Drug · FAERS side-effect profile with label screen
Doxepn side effects: what 1,972 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Doxepin Hydrochloride (Doxepin 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
1,972 reports · 67% serious · 345 with death outcome · 68% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Doxepin hydrochloride capsules are recommended for the treatment of: Psychoneurotic patients with depression and/or anxiety. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).
FDA label, Indications and Usage
What it is
DESCRIPTION Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds.
FDA label, Description section
Boxed warning
Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.
FDA 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
Labeled adverse reaction 2Labeled (related wording) 3Likely indication confounding 3Reporting / coding artifact 1Lab value / disease marker 1Outcome field, not a reaction 1Not in label — unassessed 29
What the badges mean
- 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.
- 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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 98 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 |
|---|---|---|---|---|---|---|
| Ataxia | 86 | 77.2 62.7–95.0ROR 80.6 · χ² 6,347 / p <1e-300 | 75.4 EB05 62.9 · IC025 +5.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 71.3 · ♀ 4% (drug 68%) | no trial data cached |
| Nocturia (night-time urination) | 83 | 73.3 59.3–90.5ROR 76.4 · χ² 5,807 / p <1e-300 | 71.6 EB05 59.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 106.2 · ♀ 9% (drug 68%) | no trial data cached |
| Micturition urgency | 77 | 72.6 58.3–90.4ROR 75.5 · χ² 5,331 / p <1e-300 | 70.9 EB05 58.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 101.2 · ♀ 0% (drug 68%) | no trial data cached |
| Muscle spasticity | 77 | 66.3 53.2–82.6ROR 69.0 · χ² 4,861 / p <1e-300 | 64.9 EB05 53.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 80.0 · ♀ 0% (drug 68%) | no trial data cached |
| Central nervous system lesion | 78 | 60.2 48.4–74.9ROR 62.6 · χ² 4,460 / p <1e-300 | 59.1 EB05 48.8 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 75.3 · ♀ 3% (drug 68%) | no trial data cached |
| Respiratory depression | 43 | 37.4 27.8–50.2ROR 38.2 · χ² 1,481 / p <1e-300 | 36.7 EB05 28.4 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 32.9 · ♀ 95% (drug 68%) | no trial data cached |
| Erectile dysfunction | 81 | 33.5 27.1–41.5ROR 34.9 · χ² 2,516 / p <1e-300 | 33.2 EB05 27.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 40.8 · ♀ 0% (drug 68%) | no trial data cached |
| Movement disorder | 86 | 28.4 23.1–34.9ROR 29.6 · χ² 2,241 / p <1e-300 | 28.1 EB05 23.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 30.8 · ♀ 14% (drug 68%) | no trial data cached |
| Completed suicide (death by suicide) | 189 | 23.9 20.9–27.4ROR 26.3 · χ² 4,131 / p <1e-300 | 23.8 EB05 21.1 · IC025 +4.3 3/3 methods agree | Outcome field, not a reaction | serious PRR 20.4 · 97% clinician | no trial data cached |
| Dysarthria (slurred speech) | 83 | 23.5 19.0–29.0ROR 24.5 · χ² 1,763 / p <1e-300 | 23.3 EB05 19.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 23.8 · ♀ 1% (drug 68%) | no trial data cached |
| Pollakiuria (frequent urination) | 83 | 21.2 17.2–26.2ROR 22.1 · χ² 1,577 / p <1e-300 | 21.1 EB05 17.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 35.8 · ♀ 7% (drug 68%) | no trial data cached |
| Blood test abnormal | 24 | 18.2 12.2–27.1ROR 18.4 · χ² 372 / p 3e-83 | 17.8 EB05 12.5 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 23.9 · ♀ 100% (drug 68%) | no trial data cached |
| Blood count abnormal | 26 | 18.0 12.3–26.3ROR 18.2 · χ² 400 / p 3e-89 | 17.7 EB05 12.5 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 20.8 · ♀ 100% (drug 68%) | no trial data cached |
| Bradycardia (slow heart rate) | 85 | 17.0 13.8–20.9ROR 17.7 · χ² 1,266 / p 1e-277 | 16.9 EB05 14.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 · ♀ 10% (drug 68%) | no trial data cached |
