Adverse events

The most frequent adverse events reported with Cipralex are nausea, insomnia, problems with ejaculation, somnolence, increased sweating, fatigue, decreased libido and anorgasmia.

  • The following adverse events have occurred more frequently with Cipralex than with placebo in double-blind placebo-controlled studies. The frequencies listed are not placebo-corrected.

Metabolism and nutrition disorders

Common (>1/100, <1/10):

appetite decreased

Psychiatric disorders

Common (>1/100, <1/10):

libido decreased, anorgasmia (female)

Nervous system disorders

Common (>1/100, <1/10):

insomnia, somnolence, dizziness

 

Uncommon (>1/1000, <1/100):

taste disturbance, sleep disorder

Respiratory, thoracic and mediastinal disorders

Common (>1/100, <1/10):

sinusitis, yawning

Gastrointestinal disorders

Very common (>1/10):

nausea

 

Common (>1/100, <1/10):

diarrhoea, constipation

Skin and subcutaneous tissue disorders

Common (>1/100, <1/10):

sweating increased

Reproductive system and breast disorders

Common (>1/100, <1/10):

ejaculation disorder, impotence

General disorders and administration site conditions

Common (>1/100, <1/10):

fatigue, pyrexia


The following adverse reactions apply to the therapeutic class of SSRIs.

Metabolism and nutrition disorders

Hyponatraemia, inappropriate ADH secretion

Psychiatric disorders

Hallucinations, mania, confusion, agitation, anxiety, depersonalisation, panic attacks, nervousness

Nervous system disorders

Seizures, tremor, movement disorders, serotonin syndrome

Eye disorders

Abnormal vision

Vascular disorders

Postural hypotension

Gastrointestinal disorders

Nausea, vomiting, dry mouth, diarrhoea, anorexia

Hepatobiliary disorders

Abnormal liver function tests

Skin and subcutaneous tissue disorders

Rash, ecchymoses, pruritus, angioedema, sweating

Musculoskeletal and connective tissue disorders

Arthralgia, myalgia

Renal and urinary disorders

Urinary retention

Reproductive system and breast disorders

Galactorrhoea, sexual dysfunction terms including impotence, ejaculation disorder, anorgasmia

General disorders and administration site conditions

Insomnia, dizziness, fatigue, drowsiness, anaphylactic reactions


Last updated: 31.07.2008
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