Berlontin 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, <1/10), uncommon (>1/1000, <1/100) and rare (>1/10,000; <1/1,000). Where an adverse reaction was seen at different frequencies in clinical studies, it was assigned to the highest frequency reported.
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.
Rare: thrombocytopenia.
Immune system disorders: Rare: allergic reactions (e.g. urticaria).
Metabolism and Nutrition Disorders: Common: anorexia, increased appetite.
Psychiatric disorders: Common: hostility, confusion and emotional lability, depression, anxiety, nervousness, thinking abnormal.
Rare: 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.
Rare: movement disorders (e.g. choreoathetosis, dyskinesia, dystonia).
Eye disorders: Common: visual disturbances such as amblyopia, diplopia.
Ear and Labyrinth disorders: Common: vertigo.
Rare: tinnitus.
Cardiac disorders: Rare: palpitations.
Vascular disorder: Common: hypertension, vasodilatation.
Respiratory, thoracic and mediastinal disorders: Common: dyspnoea, bronchitis, pharyngitis, cough, rhinitis.
Gastrointestinal disorders: Common: vomiting, nausea, dental abnormalities, gingivitis, diarrhea, abdominal pain, dyspepsia, constipation, dry mouth or throat, flatulence.
Rare: pancreatitis.
Hepatobiliary disorders: Rare: hepatitis, jaundice.
Skin and subcutaneous tissue disorders: Common: facial oedema, purpura most often described as bruises resulting from physical trauma, rash, pruritus, acne.
Rare: Stevens-Johnson syndrome, angioedema, erythema multiforme, alopecia.
Musculoskeletal, connective tissue and bone disorders: Common: arthralgia, myalgia, back pain, twitching.
Renal and urinary disorders: Common: incontinence.
Rare: acute renal failure.
Reproductive system and breast disorders: Common: impotence.
General disorders and administration site conditions: Very Common: fatigue, fever.
Common: peripheral or generalized oedema, abnormal gait, asthenia, pain, malaise, flu syndrome.
Rare: 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.
Rare: Blood glucose fluctuations in patients with diabetes, elevated liver function tests.
Injury and poisoning: Common: accidental injury, fracture, abrasion.
Under treatment with gabapentin cases of acute pancreatitis were reported. Causality with gabapentin is unclear (see Precautions).
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.