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Side-effects:
The most frequent clinical adverse events occurring in all clinical studies were: somnolence, dizziness, ataxia, headache, nystagmus, tremor, fatigue, diplopia, nausea and/or vomiting and rhinitis.
From data drawn from placebo controlled studies, adverse events are listed in descending order of frequency both by bodily system and by associated adverse events:
Nervous system: Somnolence, dizziness, ataxia, nystagmus, tremor, dysarthria, amnesia, confusion, insomnia, twitching, abnormal co-ordination, paresthesia, vertigo.
Body as a whole: Fatigue, headache, weight increase, back pain, peripheral oedema, viral infection, fever.
Digestive System: Nausea and vomiting, dyspepsia, abdominal pain, dry mouth or throat, constipation, dental abnormalities, diarrhoea, increased appetite.
Special Senses: Diplopia, amblyopia.
Respiratory System: Rhinitis, pharyngitis, coughing, respiratory tract infection.
Skin and Appendages: Rash, pruritus, abrasion, acne, maculopapular rash.
Psychobiologic Function: Nervousness, depression, thinking abnormal, emotional lability.
Laboratory Deviations: White blood cells decreased.
Urogenital System: Impotence.
Musculoskeletal System: Myalgia, fracture.
Cardiovascular System: Vasodilation.
Haemic & Lymphatic System: Leucopenia, purpura.
Sudden and Unexplained Deaths:
During the course of premarketing development of Neurontin, 8 sudden and unexplained deaths were recorded among a cohort of 2203 patients treated (2103 patient-years of exposure).
Some of these could represent seizure-related deaths in which the seizure was not observed e.g. at night. This represents an incidence of 0,0038 deaths per patient-year. Although this rate exceeds that expected in a healthy population matched for age and sex, it is within the range of estimates for the incidence of sudden unexplained deaths in patients with epilepsy not receiving Neurontin (ranging from 0.0005 for the general population of epileptics, to 0,003 for a clinical trial population similar to that in the Neurontin program, to 0,005 for patients with refractory epilepsy). Consequently, whether these figures are reassuring or raise further concern depends on comparability of the populations reported upon to the Neurontin cohort and the accuracy of the estimates provided.
Additional post-marketing adverse events reported include pancreatitis, erythema multiforme, Stevens-Johnson syndrome and elevated liver function tests (LFTS).