Neurovyx Side Effects

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 (<1/10000).
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 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), anaphylaxis.
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. Uncommon: agitation. Not known: suicidal ideation, hallucinations, drug dependence.
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.
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: generalized oedema. Not known: withdrawal reactions*, chest pain.
Sudden unexplained deaths have been reported where a causal relationship to treatment with gabapentin has not been established.
Investigations: Common: white blood cell (WBC) 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.
*After discontinuation of short-term and long-term treatment with gabapentin, withdrawal symptoms have been observed. Withdrawal symptoms may occur shortly after discontinuation, usually within 48 hours. Most frequently reported symptoms include anxiety, insomnia, nausea, pains, sweating, tremor, headache, depression, feeling abnormal, dizziness, and malaise. The occurrence of withdrawal symptoms following discontinuation of gabapentin may indicate drug dependence. The patients should be informed about this at the start of the treatment. If gabapentin should be discontinued, it is recommended this should be done gradually over a minimum of 1 week, independent of the indication.
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.
Post-marketing experience: Dysphagia.