Ethionamide

Chemical formula: C₈H₁₀N₂S  Molecular mass: 166.243 g/mol  PubChem compound: 2761171

Pregnancy

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.

Nursing mothers

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.

Carcinogenesis, mutagenesis and fertility

Fertility

No data on the effect of ethionamide on fertility are available.

Effects on ability to drive and use machines

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 reactions


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.

Blood and lymphatic system disorders

Not known: thrombocytopenia.

Metabolism and nutrition disorders

Not known: pellagra-like syndrome, hypothyroidism, hypoglycaemia.

Psychiatric disorders

Not known: psychotic reactions.

Nervous system disorders

Common: headache, dizziness, drowsiness, asthenia, paresthaesia

Not known: encephalopathy, peripheral neuritis, olfactory disturbance.

Cardiovascular disorders

Not known: postural hypotension.

Gastrointestinal disorders

Very common: epigastric discomfort, abdominal pain, anorexia, nausea, vomiting, diarrhoea

Not known: metallic taste and sulphurous belching, increased salivation, taste disorders.

Hepatobiliary disorders

Very common: elevated serum transaminases

Common: hepatitis, jaundice.

Skin and subcutaneous tissue disorders

Not known: rash, urticaria, acne, photosensitivity, stomatitis, alopecia, purpura.

Reproductive system and breast disorders

Not known: gynaecomastia, menstrual disturbance, impotence.

Eye disorders

Not known: visual disturbances (e.g. diplopia, blurred vision, optic neuritis).

Ear disorders

Not known: ototoxicity.

General disorders and administration site conditions

Not known: hypersensitivity reaction (rash, fever)

Cross-check medications

Review your medication to ensure that there are no potentially harmful drug interactions or contraindications.

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