Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Starting at low doses:
Autonomic disorders
• Postural hypotension.
• Anticholinergic effects such as dry mouth, constipation and even paralytic ileus (see section 4.4), visual accommodation disorders, risk of urinary retention.

Neuropsychaitric disorders:
• Sedation or drowsiness, particularly at the start of treatment.
• Indifference, anxiety reactions, mood changes.

At higher doses:
Neuropsychaitric disorders:
• Early onset dyskinesia (spasmodic torticollis, oculogyric crises, trismus, etc.).
• Tardive dyskinesia during long-term treatment.

Anticholinergic antiparkinsonian agents have no effect or may cause exacerbation.

•   Extrapyramidal syndrome : o akinetic symptoms with or without hyertonia, partially resolving with anticholinergic antiparkinsonian agents,
o hyperkinetic-hypertonic and excitatory motor activity,
o akathisia

Endocrine and metabolic disorders:
• Hyperprolactinemia : amenorrhoea, galactorrhoea, gynecomastia, impotence, frigidity.
•   Weight gain.
•   Thermoregulation disorders
•   Elevated blood glucose levels, diabetes, impaired glucose tolerance. (see section 4.4) 
Dose dependent and rarely reported:

Cardiac disorders:
•    Risk of QT interval prolongation.
Non dose-dependent and more rarely reported:

Skin reactions:
•     Allergic skin reactions.
•     Photosensitization.

Blood disorders:
•    Exceptionally agranulocytosis: regular complete blood counts are recommended.
•    Leucocytopenia 
Eye disorders:
• Brownish deposits in the anterior segment of the eye caused by accumulation of the drug and generally without effect on vision.

Other disorders observed
• Positive titer for antinuclear antibodies in the absence of clinical lupus erythematosus,
• Very rare cases of cholestatic jaundice and predominantly cholestatic, cytolytic or mixed hepatic disorders have been reported,
• Neuroleptic malignant syndrome (see Section 4.4 ).
• Very rare cases of priapism.

In addition, isolated cases of sudden death of cardiac origin and unexplained sudden death have been reported in patients treated with phenothiazine, butyrophenone or benzamide antipsychotic neuroleptics (see Section 4.4).

Cases of venous thromboembolism, including cases of pulmonary embolism and deep vein thrombosis, have been reported with antipsychotic drugs - unknown frequency (see Section 4.4).