What is Orfadin used for?

( ARTG ) Orfadin (nitisinone) is indicated for the treatment of patients with hereditary tyrosinaemia type 1 in combination with dietary restriction of tyrosine and phenylalanine.

How does Orfadin work?

USDailyMed:Nitisinone A16AX04(WHO) CA:℞-onlyUS:℞-onlyEU:Rx-only 2-[2-nitro-4-(trifluoromethyl)benzoyl]cyclohexane-1,3-dione 104206-65-7Y 115355 6834 DB00348Y 103195Y K5BN214699 D05177Y CHEBI:50378Y ChEMBL1337Y DTXSID9042673 Interactive image O=C(c1ccc(cc1[N+]([O-])=O)C(F)(F)F)C2C(=O)CCCC2=O InChI=1S/C14H10F3NO5/c15-14(16,17)7-4-5-8(9(6-7)18(22)23)13(21)12-10(19)2-1-3-11(12)20/h4-6,12H,1-3H2YKey:OU

What are the side effects of Orfadin?

You can help ensure medicines are safe by reporting the side effects you experience. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

Can Orfadin be used during pregnancy?

( AHT ) For the active ingredient nitisinone You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.

What precautions should be taken with Orfadin?

• Caution should be exercised in patients with history of metabolic disorder, any allergy, who are taking other medications, during pregnancy and breastfeeding. • Follow proper diet program as per your healthcare provider’s advice. • Monitor sugar level regularly for diabetic patients during the treatment. • Monitor blood cell counts, vision tests, liver function tests and blood phosphate or tyrosine levels regularly while taking this medication.

Who manufactures Orfadin?

Swedish Orphan Biovitrum International AB

What ATC class does Orfadin belong to?

Orfadin: ATC A16AX04. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

OTC

Orfadin

INN: nitisinone

Data updated: 2026-05-28

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