OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Flecainide Acetate

383 flagged reaction(s) · 9,154 total co-reports · max PRR 23.3
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 Ventricular Tachycardia 96 23.3 23.7 signal
2 Ventricular Extrasystoles 41 15.8 15.9 signal
3 Atrial Fibrillation 350 14.4 15.4 signal
4 Sinus Bradycardia 30 12.4 12.5 signal
5 Cardiogenic Shock 41 11.5 11.6 signal
6 Supraventricular Tachycardia 25 10.5 10.5 signal
7 Electrocardiogram Qt Prolonged 88 9.8 9.9 signal
8 Heart Rate Irregular 52 9.2 9.2 signal
9 Drug Toxicity 30 8.7 8.7 signal
10 Bradycardia 115 8.7 8.8 signal
11 Arrhythmia 99 8.3 8.5 signal
12 Ventricular Fibrillation 22 7.9 7.9 signal
13 International Normalised Ratio Increased 56 7.8 7.9 signal
14 Mitral Valve Incompetence 22 7.8 7.8 signal
15 Cholestasis 37 7.8 7.8 signal
16 Seasonal Allergy 25 7.1 7.1 signal
17 Hypertensive Crisis 19 6.8 6.8 signal
18 Hyponatraemia 94 6.7 6.8 signal
19 Subdural Haematoma 24 6.7 6.7 signal
20 Peripheral Coldness 23 6.7 6.7 signal
21 Heart Rate Decreased 58 6.6 6.6 signal
22 Hepatic Cytolysis 17 5.6 5.6 signal
23 Haematoma 34 5.2 5.3 signal
24 Blood Pressure Systolic Increased 25 5.1 5.1 signal
25 Gingival Bleeding 17 5.0 5.0 signal
26 Basal Cell Carcinoma 19 4.9 4.9 signal
27 Bladder Disorder 12 4.8 4.8 signal
28 Osteopenia 18 4.7 4.7 signal
29 Cardio-respiratory Arrest 48 4.6 4.6 signal
30 Cardiac Arrest 94 4.5 4.6 signal
31 Interstitial Lung Disease 54 4.5 4.5 signal
32 Hyperkalaemia 39 4.5 4.5 signal
33 Tachycardia 97 4.4 4.4 signal
34 Cerebral Haemorrhage 39 4.4 4.4 signal
35 Drug Interaction 172 4.3 4.5 signal
36 Blood Thyroid Stimulating Hormone Increased 10 4.3 4.3 signal
37 Anorexia 14 4.3 4.3 signal
38 Hyperbilirubinaemia 11 4.3 4.3 signal
39 Circulatory Collapse 18 4.2 4.2 signal
40 Toxicity To Various Agents 175 4.2 4.3 signal
41 Orthostatic Hypotension 18 4.1 4.1 signal
42 Syncope 103 4.1 4.2 signal
43 Ejection Fraction Decreased 16 4.1 4.1 signal
44 Drug Level Increased 17 4.1 4.1 signal
45 Renal Failure Acute 43 4.0 4.0 signal
46 Metabolic Acidosis 31 3.9 3.9 signal
47 Thyroid Disorder 15 3.9 3.9 signal
48 Haematotoxicity 9 3.9 3.9 signal
49 Multi-organ Failure 17 3.9 3.9 signal
50 Haematuria 33 3.8 3.9 signal
51 Grand Mal Convulsion 9 3.8 3.8 signal
52 Sinus Congestion 13 3.8 3.9 signal
53 Myocardial Ischaemia 11 3.8 3.8 signal
54 Accidental Overdose 35 3.8 3.8 signal
55 Dizziness Postural 9 3.7 3.8 signal
56 Mass 13 3.7 3.7 signal
57 Palpitations 108 3.7 3.7 signal
58 Haematocrit Decreased 18 3.6 3.6 signal
59 Gamma-glutamyltransferase Increased 20 3.6 3.6 signal
60 Hypotension 178 3.6 3.6 signal
61 Helicobacter Infection 9 3.5 3.5 signal
