Adverse reactions : תופעות לוואי

4.8    Undesirable effects
Some of the adverse experiences listed below may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy.

Adverse drug reactions are listed below 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. The frequencies of the 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 postmarketing data and refer to reporting rate rather than true frequency.

Blood & lymphatic system disorders
Uncommon: abnormal bleeding, predominantly of the skin and mucous membranes (mostly ecchymosis).
Very rare: thrombocytopenia.
Immune system disorders
Very rare: allergic reactions (including urticaria and angioedema).
Endocrine disorders
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).
Psychiatric disorders
Common: somnolence, insomnia, agitation.
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.
Very rare: Reports of extrapyramidal disorders including oro-facial dystonia have been received in patients sometimes with underlying movement disorders or who were using neuroleptic medication.
Eye disorders
Common: blurred vision.
Uncommon: mydriasis (see 4.4 Special Warnings and Precautions for use).
Very rare: acute glaucoma.
Cardiac disorders
Uncommon: sinus tachycardia
Vascular disorders
Uncommon: postural hypotension.
Respiratory, thoracic and mediastinal disorders
Common: yawning.
Gastrointestinal disorders
Very common: nausea.
Common: constipation, diarrhoea, dry mouth.
Very rare: gastrointestinal bleeding.
Hepato-biliary disorders
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: photosensitivity reactions.
Renal & urinary disorders
Uncommon: urinary retention.
Reproductive system & breast disorders
Very common: sexual dysfunction.
Rare: hyperprolactinaemia / galactorrhoea.
General disorders & administration site conditions
Common: asthenia, body weight gain.
Very rare: peripheral oedema.
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)- like reactions: Very rare: mental status changes (eg, agitation, hallucinations, and coma), autonomic instability (eg, tachycardia, labile blood pressure, and hyperthermia), neuromuscular aberrations (eg, hyperreflexia and incoordination), and/or gastrointestinal tract symptoms (eg, nausea, vomiting, and diarrhea).
Severe cases can resemble NMS, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. (see 4.4 Special Warnings and Precautions for Use).
Symptoms seen on discontinuation of paroxetine treatment:
Common: Dizziness, sensory disturbances, sleep disturbances, anxiety, headache.
Uncommon: Agitation, nausea, tremor, confusion, sweating, diarrhea.
As with many psychoactive medicines, discontinuation of paroxetine (particularly when abrupt) may lead tosymptoms such as dizziness, sensory disturbances (including paraesthesia and electric shock sensations), 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 4.2 Posology and Method of Administration &4.4 Special Warnings and Precautions for Use).
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 paroxetine 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 4.4 Special Warnings and Precautions for Use).