Side effects observed in clinical studies in patients with epilepsy (with gabapentin alone or in combination with other anticonvulsant drugs) or neuropathic pain are presented below and are distributed according to organ systems and frequency.
The frequency category was defined as follows: very often (≥1 / 10); often (from ≥1 / 100 to <1/10); infrequently (from ≥1 / 1000 to <1/100); rarely (from ≥1 / 10000 to <1/1000); very rarely (<1/10000). If the frequency category was different in different studies, the side effect was assigned a higher category.
Side effects, reported during the use of the drug after registration, assigned the category of frequency "unknown" (the frequency can not be calculated on the basis of available data).
In each section by frequency, side effects are presented in order of decreasing severity.
Infectious and parasitic diseases: Often - viral infection; often - pneumonia, respiratory tract infection, infection urinary tract, other infections, otitis media.
Violations of the blood and lymphatic system: often leukopenia; unknown - thrombocytopenia.
Disorders from the immune system systems: infrequently - allergic reactions, including hives; unknown - hypersensitivity, including systemic reactions such as fever, rashes, hepatitis, lymphadenopathy, eosinophilia and others.
Disorders from the metabolism and nutrition: often - Anorexia, increased appetite.
Disorders of the psyche: often - hostility, confusion, depression, anxiety, nervousness, disturbance of thinking, emotional lability; infrequently - deterioration mental state; unknown - hallucinations.
Disturbances from the nervous system: Often - drowsiness, dizziness, ataxia; often convulsions, hyperkinesia, dysarthria, amnesia, tremor, insomnia, headache, impaired sensation (eg, paresthesia, hypoesthesia), impaired coordination, nystagmus, amplification, attenuation or absence of reflexes; infrequently - hypokinesia; rarely - loss of consciousness; unknown - Other disorders of movement (eg, choreoathetosis, dyskinesia and dystonia).
Disorders from the side of the organ of vision: often - impaired vision (such as amblyopia, diplopia).
Hearing disorders and labyrinthine disturbances: often - vertigo; unknown - noise in ears.
Heart Disease: infrequently - a feeling of palpitations.
Vascular disorders: often - symptoms of vasodilation, hypertension.
Disturbances from the respiratory system, organs of the thorax and mediastinum: often - shortness of breath, bronchitis, pharyngitis, cough, rhinitis.
Disorders from the gastrointestinal tract: often - constipation, diarrhea, dryness of the oral mucosa or pharynx, dyspepsia, flatulence, nausea, vomiting, abdominal pain, dental diseases, gingivitis; unknown - pancreatitis.
Disorders from the liver and bile ducts: unknown - hepatitis, jaundice.
Disturbances from the skin and subcutaneous tissues: often - swelling of the face, purpura (most often it was described as bruising caused by physical trauma), skin rash, acne, itching of the skin; unknown - Stevens-Johnson syndrome, angioedema, anaphylaxis, erythema multiforme, alopecia, dermal rash, including eosinophilia and systemic reactions.section "Special instructions").
Disturbances from the musculoskeletal and connective tissue: often - Myalgia, arthralgia, back pain, muscle twitching; unknown rhabdomyolysis, myoclonus.
Disorders from the kidneys and urinary tract: unknown -incontinence, acute renal failure.
Violations of the genitals and breast: often - impotence; unknown - an increase in the volume of mammary glands, gynecomastia, sexual dysfunction (including changes in libido, ejaculation and anorgasmia).
General disorders and disorders at the site of administration: Often -fatigue, fever; often peripheral edema, gait disturbance, asthenia, pain of different localization, general malaise, flu-like syndrome; infrequently generalized swelling, falls; unknown - withdrawal syndrome (most often the following side effects: anxiety, insomnia, nausea, pain of different localization and increased sweating), chest pain. Cases of sudden unexplained death have been reported, whose association with treatment with gabapentin has not been established.
Laboratory and instrumental data: often - reduction of white blood cell concentration, weight gain; infrequently - increased activity of alanine aminotransferase, aspartate aminotransferase and bilirubin concentration in blood plasma, hyperglycemia; rarely - hypoglycemia (mainly in patients with diabetes mellitus); unknown - hyponatremia, increased activity of creatine phosphokinase.
Trauma, intoxication and complications of manipulation: often - trauma, fractures, abrasions associated with falls.
There are reports of the development of acute pancreatitis with gabapentin therapy. The causal relationship with gabapentin remains unclear (see section "Special instructions").
There are reports of cases of myopathy with an increase in creatine kinase activity in patients with terminal stage of renal failure who are on hemodialysis.
Cases of respiratory tract infection, otitis media, bronchitis and seizures were noted only in clinical studies. In addition, clinical studies reported cases of aggressive behavior and hyperkinesis in children.