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Drug

Atovaquone Oral Suspension

315 flagged reaction(s) · 12,206 total co-reports · max PRR 46.9
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 Pneumocystis Jirovecii Pneumonia 148 46.9 48.0 signal
2 Thrombotic Microangiopathy 89 29.0 29.3 signal
3 Hepatic Cytolysis 105 27.1 27.5 signal
4 Cytokine Release Syndrome 118 19.5 19.8 signal
5 Agranulocytosis 86 14.6 14.8 signal
6 Toxic Epidermal Necrolysis 63 13.1 13.2 signal
7 Bacteraemia 49 13.1 13.1 signal
8 Cytopenia 48 12.6 12.7 signal
9 Encephalopathy 96 12.3 12.5 signal
10 Hyperbilirubinaemia 40 12.2 12.2 signal
11 Cytomegalovirus Infection 59 11.1 11.2 signal
12 Febrile Neutropenia 211 10.0 10.3 signal
13 Drug Resistance 80 9.8 9.9 signal
14 Cholestasis 59 9.7 9.8 signal
15 Pancytopenia 171 9.6 9.8 signal
16 Acute Myeloid Leukaemia 45 9.1 9.1 signal
17 Rash Maculo-papular 64 9.0 9.1 signal
18 Schizophrenia 35 9.0 9.1 signal
19 Covid-19 Pneumonia 32 8.4 8.5 signal
20 Septic Shock 114 8.3 8.4 signal
21 Drug Eruption 46 8.2 8.2 signal
22 Drug Reaction With Eosinophilia And Systemic Symptoms 65 8.0 8.0 signal
23 Drug Level Increased 41 7.7 7.8 signal
24 Oesophagitis 27 7.7 7.8 signal
25 Clostridium Difficile Colitis 26 7.7 7.7 signal
26 Respiratory Failure 170 7.3 7.5 signal
27 Disseminated Intravascular Coagulation 31 6.9 6.9 signal
28 Candida Infection 36 6.8 6.8 signal
29 Multiple Organ Dysfunction Syndrome 60 6.7 6.8 signal
30 Acute Respiratory Distress Syndrome 38 6.7 6.8 signal
31 Acute Respiratory Failure 41 6.7 6.7 signal
32 Thrombocytopenia 238 6.7 6.9 signal
33 Hepatotoxicity 45 6.4 6.4 signal
34 Colitis 73 6.1 6.1 signal
35 Renal Tubular Necrosis 19 6.0 6.1 signal
36 Bone Marrow Failure 37 5.7 5.7 signal
37 Lymphopenia 25 5.6 5.6 signal
38 Neutropenia 237 5.5 5.6 signal
39 Hepatic Function Abnormal 64 5.4 5.4 signal
40 Anhedonia 45 5.3 5.3 signal
41 Hyperkalaemia 59 5.3 5.3 signal
42 Neutrophil Count Decreased 68 5.3 5.3 signal
43 Stevens-johnson Syndrome 37 5.2 5.2 signal
44 Osteopenia 25 5.1 5.1 signal
45 Blood Bilirubin Increased 44 5.1 5.1 signal
46 Cholelithiasis 53 5.1 5.1 signal
47 Acute Kidney Injury 246 5.1 5.2 signal
48 Staphylococcal Infection 52 4.9 4.9 signal
49 Drug-induced Liver Injury 47 4.8 4.8 signal
50 Hyperlipidaemia 18 4.7 4.7 signal
51 Hypoxia 52 4.6 4.7 signal
52 Sepsis 165 4.6 4.7 signal
53 End Stage Renal Disease 27 4.6 4.6 signal
54 Ischaemic Stroke 25 4.4 4.4 signal
55 Leukocytosis 25 4.3 4.3 signal
56 Nephropathy Toxic 15 4.2 4.2 signal
57 Pneumonitis 36 4.2 4.2 signal
58 Platelet Count Decreased 140 4.1 4.2 signal
59 Drug Ineffective For Unapproved Indication 73 4.1 4.1 signal
60 Gamma-glutamyltransferase Increased 29 4.1 4.1 signal
