Drug

Baloxavir Marboxil

37 flagged reaction(s) · 1,816 total co-reports · max PRR 29.4

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	Intentional Product Use Issue	283	29.4	33.4	signal
2	No Adverse Event	546	28.1	36.6	signal
3	Product Packaging Quantity Issue	31	26.0	26.3	signal
4	Erythema Multiforme	17	16.6	16.8	signal
5	Melaena	30	12.4	12.6	signal
6	Drug Eruption	18	9.3	9.4	signal
7	Altered State Of Consciousness	20	8.5	8.5	signal
8	Prescribed Underdose	18	8.2	8.3	signal
9	Abnormal Behaviour	30	6.9	6.9	signal
10	Anaphylactic Shock	19	6.8	6.8	signal
11	Anaphylactic Reaction	40	6.6	6.7	signal
12	Delirium	22	5.8	5.8	signal
13	Rhabdomyolysis	26	5.7	5.7	signal
14	Hepatic Function Abnormal	23	5.7	5.7	signal
15	Influenza	60	4.9	5.0	signal
16	Face Oedema	9	4.8	4.9	signal
17	Feeding Disorder	10	4.6	4.6	signal
18	Disseminated Intravascular Coagulation	7	4.5	4.5	signal
19	Off Label Use	426	4.5	5.3	signal
20	Encephalopathy	12	4.5	4.5	signal
21	Liver Injury	11	4.1	4.2	signal
22	Acute Respiratory Distress Syndrome	8	4.1	4.1	signal
23	Product Administration Error	9	4.1	4.1	signal
24	Haematochezia	24	4.0	4.0	signal
25	Depressed Level Of Consciousness	17	3.9	3.9	signal
26	Diarrhoea Haemorrhagic	4	3.9	3.9	signal
27	Product Prescribing Error	10	3.8	3.9	signal
28	Hallucination	30	3.6	3.7	signal
29	Shock	9	3.6	3.6	signal
30	Product Use Complaint	6	3.5	3.5	signal
31	International Normalised Ratio Increased	11	3.5	3.5	signal
32	Cyanosis	6	3.5	3.5	signal
33	Product Dispensing Error	8	3.4	3.4	signal
34	Posterior Reversible Encephalopathy Syndrome	3	2.9	2.9	no signal
35	Internal Haemorrhage	3	2.4	2.4	no signal
36	Pregnancy	4	1.8	1.8	no signal
37	Extra Dose Administered	6	1.4	1.4	no signal