Doxepin side effects: what 10,076 FDA adverse event reports show

Doxepin · 1,121 reaction terms · 46,445 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

10,076 reports · 71% serious · 1,804 with death outcome · 68% female

openFDA FAERS counts, all years, deduplication not applied

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 )

FDA label, Indications and Usage

What it is

Doxepin Tablets are available in 3 mg and 6 mg strengths for oral administration.

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 40 strongest signals

Labeled (related wording) 2Not in label — unassessed 38

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.
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. 1,081 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
Junctional ectopic tachycardia	14	668.2 365.7–1,221.0ROR 669.2 · χ² 6,542 / p <1e-300	298.6 EB05 189.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=14	no trial data cached
Foramen magnum stenosis	10	253.4 131.4–488.6ROR 253.6 · χ² 2,019 / p <1e-300	158.2 EB05 91.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Sinobronchitis	16	246.9 147.0–414.6ROR 247.3 · χ² 3,282 / p <1e-300	174.8 EB05 114.1 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=16	no trial data cached
Osteoporosis postmenopausal	14	229.9 132.4–399.2ROR 230.2 · χ² 2,667 / p <1e-300	161.7 EB05 102.3 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=14	no trial data cached
Urticaria thermal	12	189.5 104.9–342.1ROR 189.7 · χ² 1,890 / p <1e-300	136.4 EB05 83.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Paranasal sinus inflammation	17	177.1 108.0–290.6ROR 177.4 · χ² 2,581 / p <1e-300	138.2 EB05 91.4 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=17	no trial data cached
Drug-genetic interaction	19	127.9 80.5–203.2ROR 128.1 · χ² 2,133 / p <1e-300	107.7 EB05 72.9 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=18	no trial data cached
Iliotibial band syndrome	13	126.5 72.2–221.3ROR 126.6 · χ² 1,408 / p <1e-300	101.8 EB05 63.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Nail avulsion	13	125.9 71.9–220.3ROR 126.0 · χ² 1,402 / p <1e-300	101.4 EB05 63.1 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Corneal reflex decreased	17	98.6 60.6–160.3ROR 98.7 · χ² 1,475 / p <1e-300	85.4 EB05 56.4 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=17	no trial data cached
Peripheral nerve lesion	14	93.0 54.5–158.8ROR 93.1 · χ² 1,132 / p 2e-248	79.7 EB05 50.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=14	no trial data cached
Nasal turbinate hypertrophy	16	92.5 56.1–152.6ROR 92.7 · χ² 1,300 / p 7e-285	80.4 EB05 52.4 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=15	no trial data cached
Radial nerve palsy	14	84.8 49.7–144.6ROR 84.9 · χ² 1,034 / p 4e-227	73.6 EB05 46.6 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=14	no trial data cached
Congestive hepatopathy	16	77.6 47.1–127.8ROR 77.8 · χ² 1,094 / p 4e-240	68.9 EB05 45.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=16	no trial data cached
Persistent depressive disorder	13	69.7 40.1–121.0ROR 69.8 · χ² 786 / p 3e-173	61.6 EB05 38.3 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Myofascial pain syndrome	23	69.2 45.7–104.8ROR 69.4 · χ² 1,431 / p <1e-300	63.6 EB05 44.6 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=23 · ♀ 100% (drug 68%)	no trial data cached
