Gabafast Adverse Reactions

The adverse reactions observed during clinical studies conducted in epilepsy (adjunctive and monotherapy) and neuropathic pain have been provided in a single list as follows by class and frequency (very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10,000).
Infections and infestations: Very common: Viral infection.
Common: Pneumonia, respiratory infection, urinary tract infection, infection, otitis media.
Blood and the lymphatic system disorders: Common: Leucopenia.
Not known: Thrombocytopenia.
Immune system disorders: Uncommon: Allergic reactions (e.g. urticaria).
Not known: Hypersensitivity syndrome, a systemic reaction with a variable presentation that can include fever, rash, hepatitis, lymphadenopathy, eosinophilia, and sometimes other signs and symptoms.
Metabolism and nutrition disorders: Common: Anorexia, increased appetite.
Uncommon: Hyperglycaemia (most often observed in patients with diabetes).
Rare: Hypoglycaemia (most often observed in patients with diabetes).
Not known: Hyponatraemia.
Psychiatric disorders: Common: Hostility, confusion and emotional lability, depression, anxiety, nervousness, thinking abnormal.
Not known: Hallucinations.
Nervous system disorders: Very common: Somnolence, dizziness, ataxia.
Common: Convulsions, hyperkinesias, dysarthria, amnesia, tremor, insomnia, headache, sensations such as paresthesia, hypaesthesia, coordination abnormal, nystagmus, increased, decreased, or absent reflexes.
Uncommon: Hypokinesia, mental impairment.
Rare: Loss of consciousness.
Not known: Other movement disorders (e.g. choreoathetosis, dyskinesia, dystonia).
Eye disorders: Common: Visual disturbances such as amblyopia, diplopia.
Ear and labyrinth disorders: Common: Vertigo.
Not known: Tinnitus.
Cardiac disorders: Uncommon: Palpitations.
Vascular disorders: Common:  Hypertension, vasodilatation.
Respiratory, thoracic and mediastinal disorders: Common: Dyspnoea, bronchitis, pharyngitis, cough, rhinitis.
Gastrointestinal disorders: Common: Vomiting, nausea, dental abnormalities, gingivitis, diarrhoea, abdominal pain, dyspepsia, constipation, dry mouth or throat, flatulence.
Not known: Pancreatitis.
Hepatobiliary disorders: Not known: Hepatitis, jaundice.
Skin and subcutaneous tissue disorders: Common: Facial oedema, purpura most often described as bruises resulting from physical trauma, rash, pruritus, acne.
Not known: Stevens-Johnson syndrome, angioedema, erythema multiforme, alopecia, drug rash with eosinophilia and systemic symptoms.
Musculoskeletal and connective tissue disorders: Common: Arthralgia, myalgia, back pain, twitching.
Uncommon: Rhabdomyolysis, myoclonus.
Renal and urinary disorder: Not known: Acute renal failure, incontinence.
Reproductive system and breast disorders: Common: Impotence.
Not known: Breast hypertrophy, gynaecomastia, sexual dysfunction (including changes in libido, ejaculation disorders and anorgasmia)..
General disorders and administration site conditions: Very common: Fatigue, fever.
Common: Peripheral oedema, abnormal gait, asthenia, pain, malaise, flu syndrome.
Uncommon: Generalized oedema.
Not known: Withdrawal reactions (mostly anxiety, insomnia, nausea, pains, sweating), chest pain. Sudden unexplained deaths have been reported where a causal relationship to treatment with gabapentin has not been established.
Investigations: Common: WBC (white blood cell count) decreased, weight gain.
Uncommon: Elevated liver function tests SGOT (AST), SGPT (ALT) and bilirubin.
Not known: Blood creatine phosphokinase increased.
Injury and poisoning: Common: Accidental injury, fracture, abrasion.
Uncommon: Fall.
Under treatment with gabapentin cases of acute pancreatitis were reported. Causality with gabapentin is unclear.
In patients on haemodialysis due to end-stage renal failure, myopathy with elevated creatine kinase levels has been reported.
Respiratory tract infections, otitis media, convulsions and bronchitis were reported only in clinical studies in children. Additionally, in clinical studies in children, aggressive behaviour and hyperkinesias were reported commonly.
Adverse Drug Reaction: Inform doctors about unexpected reactions after using drugs.