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 00 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.
Frequency not known: children less than 6 years of age also experienced psychomotor hyperactivity.
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
Frequency not known: children less than 6 years of age also experienced aggression and hallucination.
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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.