The safety profile of tolperisone drugs is supported by data from more than 12,000 patients. According to these data, the most frequent violations are from the skin and subcutaneous tissues, general, neurological and gastrointestinal disorders.
During the post-registration period, the number of reports received about the development of hypersensitivity reactions associated with the application of tolperisone was about 50-60% of all received messages. In most cases, these were not serious adverse reactions. Allergy-threatening reactions have been reported very rarely.
The incidence of adverse reactions is classified according to the recommendations of the World Health Organization, is characterized as: very often (≥1 / 10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥1 / 10000.<1/1000), very rarely (<1/10000), including single cases, the frequency is unknown (can not be calculated on the basis of available data).
On the part of the blood and lymphatic system: very rarely - anemia, lymphadenopathy.
From the immune system; rarely - hypersensitivity reactions *, anaphylactic reactions; very rarely - anaphylactic shock.
From the side of metabolism and nutrition: infrequently - anorexia, a very rare polydipsia.
From the side of the psyche: infrequently - sleep disturbance, insomnia; rarely - weakness, depression; very rarely confusion.
From the nervous system: infrequently - headache, dizziness, drowsiness; rarely - attention deficit disorder, tremor, convulsions, paresthesia, malaise, lethargy.
From the side of the organ of vision: rarely - reduced visual acuity.
From the side of the hearing organ: rarely - noise in the ears, vertigo.
From the cardiovascular system: infrequently - arterial hypotension; rarely - angina pectoris, tachycardia, palpitation, "tides" of blood to the face; very rarely - a bradycardia.
From the respiratory system: rarely shortness of breath, nasal bleeding, tachypnea.
From the gastrointestinal tract: infrequently - discomfort in the abdomen, dyspepsia, diarrhea, dry mouth, nausea; rarely - epigastric pain, constipation, flatulence, vomiting.
From the liver and biliary tract: rarely - moderate hepatic insufficiency.
From the skin and subcutaneous tissues: rarely - allergic dermatitis, hyperhidrosis, itching, skin rash, urticaria.
From the musculoskeletal system and connective tissue: infrequently - muscle pain, muscle weakness, pain in the limbs; rarely - discomfort in the limbs; very rarely - osteopenia.
From the side of the kidneys and urinary tract: rarely - enuresis, proteinuria.
General disorders and reactions at the site of administration: infrequently - asthenia, a feeling of fatigue, malaise; rarely - a feeling of intoxication, a feeling of warmth, irritability, thirst; very rarely - discomfort in the chest.
Laboratory indicators: rarely - hyperbilirubinemia, impaired liver function, thrombocytopenia, leukocytosis; very rarely hypercreatininaemia.
* Post-event monitoring reported angioedema, including facial edema and lips (frequency unknown).