OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Topotecan

203 flagged reaction(s) · 12,093 total co-reports · max PRR 32.4
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 Haematotoxicity 86 32.4 32.8 signal
2 Febrile Neutropenia 426 22.4 24.0 signal
3 Ovarian Cancer 58 21.8 22.0 signal
4 Acute Myeloid Leukaemia 90 20.1 20.4 signal
5 Therapy Partial Responder 78 18.0 18.2 signal
6 Lymphopenia 71 17.5 17.7 signal
7 Neutrophil Count Decreased 192 16.5 17.0 signal
8 Mucosal Inflammation 123 16.4 16.7 signal
9 Bronchospasm 66 16.0 16.2 signal
10 Bone Marrow Failure 89 15.1 15.3 signal
11 Pancytopenia 236 14.7 15.3 signal
12 Myelodysplastic Syndrome 60 14.4 14.5 signal
13 Metastases To Liver 70 13.9 14.0 signal
14 Ileus 49 13.8 13.9 signal
15 Disease Progression 436 12.8 13.8 signal
16 Ascites 107 12.6 12.8 signal
17 Thrombocytopenia 402 12.5 13.3 signal
18 Neutropenia 484 12.4 13.4 signal
19 Red Blood Cell Count Decreased 100 12.1 12.3 signal
20 Neoplasm Progression 120 11.9 12.1 signal
21 Metastases To Central Nervous System 41 11.1 11.2 signal
22 Malignant Neoplasm Progression 299 10.2 10.7 signal
23 Metastases To Bone 48 10.2 10.3 signal
24 Leukopenia 137 9.5 9.7 signal
25 Anaemia 509 9.2 10.0 signal
26 White Blood Cell Count Decreased 281 9.0 9.4 signal
27 Eyelid Oedema 30 8.9 8.9 signal
28 Drug Toxicity 34 8.5 8.6 signal
29 Hypomagnesaemia 34 8.5 8.5 signal
30 Drug Resistance 62 8.4 8.4 signal
31 Retinal Detachment 22 8.3 8.3 signal
32 Platelet Count Decreased 249 8.1 8.4 signal
33 Posterior Reversible Encephalopathy Syndrome 22 8.0 8.0 signal
34 Anorexia 30 8.0 8.0 signal
35 Eyelid Ptosis 23 7.8 7.9 signal
36 Hypotonia 22 7.6 7.6 signal
37 Cytopenia 26 7.5 7.6 signal
38 Blood Lactate Dehydrogenase Increased 34 7.4 7.4 signal
39 Metastases To Lung 24 7.2 7.2 signal
40 Small Intestinal Obstruction 25 7.1 7.1 signal
41 Hospice Care 20 7.0 7.1 signal
42 Intestinal Perforation 22 6.8 6.8 signal
43 Thrombotic Microangiopathy 18 6.4 6.5 signal
44 Hypokalaemia 79 6.0 6.0 signal
45 Madarosis 20 5.9 5.9 signal
46 Adrenal Insufficiency 20 5.8 5.8 signal
47 Blood Urea Increased 28 5.8 5.8 signal
48 Hyperbilirubinaemia 17 5.7 5.7 signal
49 Oesophagitis 18 5.7 5.7 signal
50 Disseminated Intravascular Coagulation 23 5.6 5.7 signal
51 Flank Pain 15 5.6 5.6 signal
52 Respiratory Distress 41 5.1 5.2 signal
53 Blood Bilirubin Increased 40 5.1 5.1 signal
54 Haematocrit Decreased 29 5.0 5.1 signal
55 Atelectasis 14 5.0 5.0 signal
56 Blood Sodium Decreased 27 5.0 5.0 signal
57 Lymphocyte Count Decreased 25 4.9 4.9 signal
58 Haemoglobin Decreased 143 4.8 4.9 signal
59 Transfusion 14 4.6 4.6 signal
60 Mental Status Changes 37 4.6 4.6 signal
61 Tachypnoea 18 4.6 4.6 signal
62 Proteinuria 25 4.6 4.6 signal
63 Product Use In Unapproved Indication 323 4.6 4.8 signal
64 Hepatomegaly 13 4.6 4.6 signal
65 Electrolyte Imbalance 15 4.5 4.5 signal
66 Urosepsis 12 4.5 4.5 signal
67 Multi-organ Failure 22 4.3 4.4 signal
68 Acute Respiratory Distress Syndrome 22 4.3 4.3 signal
69 Hypocalcaemia 23 4.2 4.2 signal
70 Septic Shock 52 4.2 4.2 signal
71 Interstitial Lung Disease 58 4.2 4.2 signal
72 Bacteraemia 14 4.1 4.1 signal
73 Hypoxia 40 3.9 4.0 signal
74 Clostridium Difficile Colitis 12 3.9 3.9 signal
75 Myelosuppression 38 3.9 3.9 signal
76 Sepsis 124 3.8 3.9 signal
77 Device Related Infection 17 3.8 3.8 signal
78 Hyponatraemia 61 3.8 3.8 signal
79 Pleural Effusion 66 3.8 3.8 signal
80 Inappropriate Antidiuretic Hormone Secretion 11 3.7 3.7 signal
81 Nephropathy Toxic 12 3.7 3.7 signal
82 Platelet Count Increased 14 3.7 3.7 signal
83 Blood Calcium Decreased 12 3.7 3.7 signal
84 Petechiae 11 3.7 3.7 signal
85 Disease Recurrence 50 3.6 3.6 signal
86 Epistaxis 78 3.6 3.6 signal
87 Body Temperature Increased 21 3.6 3.6 signal
88 General Physical Health Deterioration 117 3.5 3.6 signal
89 Respiratory Failure 74 3.5 3.5 signal
90 Intraocular Pressure Increased 13 3.5 3.5 signal
91 Fistula 11 3.4 3.4 signal
92 C-reactive Protein Increased 35 3.3 3.3 signal
93 Diarrhoea Haemorrhagic 9 3.3 3.3 signal
94 Candida Infection 16 3.3 3.3 signal
95 Pyrexia 331 3.3 3.4 signal
96 Colitis 36 3.3 3.3 signal
97 Pneumothorax 15 3.3 3.3 signal
98 Haematuria 32 3.2 3.2 signal
99 Blood Test Abnormal 13 3.2 3.2 signal
100 Accident 11 3.2 3.2 signal
101 Aspartate Aminotransferase Increased 49 3.2 3.2 signal
102 Ejection Fraction Decreased 14 3.1 3.1 signal
103 No Therapeutic Response 11 3.1 3.1 signal
104 Blood Alkaline Phosphatase Increased 22 3.1 3.1 signal
105 Central Nervous System Lesion 12 3.0 3.0 signal
106 Hypophagia 22 3.0 3.0 signal
107 Tachycardia 77 3.0 3.0 signal
108 Grand Mal Convulsion 8 3.0 3.0 signal
109 Sinus Tachycardia 12 2.9 2.9 signal
110 Alanine Aminotransferase Increased 52 2.9 2.9 signal
111 Full Blood Count Decreased 17 2.9 2.9 signal
112 Deafness 22 2.9 2.9 signal
113 Hepatic Failure 25 2.9 2.9 signal
114 Dehydration 110 2.9 2.9 signal
115 Hepatotoxicity 18 2.8 2.8 signal
116 Intestinal Obstruction 30 2.8 2.8 signal
117 Status Epilepticus 9 2.8 2.8 signal
118 Neoplasm 9 2.7 2.7 signal
119 Neutrophil Count Increased 8 2.7 2.7 signal
120 Pneumonitis 21 2.7 2.7 signal
121 Peritonitis 16 2.7 2.7 signal
122 Vomiting 360 2.7 2.8 signal
123 Blood Potassium Decreased 23 2.6 2.7 signal
124 Therapy Non-responder 34 2.6 2.6 signal
125 Staphylococcal Infection 25 2.6 2.6 signal
126 Respiratory Arrest 21 2.6 2.6 signal
127 Sudden Death 8 2.6 2.6 signal
128 Renal Failure Acute 32 2.6 2.6 signal
129 Blood Creatinine Increased 48 2.5 2.6 signal
130 Pulmonary Fibrosis 14 2.5 2.5 signal
131 Palmar-plantar Erythrodysaesthesia Syndrome 17 2.5 2.5 signal
132 Decreased Appetite 167 2.5 2.5 signal
133 Choking 14 2.5 2.5 signal
134 Blood Count Abnormal 11 2.5 2.5 signal
135 Renal Tubular Necrosis 7 2.5 2.5 signal
136 Drug Ineffective For Unapproved Indication 39 2.4 2.4 signal
137 Infection 100 2.4 2.4 signal
138 Abdominal Pain 161 2.4 2.4 signal
139 Stomatitis 41 2.3 2.3 signal
140 Cholecystitis 8 2.3 2.3 signal
141 Pulmonary Hypertension 14 2.3 2.3 signal
142 Haemorrhoids 13 2.3 2.3 signal
143 Eating Disorder 14 2.3 2.3 signal
144 Agranulocytosis 12 2.2 2.2 signal
145 Hepatic Function Abnormal 24 2.2 2.2 signal
146 Death 556 2.2 2.4 signal
147 Cyst 8 2.2 2.2 signal
148 Circulatory Collapse 11 2.2 2.2 signal
149 Leukaemia 6 2.2 2.2 no signal
150 Neurotoxicity 11 2.2 2.2 signal
151 Hypothyroidism 20 2.2 2.2 signal
152 Hypotension 124 2.1 2.2 signal
153 Blood Potassium Increased 10 2.1 2.1 signal
154 Encephalopathy 15 2.1 2.1 signal
155 Pericardial Effusion 14 2.1 2.1 signal
156 Lethargy 34 2.0 2.1 signal
157 Haematemesis 15 2.0 2.0 signal
158 Product Use Issue 109 2.0 2.0 signal
159 Depressed Level Of Consciousness 23 2.0 2.0 signal
160 Lung Neoplasm Malignant 23 1.9 1.9 no signal
161 Rectal Haemorrhage 24 1.9 1.9 no signal
162 Neuropathy Peripheral 52 1.9 1.9 no signal
163 Nausea 432 1.9 2.0 no signal
164 Transaminases Increased 12 1.9 1.9 no signal
165 Appendicitis 5 1.9 1.9 no signal
166 Off Label Use 466 1.9 1.9 no signal
167 Incorrect Route Of Product Administration 9 1.9 1.9 no signal
168 Cholestasis 10 1.8 1.8 no signal
169 Vaginal Haemorrhage 22 1.8 1.8 no signal
170 Pallor 14 1.8 1.8 no signal
171 Lymphadenopathy 18 1.8 1.8 no signal
172 Lung Infection 8 1.8 1.8 no signal
173 Cardiac Failure 40 1.7 1.7 no signal
174 Respiratory Depression 6 1.7 1.7 no signal
175 Drug Effect Incomplete 18 1.7 1.7 no signal
176 Paralysis 7 1.7 1.7 no signal
177 Disorientation 19 1.7 1.7 no signal
178 Convulsion 27 1.6 1.6 no signal
179 Genital Haemorrhage 6 1.6 1.6 no signal
180 Pelvic Pain 8 1.5 1.5 no signal
181 Treatment Failure 36 1.5 1.5 no signal
182 Abdominal Pain Lower 11 1.5 1.5 no signal
183 Erythema Multiforme 4 1.5 1.5 no signal
184 Cytomegalovirus Infection 7 1.5 1.5 no signal
185 Polyneuropathy 5 1.5 1.5 no signal
186 Therapeutic Response Decreased 25 1.4 1.4 no signal
187 Vaginal Discharge 4 1.4 1.4 no signal
188 Toxicity To Various Agents 66 1.4 1.4 no signal
189 Neoplasm Malignant 26 1.3 1.4 no signal
190 Sars-cov-2 Test Positive 5 1.3 1.3 no signal
191 Cytokine Release Syndrome 7 1.3 1.3 no signal
192 Alopecia 69 1.2 1.2 no signal
193 Local Swelling 6 1.2 1.2 no signal
194 Hepatic Cytolysis 4 1.1 1.1 no signal
195 Brain Neoplasm 3 1.1 1.1 no signal
196 Poor Quality Product Administered 3 1.0 1.0 no signal
197 Drug Administration Error 8 0.9 0.9 no signal
198 Hair Colour Changes 3 0.8 0.8 no signal
199 Hair Texture Abnormal 3 0.8 0.8 no signal
200 Diabetic Ketoacidosis 5 0.7 0.7 no signal
201 Device Failure 3 0.7 0.7 no signal
202 Colorectal Cancer 9 0.6 0.6 no signal
203 Device Leakage 6 0.5 0.5 no signal