62 Temperature Intolerance 9 3.5 3.5 signal
63 Haematemesis 22 3.5 3.5 signal
64 Petechiae 9 3.5 3.5 signal
65 Blood Potassium Decreased 26 3.5 3.5 signal
66 Blood Pressure Abnormal 17 3.4 3.4 signal
67 Rectal Haemorrhage 37 3.4 3.5 signal
68 Incontinence 9 3.4 3.4 signal
69 Heart Rate Increased 84 3.4 3.4 signal
70 Oral Candidiasis 11 3.4 3.4 signal
71 Hepatitis 21 3.3 3.3 signal
72 Product Taste Abnormal 11 3.3 3.3 signal
73 Lung Disorder 40 3.3 3.3 signal
74 Unresponsive To Stimuli 21 3.3 3.3 signal
75 Bone Disorder 15 3.3 3.3 signal
76 Melaena 18 3.3 3.3 signal
77 Musculoskeletal Discomfort 14 3.3 3.3 signal
78 Cardiomyopathy 12 3.2 3.2 signal
79 Insurance Issue 12 3.2 3.2 signal
80 Dyspnoea Exertional 30 3.2 3.2 signal
81 Hypoxia 28 3.2 3.2 signal
82 Loss Of Consciousness 102 3.2 3.2 signal
83 Toxic Skin Eruption 8 3.2 3.2 signal
84 Oxygen Saturation Decreased 44 3.2 3.2 signal
85 Presyncope 19 3.1 3.1 signal
86 Electrolyte Imbalance 9 3.1 3.1 signal
87 Pulmonary Oedema 35 3.1 3.1 signal
88 Injection Site Discomfort 8 3.1 3.1 signal
89 Intentional Overdose 49 3.1 3.1 signal
90 Increased Tendency To Bruise 7 3.0 3.0 signal
91 Agranulocytosis 14 3.0 3.0 signal
92 Spinal Fracture 15 3.0 3.0 signal
93 Sopor 10 3.0 3.0 signal
94 Full Blood Count Decreased 15 3.0 3.0 signal
95 Faeces Discoloured 16 3.0 3.0 signal
96 Pulmonary Fibrosis 14 2.9 2.9 signal
97 Acute Respiratory Failure 14 2.9 2.9 signal
98 Generalised Oedema 9 2.9 2.9 signal
99 Hypokalaemia 33 2.9 2.9 signal
100 Pulmonary Hypertension 15 2.9 2.9 signal
101 Hallucination, Visual 15 2.9 2.9 signal
102 Urinary Incontinence 21 2.8 2.8 signal
103 Shock 16 2.8 2.8 signal
104 Hypotonia 7 2.8 2.8 signal
105 Cyanosis 11 2.8 2.8 signal
106 Premature Baby 21 2.8 2.8 signal
107 Pericardial Effusion 16 2.8 2.8 signal
108 Respiratory Tract Congestion 11 2.8 2.8 signal
109 Blood Sodium Decreased 13 2.8 2.8 signal
110 Hyperthyroidism 10 2.8 2.8 signal
111 Respiratory Distress 19 2.8 2.8 signal
112 Eosinophilia 12 2.7 2.8 signal
113 Subarachnoid Haemorrhage 7 2.7 2.7 signal
114 Foot Fracture 13 2.7 2.7 signal
115 Transient Ischaemic Attack 23 2.7 2.7 signal
116 Haemorrhoids 13 2.7 2.7 signal
117 Blood Pressure Decreased 44 2.7 2.7 signal
118 Gastroenteritis Viral 12 2.7 2.7 signal
119 Localised Infection 16 2.6 2.6 signal
120 Depressed Level Of Consciousness 26 2.6 2.6 signal
121 Vertigo 40 2.6 2.6 signal
122 Respiratory Tract Infection 17 2.6 2.6 signal
123 Sudden Death 7 2.6 2.6 signal
124 Epistaxis 49 2.6 2.6 signal
125 Blood Urea Increased 11 2.6 2.6 signal
126 Face Oedema 11 2.6 2.6 signal
127 Mental Status Changes 18 2.6 2.6 signal
128 Cardiac Failure 52 2.6 2.6 signal
129 Lymphoma 10 2.6 2.6 signal
130 Bronchitis 48 2.6 2.6 signal