61 Economic Problem 20 4.1 4.1 signal
62 Toxic Skin Eruption 13 4.0 4.0 signal
63 Leukopenia 64 4.0 4.0 signal
64 Diarrhoea Haemorrhagic 12 4.0 4.0 signal
65 Interstitial Lung Disease 61 3.9 4.0 signal
66 Posterior Reversible Encephalopathy Syndrome 12 3.9 3.9 signal
67 Blood Lactate Dehydrogenase Increased 20 3.9 3.9 signal
68 Altered State Of Consciousness 27 3.9 3.9 signal
69 Red Blood Cell Count Decreased 34 3.7 3.7 signal
70 Drug Level Decreased 12 3.7 3.7 signal
71 Gastroenteritis 17 3.6 3.7 signal
72 Pleural Effusion 71 3.6 3.7 signal
73 Hepatic Failure 35 3.6 3.6 signal
74 Hypophagia 29 3.6 3.6 signal
75 Full Blood Count Decreased 23 3.6 3.6 signal
76 Shock 26 3.6 3.6 signal
77 Plasma Cell Myeloma 44 3.5 3.5 signal
78 Hepatocellular Injury 16 3.5 3.5 signal
79 Myelodysplastic Syndrome 16 3.5 3.5 signal
80 Skin Lesion 30 3.4 3.5 signal
81 Ascites 32 3.4 3.4 signal
82 Bacterial Infection 20 3.4 3.4 signal
83 Liver Injury 26 3.4 3.4 signal
84 Lymphocyte Count Decreased 19 3.4 3.4 signal
85 Alanine Aminotransferase Increased 65 3.3 3.3 signal
86 Blood Alkaline Phosphatase Increased 26 3.3 3.3 signal
87 Electrolyte Imbalance 12 3.3 3.3 signal
88 Liver Disorder 46 3.2 3.3 signal
89 Transaminases Increased 23 3.2 3.2 signal
90 Pyrexia 358 3.2 3.4 signal
91 Hypocalcaemia 19 3.1 3.2 signal
92 Pericardial Effusion 23 3.1 3.1 signal
93 Mouth Ulceration 21 3.1 3.1 signal
94 Renal Impairment 83 3.1 3.1 signal
95 Renal Failure 132 3.1 3.1 signal
96 Pancreatitis Acute 22 3.1 3.1 signal
97 Pneumonia 318 3.1 3.2 signal
98 Inappropriate Antidiuretic Hormone Secretion 10 3.1 3.1 signal
99 Device Related Infection 15 3.0 3.0 signal
100 Jaundice 26 3.0 3.0 signal
101 Cellulitis 48 3.0 3.0 signal
102 Anaemia 177 2.9 3.0 signal
103 Covid-19 164 2.9 2.9 signal
104 Aspartate Aminotransferase Increased 49 2.9 2.9 signal
105 Adrenal Insufficiency 11 2.9 2.9 signal
106 Malnutrition 10 2.8 2.8 signal
107 Lung Disorder 44 2.8 2.8 signal
108 Treatment Failure 73 2.8 2.8 signal
109 Drug Interaction 141 2.8 2.8 signal
110 Immunodeficiency 13 2.8 2.8 signal
111 Rebound Effect 10 2.8 2.8 signal
112 White Blood Cell Count Decreased 94 2.7 2.7 signal
113 Neurotoxicity 15 2.7 2.7 signal
114 Disease Recurrence 41 2.7 2.7 signal
115 Erythema Multiforme 8 2.7 2.7 signal
116 Blood Creatinine Increased 56 2.7 2.7 signal
117 Mucosal Inflammation 22 2.6 2.6 signal
118 Liver Function Test Increased 18 2.6 2.6 signal
119 Lymphoma 13 2.6 2.6 signal
120 Off Label Use 719 2.6 2.8 signal
121 Hypokalaemia 38 2.6 2.6 signal
122 Mental Status Changes 23 2.6 2.6 signal
123 Dyspnoea Exertional 31 2.6 2.6 signal
124 Hyperglycaemia 30 2.6 2.6 signal
125 Hepatic Enzyme Increased 56 2.6 2.6 signal
126 Blood Pressure Systolic Increased 16 2.6 2.6 signal
