Adverse Drug Reaction Table: ADRs by SOC and CIOMS frequency category listed in order of decreasing medical seriousness within each frequency category and SOC. (See table.)
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Discontinuation Effects: 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, paresthaesia, dizziness, convulsion, vertigo, headache, flu-like symptoms, tinnitus, impaired coordination and balance, tremor, sweating, dry mouth, anorexia, diarrhoea, nausea, vomiting, visual impairment, and hypertension. In premarketing studies, the majority of discontinuation reactions were mild and resolved without treatment (see Dosage & Administration and Precautions). While these events are generally self-limiting, there have been reports of serious discontinuation symptoms, and sometimes these effects can be protracted and severe.
Pediatric Patients: In general, the adverse reaction profile of venlafaxine (in placebo-controlled clinical trials) in children and adolescents (aged 6 to 17) was similar to that seen in adults. As with adults, decreased appetite, weight loss, increased blood pressure, and increased serum cholesterol were observed (see Precautions and Adverse Reactions).
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.