131 Cardiomegaly 8 2.6 2.6 signal
132 Wound Infection 7 2.6 2.6 signal
133 Acute Myocardial Infarction 19 2.6 2.6 signal
134 Eczema 32 2.5 2.6 signal
135 Eructation 12 2.5 2.5 signal
136 Gastric Ulcer 12 2.5 2.5 signal
137 Blood Urine Present 12 2.5 2.5 signal
138 Sleep Apnoea Syndrome 12 2.5 2.5 signal
139 Pollakiuria 26 2.5 2.5 signal
140 Blood Pressure Fluctuation 15 2.5 2.5 signal
141 Hip Fracture 20 2.5 2.5 signal
142 Vitreous Floaters 6 2.5 2.5 no signal
143 Gallbladder Disorder 11 2.5 2.5 signal
144 Gout 11 2.4 2.5 signal
145 Feeling Cold 17 2.4 2.4 signal
146 Completed Suicide 51 2.4 2.4 signal
147 Coagulopathy 10 2.4 2.4 signal
148 Caesarean Section 7 2.4 2.4 signal
149 Jaundice 16 2.4 2.4 signal
150 Emphysema 6 2.4 2.4 no signal
151 Hypothermia 6 2.4 2.4 no signal
152 Photophobia 11 2.4 2.4 signal
153 Tooth Abscess 6 2.3 2.3 no signal
154 Hemiparesis 10 2.3 2.3 signal
155 Rib Fracture 12 2.3 2.3 signal
156 Hypomagnesaemia 8 2.3 2.3 signal
157 Cardiac Disorder 54 2.3 2.3 signal
158 Muscular Weakness 65 2.3 2.3 signal
159 Fall 190 2.3 2.3 signal
160 Hereditary Angioedema 6 2.3 2.3 no signal
161 Small Intestinal Obstruction 7 2.3 2.3 no signal
162 Pharmaceutical Product Complaint 15 2.3 2.3 signal
163 Drug Eruption 10 2.3 2.3 signal
164 Blood Creatinine Increased 37 2.3 2.3 signal
165 Acute Respiratory Distress Syndrome 10 2.3 2.3 signal
166 Tooth Extraction 7 2.2 2.2 no signal
167 Skin Cancer 12 2.2 2.2 signal
168 Pneumonitis 15 2.2 2.2 signal
169 Back Injury 6 2.2 2.2 no signal
170 Leukocytosis 10 2.2 2.2 signal
171 Ocular Discomfort 6 2.2 2.2 no signal
172 Gastrointestinal Pain 6 2.2 2.2 no signal
173 Thrombocytopenia 61 2.2 2.2 signal
174 Blood Creatine Phosphokinase Increased 16 2.2 2.2 signal
175 Photosensitivity Reaction 9 2.2 2.2 signal
176 Coma 26 2.2 2.2 signal
177 Conjunctivitis 10 2.2 2.2 signal
178 Eye Pain 30 2.2 2.2 signal
179 Rotator Cuff Syndrome 7 2.2 2.2 no signal
180 Nerve Compression 5 2.2 2.2 no signal
181 Dizziness 270 2.2 2.2 signal
182 Transaminases Increased 12 2.2 2.2 signal
183 Asthenia 203 2.2 2.2 signal
184 Head Injury 17 2.2 2.2 signal
185 Bone Marrow Failure 11 2.1 2.2 signal
186 Upper Gastrointestinal Haemorrhage 9 2.1 2.1 signal
187 Bedridden 7 2.1 2.1 no signal
188 Encephalopathy 13 2.1 2.1 signal
189 Hot Flush 40 2.1 2.1 signal
190 Lactic Acidosis 17 2.1 2.1 signal
191 Dermatitis Contact 6 2.1 2.1 no signal
192 Coronary Artery Disease 16 2.1 2.1 signal
193 Malignant Melanoma 7 2.1 2.1 no signal
194 Hernia 10 2.1 2.1 signal
195 Cough 145 2.1 2.1 signal
196 Gastric Haemorrhage 6 2.1 2.1 no signal
197 Hypoglycaemia 25 2.1 2.1 signal
198 Renal Impairment 43 2.1 2.1 signal
199 Acute Myeloid Leukaemia 8 2.1 2.1 no signal
