Nausea, sometimes accompanied by vomiting, is the most frequently observed symptom associated with fluvoxamine treatment. This side effect usually diminishes within the first two weeks of treatment. Other adverse events, observed in clinical studies at frequencies listed below, are often associated with the illness and are not necessarily related to treatment.
Common (Frequency 1-10%):
Body: Asthenia, headache, malaise.
Digestive System: Abdominal pain, anorexia, constipation, diarrhoea, dry mouth, dyspepsia.
Nervous System: Agitation, anxiety, dizziness, insomnia, nervousness, somnolence, tremor.
Uncommon (Frequency <1%):
Cardiovascular: Postural hypotension.
Musculoskeletal: Arthralgia, myalgia.
Nervous System: Ataxia, confusion, extrapyramidal symptoms, hallucinations.
Urogenital: Abnormal (delayed) ejaculation.
Skin: Cutaneous hypersensitivity reactions (including rash, pruritus, angioedema).
Rare (Frequency <0.1%):
Digestive System: Liver function abnormality.
Nervous System: Convulsions, mania, psychomotor restlessness/akathisia.
Other Adverse Events Observed during Marketing:
Weight gain or weight loss have been reported.
Rarely, serotonin syndrome, neuroleptic malignant syndrome-like events, hyponatremia and SIADH have been reported. (See Precautions).
It is possible that withdrawal reactions may occur on stopping therapy with fluvoxamine although the available preclinical and clinical evidence does not suggest that this treatment cause dependence.
The following symptoms have been reported in association with withdrawal of the product: Dizziness, paresthesia, headache, nausea and anxiety.
The majority of the withdrawal reactions are mild and self-limiting. When stopping, a gradual dose reduction may be considered.
Haemorrhage: (See Precautions).
Very rarely, paresthesia, anorgasmy and taste perversion have been reported.
In one 10-week placebo-controlled trial in children and adolescents with OCD, frequently reported adverse events with a higher incidence than placebo, were: Insomnia, asthenia, agitation, hyperkinesia, somnolence and dyspepsia. Serious adverse events in this study included: Agitation and hypomania.
Convulsions in children and adolescents have been reported during use outside clinical trials.
Withdrawal Symptoms seen on Discontinuation of Fluvoxamine Treatment:
Discontinuation of fluvoxamine (particularly when abrupt) commonly leads to withdrawal symptoms.
Dizziness, sleep disturbances (including insomnia and intense dreams), nausea, headache and asthenia are the most commonly reported reactions. Generally these events are mild to moderate and are self-limiting, however, in some patients they may be severe and/or prolonged. It is therefore advised that when fluvoxamine treatment is no longer required, gradual discontinuation by dose tapering should be carried out.