127 Melaena 18 2.5 2.6 signal
128 Tachypnoea 11 2.5 2.5 signal
129 Fungal Infection 27 2.5 2.5 signal
130 Hypercalcaemia 10 2.5 2.5 signal
131 Eosinophilia 14 2.5 2.5 signal
132 Condition Aggravated 241 2.5 2.5 signal
133 Central Nervous System Lesion 11 2.5 2.5 signal
134 Myocarditis 9 2.5 2.5 signal
135 Clostridium Difficile Infection 17 2.5 2.5 signal
136 Hepatitis 20 2.4 2.4 signal
137 Disease Progression 92 2.4 2.5 signal
138 Neutrophil Count Increased 8 2.4 2.4 signal
139 Petechiae 8 2.4 2.4 signal
140 Oral Candidiasis 10 2.4 2.4 signal
141 Urosepsis 7 2.4 2.4 signal
142 Full Blood Count Abnormal 8 2.4 2.4 signal
143 Prescribed Underdose 15 2.3 2.4 signal
144 Taste Disorder 15 2.3 2.3 signal
145 Quality Of Life Decreased 10 2.3 2.3 signal
146 Localised Infection 18 2.3 2.3 signal
147 Glomerular Filtration Rate Decreased 9 2.3 2.3 signal
148 Leukaemia 7 2.3 2.3 signal
149 Multi-organ Failure 13 2.3 2.3 signal
150 Generalised Tonic-clonic Seizure 12 2.3 2.3 signal
151 Haematoma 19 2.3 2.3 signal
152 Dizziness Postural 7 2.3 2.3 no signal
153 Osteoporosis 30 2.3 2.3 signal
154 Respiratory Distress 20 2.3 2.3 signal
155 Multiple Fractures 12 2.3 2.3 signal
156 Gout 13 2.3 2.3 signal
157 Red Blood Cell Sedimentation Rate Increased 8 2.3 2.3 signal
158 Osteomyelitis 13 2.2 2.2 signal
159 Blood Count Abnormal 11 2.2 2.2 signal
160 C-reactive Protein Increased 26 2.2 2.2 signal
161 Hepatomegaly 7 2.2 2.2 no signal
162 Seasonal Allergy 10 2.2 2.2 signal
163 Dialysis 10 2.2 2.2 signal
164 Feeding Disorder 14 2.2 2.2 signal
165 Skin Ulcer 18 2.2 2.2 signal
166 Haemoglobin Decreased 71 2.2 2.2 signal
167 Deep Vein Thrombosis 45 2.2 2.2 signal
168 Splenomegaly 8 2.1 2.1 no signal
169 Pneumonia Aspiration 17 2.1 2.1 signal
170 Oxygen Saturation Decreased 38 2.1 2.1 signal
171 Ventricular Extrasystoles 7 2.1 2.1 no signal
172 Chills 79 2.1 2.1 signal
173 Transfusion 7 2.1 2.1 no signal
174 Treatment Noncompliance 36 2.1 2.1 signal
175 Acute Hepatic Failure 9 2.1 2.1 no signal
176 Herpes Zoster 38 2.1 2.1 signal
177 Blood Urea Increased 11 2.0 2.0 signal
178 Face Oedema 11 2.0 2.0 signal
179 Hypomagnesaemia 9 2.0 2.0 no signal
180 Myelosuppression 22 2.0 2.0 signal
181 Hepatic Steatosis 12 2.0 2.0 signal
182 Wound Infection 7 2.0 2.0 no signal
183 Chronic Kidney Disease 49 2.0 2.0 no signal
184 Muscle Atrophy 8 2.0 2.0 no signal
185 Viral Infection 21 2.0 2.0 no signal
186 Bone Density Decreased 20 2.0 2.0 no signal
187 Supraventricular Tachycardia 6 2.0 2.0 no signal
188 Subdural Haematoma 9 2.0 2.0 no signal
189 Intestinal Perforation 7 1.9 1.9 no signal
190 Mitral Valve Incompetence 7 1.9 1.9 no signal
191 Atrial Fibrillation 60 1.9 1.9 no signal
192 Psychotic Disorder 18 1.9 1.9 no signal
