The most common adverse events as diarrhoea, muscle cramps, fatigue, nausea, vomiting, headache and insomnia.
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:
, agitation**, agressive behaviour**, abnormal dreams and nightmares**.
Nervous system disorders:
Common: Syncope*, dizziness, insomnia.
Rare: Extrapyramidal symptoms.
Very rare: Neuroleptic Malignant Syndrome.
Rare: Sinoatrial block, atrioventricular block.
Very common: Diarrhoea, nausea.
Common: Vomiting, abdominal disturbance.
Uncommon: Gastrointestinal haemorrhage, gastric and duodenal ulcers.
Rare: Liver dysfunction including hepatitis.***
Skin and subcutaneous tissue disorders:
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.
Uncommon: Minor increase in serum concentration of muscle creatine kinase.
Injury, poisoning and procedural complications:
*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.