Chemical formula: C₈H₁₀N₂S Molecular mass: 166.243 g/mol PubChem compound: 2761171
Ethionamide has been demonstrated to have a teratogenic potential in rabbits and rats. Some data indicate an excess of congenital malformations when ethionamide is given to pregnant women. Therefore ethionamide should be withheld from women who are pregnant, or are likely to become pregnant during therapy, unless the benefit is considered to outweigh the risk.
It is not known whether ethionamide is excreted into human milk. In case of breast-feeding during treatment with ethionamide, the baby should be monitored for side effects of ethionamide.
No data on the effect of ethionamide on fertility are available.
No studies on the effects on the ability to drive and use machines have been performed. Nevertheless, the clinical status of the patient and the adverse reaction profile of ethionamide 125 mg dispersible tablets should be borne in mind when considering the patient’s ability to drive or operate machinery.
Adverse events considered to be at least possibly related to treatment with ethionamide are listed below by body system, organ class and absolute frequency. Frequencies are defined as very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000) or very rare (≤1/10,000). In addition, adverse events identified during post-approval use of ethionamide are listed (frequency category: ‘not known’). Since they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been included for their potential causal connection to ethionamide, taking also into account their seriousness and the number of reports.
Not known: thrombocytopenia.
Not known: pellagra-like syndrome, hypothyroidism, hypoglycaemia.
Not known: psychotic reactions.
Common: headache, dizziness, drowsiness, asthenia, paresthaesia
Not known: encephalopathy, peripheral neuritis, olfactory disturbance.
Not known: postural hypotension.
Very common: epigastric discomfort, abdominal pain, anorexia, nausea, vomiting, diarrhoea
Not known: metallic taste and sulphurous belching, increased salivation, taste disorders.
Very common: elevated serum transaminases
Common: hepatitis, jaundice.
Not known: rash, urticaria, acne, photosensitivity, stomatitis, alopecia, purpura.
Not known: gynaecomastia, menstrual disturbance, impotence.
Not known: visual disturbances (e.g. diplopia, blurred vision, optic neuritis).
Not known: ototoxicity.
Not known: hypersensitivity reaction (rash, fever)
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