In the treatment of neuropathic pain
The main undesirable reactions that occurred on the background of treatment at least, in 1% of patients:
From the digestive system: constipation, diarrhea, dryness of the oral mucosa, dyspepsia, flatulence, nausea, vomiting, abdominal pain.
From the nervous system: impaired gait, impaired coordination, amnesia, ataxia, confusion, dizziness, hypoesthesia, drowsiness, thinking, tremor, headache.
From the respiratory system: shortness of breath, pharyngitis.
From the skin: skin rash.
From the sense organs: amblyopia, vertigo, conjunctivitis, otitis media.
Other: accidental injuries, asthenia, back pain, flu-like syndrome, infections, pain of different localization, peripheral edema, weight gain, hyperglycemia.
When treating partial seizures
The safety of gabapentin
as an additional tool studied in more than 200 patients; its tolerability was satisfactory.
Gabapentin most often it is used in combination with other anticonvulsants, so it is impossible to determine which drug causes an undesirable reaction (if such a relationship exists at all). The main undesirable reactions that occurred on the background of treatment at least, in 1% of patients:
From the cardiovascular system: symptoms of vasodilation or hypertension.
From the digestive system: constipation, dental disease, diarrhea, dyspepsia, increased appetite, dryness of the oral mucosa or pharynx, nausea and / or vomiting, abdominal pain, flatulence, anorexia, gingivitis.
From the hematopoiesis: leucopenia, a decrease in the concentration of white blood cells, purpura (most often it was described as bruising caused by physical trauma).
From the musculoskeletal system: fractures, myalgia, arthralgia.
From the nervous system: amnesia, ataxia, confusion, coordination disorder, depression, dysarthria, emotional lability, insomnia, nervousness nystagmus, drowsiness,impaired thinking, tremor, muscle twitching, dizziness, hyperkinesia, strengthening, weakening or lack of reflexes, paresthesia, anxiety, hostility, headache. From the respiratory system: cough, pharyngitis, rhinitis, pneumonia, bronchial airway infection.
From the skin: abrasions, acne, skin itching, skin rash.
From the sense organs: amblyopia, diplopia, impaired vision, vertigo. From the genitourinary system: urinary tract infection, impotence. Other: back pain, fatigue, fever, viral infection, peripheral edema, weight gain, asthenia, general malaise, face swelling, erectile dysfunction.
These undesirable reactions were easily or moderately expressed. The adverse reactions observed in elderly patients did not differ from those of younger people. Against the background of monotherapy, no new or unexpected adverse reactions were noted.
When comparing the tolerability of the drug at doses of 300 and 360 mg / day, the dependence on the dose of such phenomena as dizziness, ataxia, drowsiness, paresthesia and nystagmus is noted.
Children
Listed below are the side effects observed with additional therapy for children 3-12 years of age with a frequency of about 2% and higher than with placebo.
From the digestive system: nausea and / or vomiting.
From the nervous system: drowsiness, hostility, emotional lability, dizziness, hyperkinesia.
From the respiratory system: bronchitis, respiratory infection.
Other: viral infection, fever, weight gain, fatigue. Other adverse events observed in more than 2% of children who had a similar or higher incidence of placebo: pharyngitis, upper respiratory tract infection, headache, rhinitis, convulsions, diarrhea, anorexia, cough and otitis media.
Termination of treatment due to adverse events
Undesirable reactions that most often led to the withdrawal of the drug used as an auxiliary therapy: drowsiness, ataxia, dizziness fatigue, nausea and (or) vomiting; as a monotherapy: dizziness, nervousness, weight gain, nausea and / or vomiting and drowsiness.
Undesirable effects, most often leading to the withdrawal of the drug in children: drowsiness, hyperkinesia and hostility.
Post-registration application experience
Cases of sudden unexplained death have been reported, the relationship of which with treatment with gabantin has not been established. Other adverse events were recorded during the post-registration of the drug have included acute renal failure, allergic reactions including urticaria, alopecia angioneurotic edema, generalized edema; fluctuations in blood glucose concentration in diabetics, chest pain, an increase in the volume of the mammary glands, a drug rash that includes zosinophilia and systemic reactions; gynecomastia, increased liver function tests, hepatitis, jaundice, exudative erythema multiforme, including Stevens-Johnson syndrome, hallucinations, hypersensitivity, including systemic reactions, movement disorders such as choreoathetosis dyskinesia and dystopia, myoclonus, palpitations, pancreatitis, anemia, noise in the ears, urinary incontinence.
Abolition of therapy
After abrupt abolition of gabapentin therapy, the following undesirable reactions were most often noted: anxiety, insomnia, nausea, pain of different localization and increased sweating.