Drug

Caplacizumab

51 flagged reaction(s) · 1,684 total co-reports · max PRR 42.3

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	Gingival Bleeding	47	42.3	43.5	signal
2	Platelet Count Increased	41	38.6	39.5	signal
3	Product Use In Unapproved Indication	573	28.8	42.9	signal
4	Epistaxis	129	21.2	22.8	signal
5	Blood Lactate Dehydrogenase Increased	25	19.3	19.5	signal
6	Platelet Count Decreased	129	14.9	16.0	signal
7	Incorrect Route Of Product Administration	16	11.7	11.8	signal
8	Contusion	86	11.0	11.5	signal
9	Petechiae	9	10.6	10.7	signal
10	Ischaemic Stroke	15	10.3	10.4	signal
11	Injection Site Bruising	64	10.0	10.3	signal
12	Haematocrit Decreased	16	9.8	9.9	signal
13	Injection Site Discolouration	7	6.9	7.0	signal
14	Injection Site Rash	17	6.9	6.9	signal
15	Skin Haemorrhage	8	6.8	6.8	signal
16	Thrombotic Microangiopathy	5	6.3	6.4	signal
17	Laboratory Test Abnormal	14	5.8	5.9	signal
18	Injection Site Irritation	6	5.8	5.8	signal
19	Disease Recurrence	22	5.7	5.7	signal
20	Drug Effective For Unapproved Indication	13	5.5	5.5	signal
21	Incorrect Product Administration Duration	9	5.4	5.5	signal
22	Haemorrhage	45	5.3	5.4	signal
23	Subdural Haematoma	6	5.1	5.1	signal
24	Gastrointestinal Haemorrhage	34	5.0	5.0	signal
25	Pneumocystis Jirovecii Pneumonia	4	4.9	4.9	signal
26	Haemorrhage Intracranial	6	4.9	4.9	signal
27	Vaginal Haemorrhage	17	4.9	4.9	signal
28	Subarachnoid Haemorrhage	4	4.8	4.8	signal
29	Cerebral Haemorrhage	14	4.8	4.8	signal
30	Poor Quality Product Administered	4	4.8	4.8	signal
31	Injection Site Haemorrhage	31	4.8	4.9	signal
32	Haematoma	10	4.7	4.7	signal
33	Transfusion	4	4.7	4.7	signal
34	Mood Altered	10	4.5	4.5	signal
35	Rebound Effect	4	4.3	4.3	signal
36	Dialysis	5	4.3	4.3	signal
37	Internal Haemorrhage	4	4.3	4.3	signal
38	Injection Site Pruritus	23	4.2	4.3	signal
39	Post Procedural Haemorrhage	4	4.2	4.2	signal
40	Hospitalisation	50	4.0	4.1	signal
41	Menorrhagia	6	3.7	3.7	signal
42	Blood Glucose Abnormal	5	3.3	3.3	signal
43	Menstruation Irregular	7	3.2	3.2	signal
44	Injection Site Pain	77	3.1	3.2	signal
45	Injection Site Erythema	31	3.1	3.1	signal
46	Injection Site Urticaria	6	3.0	3.0	signal
47	Injection Site Extravasation	3	2.9	3.0	no signal
48	Neurotoxicity	4	2.8	2.8	no signal
49	Metrorrhagia	3	2.1	2.1	no signal
50	Product Administered At Inappropriate Site	3	2.0	2.0	no signal
51	Product Storage Error	9	1.3	1.3	no signal