Gabapentin Sandoz 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 (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000). Where an adverse reaction was seen at different frequencies in clinical studies, it was assigned to the highest frequency reported.
Additional reactions reported from post-marketing experience are included as frequency: Not known (cannot be estimated from the available data) in the list as follows.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Infections and infestations: Very common: Viral infection.
Common: Pneumonia, respiratory infection, urinary tract infection, infection, otitis media.
Blood and lymphatic system disorders: Common: Leucopenia.
Not known: Thrombocytopenia.
Immune system disorders: Uncommon: Allergic reactions (e.g. urticaria).
Not known: Hypersensitivity syndrome (systemic reaction with a variable presentation that can include fever, rash, hepatitis, lymphadenopathy, eosinophilia, and sometimes other signs and symptoms), anaphylaxis (see Precautions).
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: Hyponatremia.
Psychiatric disorders: Common: Hostility, confusion and emotional lability, depression, anxiety, nervousness, thinking abnormal.
Uncommon: Agitation.
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.
Rare: Respiratory depression.
Gastrointestinal disorders: Common: Vomiting, nausea, dental abnormalities, gingivitis, diarrhoea, abdominal pain, dyspepsia, constipation, dry mouth or throat, flatulence.
Uncommon: Dysphagia.
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 (see Precautions).
Musculoskeletal, and connective tissue disorders: Common: Arthralgia, myalgia, back pain, twitching.
Not known: Rhabdomyolysis, myoclonus.
Renal and urinary disorders: 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: Generalised 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.
lnvestigations: 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, poisoning and procedural complications: Common: Accidental injury, fracture, abrasion.
Uncommon: Fall.
Under treatment with gabapentin cases of acute pancreatitis were reported. Causality with gabapentin is unclear (see Precautions).
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.