200 Fluid Retention 26 2.0 2.1 signal
201 Musculoskeletal Pain 27 2.0 2.0 signal
202 Head Discomfort 9 2.0 2.0 no signal
203 Cold Sweat 9 2.0 2.0 no signal
204 Chest Discomfort 52 2.0 2.0 signal
205 Gastrointestinal Disorder 45 2.0 2.0 signal
206 Blood Iron Decreased 6 2.0 2.0 no signal
207 Balance Disorder 44 2.0 2.0 signal
208 Lethargy 29 2.0 2.0 signal
209 Ischaemic Stroke 9 2.0 2.0 no signal
210 Ataxia 6 2.0 2.0 no signal
211 Blood Pressure Increased 77 2.0 2.0 signal
212 Wrist Fracture 6 2.0 2.0 no signal
213 Dyspnoea 283 2.0 2.1 signal
214 Neck Pain 28 2.0 2.0 signal
215 Respiratory Disorder 15 2.0 2.0 no signal
216 Abdominal Discomfort 83 2.0 2.0 no signal
217 Rash Maculo-papular 11 2.0 2.0 no signal
218 Glomerular Filtration Rate Decreased 6 2.0 2.0 no signal
219 Eye Discharge 5 2.0 2.0 no signal
220 Bronchospasm 7 2.0 2.0 no signal
221 Illness 49 2.0 2.0 no signal
222 Paraesthesia Oral 7 1.9 1.9 no signal
223 Haemoglobin Decreased 50 1.9 2.0 no signal
224 No Therapeutic Response 6 1.9 1.9 no signal
225 Limb Discomfort 15 1.9 1.9 no signal
226 Pancytopenia 27 1.9 1.9 no signal
227 Hypokinesia 7 1.9 1.9 no signal
228 Throat Tightness 13 1.9 1.9 no signal
229 Tubulointerstitial Nephritis 9 1.9 1.9 no signal
230 Limb Injury 13 1.9 1.9 no signal
231 Pallor 13 1.9 1.9 no signal
232 Renal Pain 5 1.9 1.9 no signal
233 Infusion Site Pain 6 1.9 1.9 no signal
234 Throat Irritation 21 1.9 1.9 no signal
235 Haemorrhage Intracranial 7 1.9 1.9 no signal
236 Body Height Decreased 5 1.8 1.8 no signal
237 Disease Recurrence 22 1.8 1.8 no signal
238 Flushing 47 1.8 1.8 no signal
239 Product Dispensing Error 10 1.8 1.8 no signal
240 Cholelithiasis 15 1.8 1.8 no signal
241 Immune System Disorder 6 1.8 1.8 no signal
242 Blood Count Abnormal 7 1.8 1.8 no signal
243 Blood Glucose Fluctuation 5 1.8 1.8 no signal
244 Economic Problem 7 1.8 1.8 no signal
245 Vision Blurred 62 1.8 1.8 no signal
246 Haematochezia 25 1.8 1.8 no signal
247 Pancreatitis 24 1.8 1.8 no signal
248 Gastrointestinal Haemorrhage 38 1.8 1.8 no signal
249 Product Use Complaint 7 1.8 1.8 no signal
250 Tendonitis 7 1.8 1.8 no signal
251 Pharyngeal Oedema 7 1.8 1.8 no signal
252 Eye Haemorrhage 6 1.8 1.8 no signal
253 Psoriatic Arthropathy 18 1.8 1.8 no signal
254 Thrombosis 36 1.8 1.8 no signal
255 Eye Infection 5 1.8 1.8 no signal
256 Suicide Attempt 27 1.8 1.8 no signal
257 Lung Infection 7 1.8 1.8 no signal
258 Blood Lactate Dehydrogenase Increased 7 1.8 1.8 no signal
259 Abasia 11 1.8 1.8 no signal
260 Brain Neoplasm 4 1.7 1.7 no signal
261 Dry Eye 21 1.7 1.7 no signal
262 Rhabdomyolysis 18 1.7 1.7 no signal
263 Knee Arthroplasty 9 1.7 1.7 no signal
264 Respiratory Arrest 12 1.7 1.7 no signal
