Drug

Protamine Sulfate

67 flagged reaction(s) · 11,814 total co-reports · max PRR 364.1

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	Fear	837	364.1	668.2	signal
2	Multi-organ Failure	441	294.5	387.3	signal
3	Renal Injury	729	284.3	470.9	signal
4	Anhedonia	625	276.1	418.0	signal
5	Injury	971	159.1	336.7	signal
6	Unevaluable Event	932	142.4	288.3	signal
7	Stress	585	93.7	137.0	signal
8	Renal Failure	1,007	86.6	190.6	signal
9	Renal Impairment	592	81.4	119.6	signal
10	Emotional Distress	708	66.9	108.3	signal
11	Renal Failure Acute	180	48.0	53.1	signal
12	Post Procedural Haemorrhage	44	43.2	44.2	signal
13	Cardiogenic Shock	46	36.9	37.9	signal
14	Anxiety	902	36.2	70.2	signal
15	Disability	47	27.2	27.9	signal
16	Pulmonary Hypertension	40	21.9	22.4	signal
17	Pain	1,031	19.2	42.4	signal
18	Depression	343	17.2	20.9	signal
19	Mucosal Inflammation	36	15.8	16.1	signal
20	Transfusion	14	15.2	15.3	signal
21	Nervousness	69	15.0	15.6	signal
22	Post Procedural Complication	25	14.9	15.0	signal
23	Ventricular Fibrillation	14	14.4	14.5	signal
24	Cerebrovascular Accident	213	14.3	16.1	signal
25	Anaphylactic Reaction	67	13.9	14.4	signal
26	Coagulopathy	18	12.4	12.5	signal
27	Disseminated Intravascular Coagulation	14	11.3	11.4	signal
28	Bronchospasm	14	11.2	11.3	signal
29	Circulatory Collapse	15	10.0	10.1	signal
30	Emotional Disorder	27	9.9	10.1	signal
31	Ventricular Tachycardia	14	9.7	9.7	signal
32	Renal Tubular Necrosis	8	9.3	9.3	signal
33	Cardiac Arrest	67	9.2	9.6	signal
34	No Therapeutic Response	10	9.2	9.3	signal
35	Mitral Valve Incompetence	9	9.1	9.1	signal
36	Hypotension	159	9.1	9.8	signal
37	Bradycardia	36	7.7	7.9	signal
38	Therapeutic Product Effect Decreased	30	7.7	7.8	signal
39	Blood Urea Increased	11	7.5	7.5	signal
40	Mental Disorder	27	7.1	7.2	signal
41	Adrenal Insufficiency	7	6.7	6.7	signal
42	Neutrophil Count Increased	6	6.7	6.7	signal
43	Shock	13	6.5	6.5	signal
44	Cardiac Disorder	53	6.4	6.6	signal
45	Myocardial Infarction	97	6.3	6.6	signal
46	Myocardial Ischaemia	6	6.0	6.0	signal
47	Cardio-respiratory Arrest	22	6.0	6.0	signal
48	Death	448	5.9	7.5	signal
49	Hypotonia	5	5.7	5.7	signal
50	Coronary Artery Disease	15	5.6	5.7	signal
51	Generalised Tonic-clonic Seizure	8	5.6	5.6	signal
52	Unresponsive To Stimuli	12	5.3	5.4	signal
53	Ischaemic Stroke	8	5.1	5.1	signal
54	Acute Myocardial Infarction	13	5.0	5.0	signal
55	Hepatic Failure	13	4.9	4.9	signal
56	Grand Mal Convulsion	4	4.9	4.9	signal
57	Deformity	4	4.9	4.9	signal
58	Cerebral Infarction	10	4.7	4.7	signal
59	Cardiac Failure Congestive	31	4.4	4.4	signal
60	Dialysis	5	4.0	4.0	signal
61	Activities Of Daily Living Impaired	7	4.0	4.0	signal
62	Caesarean Section	4	3.9	3.9	signal
63	Adverse Event	31	3.8	3.9	signal
64	Haemorrhage Intracranial	5	3.8	3.8	signal
65	Convulsion	17	3.3	3.4	signal
66	Drug Exposure During Pregnancy	10	3.3	3.3	signal
67	Premature Delivery	3	2.1	2.1	no signal