Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The following CIOMS frequency rating is used: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to ≥1/1000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Immune system disorders
Frequency not known: Allergic reactions, including anaphylactic reaction, urticaria, angioedema.

Skin and subcutaneous tissue disorders
Frequency not known: Rash, photosensitivity reaction.

Nervous system disorders
Very common: Sedation or somnolence.
Frequency not known: Dizziness, headaches, extrapyramidal effects including restless legs syndrome, muscle spasms and tic-like movements of the head and face.
Frequency not known: Dystonia, including oculogyric crisis, usually transitory are commoner in children and young adults, and usually occur within the first 4 days of treatment or after dosage increases.
Frequency not known: Anticholinergic effects such as ileus paralytic, risk of urinary retention, dry mouth, constipation, accommodation disorder.

The elderly are particularly susceptible to the anticholinergic effects and confusion due to promethazine.

Psychiatric disorders
Frequency not known: Agitation, confusional state, anxiety.
Frequency not known: Infants, newborns and premature are susceptible to the anticholinergic effects of promethazine, while other children may display paradoxical hyperexcitability, restlessness, nightmares, disorientation.

Eye disorders
Frequency not
known: Blurred vision.

Gastrointestinal disorders
Frequency not known: Epigastric irritation/discomfort, dry mouth 
Renal and urinary disorders
Frequency not known: Urinary retention

Metabolism and nutrition disorders
Frequency not known:
Decreased appetite

Cardiac disorders
Frequency not known: Palpitations, arrhythmias (including QT prolongation and torsade de pointes)

Vascular disorders
Frequency not known: Hypotension

Respiratory, thoracic and mediastinal disorders
Frequency not known: Respiratory depression (see section 4.4), nasal congestion


Hepatobiliary disorders
Frequency not known: Jaundice cholestatic
Blood and lymphatic system disorders
Frequency not known: Blood dyscrasias including haemolytic anaemia,     agranulocytosis,     leukopenia,    eosinophilia, thrombocytopenia (including thrombocytopenic purpura).

General disorders and administration site conditions
Frequency not known: Tiredness

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il