Undesirable reactions when taking the drug are usually observed from the side of the gastrointestinal tract and are caused by the pharmacological action of the drug. The frequency of undesirable reactions is determined as follows: very often (≥ 1/10); often (≥ 1/100, but <1/10); infrequently (≥ 1/1000, but <1/100); rarely (≥ 1/10000, but <1/1000) and very rarely (<1/10000), including individual messages.
Below is the frequency of reactions from various organs and systems.
Clinical studies of orlistat in a dose of 60 mg for a period of 18 to 24 months revealed unwanted reactions from the gastrointestinal tract, which were generally light and reversible.Usually they were manifested at the beginning of treatment. Compliance with a diet low in fat reduces the likelihood of such reactions. From the gastrointestinal tract were observed: very often - oily discharge from the rectum, the passage of gases with a certain amount of detachable, imperative urges for defecation, steatorrhea; often - abdominal pain, fecal incontinence, loose stool, frequent bowel movements.
As a rule, these adverse reactions are mild and transient. They occur in the early stages of treatment (in the first 3 months), and in most patients there was not more than one episode of such reactions.
Postmarketing research
During the postmarketing application of orlistat, the following undesirable reactions were noted, the frequency of which is unknown:
The circulatory system: a decrease in the level of prothrombin and an increase in the international standardized ratio (INR) in patients taking orlistag together with indirect anticoagulants.
Gastrointestinal tract: mild rectal bleeding, diverticulitis.
Skin and subcutaneous tissue: bullous rash.
The immune system: hypersensitivity reactions, including itching, rash, hives, angioedema, bronchospasm and anaphylaxis.
Liver and biliary excretion withsystem: cholelithiasis, hepatitis, an increase in the level of hepatic transaminases and alkaline phosphatase.