265 Intestinal Obstruction 16 1.7 1.7 no signal
266 Squamous Cell Carcinoma 4 1.7 1.7 no signal
267 Eye Inflammation 4 1.7 1.7 no signal
268 Hepatocellular Injury 6 1.7 1.7 no signal
269 Dialysis 6 1.7 1.7 no signal
270 Spinal Disorder 4 1.7 1.7 no signal
271 Oropharyngeal Pain 39 1.7 1.7 no signal
272 Myoclonus 5 1.7 1.7 no signal
273 Cytopenia 5 1.7 1.7 no signal
274 Pharyngeal Swelling 4 1.7 1.7 no signal
275 Altered State Of Consciousness 9 1.7 1.7 no signal
276 Skin Haemorrhage 6 1.7 1.7 no signal
277 Spinal Operation 5 1.7 1.7 no signal
278 Rash Pruritic 22 1.6 1.6 no signal
279 Respiratory Depression 5 1.6 1.6 no signal
280 Feeling Hot 25 1.6 1.6 no signal
281 Laboratory Test Abnormal 12 1.6 1.6 no signal
282 Hospice Care 4 1.6 1.6 no signal
283 Chronic Obstructive Pulmonary Disease 21 1.6 1.6 no signal
284 Tooth Disorder 9 1.6 1.6 no signal
285 Overdose 87 1.6 1.6 no signal
286 Renal Injury 12 1.6 1.6 no signal
287 Therapy Partial Responder 6 1.6 1.6 no signal
288 Inappropriate Antidiuretic Hormone Secretion 4 1.6 1.6 no signal
289 Initial Insomnia 4 1.6 1.6 no signal
290 Ear Discomfort 4 1.6 1.6 no signal
291 Disturbance In Attention 21 1.6 1.6 no signal
292 Drug Dispensing Error 6 1.5 1.5 no signal
293 Emotional Disorder 12 1.5 1.5 no signal
294 Asthma 43 1.5 1.5 no signal
295 Cardiac Failure Congestive 31 1.5 1.5 no signal
296 Tooth Infection 5 1.5 1.5 no signal
297 Complication Associated With Device 5 1.5 1.5 no signal
298 Intentional Drug Misuse 8 1.5 1.5 no signal
299 Sleep Disorder Due To A General Medical Condition 6 1.5 1.5 no signal
300 Feeling Abnormal 89 1.5 1.5 no signal
301 Fracture 7 1.5 1.5 no signal
302 Pharyngitis Streptococcal 4 1.5 1.5 no signal
303 Eye Pruritus 12 1.5 1.5 no signal
304 Choking 7 1.4 1.4 no signal
305 Pericarditis 6 1.4 1.4 no signal
306 Haemorrhage 37 1.4 1.4 no signal
307 Upper Limb Fracture 7 1.4 1.4 no signal
308 Internal Haemorrhage 4 1.4 1.4 no signal
309 Activities Of Daily Living Impaired 7 1.4 1.4 no signal
310 Dysgeusia 26 1.4 1.4 no signal
311 Mucosal Inflammation 9 1.4 1.4 no signal
312 Post Procedural Haemorrhage 4 1.4 1.4 no signal
313 Metastases To Liver 6 1.4 1.4 no signal
314 Eyelid Oedema 4 1.4 1.4 no signal
315 Fluid Overload 5 1.4 1.4 no signal
316 Macular Degeneration 4 1.3 1.3 no signal
317 Product Dose Omission In Error 9 1.3 1.3 no signal
318 Convulsion 19 1.3 1.3 no signal
319 Medication Error 18 1.3 1.3 no signal
320 Dementia 9 1.3 1.3 no signal
321 Tendon Rupture 4 1.3 1.3 no signal
322 Poisoning Deliberate 3 1.3 1.3 no signal
323 Poisoning 4 1.3 1.3 no signal
324 Laceration 3 1.3 1.3 no signal
325 Premature Delivery 5 1.2 1.2 no signal
326 Anaphylactic Shock 8 1.2 1.2 no signal
