Adverse reactions reported as more than an isolated case are listed as follows, arranged by system organ class and by frequency. Frequencies are defined as: Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000) and not known (cannot be estimated from available data).
Infections and Infestations: Common: Common cold.
Metabolism and Nutrition Disorders: Common: Anorexia.
Psychiatric Disorders: Common: Hallucinations**, agitation**, aggressive behaviour**.
Nervous System Disorders: Common: Syncope*, dizziness, insomnia. Uncommon: Seizure*. Rare: Extrapyramidal symptoms.
Cardiac Disorders: Uncommon: Bradycardia. Rare: Sino-atrial block, atrioventricular block.
Gastrointestinal Disorders: Very Common: Diarrhoea, nausea. Common: Vomiting, abdominal disturbance. Uncommon: Gastrointestinal haemorrhage, gastric ulcer and duodenal ulcers.
Hepatobiliary Disorders: Rare: Liver dysfunction including hepatitis (in cases of unexplained liver dysfunction, withdrawal of Aricept should be considered).
Skin and Subcutaneous Tissue Disorders: Common: Rash, pruritus.
Musculoskeletal, Connective Tissue and Bone Disorders: Common: Muscle cramps.
Renal and Urinary Disorders: Common: Urinary incontinence.
General Disorders and Administration Site Conditions: Very Common: Headache. Common: Fatigue, pain.
Investigations: Uncommon: Minor increase in serum concentration of muscle creatine kinase.
Injury and Poisoning: Common: Accident.
*In investigating patients for syncope or seizure, the possibility of heart block or long sinusal pauses should be considered (see Precautions).
**Reports of hallucinations, agitation and aggressive behaviour have resolved on dose-reduction or discontinuation of treatment.
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