Drug

Ivosidenib

40 flagged reaction(s) · 1,717 total co-reports · max PRR 21.6

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	Electrocardiogram Qt Prolonged	76	21.6	22.4	signal
2	Cytopenia	19	16.2	16.4	signal
3	Blood Count Abnormal	21	13.9	14.1	signal
4	Leukocytosis	24	13.5	13.7	signal
5	Transfusion	13	12.6	12.7	signal
6	Hospice Care	12	12.4	12.5	signal
7	Acute Myeloid Leukaemia	18	11.8	11.9	signal
8	Febrile Neutropenia	74	11.4	11.8	signal
9	Blood Test Abnormal	14	10.2	10.2	signal
10	Decreased Activity	9	8.6	8.6	signal
11	Malignant Neoplasm Progression	79	7.9	8.2	signal
12	Platelet Count Increased	10	7.8	7.8	signal
13	Off Label Use	652	7.7	10.8	signal
14	Disease Progression	88	7.6	7.9	signal
15	White Blood Cell Count Increased	27	7.2	7.2	signal
16	Red Blood Cell Count Decreased	20	7.1	7.2	signal
17	Platelet Count Decreased	74	7.1	7.3	signal
18	Full Blood Count Decreased	14	7.1	7.1	signal
19	Ascites	20	6.9	7.0	signal
20	Squamous Cell Carcinoma	6	6.5	6.5	signal
21	Myelosuppression	18	5.4	5.4	signal
22	Pancytopenia	29	5.3	5.4	signal
23	Haemoglobin Decreased	53	5.3	5.4	signal
24	Neoplasm Progression	18	5.2	5.3	signal
25	Thrombocytopenia	57	5.2	5.3	signal
26	Drug Ineffective For Unapproved Indication	28	5.1	5.2	signal
27	Pericarditis	8	4.9	4.9	signal
28	Neutropenia	65	4.9	5.0	signal
29	Full Blood Count Abnormal	5	4.8	4.8	signal
30	Haematotoxicity	4	4.4	4.4	signal
31	Leukaemia	4	4.3	4.3	signal
32	Subdural Haematoma	6	4.3	4.3	signal
33	Product Use Issue	78	4.3	4.4	signal
34	Drug Level Decreased	4	4.0	4.0	signal
35	Product Use Complaint	6	3.9	4.0	signal
36	Laboratory Test Abnormal	11	3.8	3.8	signal
37	Underdose	24	3.3	3.4	signal
38	Drug Resistance	8	3.2	3.2	signal
39	Product Dose Omission	18	2.8	2.8	signal
40	Hepatic Cytolysis	3	2.5	2.5	no signal