Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Summary of the safety profile

Most frequent adverse reactions were related to the gastrointestinal system. Cutaneous hypersensitivity reactions were also frequent as well as adverse reactions related to the nervous system.

Tabulated list of adverse reactions
In the table below all adverse reactions are listed by system organ class and by frequency. Frequency is defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.


System Organ Class                Frequency            Adverse reaction Blood and lymphatic system                             Thrombocytopenia, purpura, leukopenia, Very rare disorders                                              anemia, methemoglobinemia, agranulocytosis.
Metabolism and nutrition          Rare                 Hypothyroidism*.
disorders                         Very rare            Hypoglycemia.
Tendon pain, headache, visual abnormalities,
Very rare
Nervous system disorders                               peripheral neuropathy, dizziness.
Common               Giddiness, vestibular syndrome.
abdominal pain, vomiting, nausea, bloating,
Common diarrhea, soft stools.
Uncommon             Anorexia.
Gastrointestinal disorders
Malabsorption syndrome*, peptic ulcer,
Rare                 gastrointestinal bleeding, jaundice, metallic taste.
Hepatobiliary disorders           Unknown              Hepatitis.
Skin and subcutaneous tissue      Common               Cutaneous hypersensitivity, skin rash.
disorders                         Rare                 Urticaria.
Renal and urinary disorders       Very rare            Crystalluria.
Decreased prothrombine level, hepatocytolysis.
Investigations                    Very rare            Increased blood alkaline phosphatase, transaminases, weight loss.
*see Description of selected adverse reactions below

Description of selected adverse reactions

Hypothyroidism
Hypothyroidism in HIV co-infected patients is a very common event and occurs in ≥1/10 subjects, particularly when para-aminosalicylic acid is administered with ethionamide/prothionamide.

Malabsorption syndrome
A malabsorption syndrome can develop in patients on para-aminosalicylic acid, but is usually not complete. The complete syndrome includes steatorrhoea, an abnormal small bowel pattern on x-ray, villus atrophy, depressed cholesterol, reduced D-xylose and iron absorption. Triglyceride absorption is always normal.

Paediatric population
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il