Bezoar	41	63.8 46.7–86.9ROR 64.0 · χ² 2,396 / p <1e-300	60.2 EB05 46.3 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=41 · ♀ 100% (drug 68%) · 100% clinician	no trial data cached
Myosclerosis	11	63.6 34.9–115.9ROR 63.7 · χ² 598 / p 2e-132	56.1 EB05 33.4 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Vertebral lesion	15	63.1 37.8–105.4ROR 63.2 · χ² 830 / p 8e-183	57.0 EB05 36.7 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=15	no trial data cached
Patellofemoral pain syndrome	15	62.3 37.3–104.1ROR 62.4 · χ² 820 / p 1e-180	56.4 EB05 36.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=14	no trial data cached
Chronic spontaneous urticaria	32	62.2 43.8–88.4ROR 62.4 · χ² 1,811 / p <1e-300	58.4 EB05 43.3 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=28 · ♀ 93% (drug 68%)	no trial data cached
Visceral congestion	13	56.2 32.4–97.4ROR 56.2 · χ² 633 / p 5e-140	50.9 EB05 31.6 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Measles	13	51.4 29.7–89.1ROR 51.5 · χ² 579 / p 4e-128	47.0 EB05 29.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Mastocytosis	10	45.8 24.5–85.7ROR 45.9 · χ² 386 / p 3e-86	41.6 EB05 24.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Chronic kidney disease-mineral and bone disorder	23	45.4 30.1–68.6ROR 45.5 · χ² 935 / p 1e-205	43.0 EB05 30.2 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=23	no trial data cached
Dissociative disorder	15	44.5 26.7–74.2ROR 44.6 · χ² 582 / p 6e-129	41.5 EB05 26.7 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=15	no trial data cached
Somatic symptom disorder	22	43.2 28.3–65.9ROR 43.3 · χ² 848 / p 1e-186	41.0 EB05 28.5 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=22	no trial data cached
Defaecation disorder	13	41.4 23.9–71.7ROR 41.5 · χ² 464 / p 3e-103	38.5 EB05 24.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Sleep-related eating disorder	15	33.8 20.3–56.2ROR 33.8 · χ² 437 / p 2e-97	32.0 EB05 20.6 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Reduced facial expression	14	29.5 17.4–49.9ROR 29.5 · χ² 352 / p 7e-79	28.1 EB05 17.7 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=14	no trial data cached
Rebound acid hypersecretion	42	28.9 21.3–39.1ROR 29.0 · χ² 1,088 / p 9e-239	28.2 EB05 21.7 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=42	no trial data cached
Suspected suicide	57	25.2 19.4–32.7ROR 25.3 · χ² 1,283 / p 3e-281	24.7 EB05 19.8 · IC025 +3.9 3/3 methods agree	Labeled (related wording) related wording	serious n=57 · 100% clinician	no trial data cached
Hyperparathyroidism secondary	30	24.9 17.4–35.7ROR 25.0 · χ² 658 / p 2e-145	24.3 EB05 17.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=30	no trial data cached
Dysplasia	14	24.7 14.6–41.9ROR 24.8 · χ² 292 / p 9e-66	23.7 EB05 14.8 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=14	no trial data cached
Brugada syndrome	12	24.7 14.0–43.6ROR 24.7 · χ² 247 / p 8e-56	23.5 EB05 14.1 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Nephrogenic anaemia	54	24.3 18.6–31.8ROR 24.4 · χ² 1,170 / p 1e-256	23.9 EB05 19.0 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=54	no trial data cached
Pupillary reflex impaired	21	24.3 15.8–37.3ROR 24.3 · χ² 440 / p 5e-98	23.5 EB05 16.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=21 · 100% clinician	no trial data cached
Dysaesthesia	31	21.5 15.1–30.7ROR 21.6 · χ² 581 / p 1e-128	21.1 EB05 15.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=31 · ♀ 100% (drug 68%)	no trial data cached