| Hyperlipidaemia | 19 | 16.9 10.8–26.4ROR 17.0 · χ² 267 / p 2e-60 | 16.3 EB05 10.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 | no trial data cached |
| Cardio-respiratory arrest | 54 | 13.6 10.5–17.7ROR 14.0 · χ² 620 / p 3e-137 | 13.4 EB05 10.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · 98% clinician | no trial data cached |
| Intervertebral disc degeneration | 11 | 12.6 7.0–22.7ROR 12.6 · χ² 106 / p 4e-25 | 10.8 EB05 5.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 | no trial data cached |
| Multiple sclerosis relapse | 80 | 12.3 9.9–15.2ROR 12.8 · χ² 821 / p 7e-181 | 12.1 EB05 10.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 · ♀ 6% (drug 68%) | no trial data cached |
| Psychotic disorder | 33 | 11.9 8.5–16.7ROR 12.1 · χ² 318 / p 2e-71 | 11.4 EB05 8.2 · IC025 +2.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 11.1 · ♀ 10% (drug 68%) | no trial data cached |
| Rotator cuff syndrome | 14 | 11.5 6.8–19.5ROR 11.6 · χ² 124 / p 3e-29 | 10.1 EB05 5.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 | no trial data cached |
| Depressed level of consciousness | 42 | 11.3 8.4–15.3ROR 11.5 · χ² 385 / p 6e-86 | 10.9 EB05 8.2 · IC025 +2.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 10.0 · ♀ 100% (drug 68%) | no trial data cached |
| Sleep disorder due to a general medical condition | 17 | 11.2 7.0–17.9ROR 11.3 · χ² 147 / p 3e-34 | 10.0 EB05 6.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Respiratory arrest | 29 | 11.1 7.7–15.9ROR 11.2 · χ² 256 / p 6e-58 | 10.4 EB05 7.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · 100% clinician | no trial data cached |
| Balance disorder | 86 | 10.6 8.6–13.0ROR 11.0 · χ² 737 / p 2e-162 | 10.3 EB05 8.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.1 · ♀ 12% (drug 68%) | no trial data cached |
| Hypothyroidism | 31 | 10.3 7.3–14.7ROR 10.5 · χ² 253 / p 4e-57 | 9.7 EB05 7.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Type 2 diabetes mellitus | 31 | 9.8 6.9–13.8ROR 9.9 · χ² 235 / p 2e-53 | 9.1 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · ♀ 89% (drug 68%) | no trial data cached |
| Toxicity to various agents | 153 | 9.7 8.3–11.3ROR 10.4 · χ² 1,192 / p 2e-261 | 9.6 EB05 8.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · 91% clinician | no trial data cached |
| Skin haemorrhage | 13 | 9.6 5.6–16.5ROR 9.6 · χ² 91 / p 6e-22 | 8.0 EB05 4.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Aggression | 42 | 8.9 6.6–12.0ROR 9.1 · χ² 287 / p 1e-64 | 8.4 EB05 6.4 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.3 · ♀ 8% (drug 68%) | no trial data cached |
| Impaired quality of life | 12 | 8.9 5.0–15.6ROR 8.9 · χ² 76 / p 1e-18 | 7.2 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Memory impairment | 111 | 8.6 7.2–10.3ROR 9.0 · χ² 739 / p 4e-163 | 8.4 EB05 7.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 · ♀ 19% (drug 68%) | no trial data cached |
| Irritable bowel syndrome | 17 | 8.5 5.3–13.6ROR 8.5 · χ² 104 / p 8e-25 | 7.3 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Mania | 13 | 8.4 4.9–14.5ROR 8.5 · χ² 78 / p 6e-19 | 6.9 EB05 4.2 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
| Fibromyalgia | 19 | 8.3 5.3–13.0ROR 8.4 · χ² 115 / p 4e-27 | 7.3 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Pulmonary congestion | 10 | 8.0 4.3–14.9ROR 8.1 · χ² 55 / p 7e-14 | 6.3 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Osteopenia | 11 | 7.7 4.2–13.8ROR 7.7 · χ² 57 / p 2e-14 | 6.1 EB05 3.6 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Chronic obstructive pulmonary disease | 37 | 7.5 5.5–10.4ROR 7.7 · χ² 204 / p 2e-46 | 7.0 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · ♀ 97% (drug 68%) | no trial data cached |
| Bronchitis | 52 | 7.4 5.7–9.7ROR 7.6 · χ² 283 / p 6e-64 | 7.0 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · ♀ 90% (drug 68%) | no trial data cached |
| Obesity | 11 | 7.3 4.1–13.2ROR 7.4 · χ² 54 / p 1e-13 | 5.8 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Sleep apnoea syndrome | 13 | 7.2 4.2–12.4ROR 7.3 · χ² 64 / p 8e-16 | 6.0 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | 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 |
