System Organ Class | Frequency | Adverse reactions |
Blood and lymphatic system disorders | Not Known | Agranulocytosis, leucopenia, haemolytic anaemia, thrombocytopenia. |
Cardiac disorders | Not Known | Tachycardia palpitations, arrhythmias (see section 4.4). |
Ear and labyrinth disorders | Not Known | Tinnitus. There have been rare case reports of patients experiencing depressed levels of consciousness/loss of consciousness. |
Eye disorders | Not Known | Blurred vision, oculogyric crisis. |
Gastrointestinal system disorders | Not Known | Dryness of the mouth, nose and throat, constipation, increased gastric reflux, nausea, vomiting, diarrhoea, stomach pain, loss of appetite. |
General disorders and administration site conditions | Not Known | Asthenia, malaise. Injection site reactions including vein tracking, erythema, pain, thrombophlebitis and blisters. A sensation of heaviness, chills, flushing, agitation and pruritus have been reported rarely. Rapid IV administration can lead to symptoms similar to overdose. |
Hepatobiliary disorders | Not Known | Hepatic dysfunction (see section 4.4), hypersensitivity hepatitis, cholestatic jaundice and cholestatic hepatitis have occurred in association with cyclizine. |
Immune system disorders | Not Known | Hypersensitivity reactions, including anaphylaxis have occurred. |
Musculoskeletal and connective tissue disorders | Not Known | Twitching, muscle spasms. |
Nervous system disorders | Not Known | Effects on the central nervous system have been reported with cyclizine these include somnolence, drowsiness, incoordination, headache, dystonia, dyskinesia, extrapyramidal motor disturbances, restless legs syndrome, tremor, convulsions, dizziness, decreased consciousness, transient speech disorders, paraesthesia, paralysis* and generalised chorea. |
Psychiatric disorders | Not Known | Disorientation, restlessness or agitation, nervousness, euphoria, insomnia and auditory and visual hallucinations have been reported, particularly when dosage recommendations have been exceeded. |
Renal and urinary disorders | Not Known | Urinary retention. |
Respiratory, thoracic and mediastinal disorders | Not Known | Bronchospasm, apnoea. |
Skin and subcutaneous tissue disorders | Not Known | Urticaria, pruritus, drug rash, angioedema, allergic skin reactions, fixed drug eruption, photosensitivity. |
Vascular disorders | Not Known | Hypertension, hypotension. |