What the label lists and what reports show
Doxepin side effects
Doxepin's FDA label lists its adverse reactions in its own words. FAERS holds 12,554 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is toxicity to various agents (988 reports).
- Generic listed
- Boxed warning
Check it at the source: the doxepin FDA label on DailyMed (effective December 30, 2025, Leading Pharma, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of doxepin hydrochloride capsules?Doxepin hydrochloride capsules can cause serious side effects, including: See “What is the most important information I should know about doxepin hydrochloride capsules?” Serotonin syndrome. Taking doxepin hydrochloride capsules can cause a potentially life-threatening problem called serotonin syndrome. The risk of developing serotonin syndrome is increased when doxepin hydrochloride capsules are taken with certain other medicines. […]
Source: FDA drug label (Doxepin hydrochloride), Ajanta Pharma USA Inc., effective November 17, 2025 (SPL set 1513c98c-e7ef-4009-b932-6757048bb86a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsNOTE: Some of the adverse reactions noted below have not been specifically reported with doxepin hydrochloride use. However, due to the close pharmacological similarities among the tricyclics, the reactions should be considered when prescribing doxepin hydrochloride. Anticholinergic Effects Dry mouth, blurred vision, constipation, and urinary retention have been reported. If they do not subside with continued therapy, or become severe, it may be necessary to reduce the dosage. Central Nervous System Effects Drowsiness is the most commonly noticed side effect. This tends to disappear as therapy is continued. Other infrequently reported CNS side effects are confusion, disorientation, hallucinations, numbness, paresthesias, ataxia, extrapyramidal symptoms, seizures, tardive dyskinesia, and tremor. …
Table 1 Incidence (%) of Treatment-Emergent Adverse Reactions in Long-term Placebo-Controlled Clinical Trials
This table is printed in the Silenor label published by Currax Pharmaceuticals LLC of April 21, 2026; the label quoted above does not print one.
| Reaction | Placebo (N=278) | SILENOR 3 mg (N=157) | SILENOR 6 mg (N=203) |
|---|---|---|---|
| Somnolence/Sedation | 4 | 6 | 9 |
| Upper Respiratory Tract Infection/Nasopharyngitis | 2 | 4 | 2 |
| Gastroenteritis | 0 | 2 | 0 |
| Nausea | 1 | 2 | 2 |
| Hypertension | 0 | 3 | < 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Leading Pharma, LLC, effective December 30, 2025 (SPL set e6a4cb10-1928-4abe-8797-404c9ddc37dd), via openFDA; the full label on DailyMed
What do FAERS reports show?
12,554 reports list doxepin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,171 are coded as a death and 3,572 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 17 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Doxepin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions