Expected frequency of adverse reactions is presented in Council for International Organizations of Medical Sciences (CIOMS) frequency categories: Very common: ≥10%; common: ≥1% and <10%; uncommon: ≥0.1% and <1%; rare: ≥0.01% and <0.1%; very rare: <0.01%.
Cardiac Disorders: Common: Palpitations, tachycardia.
Ear and Labyrinth Disorders: Common: Tinnitus.
Eye Disorders: Common: Blurred vision, mydriasis.
Gastrointestinal Disorders: Very Common: Nausea, dry mouth, constipation. Common: Diarrhea, vomiting.
General Disorders: Very Common: Fatigue. Common: Chills, asthenia, feeling jittery, irritability. Uncommon: Drug withdrawal syndrome.
Immune System Disorders: Uncommon: Hypersensitivity.
Investigations: Common: Increased weight, blood pressure, blood cholesterol; decreased weight. Uncommon: Increased blood triglycerides, blood prolactin; abnormal liver function test.
Metabolism and Nutritional Disorders: Common: Decreased appetite.
Musculoskeletal, Connective Tissue and Bone Disorders: Common: Musculoskeletal stiffness.
Nervous System Disorders: Very Common: Dizziness. Common: Somnolence, tremor, paraesthesia, dysgeusia, disturbance in attention. Uncommon: Syncope. Rare: Convulsion, extrapyramidal disorder.
Psychiatric Disorders: Very Common: Insomnia. Common: Anxiety, abnormal dreams, nervousness, decreased libido, anorgasmia, abnormal orgasm. Uncommon: Depersonalization, hypomania.
Renal and Urinary Disorders: Common: Urinary hesitation. Rare: Proteinuria.
Reproductive System and Breast Disorders: Common: Erectile dysfunction, delayed ejaculation.
Respiratory, Thoracic and Mediastinal Disorders: Common: Yawning. Uncommon: Epistaxis.
Skin and Subcutaneous Tissue Disorders: Very Common: Hyperhidrosis. Common: Rash.
Vascular Disorders: Common: Hot flush. Uncommon: Orthostatic hypotension.
Ischemic Cardiac Adverse Events: In clinical trials, there were uncommon reports of ischemic cardiac adverse events, including myocardial ischemia, myocardial infarction and coronary occlusion requiring revascularization; these patients had multiple underlying cardiac risk factors. More patients experienced these events during desvenlafaxine treatment as compared to placebo (see Precautions).
Discontinuation Symptoms: Major Depressive Disorder: Adverse drug reactions reported in association with abrupt discontinuation, dose reduction or tapering of treatment in major depressive disorder clinical trials at a rate of ≥5% include: Dizziness, nausea, headache, irritability, diarrhoea, anxiety, abnormal dreams, fatigue and hyperhidrosis. In general, discontinuation symptoms occurred more frequently with longer duration of therapy (see Dosage & Administration and Precautions).
Vasomotor Symptoms Associated with Menopause: Adverse drug reactions reported in association with abrupt discontinuation, dose reduction or tapering of treatment in vasomotor symptoms clinical trials at a rate of >2% include: Dizziness, nausea, headache, insomnia, hot flush, diarrhoea, tinnitus, vomiting, vertigo, fatigue, abnormal dreams, irritability. In general, discontinuation symptoms occurred more frequently with longer duration of therapy. The majority of symptoms were mild and resolved without treatment (see Dosage & Administration and Precautions).
Adverse Reactions Leading to Discontinuation of Therapy: Major Depressive Disorder: The most common adverse reactions leading to discontinuation in at least 2% of the desvenlafaxine-treated patients in the short-term trials, up to 8 weeks, were: Nausea (4%); dizziness and vomiting (2% each); in the long-term trial, up to 9 months, the most common was vomiting (2%).
Vasomotor Symptoms Associated with Menopause: The most common adverse reactions that led to discontinuation (ie, leading to discontinuation in at least 1% of the 100 mg desvenlafaxine-treated subjects) were: Palpitations, dry mouth, insomnia, vomiting, fatigue, somnolence and anxiety.