This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increase the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )]. Doxepin hydrochloride capsules are not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thoughts and behaviors in pediatric and young adults taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ) Doxepin hydrochloride capsules are not approved for use in pediatric patients ( 8.4 )
Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults. Doxepin hydrochloride capsule is a tricyclic antidepressant (TCA) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).
Doxepin hydrochloride capsules are contraindicated in patients: With hypersensitivity to doxepin (hypersensitivity reactions have included tongue edema and urticaria). The possibility of cross sensitivity with other dibenzoxepines should be kept in mind. With glaucoma [see Warnings and Precautions ( 5.3 )]. With current or past urinary retention [see Adverse Reactions ( 6.1 )]. Taking MAOIs, or within 14 days of stopping MAOIs (including the MAOIs linezolid or intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7 )]. Hypersensitivity to doxepin ( 4 ) Glaucoma ( 4 ) Current or past urinary retention ( 4 ) Taking MAOIs, or within 14 days of stopping MAOIs ( 4 )
Suicidal Thoughts and Behaviors : Monitor for clinical worsening and suicide thoughts and behaviors. Consider changing the therapeutic regimen, including possibly discontinuing doxepin hydrochloride, in patients who are experiencing emergent suicidal thoughts or behaviors. ( 5.1 ) Serotonin Syndrome : Risk increases with concomitant use of other serotonergic drugs. Monitor all patients taking doxepin hydrochloride for the emergence of serotonin syndrome. Discontinue doxepin hydrochloride and any concomitant serotonergic agents immediately and initiate supportive treatment if serotonin syndrome occurs. ( 5.2 , 7 ) Angle-Closure Glaucoma : Avoid use of doxepin hydrochloride in patients with untreated anatomically narrow angles. ( 5.3 ) Sedation and Driving Risks : Because doxepin hydrochloride can cause sedation, warn patients against driving a car or operating dangerous machinery while taking doxepin hydrochloride. ( 5.4 ) Activation of Mania or Hypomania : Prior to initiating antidepressant therapy, screen for bipolar disorder. Doxepin hydrochloride is not approved for use in treating bipolar depression. ( 5.5 ) 5.1 Suicidal Thoughts and Behaviors in Adolescents and Young Adults In...
The following clinically significant adverse reactions are described elsewhere in the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions ( 5.1 )] Serotonin Syndrome [see Warnings and Precautions ( 5.2 )] Angle-Closure Glaucoma [see Warnings and Precautions ( 5.3 )] Sedation and Driving Risks [see Warnings and Precautions ( 5.4 )] Activation of Mania or Hypomania [see Warnings and Precautions ( 5.5 )] Risk of Seizures [see Warnings and Precautions ( 5.6 )] Psychosis [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (incidence greater than or equal to 5%) are somnolence, dry mouth, dizziness, constipation and fatigue. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Ajanta Pharma USP Inc. at 1-855-664-7744 and or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions (greater than or equal to 2% of doxepin ...
Dosage and Administration ( 2.4 , 2.5 , 2.6 , 2.7 ) 7/2025 Warnings and Precautions ( 5.2 , 5.5 ) 7/2025
Source: FDA SPL label for Doxepin hydrochloride (Ajanta Pharma USA Inc.), effective 20251117. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 1,506 | 1,218 | 1,067 | 958 | 937 | 932 | 936 | 419 |
1,779 reports blaming this drug for every million Medicare prescriptions filled, which is 0.6× the typical drug on this site. (2,262 reports in 2024–2026, against 1,271,244 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 07/2025 | Class II | Alembic Pharmaceuticals Limited | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Doxepin HCl | 1,270,415 | $52 |
| Silenor | 816 | $617 |
| Zonalon | 13 | $923 |
1 drug in the same class grades a letter or more higher than doxepin on this site. Worth asking whether one of them would do the same job for you.
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.