OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Clofazimine

266 flagged reaction(s) · 14,217 total co-reports · max PRR 71.4
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 Electrocardiogram Qt Prolonged 762 71.4 81.0 signal
2 Tuberculosis 148 38.4 39.3 signal
3 Drug Resistance 268 34.8 36.3 signal
4 Hepatotoxicity 186 27.9 28.7 signal
5 Polyneuropathy 75 20.9 21.2 signal
6 Drug-induced Liver Injury 143 15.4 15.7 signal
7 Drug Reaction With Eosinophilia And Systemic Symptoms 115 14.9 15.2 signal
8 Electrolyte Imbalance 50 14.4 14.5 signal
9 Incorrect Product Administration Duration 88 14.4 14.6 signal
10 Haemoptysis 116 13.8 14.0 signal
11 Neuropathy Peripheral 383 13.4 14.2 signal
12 Deafness 95 12.0 12.2 signal
13 Pneumothorax 54 11.3 11.4 signal
14 Nephropathy Toxic 37 11.0 11.1 signal
15 Malnutrition 35 10.4 10.5 signal
16 Aspartate Aminotransferase Increased 158 9.9 10.1 signal
17 Transaminases Increased 66 9.8 9.9 signal
18 Blood Sodium Decreased 55 9.7 9.8 signal
19 Hypomagnesaemia 39 9.3 9.4 signal
20 Sputum Discoloured 26 9.1 9.1 signal
21 Blood Calcium Decreased 31 9.1 9.1 signal
22 Hypokalaemia 121 8.7 8.9 signal
23 Myelosuppression 87 8.5 8.6 signal
24 Skin Discolouration 117 8.4 8.6 signal
25 Anaemia 474 8.2 8.8 signal
26 Gastroenteritis 36 8.2 8.2 signal
27 Oral Candidiasis 32 8.1 8.2 signal
28 Alanine Aminotransferase Increased 151 8.1 8.3 signal
29 Hepatitis 61 7.9 8.0 signal
30 Respiratory Failure 173 7.8 8.0 signal
31 Tinnitus 104 7.5 7.6 signal
32 Clostridium Difficile Colitis 24 7.5 7.5 signal
33 Lymphopenia 30 7.1 7.1 signal
34 Platelet Count Increased 26 6.6 6.6 signal
35 Toxic Skin Eruption 20 6.5 6.6 signal
36 Hepatocellular Injury 28 6.5 6.5 signal
37 Hyperbilirubinaemia 20 6.4 6.4 signal
38 Psychotic Disorder 57 6.4 6.4 signal
39 Productive Cough 87 6.1 6.1 signal
40 Hypothyroidism 58 6.0 6.1 signal
41 Gamma-glutamyltransferase Increased 40 6.0 6.0 signal
42 Acute Respiratory Failure 34 5.9 5.9 signal
43 Treatment Failure 144 5.8 5.9 signal
44 Ventricular Extrasystoles 18 5.7 5.7 signal
45 Hepatomegaly 17 5.7 5.7 signal
46 Hepatic Cytolysis 21 5.7 5.7 signal
47 Hypoacusis 73 5.6 5.7 signal
48 Hypocalcaemia 32 5.6 5.6 signal
49 Intentional Product Use Issue 149 5.6 5.7 signal
50 Blood Alkaline Phosphatase Increased 42 5.6 5.6 signal
51 Liver Function Test Increased 32 5.0 5.0 signal
52 Sudden Death 16 4.9 5.0 signal
53 Bone Marrow Failure 30 4.8 4.9 signal
54 Lactic Acidosis 47 4.8 4.9 signal
55 Gastritis 38 4.8 4.8 signal
56 Eosinophilia 25 4.7 4.7 signal
57 Chronic Obstructive Pulmonary Disease 73 4.6 4.7 signal
58 Haemoglobin Decreased 144 4.6 4.7 signal
59 Hepatitis C 17 4.6 4.6 signal
60 Emphysema 14 4.6 4.6 signal
61 Blood Bilirubin Increased 37 4.5 4.5 signal
62 Cardiomyopathy 20 4.5 4.5 signal
63 Generalised Tonic-clonic Seizure 22 4.4 4.5 signal
