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4-Aminosalicylic acid



Active ingredient 4-Aminosalicylic acid interacts in the following cases:

Hepatic impairment

Para-aminosalicylic acid should be used with caution in patients with hepatic impairment.

Hepatic toxicity

Para-aminosalicylic acid may cause hepatitis. The first symptoms usually appear within three months of the start of therapy with a rash as the most common adverse reaction followed by fever and much less frequently by gastrointestinal disturbances of anorexia, nausea or diarrhoea. Treatment should be stopped immediately in this case.

Peptic ulcer

Para-aminosalicylic acid should be used with caution in patients with peptic ulcer.

Mild to moderate renal impairment

Given that the metabolites of para-aminosalicylic acid are largely excreted via glomerular filtration, caution is warranted in patients with mild to moderate renal impairment.


Para-aminosalicylic acid may be associated with an increased risk of hypothyroidism in HIV coinfected patients. Thyroid function should be monitored in HIV co-infected patients before commencing treatment and regularly during treatment, in particular when para-aminosalicylic acid is co-administered with ethionamide/prothionamide.


Para-aminosalicylic acid may decrease the gastrointestinal absorption of digoxin, by inhibiting the absorption function of intestinal cells. Serum digoxin levels should be monitored in patients on concomitant therapy.


Co-administration of para- aminosalicylic acid and ethionamide may intensify adverse reactions of para-aminosalicylic acid, mainly the gastrointestinal effects, including jaundice, hepatitis, nausea, vomiting, diarrhoea, abdominal pain or anorexia. Ethionamide should be withdrawn if these effects are significant.

Vitamin B12

Vitamin B12 absorption may be reduced by para-aminosalicylic acid with clinically significant erythrocyte abnormalities developing after depletion; patients on therapy of more than one month should be considered for maintenance of vitamin B12.

Effects on ability to drive and use machine

Aminosalicylic acid has negligible influence on the ability to drive and use machines.


There are no or limited amount of data from the use of aminosalicylic acid in pregnant women.

Studies in animals have shown some reproductive toxicity.

Aminosalicylic acid is not recommended during pregnancy and in women of childbearing potential not using contraception.

Literature reports on aminosalicylic acid in pregnant women always report co-administration of other medicinal products. As there are no adequate and well controlled studies of aminosalicylic acid in humans, aminosalicylic acid should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Para-aminosalicylic acid is excreted in human milk. There is insufficient information on the effects of aminosalicylic acid in newborns/infants.

Aminosalicylic acid should not be used during breast-feeding.

Carcinogenesis, Mutagenesis and Fertility


There is no evidence available on the effect of aminosalicylic acid on fertility.

Effects on Ability to Drive and Use Machines

Aminosalicylic acid has negligible influence on the ability to drive and use machines.