193 Renal Failure Acute 26 1.9 1.9 no signal
194 Pulmonary Oedema 27 1.9 1.9 no signal
195 Spinal Fracture 12 1.9 1.9 no signal
196 Haematocrit Decreased 12 1.9 1.9 no signal
197 Haemorrhage Intracranial 9 1.9 1.9 no signal
198 Brain Injury 6 1.9 1.9 no signal
199 Aphasia 18 1.9 1.9 no signal
200 Product Use In Unapproved Indication 145 1.9 1.9 no signal
201 Liver Function Test Abnormal 17 1.8 1.8 no signal
202 Laboratory Test Abnormal 17 1.8 1.8 no signal
203 Infection 83 1.8 1.8 no signal
204 Metabolic Acidosis 18 1.8 1.8 no signal
205 Pneumothorax 9 1.8 1.8 no signal
206 Stomatitis 34 1.8 1.8 no signal
207 Decreased Activity 6 1.7 1.8 no signal
208 Renal Disorder 26 1.7 1.7 no signal
209 Skin Laceration 6 1.7 1.7 no signal
210 Blood Potassium Increased 9 1.7 1.7 no signal
211 Fluid Overload 8 1.7 1.7 no signal
212 Acute Myocardial Infarction 16 1.7 1.7 no signal
213 Neuropathy Peripheral 51 1.7 1.7 no signal
214 Diplopia 14 1.7 1.7 no signal
215 Presyncope 13 1.7 1.7 no signal
216 Deafness 14 1.7 1.7 no signal
217 Diarrhoea 343 1.7 1.7 no signal
218 Squamous Cell Carcinoma 5 1.7 1.7 no signal
219 Lactic Acidosis 17 1.7 1.7 no signal
220 Scab 6 1.7 1.7 no signal
221 Fracture 10 1.6 1.7 no signal
222 Bone Loss 8 1.6 1.6 no signal
223 Pulmonary Hypertension 11 1.6 1.6 no signal
224 Gastrointestinal Haemorrhage 44 1.6 1.6 no signal
225 Product Taste Abnormal 7 1.6 1.6 no signal
226 Infusion Related Reaction 34 1.6 1.6 no signal
227 Vasculitis 6 1.6 1.6 no signal
228 Ejection Fraction Decreased 8 1.6 1.6 no signal
229 Abdominal Pain Lower 13 1.6 1.6 no signal
230 Rash 221 1.6 1.6 no signal
231 Inability To Afford Medication 5 1.6 1.6 no signal
232 Hospice Care 5 1.6 1.6 no signal
233 Cholecystitis 6 1.6 1.6 no signal
234 Body Temperature Decreased 5 1.6 1.6 no signal
235 Myoclonus 6 1.6 1.6 no signal
236 Respiratory Tract Congestion 8 1.6 1.6 no signal
237 Electrocardiogram Qt Prolonged 18 1.6 1.6 no signal
238 Premature Delivery 8 1.6 1.6 no signal
239 Incorrect Product Administration Duration 10 1.5 1.5 no signal
240 Eye Discharge 5 1.5 1.5 no signal
241 Intentional Product Use Issue 43 1.5 1.5 no signal
242 Product Odour Abnormal 5 1.5 1.5 no signal
243 Dermatitis Allergic 6 1.5 1.5 no signal
244 Drug Effective For Unapproved Indication 14 1.5 1.5 no signal
245 Insurance Issue 7 1.5 1.5 no signal
246 Infusion Site Pain 6 1.5 1.5 no signal
247 Cough 131 1.5 1.5 no signal
248 Epistaxis 35 1.5 1.5 no signal
249 Haematuria 16 1.5 1.5 no signal
250 Therapy Partial Responder 7 1.5 1.5 no signal
251 Blood Pressure Fluctuation 11 1.4 1.4 no signal
252 Depressed Level Of Consciousness 18 1.4 1.4 no signal
253 Tooth Infection 6 1.4 1.4 no signal
254 Blood Pressure Abnormal 9 1.4 1.4 no signal
