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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

NITISINONE for Alkaptonuria: Side Effects & Safety Data

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There are 92 adverse event reports in the FDA FAERS database where NITISINONE was used for Alkaptonuria.

Most Reported Side Effects for NITISINONE

Side Effect Reports % Deaths Hosp.
Amino acid level increased 118 15.7% 2 18
Liver transplant 62 8.2% 5 32
Hepatocellular carcinoma 58 7.7% 17 18
Cataract 47 6.3% 0 0
Off label use 41 5.5% 3 7
Alpha 1 foetoprotein increased 39 5.2% 5 10
Lenticular opacities 34 4.5% 0 0
Vomiting 32 4.3% 4 23
Succinylacetone increased 31 4.1% 2 9
Treatment noncompliance 30 4.0% 0 15
Death 29 3.9% 29 2
Abdominal pain 26 3.5% 1 21
Hepatic failure 25 3.3% 13 11
Seizure 24 3.2% 8 8
Product dose omission issue 18 2.4% 2 7

Other Indications for NITISINONE

Tyrosinaemia (566) Amino acid metabolism disorder (44) Product used for unknown indication (29)

Related Pages

NITISINONE Full Profile All Alkaptonuria Drugs NITISINONE Demographics NITISINONE Timeline