Osteosclerosis	16	21.3 13.0–34.9ROR 21.3 · χ² 287 / p 1e-64	20.5 EB05 13.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=16	no trial data cached
Respiratory depression	124	21.2 17.8–25.3ROR 21.5 · χ² 2,349 / p <1e-300	21.0 EB05 18.1 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 17.6 · ♀ 90% (drug 68%)	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
Toxicity to various agents	830	10.3 9.7–11.0ROR 11.2 · χ² 7,012 / p <1e-300	10.3 EB05 9.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.5 · 93% clinician	no trial data cached
Drug ineffective (drug did not work)	746	1.2 1.1–1.3ROR 1.2 · χ² 21 / p 2e-6	1.2 EB05 1.1 · IC025 +0.1	Reporting / coding artifact	serious PRR 1.4	no trial data cached
Completed suicide (death by suicide)	638	15.9 14.7–17.1ROR 16.9 · χ² 8,856 / p <1e-300	15.8 EB05 14.8 · IC025 +3.8 3/3 methods agree	Outcome field, not a reaction	serious PRR 12.8 · 97% clinician	no trial data cached
Fatigue (tiredness)	613	1.6 1.5–1.8ROR 1.7 · χ² 159 / p 8e-37	1.6 EB05 1.5 · IC025 +0.6	Labeled adverse reaction exact term	serious PRR 1.9	no trial data cached
Nausea	570	1.5 1.4–1.6ROR 1.5 · χ² 99 / p 1e-23	1.5 EB05 1.4 · IC025 +0.4	Labeled adverse reaction exact term	serious PRR 1.5	no trial data cached
Pain	531	1.8 1.7–2.0ROR 1.8 · χ² 192 / p 5e-44	1.8 EB05 1.7 · IC025 +0.7	Labeled adverse reaction exact term	serious PRR 1.8	no trial data cached
Headache	495	1.6 1.5–1.8ROR 1.7 · χ² 128 / p 4e-30	1.6 EB05 1.5 · IC025 +0.6	Not in label — unassessed	serious PRR 1.9	no trial data cached
Off label use (used outside approved label)	486	1.2 1.1–1.3ROR 1.2 · χ² 12 / p 3e-4	1.2 EB05 1.1 · IC025 +0.1	Reporting / coding artifact	serious PRR 1.2	no trial data cached
Pruritus (itching)	480	2.6 2.4–2.9ROR 2.7 · χ² 498 / p 1e-110	2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 3.6	no trial data cached
Diarrhoea (diarrhea)	449	1.5 1.3–1.6ROR 1.5 · χ² 65 / p 4e-16	1.5 EB05 1.3 · IC025 +0.4	Not in label — unassessed	serious PRR 1.5	no trial data cached
Dyspnoea (shortness of breath)	432	1.6 1.4–1.7ROR 1.6 · χ² 96 / p 4e-23	1.6 EB05 1.5 · IC025 +0.5	Labeled adverse reaction exact term	serious PRR 1.5	no trial data cached
Insomnia (trouble sleeping)	426	3.3 3.0–3.7ROR 3.4 · χ² 699 / p 3e-154	3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 3.5	no trial data cached
Anxiety	411	3.0 2.7–3.3ROR 3.1 · χ² 553 / p 1e-122	3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.9	no trial data cached
Dizziness	410	1.7 1.6–1.9ROR 1.7 · χ² 124 / p 4e-29	1.7 EB05 1.6 · IC025 +0.6	Labeled adverse reaction exact term	serious PRR 1.8	no trial data cached
Chronic kidney disease	408	11.1 10.1–12.2ROR 11.6 · χ² 3,745 / p <1e-300	11.0 EB05 10.2 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 9.1	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.

Myofascial pain syndrome — n=23, PRR 69.2
Bezoar — n=41, PRR 63.8
Chronic spontaneous urticaria — n=32, PRR 62.2
Chronic kidney disease-mineral and bone disorder — n=23, PRR 45.4
Somatic symptom disorder — n=22, PRR 43.2
Rebound acid hypersecretion — n=42, PRR 28.9
Hyperparathyroidism secondary — n=30, PRR 24.9
Nephrogenic anaemia — n=54, PRR 24.3
Pupillary reflex impaired — n=21, PRR 24.3
Dysaesthesia — n=31, PRR 21.5

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, nausea, pain, headache, pruritus. 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, field patient.drug.openfda.generic_name.exact, 1,121 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.