Adverse reactions reported as more than an isolated case are listed as follows, by system organ class and by frequency.
Frequencies are defined as: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000) and not known (cannot be estimated from the available data).
Infections and infestations: Common: Common cold.
Metabolism and nutrition disorders: Common: Anorexia.
Psychiatric disorders: Common: Hallucinations**, agitation**, agressive behaviour**, abnormal dreams and nightmares**.
Nervous system disorders: Common: Syncope*, dizziness, insomnia.
Uncommon: Seizure*.
Rare: Extrapyramidal symptoms.
Very rare: Neuroleptic Malignant Syndrome.
Cardiac disorders: Uncommon: Bradycardia.
Rare: Sinoatrial block, atrioventricular block.
Gastrointestinal disorders: Very common: Diarrhoea, nausea.
Common: Vomiting, abdominal disturbance.
Uncommon: Gastrointestinal haemorrhage, gastric and duodenal ulcers.
Hepatobiliary disorders: Rare: Liver dysfunction including hepatitis.***
Skin and subcutaneous tissue disorders: Rash, pruritis.
Musculoskeletal and connective tissue disorders: Common: Muscle cramps.
Very rare: Rhabdomyolysis****.
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, poisoning and procedural complications: 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, abnormal dreams, nightmares, agitation and aggressive behaviour have resolved on dose-reduction or discontinuation of treatment.
***In cases of unexplained liver dysfunction, withdrawal of donepezil should be considered.
****Rhabdomyolysis has been reported to occur independently of neuroleptic malignant syndrome and in close temporal association with donepezil initiation or dose increase.
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