255 Pancreatitis 24 1.4 1.4 no signal
256 International Normalised Ratio Increased 13 1.4 1.4 no signal
257 Cerebral Infarction 11 1.4 1.4 no signal
258 Uveitis 6 1.4 1.4 no signal
259 Status Epilepticus 5 1.4 1.4 no signal
260 Abscess 7 1.4 1.4 no signal
261 Sensory Disturbance 7 1.4 1.4 no signal
262 Hepatic Encephalopathy 4 1.3 1.3 no signal
263 Cardio-respiratory Arrest 18 1.3 1.3 no signal
264 Spinal Pain 5 1.3 1.3 no signal
265 Heart Rate Decreased 15 1.3 1.3 no signal
266 Osteonecrosis 14 1.3 1.3 no signal
267 Cardiogenic Shock 6 1.3 1.3 no signal
268 Emotional Distress 51 1.3 1.3 no signal
269 Pharyngeal Swelling 4 1.3 1.3 no signal
270 Paralysis 6 1.3 1.3 no signal
271 Hospitalisation 63 1.3 1.3 no signal
272 Inflammatory Bowel Disease 4 1.3 1.3 no signal
273 Haematochezia 22 1.2 1.2 no signal
274 Diabetes Mellitus Inadequate Control 7 1.2 1.2 no signal
275 Folliculitis 4 1.2 1.2 no signal
276 Rhabdomyolysis 16 1.2 1.2 no signal
277 Ankylosing Spondylitis 5 1.2 1.2 no signal
278 Chronic Obstructive Pulmonary Disease 20 1.2 1.2 no signal
279 Toxicity To Various Agents 62 1.2 1.2 no signal
280 Pulmonary Thrombosis 4 1.1 1.1 no signal
281 Blood Glucose Fluctuation 4 1.1 1.1 no signal
282 Visual Acuity Reduced 12 1.1 1.1 no signal
283 Product Availability Issue 8 1.1 1.1 no signal
284 Blood Test Abnormal 5 1.1 1.1 no signal
285 Skin Reaction 5 1.1 1.1 no signal
286 Maternal Exposure During Pregnancy 31 1.1 1.1 no signal
287 Product Prescribing Issue 7 1.1 1.1 no signal
288 Therapy Cessation 17 1.0 1.0 no signal
289 Foetal Exposure During Pregnancy 27 1.0 1.0 no signal
290 Retinal Detachment 3 1.0 1.0 no signal
291 Increased Tendency To Bruise 3 1.0 1.0 no signal
292 Skin Cancer 7 1.0 1.0 no signal
293 Middle Insomnia 6 1.0 1.0 no signal
294 Mydriasis 4 1.0 1.0 no signal
295 Decreased Immune Responsiveness 3 1.0 1.0 no signal
296 Sars-cov-2 Test Positive 4 0.9 0.9 no signal
297 Hunger 4 0.9 0.9 no signal
298 Paranoia 5 0.9 0.9 no signal
299 Vaginal Haemorrhage 12 0.9 0.9 no signal
300 Product Packaging Quantity Issue 3 0.9 0.9 no signal
301 Death 236 0.9 0.9 no signal
302 Blood Glucose Abnormal 5 0.8 0.8 no signal
303 Colitis Ulcerative 12 0.8 0.8 no signal
304 Lung Neoplasm Malignant 11 0.8 0.8 no signal
305 Internal Haemorrhage 3 0.8 0.8 no signal
306 Therapy Interrupted 18 0.8 0.8 no signal
307 Product Physical Issue 5 0.8 0.8 no signal
308 Hepatitis C 3 0.8 0.8 no signal
309 Respiratory Depression 3 0.8 0.8 no signal
310 Osteonecrosis Of Jaw 6 0.8 0.8 no signal
311 Tooth Loss 5 0.7 0.7 no signal
312 Malignant Neoplasm Progression 24 0.7 0.7 no signal
313 Pulmonary Arterial Hypertension 3 0.6 0.6 no signal
314 Premature Baby 5 0.5 0.5 no signal
315 Dermatitis Atopic 5 0.3 0.3 no signal