327 Blood Glucose Decreased 15 1.2 1.2 no signal
328 Exposure Via Skin Contact 7 1.2 1.2 no signal
329 Osteonecrosis 10 1.2 1.2 no signal
330 Coronary Artery Occlusion 4 1.2 1.2 no signal
331 Drug Exposure During Pregnancy 10 1.2 1.2 no signal
332 Product Odour Abnormal 3 1.2 1.2 no signal
333 Prostatic Specific Antigen Increased 4 1.2 1.2 no signal
334 Neurotoxicity 5 1.2 1.2 no signal
335 Gastric Disorder 10 1.1 1.1 no signal
336 Product Substitution Issue 16 1.1 1.1 no signal
337 Glycosylated Haemoglobin Increased 7 1.1 1.1 no signal
338 Erectile Dysfunction 7 1.1 1.1 no signal
339 Dry Skin 34 1.0 1.0 no signal
340 Incorrect Product Administration Duration 5 1.0 1.0 no signal
341 Foetal Exposure During Pregnancy 20 1.0 1.0 no signal
342 Needle Issue 7 1.0 1.0 no signal
343 Injection Site Mass 9 1.0 1.0 no signal
344 Lung Neoplasm Malignant 10 1.0 1.0 no signal
345 Muscle Spasticity 3 1.0 1.0 no signal
346 Product Preparation Error 5 1.0 1.0 no signal
347 Psoriasis 30 0.9 0.9 no signal
348 Drug Administration Error 7 0.9 0.9 no signal
349 Pelvic Pain 4 0.9 0.9 no signal
350 Incorrect Dose Administered 49 0.9 0.9 no signal
351 Cytokine Release Syndrome 4 0.8 0.8 no signal
352 Multiple Sclerosis 10 0.8 0.8 no signal
353 Plasma Cell Myeloma 8 0.8 0.8 no signal
354 Menorrhagia 4 0.8 0.8 no signal
355 Product Physical Issue 4 0.8 0.8 no signal
356 Extra Dose Administered 8 0.8 0.8 no signal
357 Product Quality Issue 27 0.8 0.8 no signal
358 Dermatitis Atopic 10 0.8 0.8 no signal
359 Injection Site Rash 6 0.8 0.8 no signal
360 Incorrect Drug Administration Duration 5 0.7 0.7 no signal
361 Withdrawal Syndrome 7 0.7 0.7 no signal
362 Injection Site Urticaria 4 0.7 0.7 no signal
363 Drug Effect Decreased 9 0.7 0.7 no signal
364 Wrong Technique In Drug Usage Process 6 0.7 0.7 no signal
365 Therapeutic Response Shortened 5 0.6 0.6 no signal
366 Skin Burning Sensation 11 0.6 0.6 no signal
367 Drug Prescribing Error 3 0.6 0.6 no signal
368 Intentional Self-injury 3 0.6 0.6 no signal
369 Accidental Exposure To Product 14 0.6 0.6 no signal
370 Injection Site Pain 41 0.5 0.5 no signal
371 Injection Site Swelling 10 0.5 0.5 no signal
372 Injection Site Bruising 10 0.5 0.5 no signal
373 Injection Site Erythema 15 0.5 0.5 no signal
374 Injection Site Pruritus 8 0.5 0.5 no signal
375 Device Malfunction 8 0.5 0.5 no signal
376 Device Use Error 4 0.5 0.5 no signal
377 Injection Site Haemorrhage 9 0.5 0.5 no signal
378 Breast Cancer Female 3 0.4 0.4 no signal
379 Pancreatic Carcinoma 3 0.4 0.4 no signal
380 Device Breakage 4 0.4 0.4 no signal
381 Device Dislocation 4 0.4 0.4 no signal
382 Drug Dependence 8 0.2 0.2 no signal
383 Device Difficult To Use 3 0.2 0.2 no signal