Drug

Mitomycin

106 flagged reaction(s) · 2,251 total co-reports · max PRR 29.0

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	Flank Pain	44	29.0	29.3	signal
2	Dysuria	100	16.7	17.2	signal
3	Thrombotic Microangiopathy	24	15.2	15.3	signal
4	Haematotoxicity	21	13.9	14.0	signal
5	Mucosal Inflammation	58	13.7	13.9	signal
6	Metastases To Liver	39	13.7	13.8	signal
7	Haematuria	69	12.4	12.6	signal
8	Pancytopenia	103	11.4	11.7	signal
9	Micturition Urgency	20	10.8	10.9	signal
10	Metastases To Central Nervous System	21	10.1	10.1	signal
11	Metastases To Lung	18	9.6	9.6	signal
12	Leukopenia	77	9.5	9.7	signal
13	Ileus	18	9.0	9.0	signal
14	Urosepsis	13	8.7	8.7	signal
15	Bone Marrow Failure	28	8.4	8.5	signal
16	Post Procedural Complication	26	8.3	8.4	signal
17	Uveitis	16	7.3	7.3	signal
18	Myelodysplastic Syndrome	17	7.2	7.2	signal
19	Pollakiuria	48	7.1	7.2	signal
20	Renal Pain	12	7.0	7.0	signal
21	Cardiogenic Shock	16	6.9	6.9	signal
22	Palmar-plantar Erythrodysaesthesia Syndrome	26	6.8	6.9	signal
23	Pulmonary Arterial Hypertension	16	6.7	6.8	signal
24	Febrile Neutropenia	72	6.7	6.8	signal
25	Hepatic Failure	32	6.5	6.6	signal
26	Visual Acuity Reduced	34	6.2	6.3	signal
27	Thrombocytopenia	110	6.1	6.2	signal
28	Obstructive Airways Disorder	11	6.1	6.1	signal
29	Metastases To Bone	16	6.0	6.0	signal
30	Bacterial Infection	18	6.0	6.0	signal
31	Dermatitis	20	5.9	6.0	signal
32	Urinary Retention	32	5.9	5.9	signal
33	Therapy Interrupted	62	5.5	5.6	signal
34	Interstitial Lung Disease	42	5.3	5.4	signal
35	Disease Progression	100	5.2	5.3	signal
36	Neutropenia	108	4.9	5.0	signal
37	Therapy Partial Responder	12	4.9	4.9	signal
38	Cystitis	25	4.8	4.8	signal
39	Incorrect Route Of Drug Administration	28	4.7	4.8	signal
40	Tenderness	8	4.7	4.7	signal
41	Hepatic Steatosis	14	4.6	4.6	signal
42	Drug Toxicity	10	4.4	4.5	signal
43	Nephropathy Toxic	8	4.4	4.4	signal
44	Pulmonary Hypertension	15	4.4	4.4	signal
45	Skin Reaction	10	4.4	4.4	signal
46	Acute Myeloid Leukaemia	11	4.3	4.3	signal
47	Myocarditis	8	4.3	4.3	signal
48	Bladder Disorder	7	4.3	4.3	signal
49	Intraocular Pressure Increased	9	4.3	4.3	signal
50	Acute Respiratory Distress Syndrome	12	4.2	4.2	signal
51	Erythema Multiforme	6	3.9	4.0	signal
52	Staphylococcal Infection	21	3.9	3.9	signal
53	Ulcer	10	3.9	3.9	signal
54	Ascites	18	3.8	3.8	signal
55	Malignant Neoplasm Progression	61	3.7	3.7	signal
56	Incorrect Route Of Product Administration	10	3.7	3.7	signal
57	Toxic Skin Eruption	6	3.6	3.6	signal
58	Eyelid Ptosis	6	3.6	3.6	signal
59	Peritonitis	12	3.6	3.6	signal
60	Neoplasm Progression	20	3.5	3.5	signal
61	No Therapeutic Response	7	3.5	3.5	signal
62	Mydriasis	7	3.4	3.4	signal
63	Body Temperature Increased	11	3.3	3.3	signal
64	Dermatitis Contact	6	3.2	3.2	signal
65	Posterior Reversible Encephalopathy Syndrome	5	3.2	3.2	signal
66	Pulmonary Fibrosis	10	3.2	3.2	signal
67	Adverse Event	48	3.2	3.2	signal
68	Therapy Cessation	26	3.1	3.1	signal
69	Polyneuropathy	6	3.1	3.1	signal
70	Product Administration Error	10	3.1	3.1	signal
71	Disseminated Intravascular Coagulation	7	3.0	3.0	signal
72	Small Intestinal Obstruction	6	3.0	3.0	signal
73	Hyperbilirubinaemia	5	3.0	3.0	signal
74	Pneumonitis	13	3.0	3.0	signal
75	Proteinuria	9	2.9	2.9	signal
76	Upper Gastrointestinal Haemorrhage	8	2.9	2.9	signal
77	Intestinal Perforation	5	2.7	2.7	no signal
78	Fistula	5	2.7	2.7	no signal
79	Product Administered At Inappropriate Site	8	2.7	2.7	signal
80	Spinal Pain	5	2.6	2.6	no signal
81	Lymphopenia	6	2.6	2.6	signal
82	Rash Pruritic	23	2.6	2.6	signal
83	Neurotoxicity	7	2.5	2.5	signal
84	White Blood Cell Count Decreased	42	2.4	2.4	signal
85	Anorexia	5	2.3	2.3	no signal
86	Breast Cancer Metastatic	4	2.3	2.3	no signal
87	Abdominal Pain Lower	9	2.2	2.2	signal
88	Multi-organ Failure	6	2.1	2.1	no signal
89	Laboratory Test Abnormal	10	2.1	2.1	signal
90	Respiratory Depression	4	2.0	2.0	no signal
91	Leukaemia	3	2.0	2.0	no signal
92	Complication Associated With Device	4	1.9	1.9	no signal
93	Pneumocystis Jirovecii Pneumonia	3	1.8	1.8	no signal
94	Malignant Melanoma	4	1.8	1.8	no signal
95	Myelosuppression	10	1.8	1.8	no signal
96	Pelvic Pain	5	1.7	1.7	no signal
97	Device Dislocation	11	1.6	1.6	no signal
98	Osteonecrosis	8	1.5	1.5	no signal
99	Osteonecrosis Of Jaw	6	1.5	1.5	no signal
100	Gastric Cancer	5	1.2	1.2	no signal
101	Bladder Cancer	9	0.9	0.9	no signal
102	Circumstance Or Information Capable Of Leading To Medication Error	5	0.9	0.9	no signal
103	Breast Cancer	12	0.8	0.8	no signal
104	Pharmaceutical Product Complaint	3	0.7	0.7	no signal
105	Device Breakage	3	0.5	0.5	no signal
106	Renal Cancer	3	0.4	0.4	no signal