Drug

Nitisinone

14 flagged reaction(s) · 260 total co-reports · max PRR 43.9

Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.

	Reaction	Co-reports (a)	PRR	ROR	Signal
1	Hepatic Cirrhosis	37	43.9	45.6	signal
2	Hepatic Failure	45	33.0	34.6	signal
3	Hepatomegaly	12	26.9	27.2	signal
4	Treatment Noncompliance	50	20.4	21.5	signal
5	Cataract	47	17.5	18.4	signal
6	Hepatic Encephalopathy	7	16.6	16.7	signal
7	Inappropriate Antidiuretic Hormone Secretion	7	15.2	15.3	signal
8	Acute Hepatic Failure	7	11.4	11.5	signal
9	Drug Level Decreased	5	10.8	10.9	signal
10	No Therapeutic Response	6	10.7	10.8	signal
11	Hepatic Cancer	9	8.2	8.3	signal
12	Product Availability Issue	6	5.9	6.0	signal
13	Eye Irritation	14	5.6	5.6	signal
14	Abortion Spontaneous	8	4.4	4.4	signal