|---|---|---|---|---|---|---|
| Completed suicide (death by suicide) | 189 | 23.9 20.9–27.4ROR 26.3 · χ² 4,131 / p <1e-300 | 23.8 EB05 21.1 · IC025 +4.3 3/3 methods agree | Outcome field, not a reaction | serious PRR 20.4 · 97% clinician | no trial data cached |
| Insomnia (trouble sleeping) | 159 | 6.3 5.5–7.3ROR 6.8 · χ² 717 / p 3e-158 | 6.2 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.7 · ♀ 42% (drug 68%) | no trial data cached |
| Toxicity to various agents | 153 | 9.7 8.3–11.3ROR 10.4 · χ² 1,192 / p 2e-261 | 9.6 EB05 8.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · 91% clinician | no trial data cached |
| Anxiety | 140 | 5.2 4.4–6.1ROR 5.5 · χ² 479 / p 2e-106 | 5.1 EB05 4.5 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.2 · ♀ 32% (drug 68%) | no trial data cached |
| Product use in unapproved indication | 118 | 5.1 4.3–6.1ROR 5.4 · χ² 393 / p 1e-87 | 5.0 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 · ♀ 45% (drug 68%) | no trial data cached |
| Memory impairment | 111 | 8.6 7.2–10.3ROR 9.0 · χ² 739 / p 4e-163 | 8.4 EB05 7.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 · ♀ 19% (drug 68%) | no trial data cached |
| Hypoaesthesia (numbness) | 100 | 7.1 5.9–8.6ROR 7.4 · χ² 520 / p 2e-115 | 6.9 EB05 5.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · ♀ 18% (drug 68%) | no trial data cached |
| Balance disorder | 86 | 10.6 8.6–13.0ROR 11.0 · χ² 737 / p 2e-162 | 10.3 EB05 8.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.1 · ♀ 12% (drug 68%) | no trial data cached |
| Movement disorder | 86 | 28.4 23.1–34.9ROR 29.6 · χ² 2,241 / p <1e-300 | 28.1 EB05 23.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 30.8 · ♀ 14% (drug 68%) | no trial data cached |
| Ataxia | 86 | 77.2 62.7–95.0ROR 80.6 · χ² 6,347 / p <1e-300 | 75.4 EB05 62.9 · IC025 +5.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 71.3 · ♀ 4% (drug 68%) | no trial data cached |
| Bradycardia (slow heart rate) | 85 | 17.0 13.8–20.9ROR 17.7 · χ² 1,266 / p 1e-277 | 16.9 EB05 14.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 · ♀ 10% (drug 68%) | no trial data cached |
| Pollakiuria (frequent urination) | 83 | 21.2 17.2–26.2ROR 22.1 · χ² 1,577 / p <1e-300 | 21.1 EB05 17.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 35.8 · ♀ 7% (drug 68%) | no trial data cached |
| Dysarthria (slurred speech) | 83 | 23.5 19.0–29.0ROR 24.5 · χ² 1,763 / p <1e-300 | 23.3 EB05 19.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 23.8 · ♀ 1% (drug 68%) | no trial data cached |
| Nocturia (night-time urination) | 83 | 73.3 59.3–90.5ROR 76.4 · χ² 5,807 / p <1e-300 | 71.6 EB05 59.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 106.2 · ♀ 9% (drug 68%) | no trial data cached |
| Erectile dysfunction | 81 | 33.5 27.1–41.5ROR 34.9 · χ² 2,516 / p <1e-300 | 33.2 EB05 27.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 40.8 · ♀ 0% (drug 68%) | 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.
- Nocturia — n=83, PRR 73.3
- Micturition urgency — n=77, PRR 72.6
- Muscle spasticity — n=77, PRR 66.3
- Erectile dysfunction — n=81, PRR 33.5
- Movement disorder — n=86, PRR 28.4
- Dysarthria — n=83, PRR 23.5
- Pollakiuria — n=83, PRR 21.2
- Bradycardia — n=85, PRR 17.0
- Cardio-respiratory arrest — n=54, PRR 13.6
- Multiple sclerosis relapse — n=80, PRR 12.3
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 Doxepn?
In FDA FAERS, the most frequently co-reported reaction terms for Doxepn are insomnia, toxicity to various agents, anxiety, memory impairment, hypoaesthesia, balance disorder. 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 Doxepn have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.
Do FAERS signals prove that Doxepn 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 abf4c515-8888-4733-80a0-fd4e1cdb84a2, effective 20210429; matched on
openfda.generic_name.exact:"DOXEPN 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, fieldpatient.drug.openfda.generic_name.exact, 138 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.