Nootropil Adverse Reactions

Clinical Trial and Post-Marketing Data: Double-blind placebo-controlled clinical or pharmaco-clinical trials, of which quantified safety data are available, included more than 3000 subjects receiving piracetam, regardless of indication, dosage form, daily dosage or population characteristics.
Adverse drug reactions (ADRs) are listed as follows by MedDRA system organ class and by frequency.
Frequencies are defined as: Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1000 to <1/100; Rare ≥1/10000 to <1/1000; Very rare <1/10000; Not known (cannot be estimated from the available data).
Blood and lymphatic system disorders: Not known: haemorrhagic disorder.
Immune system disorders: Not known: anaphylactoid reaction, hypersensitivity.
Psychiatric disorders: Common: nervousness. Uncommon: depression. Not known: agitation, anxiety, confusion, hallucination.
Nervous system disorders: Common: hyperkinesia. Uncommon: somnolence. Not known: ataxia, balance disorder, epilepsy aggravated, headache, insomnia.
Ear and labyrinth disorders: Not known: vertigo.
Vascular disorders: Rare: thrombophlebitis (only for injectable form), hypotension (only for injectable form).
Gastrointestinal disorders: Not known: abdominal pain, abdominal pain upper, diarrhoea, nausea, vomiting.
Skin and subcutaneous tissue disorders: Not known: angioneurotic oedema, dermatitis, pruritus, urticaria.
General disorders and administration site conditions: Uncommon: asthenia. Rare: pyrexia (only for injectable form), injection site pain (only for injectable form).
Investigations: Common: weight increased.