Doxepin Hydrochloride side effects: what 12,550 FDA adverse event reports show
Drug class
Not stated in label
Who reports
12,550 reports · 69% serious · 2,171 with death outcome · 68% female
Used for
Doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration. Doxepin tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. ( 1 , 14 )
What it is
Doxepin Tablets are available in 3 mg and 6 mg strengths for oral administration.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
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. 1,105 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Decreased bronchial secretion | 17 | 1,333.5 703.7–2,527.0ROR 1,335.3 · χ² 11,783 / p <1e-300 | 402.4 EB05 266.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Junctional ectopic tachycardia | 18 | 760.3 435.1–1,328.7ROR 761.4 · χ² 8,826 / p <1e-300 | 335.0 EB05 224.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Gait spastic | 85 | 542.7 425.0–693.0ROR 546.4 · χ² 34,165 / p <1e-300 | 374.0 EB05 311.9 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=85 · ♀ 0% (drug 68%) | not reported in cached trials |
| Needle fatigue | 85 | 381.5 301.5–482.7ROR 384.1 · χ² 25,886 / p <1e-300 | 289.8 EB05 241.6 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=85 · ♀ 0% (drug 68%) | not reported in cached trials |
| Foramen magnum stenosis | 12 | 250.2 136.4–459.1ROR 250.5 · χ² 2,374 / p <1e-300 | 161.9 EB05 98.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Sinobronchitis | 19 | 240.8 148.8–389.5ROR 241.1 · χ² 3,751 / p <1e-300 | 173.8 EB05 117.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Osteoporosis postmenopausal | 17 | 229.5 138.2–381.1ROR 229.9 · χ² 3,197 / p <1e-300 | 164.6 EB05 108.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Relapsing-remitting multiple sclerosis | 86 | 184.9 148.1–231.0ROR 186.2 · χ² 13,981 / p <1e-300 | 160.5 EB05 134.0 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=86 · ♀ 0% (drug 68%) | not reported in cached trials |
| Paranasal sinus inflammation | 20 | 169.8 107.2–269.0ROR 170.1 · χ² 2,892 / p <1e-300 | 134.5 EB05 92.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=20 · ♀ 100% (drug 68%) | not reported in cached trials |
| Urticaria thermal | 12 | 152.1 84.2–274.6ROR 152.2 · χ² 1,513 / p <1e-300 | 114.4 EB05 69.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Iliotibial band syndrome | 16 | 126.7 76.2–210.6ROR 126.9 · χ² 1,738 / p <1e-300 | 103.5 EB05 67.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Nail avulsion | 16 | 126.1 75.9–209.6ROR 126.3 · χ² 1,730 / p <1e-300 | 103.1 EB05 67.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Drug-genetic interaction | 21 | 114.2 73.4–177.6ROR 114.4 · χ² 2,098 / p <1e-300 | 97.6 EB05 67.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | not reported in cached trials |
| Nasal turbinate hypertrophy | 20 | 93.9 59.8–147.2ROR 94.0 · χ² 1,652 / p <1e-300 | 82.1 EB05 56.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Peripheral nerve lesion | 17 | 91.5 56.2–149.1ROR 91.6 · χ² 1,357 / p 2e-297 | 79.3 EB05 52.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Corneal reflex decreased | 18 | 84.0 52.3–134.8ROR 84.1 · χ² 1,327 / p 9e-291 | 73.9 EB05 49.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Radial nerve palsy | 17 | 83.3 51.2–135.6ROR 83.5 · χ² 1,239 / p 9e-272 | 73.1 EB05 48.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Monoparesis | 86 | 82.8 66.7–102.7ROR 83.4 · χ² 6,540 / p <1e-300 | 77.6 EB05 64.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=86 · ♀ 0% (drug 68%) | not reported in cached trials |
| Congestive hepatopathy | 21 | 82.8 53.4–128.2ROR 82.9 · χ² 1,538 / p <1e-300 | 73.8 EB05 50.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=21 · 100% clinician | not reported in cached trials |
