Doxepinside effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults Serotonin Syndrome Angle-Closure Glaucoma Sedation and Driving Risks Activation of Mania or Hypomania Risk of Seizures Psychosis Most common adverse reactions (incidence ≥ 5%) are somnolence, dry mouth, dizziness, constipation and fatigue. To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 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 (≥ 2% of doxepin hydrochloride-treated patients) in 1,635 doxepin hydrochloride-treated patients with MDD in clinical trials included somnolence (17%), dry mouth (15%), dizziness (6%), constipation (5%), fatigue (5%), blurred vision (3%), tachycardia (3%), hypotension (3%), insomnia (2%), tremor (2%), nausea (2%), hyperhidrosis (2%), and increased weight (2%). Other Adverse Reactions Observed in Clinical Trials Other adverse reactions that occurred at an incidence of < 2% in patients treated with doxepin hydrochloride in clinical trials were: Ear and Labyrinth Disorders: Tinnitus.

Gastrointestinal Disorders: Diarrhea, dyspepsia, vomiting. General Disorders and Administration Site Conditions: Asthenia, edema, chills.

Metabolism and Nutrition Disorders: Decreased appetite.

Nervous System Disorders: Ataxia, paresthesia, headache, extrapyramidal disorder.

Psychiatric Disorders: Agitation, confusional state, libido decreased.

Pulmonary Disorders: Asthma exacerbation.

Renal and Urinary Disorders: Urinary retention. Reproductive System and Breast Disorders: Breast enlargement. Skin & Subcutaneous Tissue Disorders: Rash, pruritus.

Vascular Disorders: Flushing.

6.2 Postmarketing

Experience The following adverse reactions have been identified during post-approval use of doxepin hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and Lymphatic System Disorders: Agranulocytosis, leukopenia, thrombocytopenia, eosinophilia, purpura.

Cardiac Disorders: Conduction disorder, arrhythmia.

Endocrine Disorders: Inappropriate antidiuretic hormone secretion.

Eye Disorders: Angle-closure glaucoma, mydriasis.

Gastrointestinal Disorders: Aphthous stomatitis, abdominal pain upper. General Disorders and Administration Site Conditions: Facial edema, hyperpyrexia.

Hepatobiliary Disorders: Jaundice.

Investigations: Blood glucose increased.

Nervous System Disorders: Hypoesthesia, dysgeusia, convulsion, tardive dyskinesia, serotonin syndrome.

Psychiatric Disorders: Hallucination, disorientation. Reproductive System and Breast Disorders: Testicular swelling, gynecomastia, galactorrhea. Skin and Subcutaneous Tissue Disorders: Photosensitivity reaction, tongue edema, alopecia, urticaria.

Vascular Disorders: Hypertension. Withdrawal syndrome occurred after stopping doxepin hydrochloride. The following adverse reaction has been reported with use with other tricyclic antidepressants: decreased blood glucose.