Drug

Nirsevimab

24 flagged reaction(s) · 698 total co-reports · max PRR 25.1

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	Extra Dose Administered	82	25.1	26.3	signal
2	Hypotonia	15	18.3	18.4	signal
3	Tachypnoea	19	17.1	17.3	signal
4	Cyanosis	22	17.0	17.2	signal
5	Expired Product Administered	42	15.4	15.8	signal
6	Respiratory Distress	33	14.6	14.8	signal
7	Syringe Issue	18	12.5	12.6	signal
8	Incorrect Dose Administered	229	12.4	14.2	signal
9	Incorrect Route Of Product Administration	17	12.3	12.4	signal
10	Poor Quality Product Administered	10	11.9	12.0	signal
11	Petechiae	10	11.7	11.8	signal
12	Wheezing	41	8.4	8.6	signal
13	Product Dispensing Error	15	8.4	8.5	signal
14	Erythema Multiforme	6	7.8	7.9	signal
15	Hyperbilirubinaemia	5	5.9	5.9	signal
16	Rhinorrhoea	31	5.9	6.0	signal
17	Injection Site Induration	6	5.6	5.7	signal
18	Pallor	12	5.4	5.4	signal
19	Product Storage Error	38	5.4	5.5	signal
20	Respiratory Arrest	11	4.8	4.8	signal
21	Crying	14	4.7	4.7	signal
22	Accidental Overdose	13	4.3	4.4	signal
23	Myelosuppression	5	1.8	1.8	no signal
24	Injection Site Rash	4	1.6	1.6	no signal