ROR 4.6 · χ² 47 / p 4e-12 | 4.1 EB05 2.8 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 | no trial data cached |
| Coma | 59 | 4.3 3.4–5.6ROR 4.4 · χ² 148 / p 2e-34 | 4.2 EB05 3.4 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 · 93% clinician | no trial data cached |
| Hypersomnia | 35 | 4.3 3.1–6.0ROR 4.3 · χ² 85 / p 2e-20 | 4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.1 · ♀ 41% (drug 66%) · 94% consumer | no trial data cached |
| End stage renal disease | 22 | 4.2 2.8–6.4ROR 4.2 · χ² 50 / p 7e-13 | 3.9 EB05 2.7 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.5 | no trial data cached |
| Therapeutic product effect incomplete | 84 | 4.2 3.4–5.2ROR 4.2 · χ² 199 / p 1e-45 | 4.1 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 0.9 · 98% consumer | no trial data cached |
| Drug abuse | 95 | 4.0 3.3–4.9ROR 4.0 · χ² 210 / p 8e-48 | 3.9 EB05 3.3 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 | no trial data cached |
| Muscle spasticity | 14 | 4.0 2.3–6.7ROR 4.0 · χ² 28 / p 6e-8 | 3.6 EB05 2.3 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.1 | no trial data cached |
| Brain fog | 16 | 3.8 2.4–6.3ROR 3.9 · χ² 31 / p 1e-8 | 3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 | no trial data cached |
| Covid-19 | 192 | 3.8 3.3–4.4ROR 3.9 · χ² 397 / p 1e-88 | 3.8 EB05 3.3 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.1 · 81% consumer | no trial data cached |
| Generalised tonic-clonic seizure | 17 | 3.6 2.3–5.9ROR 3.6 · χ² 30 / p 2e-8 | 3.4 EB05 2.2 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 | no trial data cached |
| Premature delivery | 16 | 3.5 2.1–5.7ROR 3.5 · χ² 26 / p 2e-7 | 3.2 EB05 2.1 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.2 | no trial data cached |
| Psychomotor hyperactivity | 16 | 3.4 2.1–5.5ROR 3.4 · χ² 24 / p 4e-7 | 3.1 EB05 2.1 · IC025 +0.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 | no trial data cached |
| Suicide attempt | 58 | 3.3 2.6–4.3ROR 3.4 · χ² 93 / p 2e-22 | 3.3 EB05 2.6 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.2 | no trial data cached |
| Sneezing | 21 | 3.3 2.1–5.0ROR 3.3 · χ² 31 / p 1e-8 | 3.1 EB05 2.2 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | 86% consumer | no trial data cached |
| Chronic kidney disease | 71 | 3.2 2.6–4.1ROR 3.3 · χ² 108 / p 1e-25 | 3.2 EB05 2.6 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,080 | 2.9 2.7–3.0ROR 3.3 · χ² 1,406 / p <1e-300 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 1.0 · 94% consumer | no trial data cached |
| Somnolence (drowsiness) | 492 | 8.6 7.9–9.4ROR 9.3 · χ² 3,317 / p <1e-300 | 8.5 EB05 7.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 · 86% consumer | no trial data cached |
| Toxicity to various agents | 248 | 5.2 4.6–5.9ROR 5.4 · χ² 839 / p 1e-184 | 5.1 EB05 4.6 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.0 | no trial data cached |
| Insomnia (trouble sleeping) | 241 | 3.2 2.8–3.6ROR 3.3 · χ² 359 / p 2e-80 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 · 81% consumer | no trial data cached |
| Underdose | 218 | 10.5 9.2–11.9ROR 10.8 · χ² 1,861 / p <1e-300 | 10.4 EB05 9.3 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 1.1 · 99% consumer | no trial data cached |
| Feeling abnormal | 195 | 2.8 2.5–3.3ROR 2.9 · χ² 233 / p 5e-53 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.9 · 88% consumer | no trial data cached |
| Covid-19 | 192 | 3.8 3.3–4.4ROR 3.9 · χ² 397 / p 1e-88 | 3.8 EB05 3.3 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.1 · 81% consumer | no trial data cached |
| Maternal exposure during pregnancy | 192 | 7.6 6.6–8.8ROR 7.9 · χ² 1,104 / p 2e-242 | 7.5 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 · ♀ 97% (drug 66%) · 73% consumer | no trial data cached |
| Incorrect dose administered | 177 | 2.8 2.4–3.2ROR 2.8 · χ² 199 / p 2e-45 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 1.2 · 95% consumer | no trial data cached |
| Overdose | 164 | 2.7 2.3–3.1ROR 2.7 · χ² 169 / p 6e-39 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 | no trial data cached |
| Nasopharyngitis (common cold) | 161 | 3.1 2.6–3.6ROR 3.1 · χ² 222 / p 1e-50 | 3.0 EB05 2.7 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 · 73% consumer | no trial data cached |
| Disease recurrence | 140 | 10.3 8.7–12.1ROR 10.5 · χ² 1,166 / p 6e-256 | 10.2 EB05 8.8 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 88% consumer | no trial data cached |
| Exposure during pregnancy | 111 | 6.3 5.2–7.5ROR 6.4 · χ² 486 / p 5e-108 | 6.1 EB05 5.2 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 · ♀ 98% (drug 66%) | no trial data cached |
| Therapeutic product effect decreased | 101 | 8.0 6.6–9.7ROR 8.1 · χ² 610 / p 5e-135 | 7.8 EB05 6.6 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 1.2 · 97% consumer | no trial data cached |
| Intentional overdose | 98 | 5.4 4.4–6.6ROR 5.5 · χ² 347 / p 1e-77 | 5.3 EB05 4.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.1 | 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 Doxylamine?
In FDA FAERS, the most frequently co-reported reaction terms for Doxylamine are somnolence, toxicity to various agents, insomnia, feeling abnormal, covid-19, nasopharyngitis. 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 have an FDA boxed warning?
No. The FDA label retrieved for Doxylamine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Doxylamine 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 0f8c7219-7b40-27c6-e063-6294a90a27d9, effective 20251201; matched on
openfda.generic_name.exact:"DOXYLAMINE SUCCINATE") - 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, 236 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.