Efexor XR Adverse Reactions

Adverse reactions are listed as follows in CIOMS frequency categories. Common: ≥1%; uncommon: ≥0.1% and <1%; rare: ≥0.01% and <0.1%; very rare: <0.01%.
Body as a Whole: Common: Asthenia/fatigue, chills. Uncommon: Angioedema, photosensitivity reaction. Very Rare: Anaphylaxis.
Cardiovascular: Common: Hypertension, vasodilatation (mostly hot flushes/flashes), palpitations. Uncommon: Hypotension, postural hypotension, syncope, tachycardia. Very Rare: QT prolongation, ventricular fibrillation, ventricular tachycardia (including torsade de pointes).
Digestive: Common: Decreased appetite, constipation, nausea, vomiting. Uncommon: Bruxism, diarrhea. Very Rare: Pancreatitis.
Hematological/Lymphatic: Uncommon: Ecchymosis, mucous membrane bleeding, gastrointestinal hemorrhage. Rare: Prolonged bleeding time, thrombocytopenia. Very Rare: Blood dyscrasias (including agranulocytosis, aplastic anemia, neutropenia and pancytopenia).
Metabolic/Nutritional: Common: Increased serum cholesterol (particularly with prolonged administration and possibly with higher doses), weight loss. Uncommon: Abnormal liver function tests, hyponatremia, weight gain. Rare: Hepatitis, SIADH. Very Rare: Increased prolactin.
Musculoskeletal: Very Rare: Rhabdomyolysis.
Nervous: Very Common: Headache. Common: Abnormal dreams, decreased libido, dizziness, dry mouth, increased muscle tonus, insomnia, nervousness, paresthesia, sedation, tremor, confusion, depersonalization. Uncommon: Apathy, hallucinations, myoclonus, agitation, impaired coordination and balance. Rare: Akathisia/psychomotor restlessness, convulsion, manic reaction, neuroleptic malignant syndrome (NMS), serotonergic syndrome. Very Rare: Delirium, extrapyramidal reactions (including dystonia and dyskinesia), tardive dyskinesia.
Respiratory: Common: Yawning. Very Rare: Pulmonary eosinophilia.
Skin: Common: Sweating (including night sweats). Uncommon: Rash, alopecia. Very Rare: Erythema multiforme, Stevens-Johnson syndrome, pruritus, urticaria. Frequency Unknown: Toxic epidermal necrolysis.
Special Senses: Common: Abnormality of accommodation, mydriasis, visual disturbance. Uncommon: Altered taste sensation, tinnitus. Very Rare: Angle-closure glaucoma.
Urogenital: Common: Abnormal ejaculation/orgasm (males), anorgasmia, erectile dysfunction, impaired urination (mostly hesitancy), menstrual disorders associated with increased bleeding or increased irregular bleeding (eg, menorrhagia, metrorrhagia), increased urinary frequency. Uncommon: Abnormal orgasm (females), urinary retention. Rare: Urinary incontinence.
The following symptoms have been reported in association with abrupt discontinuation or dose reduction or tapering of treatment: Hypomania, anxiety, agitation, nervousness, confusion, insomnia or other sleep disturbances, fatigue, somnolence, paresthesia, dizziness, convulsion, vertigo, headache, flu-like symptoms, tinnitus, impaired coordination and balance, tremor, sweating, dry mouth, anorexia, diarrhea, nausea and vomiting. In premarketing studies, the majority of discontinuation reactions were mild and resolved without treatment.
Pediatric Patients: In general, the adverse reaction profile of venlafaxine (in placebo-controlled clinical trials) in children and adolescents (6-17 years) was similar to that seen for adults. As with adults, decreased appetite, weight loss, increased blood pressure and increased serum cholesterol were observed (see Use in children under Precautions).
In pediatric clinical trials, the adverse reaction, suicidal ideation, was observed. There were also increased reports of hostility and, especially in major depressive disorder, self-harm. Particularly, the following adverse reactions were observed in pediatric patients: Abdominal pain, agitation, dyspepsia, ecchymosis, epistaxis and myalgia.