Some of the adverse experiences listed as follows may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy.
Adverse drug reactions are listed as follows by system organ class and frequency.
Frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), including isolated reports. Common and uncommon events were generally determined from pooled safety data from a clinical trial population of >8000 paroxetine-treated patients and are quoted as excess incidence over placebo. Rare and very rare events were generally determined from post-marketing data and refer to reporting rate rather than true frequency.
Blood & lymphatic system disorders:
Uncommon: abnormal bleeding, predominantly of the skin and mucous membranes. Very rare: thrombocytopenia.
Immune system disorders:
Very rare: severe allergic reactions (including anaphylactoid reactions and angioedema).
Very rare: syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
Metabolism & nutrition disorders:
Common: increases in cholesterol levels, decreased appetite. Rare: hyponatraemia.
Hyponatraemia has been reported predominantly in elderly patients and is sometimes due to syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
Common: somnolence, insomnia, agitation, abnormal dreams (including nightmares). Uncommon: confusion, hallucinations. Rare: manic reactions.
These symptoms may be due to the underlying disease.
Nervous system disorders:
Common: dizziness, tremor, headache. Uncommon: extrapyramidal disorders. Rare: convulsions, akathisia, restless legs syndrome (RLS). Very rare: serotonin syndrome (symptoms may include agitation, confusion, diaphoresis, hallucinations, hyperreflexia, myoclonus, shivering tachycardia and tremor).
Reports of extrapyramidal disorders including oro-facial dystonia have been received in patients sometimes with underlying movement disorders or who were using neuroleptic medication.
Common: blurred vision. Uncommon: mydriasis (see Precautions). Very rare: acute glaucoma.
Uncommon: sinus tachycardia.
Uncommon: postural hypotension.
Respiratory, thoracic and mediastinal disorders:
Very common: nausea. Common: constipation, diarrhoea, vomiting, dry mouth. Very rare: gastrointestinal bleeding.
Rare: elevation of hepatic enzymes. Very rare: hepatic events (such as hepatitis, sometimes associated with jaundice and/or liver failure).
Elevation of hepatic enzymes has been reported. Post-marketing reports of hepatic events (such as hepatitis, sometimes associated with jaundice, and/or liver failure) have also been received very rarely. Discontinuation of paroxetine should be considered if there is prolonged elevation of liver function test results.
Skin & subcutaneous tissue disorders:
Common: sweating. Uncommon: skin rashes. Very rare: severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis), urticaria, photosensitivity reactions.
Renal & urinary disorders:
Uncommon: urinary retention, urinary incontinence.
Reproductive system & breast disorders:
Very common: sexual dysfunction. Rare: hyperprolactinaemia / galactorrhoea, menstrual disorders (including menorrhagia, metrorrhagia and amenorrhoea).
General disorders & administration site conditions:
Common: asthenia, body weight gain. Very rare: peripheral oedema.
Symptoms seen on discontinuation of paroxetine treatment:
Common: Dizziness, sensory disturbances, sleep disturbances, anxiety, headache. Uncommon: Agitation, nausea, tremor, confusion, sweating, diarrhoea.
As with many psychoactive medicines, discontinuation of SEROXAT (particularly when abrupt) may lead to symptoms such as dizziness, sensory disturbances (including paraesthesia, electric shock sensations and tinnitus), sleep disturbances (including intense dreams), agitation or anxiety, nausea, headache, tremor, confusion, diarrhoea and sweating. In the majority of patients, these events are mild to moderate and are self-limiting. No particular patient group appears to be at higher risk of these symptoms; it is therefore advised that when paroxetine treatment is no longer required, gradual discontinuation by dose tapering be carried out (see Dosage & Administration and Precautions).
Adverse Events from Paediatric Clinical Trials:
In paediatric clinical trials the following adverse events, were reported at a frequency of at least 2% of patients and occurred at a rate at least twice that of placebo: emotional lability (including self-harm, suicidal thoughts, attempted suicide crying and mood fluctuations), hostility, decreased appetite, tremor, sweating, hyperkinesia and agitation. Suicidal thoughts and suicide attempts were mainly observed in clinical trials of adolescents with Major Depressive Disorder. Hostility occurred particularly in children with obsessive compulsive disorder, and especially in younger children less than 12 years of age).
In studies that used a tapering regimen (daily dose decreased by 10 mg/day at weekly intervals to a dose of 10 mg/day for one week), symptoms reported during the taper phase or upon discontinuation of SEROXAT at a frequency of at least 2% of patients and occurred at a rate at least twice that of placebo were: emotional lability, nervousness, dizziness, nausea and abdominal pain (see Precautions).