| Chronic spontaneous urticaria | 46 | 72.7 54.2–97.7ROR 73.0 · χ² 3,048 / p <1e-300 | 67.8 EB05 52.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 92% (drug 68%) | not reported in cached trials |
| Myofascial pain syndrome | 29 | 70.7 48.8–102.4ROR 70.8 · χ² 1,844 / p <1e-300 | 65.0 EB05 47.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 100% (drug 68%) | not reported in cached trials |
| Myosclerosis | 15 | 70.4 42.0–118.0ROR 70.5 · χ² 919 / p 4e-202 | 62.4 EB05 40.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Patellofemoral pain syndrome | 20 | 67.4 43.1–105.3ROR 67.5 · χ² 1,193 / p 8e-262 | 61.2 EB05 41.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Vertebral lesion | 19 | 64.7 40.9–102.2ROR 64.8 · χ² 1,086 / p 2e-238 | 58.8 EB05 39.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Bezoar | 50 | 62.8 47.4–83.3ROR 63.1 · χ² 2,871 / p <1e-300 | 59.3 EB05 46.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=50 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Persistent depressive disorder | 13 | 55.9 32.2–97.2ROR 56.0 · χ² 626 / p 2e-138 | 50.4 EB05 31.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Hypertonic bladder | 93 | 55.7 45.4–68.5ROR 56.2 · χ² 4,784 / p <1e-300 | 53.4 EB05 44.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=93 · ♀ 10% (drug 68%) | not reported in cached trials |
| Somatic symptom disorder | 29 | 46.0 31.8–66.5ROR 46.1 · χ² 1,199 / p 5e-263 | 43.6 EB05 31.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=29 | not reported in cached trials |
| Visceral congestion | 13 | 45.1 26.0–78.2ROR 45.1 · χ² 503 / p 9e-112 | 41.4 EB05 25.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Substance use | 38 | 42.2 30.6–58.2ROR 42.3 · χ² 1,451 / p <1e-300 | 40.4 EB05 30.7 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=37 · ♀ 0% (drug 68%) | not reported in cached trials |
| Measles | 13 | 41.3 23.8–71.5ROR 41.3 · χ² 460 / p 3e-102 | 38.2 EB05 23.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Defaecation disorder | 16 | 41.1 25.0–67.5ROR 41.2 · χ² 573 / p 8e-127 | 38.5 EB05 25.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Mastocytosis | 11 | 40.5 22.3–73.7ROR 40.6 · χ² 376 / p 4e-84 | 37.2 EB05 22.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Dissociative disorder | 16 | 38.1 23.2–62.6ROR 38.2 · χ² 530 / p 1e-117 | 35.9 EB05 23.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 24 | 38.1 25.4–57.1ROR 38.2 · χ² 811 / p 9e-179 | 36.3 EB05 25.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Multiple drug therapy | 15 | 36.7 22.0–61.1ROR 36.7 · χ² 475 / p 2e-105 | 34.5 EB05 22.2 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious n=15 | not reported in cached trials |
| Sleep-related eating disorder | 19 | 34.5 21.9–54.3ROR 34.5 · χ² 572 / p 8e-127 | 32.8 EB05 22.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Reduced facial expression | 17 | 28.8 17.8–46.5ROR 28.8 · χ² 422 / p 5e-94 | 27.5 EB05 18.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Osteosclerosis | 25 | 26.9 18.1–39.9ROR 26.9 · χ² 588 / p 4e-130 | 26.0 EB05 18.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 100% (drug 68%) | not reported in cached trials |
| Dysplasia | 18 | 25.6 16.1–40.8ROR 25.6 · χ² 395 / p 3e-88 | 24.6 EB05 16.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Doxepin as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT02229539 — Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy W (N=275, PHASE3; 45 AE terms posted; arms: Doxepin; Placebo; DLA (Diphenhydramine, Lidocaine and Anta)
- NCT01156142 — Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiati (N=155, PHASE3; 14 AE terms posted; arms: Arm I (Doxepin-Placebo); Arm II (Placebo-Doxepin))
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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) | 1,008 | 1.3 1.2–1.4ROR 1.3 · χ² 65 / p 4e-16 | 1.3 EB05 1.2 · IC025 +0.3 | Reporting / coding artifact | serious PRR 1.4 | not reported in cached trials |