64 Drug Intolerance 129 4.4 4.5 signal
65 Peritonitis Bacterial 13 4.3 4.3 signal
66 Arrhythmia 61 4.2 4.3 signal
67 Leukocytosis 23 4.2 4.2 signal
68 Blood Potassium Decreased 38 4.2 4.2 signal
69 Covid-19 Pneumonia 15 4.2 4.2 signal
70 Bronchospasm 18 4.2 4.2 signal
71 Pancytopenia 70 4.2 4.2 signal
72 Respiratory Distress 34 4.1 4.1 signal
73 Jaundice 33 4.0 4.1 signal
74 Myocardial Ischaemia 14 4.0 4.0 signal
75 Pulmonary Mass 18 4.0 4.0 signal
76 White Blood Cell Count Increased 46 3.9 4.0 signal
77 Blood Urea Increased 20 3.9 3.9 signal
78 Hepatic Enzyme Increased 80 3.9 3.9 signal
79 Product Use In Unapproved Indication 284 3.8 4.0 signal
80 Treatment Noncompliance 61 3.7 3.7 signal
81 Gastrointestinal Disorder 99 3.7 3.7 signal
82 Red Blood Cell Count Decreased 32 3.7 3.7 signal
83 Blood Creatinine Increased 73 3.7 3.7 signal
84 Laryngitis 12 3.7 3.7 signal
85 Device Related Infection 17 3.6 3.6 signal
86 Blood Thyroid Stimulating Hormone Increased 10 3.6 3.6 signal
87 Dysphonia 63 3.6 3.6 signal
88 Pancreatitis Acute 24 3.6 3.6 signal
89 Aphonia 15 3.6 3.6 signal
90 Vomiting 503 3.5 3.8 signal
91 Cholestasis 20 3.5 3.5 signal
92 Pancreatitis 55 3.4 3.5 signal
93 Metabolic Acidosis 32 3.3 3.4 signal
94 Haematocrit Decreased 20 3.3 3.3 signal
95 Cough 276 3.3 3.4 signal
96 Blood Potassium Increased 16 3.3 3.3 signal
97 Dyspnoea Exertional 37 3.3 3.3 signal
98 Iron Deficiency Anaemia 9 3.2 3.2 signal
99 Neutrophil Count Increased 10 3.2 3.2 signal
100 Secretion Discharge 12 3.2 3.2 signal
101 Hypoxia 34 3.2 3.2 signal
102 Decreased Appetite 223 3.2 3.3 signal
103 Candida Infection 16 3.2 3.2 signal
104 Liver Function Test Abnormal 28 3.2 3.2 signal
105 Incorrect Drug Administration Duration 27 3.1 3.1 signal
106 Drug Interaction 150 3.1 3.2 signal
107 Thrombocytopenia 105 3.1 3.1 signal
108 Sinus Bradycardia 9 3.1 3.1 signal
109 Atelectasis 9 3.1 3.1 signal
110 Skin Reaction 13 3.1 3.1 signal
111 Leukopenia 46 3.0 3.1 signal
112 Agranulocytosis 17 3.0 3.0 signal
113 Nodule 12 3.0 3.0 signal
114 Tachypnoea 12 2.9 2.9 signal
115 Ear Discomfort 9 2.9 2.9 signal
116 Lung Disorder 43 2.9 2.9 signal
117 Acute Kidney Injury 132 2.9 2.9 signal
118 Multiple Organ Dysfunction Syndrome 24 2.8 2.8 signal
119 Pulmonary Embolism 82 2.8 2.9 signal
120 Hallucination, Visual 18 2.8 2.8 signal
121 Skin Lesion 23 2.8 2.8 signal
122 Tendonitis 13 2.8 2.8 signal
123 Oesophagitis 9 2.7 2.7 signal
124 Off Label Use 704 2.7 2.9 signal
125 Neurotoxicity 14 2.7 2.7 signal
126 Dermatitis Allergic 10 2.7 2.7 signal
127 Pneumocystis Jirovecii Pneumonia 8 2.6 2.6 signal
128 Hypothermia 8 2.6 2.6 signal
129 Sinus Tachycardia 11 2.6 2.6 signal
130 Mental Disorder 33 2.5 2.5 signal
131 Cytopenia 9 2.5 2.5 signal
132 Renal Impairment 63 2.5 2.5 signal
133 Adrenal Insufficiency 9 2.5 2.5 signal
134 Hypophagia 19 2.5 2.5 signal
135 Shock 17 2.5 2.5 signal
136 Drug Eruption 13 2.4 2.4 signal
137 Product Prescribing Issue 15 2.4 2.4 signal
138 Generalised Oedema 9 2.4 2.4 signal
139 Photosensitivity Reaction 12 2.4 2.4 signal
140 Rash Maculo-papular 16 2.4 2.4 signal
141 Nausea 563 2.4 2.5 signal
142 Dyspnoea 403 2.4 2.4 signal
143 Hyponatraemia 40 2.4 2.4 signal
144 Liver Injury 17 2.3 2.3 signal
145 Drug Ineffective For Unapproved Indication 39 2.3 2.3 signal
146 Hepatic Cirrhosis 13 2.3 2.3 signal
147 Hepatic Failure 21 2.3 2.3 signal
148 Abscess 11 2.3 2.3 signal
149 Night Sweats 22 2.3 2.3 signal
150 Serotonin Syndrome 13 2.2 2.2 signal
151 Ataxia 8 2.2 2.2 signal
152 Therapy Interrupted 46 2.2 2.2 signal
153 Blood Pressure Decreased 44 2.2 2.2 signal
154 Seizure 76 2.2 2.2 signal
155 Acute Hepatic Failure 9 2.2 2.2 signal
156 Pyrexia 229 2.2 2.2 signal
157 Platelet Count Decreased 70 2.2 2.2 signal
158 Gastrointestinal Carcinoma 6 2.2 2.2 no signal
159 Disease Recurrence 31 2.1 2.2 signal
160 Haematotoxicity 6 2.1 2.1 no signal
161 Deep Vein Thrombosis 42 2.1 2.1 signal
162 Weight Decreased 179 2.1 2.2 signal
163 Flank Pain 6 2.1 2.1 no signal
164 Hypoglycaemia 31 2.1 2.1 signal
165 Neutropenia 85 2.1 2.1 signal
166 Intentional Dose Omission 17 2.1 2.1 signal
167 Ascites 18 2.0 2.0 signal
168 Disease Progression 72 2.0 2.0 signal
169 Osteomyelitis 11 2.0 2.0 signal
170 General Physical Health Deterioration 68 2.0 2.0 no signal
171 Haematemesis 15 1.9 2.0 no signal
172 Rash Pruritic 31 1.9 1.9 no signal
173 Tenderness 6 1.9 1.9 no signal
174 Abdominal Pain 132 1.9 1.9 no signal
175 Cardiac Arrest 47 1.9 1.9 no signal
176 Acute Respiratory Distress Syndrome 10 1.9 1.9 no signal
177 Lymphadenopathy 20 1.9 1.9 no signal
178 Asthenia 211 1.9 1.9 no signal
179 Oxygen Saturation Decreased 31 1.8 1.8 no signal
180 Brain Oedema 7 1.8 1.8 no signal
181 Pulmonary Arterial Hypertension 8 1.8 1.8 no signal
182 Cardiac Failure 44 1.8 1.8 no signal
183 Hepatic Function Abnormal 20 1.8 1.8 no signal
184 Hepatic Encephalopathy 5 1.8 1.8 no signal
185 Renal Injury 16 1.8 1.8 no signal
186 Squamous Cell Carcinoma 5 1.8 1.8 no signal
187 Visual Impairment 65 1.7 1.8 no signal
188 Pulmonary Hypertension 11 1.7 1.7 no signal
189 Vitreous Floaters 5 1.7 1.7 no signal
190 Splenomegaly 6 1.7 1.7 no signal
191 Lymphocyte Count Decreased 9 1.7 1.7 no signal
192 Diabetes Mellitus Inadequate Control 9 1.7 1.7 no signal
193 Salivary Hypersecretion 5 1.7 1.7 no signal
194 Glomerular Filtration Rate Decreased 6 1.6 1.6 no signal
195 Foetal Exposure During Pregnancy 40 1.6 1.6 no signal
196 Chromaturia 11 1.6 1.6 no signal
197 Peritonitis 10 1.6 1.6 no signal
198 Ventricular Tachycardia 8 1.6 1.6 no signal
199 Dermatitis 10 1.6 1.6 no signal
200 Coagulopathy 8 1.6 1.6 no signal
201 Palpitations 56 1.6 1.6 no signal
202 Bradycardia 25 1.6 1.6 no signal
203 Hemiparesis 8 1.5 1.6 no signal
204 Dysgeusia 35 1.5 1.6 no signal
205 Eating Disorder 10 1.5 1.5 no signal
206 Circulatory Collapse 8 1.5 1.5 no signal
207 Exposure During Pregnancy 29 1.5 1.5 no signal
208 Premature Baby 14 1.5 1.5 no signal
209 Syncope 46 1.5 1.5 no signal
210 Hyperkalaemia 16 1.5 1.5 no signal
211 Intestinal Obstruction 17 1.5 1.5 no signal
212 Angina Pectoris 13 1.5 1.5 no signal
213 Obstructive Airways Disorder 5 1.5 1.5 no signal
214 Uveitis 6 1.5 1.5 no signal
215 Rebound Effect 5 1.5 1.5 no signal
216 Premature Delivery 7 1.4 1.4 no signal
217 Rash Erythematous 20 1.4 1.4 no signal
218 Disseminated Intravascular Coagulation 6 1.4 1.4 no signal
219 Osteonecrosis 14 1.4 1.4 no signal
220 Visual Acuity Reduced 14 1.4 1.4 no signal
221 Pharyngeal Swelling 4 1.4 1.4 no signal
222 Pneumonitis 11 1.3 1.3 no signal
223 Pallor 11 1.3 1.3 no signal
224 Therapeutic Response Decreased 24 1.3 1.3 no signal
225 Abdominal Pain Lower 10 1.3 1.3 no signal
226 Blindness 16 1.3 1.3 no signal
227 Inappropriate Antidiuretic Hormone Secretion 4 1.3 1.3 no signal
228 Drug Level Decreased 4 1.3 1.3 no signal
229 Rhabdomyolysis 16 1.3 1.3 no signal
230 Nervous System Disorder 12 1.3 1.3 no signal
231 Dry Skin 50 1.3 1.3 no signal
232 Adverse Event 35 1.3 1.3 no signal
233 Eructation 7 1.2 1.2 no signal
234 Bipolar Disorder 4 1.2 1.2 no signal
235 Drug Level Increased 6 1.2 1.2 no signal
236 Red Blood Cell Sedimentation Rate Increased 4 1.2 1.2 no signal
237 Hallucination 27 1.2 1.2 no signal
238 Adverse Drug Reaction 32 1.2 1.2 no signal
239 Fistula 4 1.2 1.2 no signal
240 Drug Effective For Unapproved Indication 10 1.1 1.1 no signal
241 Fluid Overload 5 1.1 1.1 no signal
242 Toxicity To Various Agents 54 1.1 1.1 no signal
243 Poisoning 4 1.0 1.0 no signal
244 Mydriasis 4 1.0 1.0 no signal
245 Affect Lability 3 1.0 1.0 no signal
246 Hospitalisation 46 1.0 1.0 no signal
247 Underdose 22 1.0 1.0 no signal
248 Maternal Exposure During Pregnancy 26 1.0 1.0 no signal
249 Myelodysplastic Syndrome 4 0.9 0.9 no signal
250 Death 221 0.8 0.8 no signal
251 Myocardial Infarction 45 0.8 0.8 no signal
252 Hallucination, Auditory 4 0.8 0.8 no signal
253 Diabetic Ketoacidosis 6 0.8 0.8 no signal
254 Intentional Self-injury 5 0.8 0.8 no signal
255 Hair Colour Changes 3 0.8 0.8 no signal
256 Sopor 3 0.7 0.7 no signal
257 Accidental Underdose 3 0.7 0.7 no signal
258 Gynaecomastia 6 0.6 0.6 no signal
259 Abortion Spontaneous 7 0.6 0.6 no signal
260 Device Use Issue 3 0.6 0.6 no signal
261 Device Leakage 7 0.5 0.5 no signal
262 Drug Dependence 23 0.5 0.5 no signal
263 Completed Suicide 9 0.4 0.4 no signal
264 Pancreatic Carcinoma 3 0.3 0.3 no signal
265 Device Issue 8 0.3 0.3 no signal
266 Drug Dose Omission By Device 4 0.2 0.2 no signal