The following terms and frequencies are applied: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), where frequency can not be estimated from clinical trials data, it is recorded as "Not known".
Immune system disorders: Not known: Anaphylactic reaction (including anaphylactic shock).
Psychiatric disorders: Uncommon: Loss of libido, anxiety.
Not known: Agitation, nervousness.
Nervous system disorders: Uncommon: Somnolence, headache.
Not known: Convulsion, extrapyramidal disorder.
Eye disorders: Not known: Oculogyric crisis.
Cardiac disorders: Not known: Ventricular arrhythmias, sudden cardiac death, QTc prolongation, Torsade de Pointes.
Gastrointestinal disorders: Common: Dry mouth.
Skin and subcutaneous tissue disorders: Uncommon: Rash, pruritus.
Not known: Urticaria, angioedema.
Renal and urinary disorders: Not known: Urinary retention.
Reproductive system and breast disorders: Uncommon: Galactorrhoea, breast pain, breast tenderness.
Not known: Gynaecomastia, amenorrhoea.
General disorders and administration site conditions: Uncommon: Asthenia.
Investigations: Not known: Liver function test abnormal, blood prolactin increased.