| Toxicity to various agents | 988 | 9.9 9.3–10.5ROR 10.6 · χ² 7,898 / p <1e-300 | 9.8 EB05 9.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 93% clinician | not reported in cached trials |
| Completed suicide (death by suicide) | 828 | 16.6 15.5–17.7ROR 17.7 · χ² 12,044 / p <1e-300 | 16.4 EB05 15.5 · IC025 +3.9 3/3 methods agree | Outcome field, not a reaction | serious PRR 13.7 · 97% clinician | not reported in cached trials |
| Fatigue (tiredness) | 793 | 1.7 1.6–1.8ROR 1.8 · χ² 240 / p 3e-54 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.9 | NCT02229539: 1/78 (1.3%) on Doxepin (serious AE) |
| Pain | 755 | 2.1 1.9–2.2ROR 2.1 · χ² 417 / p 5e-93 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.2 | NCT02229539: 1/74 (1.4%) on Doxepin (serious AE) |
| Nausea | 679 | 1.4 1.3–1.5ROR 1.5 · χ² 94 / p 2e-22 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.5 | NCT02229539: 1/78 (1.3%) on Doxepin; 1/72 (1.4%) control |
| Headache | 642 | 1.7 1.6–1.8ROR 1.8 · χ² 196 / p 9e-45 | 1.7 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.0 | NCT02229539: 1/78 (1.3%) on Doxepin; 1/72 (1.4%) control |
| Insomnia (trouble sleeping) | 622 | 3.9 3.6–4.2ROR 4.1 · χ² 1,353 / p 1e-296 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.4 | not reported in cached trials |
| Off label use (used outside approved label) | 616 | 1.2 1.1–1.3ROR 1.2 · χ² 18 / p 9e-6 | 1.2 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.2 | not reported in cached trials |
| Pruritus (itching) | 605 | 2.7 2.5–2.9ROR 2.8 · χ² 644 / p 2e-142 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | NCT02229539: 1/74 (1.4%) on Doxepin |
| Dizziness | 597 | 2.0 1.9–2.2ROR 2.1 · χ² 306 / p 7e-69 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.3 | not reported in cached trials |
| Anxiety | 571 | 3.3 3.1–3.6ROR 3.5 · χ² 949 / p 1e-208 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | not reported in cached trials |
| Fall | 568 | 2.9 2.6–3.1ROR 2.9 · χ² 693 / p 4e-153 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | not reported in cached trials |
| Diarrhoea (diarrhea) | 557 | 1.4 1.3–1.6ROR 1.5 · χ² 79 / p 3e-19 | 1.4 EB05 1.3 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.5 | NCT01156142: 1/74 (1.4%) control |
| Dyspnoea (shortness of breath) | 536 | 1.6 1.5–1.7ROR 1.6 · χ² 118 / p 1e-27 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.5 | not reported in cached trials |
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.
- Gait spastic — n=85, PRR 542.7
- Needle fatigue — n=85, PRR 381.5
- Relapsing-remitting multiple sclerosis — n=86, PRR 184.9
- Paranasal sinus inflammation — n=20, PRR 169.8
- Drug-genetic interaction — n=21, PRR 114.2
- Nasal turbinate hypertrophy — n=20, PRR 93.9
- Monoparesis — n=86, PRR 82.8
- Congestive hepatopathy — n=21, PRR 82.8
- Chronic spontaneous urticaria — n=46, PRR 72.7
- Myofascial pain syndrome — n=29, PRR 70.7
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 Doxepin?
In FDA FAERS, the most frequently co-reported reaction terms for Doxepin are toxicity to various agents, fatigue, pain, nausea, headache, insomnia. 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 Doxepin have an FDA boxed warning?
No. The FDA label retrieved for Doxepin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Doxepin 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 06e79a65-1455-804e-e063-6394a90a2f3d, effective 20251107; matched on
openfda.generic_name.exact:"DOXEPIN") - 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, 1,145 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 - ClinicalTrials.gov API v2 (query
DOXEPIN, results-bearing studies sorted by enrollment)
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.