Drug

Methylene Blue

66 flagged reaction(s) · 3,011 total co-reports · max PRR 340.1

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	Serotonin Syndrome	469	340.1	487.2	signal
2	Blood Potassium Increased	62	51.9	54.0	signal
3	Blood Lactate Dehydrogenase Increased	60	51.1	53.1	signal
4	Cardiogenic Shock	51	48.5	50.1	signal
5	Encephalopathy	82	45.4	47.9	signal
6	Mydriasis	41	43.4	44.6	signal
7	Shock	64	38.0	39.6	signal
8	Blood Creatine Phosphokinase Increased	72	33.4	35.0	signal
9	Muscle Rigidity	28	31.8	32.3	signal
10	Drug Interaction	358	30.6	39.5	signal
11	Lactic Acidosis	60	25.3	26.3	signal
12	Ileus	22	24.2	24.6	signal
13	Multiple Organ Dysfunction Syndrome	46	22.3	23.0	signal
14	Intentional Overdose	100	21.3	22.6	signal
15	Metabolic Acidosis	49	21.0	21.6	signal
16	Chromaturia	33	19.8	20.2	signal
17	Respiratory Depression	17	18.8	19.0	signal
18	Circulatory Collapse	21	16.6	16.8	signal
19	Coma	58	16.5	17.1	signal
20	Bradycardia	62	15.8	16.4	signal
21	Alanine Aminotransferase Increased	67	14.8	15.4	signal
22	Hypotension	207	14.0	16.0	signal
23	Myoclonus	12	13.6	13.7	signal
24	Depressed Level Of Consciousness	39	13.4	13.7	signal
25	Hypothermia	10	13.3	13.4	signal
26	Rhabdomyolysis	41	13.3	13.7	signal
27	Generalised Tonic-clonic Seizure	16	13.2	13.4	signal
28	Mental Status Changes	27	13.2	13.4	signal
29	Drug Ineffective For Unapproved Indication	52	12.6	13.0	signal
30	Acute Respiratory Distress Syndrome	15	11.5	11.6	signal
31	Toxicity To Various Agents	140	11.3	12.3	signal
32	Hyperkalaemia	29	11.2	11.4	signal
33	Agitation	61	11.2	11.6	signal
34	Neurotoxicity	14	10.9	11.0	signal
35	Brain Injury	8	10.8	10.8	signal
36	Sinus Tachycardia	11	10.5	10.6	signal
37	Delirium	26	10.2	10.3	signal
38	Leukocytosis	13	9.7	9.8	signal
39	Cardiac Arrest	59	9.6	10.0	signal
40	Post Procedural Complication	13	9.1	9.2	signal
41	Hypoxia	23	8.9	9.0	signal
42	Drug Toxicity	9	8.8	8.9	signal
43	Nephropathy Toxic	7	8.5	8.5	signal
44	Unresponsive To Stimuli	16	8.4	8.5	signal
45	Aphasia	18	8.0	8.1	signal
46	Dyskinesia	23	7.7	7.8	signal
47	Suicide Attempt	33	7.4	7.5	signal
48	Autoimmune Disorder	5	7.1	7.1	signal
49	Muscle Twitching	12	7.0	7.1	signal
50	Disorientation	20	6.8	6.9	signal
51	Overdose	106	6.6	7.0	signal
52	Paralysis	7	6.6	6.6	signal
53	Skin Discolouration	22	6.5	6.6	signal
54	Anaphylactic Reaction	26	6.4	6.5	signal
55	Anaphylactic Shock	12	6.3	6.4	signal
56	Psychomotor Hyperactivity	7	5.7	5.7	signal
57	Eosinophilia	7	5.4	5.4	signal
58	Poisoning	5	5.4	5.4	signal
59	Status Epilepticus	4	4.8	4.8	signal
60	Grand Mal Convulsion	3	4.3	4.3	signal
61	Intentional Self-injury	6	4.0	4.0	signal
62	Akathisia	3	3.0	3.0	no signal
63	Premature Delivery	3	2.5	2.5	no signal
64	Drug Effective For Unapproved Indication	5	2.3	2.3	no signal
65	Extrapyramidal Disorder	4	2.2	2.2	no signal
66	Completed Suicide	10	1.6	1.6	no signal