PREGABALIN

Pregabalin Adverse Events Reported to the FDA Over Time

How are Pregabalin adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Pregabalin, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Pregabalin is flagged as the suspect drug causing the adverse event.

Most Common Pregabalin Adverse Events Reported to the FDA

What are the most common Pregabalin adverse events reported to the FDA?

Completed Suicide	277 (4.04%)
Cardiac Arrest	161 (2.35%)
Respiratory Arrest	143 (2.09%)
Dizziness	91 (1.33%)
Confusional State	89 (1.3%)
Death	87 (1.27%)
Poisoning	79 (1.15%)
Drug Ineffective	74 (1.08%)
Drug Interaction	73 (1.07%)
Somnolence	73 (1.07%)
Vomiting	72 (1.05%)
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Cardio-respiratory Arrest	60 (.88%)
Convulsion	59 (.86%)
Tremor	58 (.85%)
Drug Toxicity	56 (.82%)
Fatigue	55 (.8%)
Nausea	55 (.8%)
Suicide Attempt	54 (.79%)
Pain	51 (.74%)
Oedema Peripheral	50 (.73%)
Depression	46 (.67%)
Anxiety	45 (.66%)
Myocardial Infarction	44 (.64%)
Malaise	43 (.63%)
Renal Failure Acute	43 (.63%)
Fall	42 (.61%)
Condition Aggravated	41 (.6%)
Hypotension	41 (.6%)
Abdominal Pain	40 (.58%)
Intentional Drug Misuse	40 (.58%)
Syncope	40 (.58%)
Grand Mal Convulsion	39 (.57%)
Status Epilepticus	39 (.57%)
Agitation	36 (.53%)
Hyperhidrosis	36 (.53%)
Loss Of Consciousness	36 (.53%)
Weight Increased	36 (.53%)
Withdrawal Syndrome	36 (.53%)
Liver Function Test Abnormal	35 (.51%)
Pyrexia	35 (.51%)
Rhabdomyolysis	35 (.51%)
Asthenia	34 (.5%)
Retinal Vein Occlusion	34 (.5%)
Pneumonia	33 (.48%)
Gait Disturbance	32 (.47%)
Abdominal Distension	30 (.44%)
Insomnia	30 (.44%)
Intentional Overdose	30 (.44%)
Hallucination	29 (.42%)
Headache	29 (.42%)
Disturbance In Attention	28 (.41%)
Feeling Abnormal	28 (.41%)
Abortion Spontaneous	27 (.39%)
Blood Homocysteine Increased	27 (.39%)
Cardiac Failure	27 (.39%)
Suicidal Ideation	27 (.39%)
Vision Blurred	27 (.39%)
Constipation	26 (.38%)
Depressed Level Of Consciousness	26 (.38%)
Dyskinesia	26 (.38%)
Muscle Twitching	26 (.38%)
Overdose	26 (.38%)
Atrial Fibrillation	24 (.35%)
Bradycardia	24 (.35%)
Hyponatraemia	24 (.35%)
Balance Disorder	23 (.34%)
Diarrhoea	23 (.34%)
Oedema	23 (.34%)
Tachycardia	23 (.34%)
Accidental Poisoning	22 (.32%)
Amnesia	22 (.32%)
Drug Abuse	22 (.32%)
Multi-organ Failure	22 (.32%)
Myalgia	22 (.32%)
Panic Attack	22 (.32%)
Urinary Retention	22 (.32%)
Urinary Tract Infection	22 (.32%)
Aggression	21 (.31%)
Sedation	21 (.31%)
Decreased Appetite	20 (.29%)
Gastrointestinal Disorder	20 (.29%)
Diplopia	19 (.28%)
Memory Impairment	19 (.28%)
Pain In Extremity	19 (.28%)
Palpitations	19 (.28%)
Pancreatitis Necrotising	19 (.28%)
Septic Shock	19 (.28%)
Thrombocytopenia	19 (.28%)
Arrhythmia	18 (.26%)
Blood Creatine Phosphokinase Increa...	18 (.26%)
Blood Pressure Increased	18 (.26%)
Coordination Abnormal	18 (.26%)
Drug Dependence	18 (.26%)
Dyspnoea	18 (.26%)
Feeling Drunk	18 (.26%)
Abdominal Pain Upper	17 (.25%)
Disorientation	17 (.25%)
Hyperpyrexia	17 (.25%)
Unresponsive To Stimuli	17 (.25%)
Arthralgia	16 (.23%)
Chest Pain	16 (.23%)

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This graph shows the top adverse events submitted to the FDA for Pregabalin, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Pregabalin is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Pregabalin

What are the most common Pregabalin adverse events reported to the FDA?

Neurological	556 (8.12%)
Suicidal And Self-injurious Behavio...	365 (5.33%)
Cardiac Arrhythmias	361 (5.27%)
Gastrointestinal Signs	259 (3.78%)
Respiratory	233 (3.4%)
Therapeutic And Nontherapeutic Effe...	189 (2.76%)
Chemical Injury And Poisoning	180 (2.63%)
Seizures	180 (2.63%)
Anxiety Disorders	145 (2.12%)
Muscle	141 (2.06%)
Psychiatric	138 (2.01%)
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Movement Disorders	135 (1.97%)
Infections - Pathogen Unspecified	131 (1.91%)
Fatal Outcomes	124 (1.81%)
Deliria	118 (1.72%)
Epidermal And Dermal Conditions	107 (1.56%)
Injuries	104 (1.52%)
Medication Errors	104 (1.52%)
Mental Impairment	95 (1.39%)
Physical Examination Topics	84 (1.23%)
Vision	80 (1.17%)
Hepatobiliary	79 (1.15%)
Disturbances In Thinking	69 (1.01%)
Renal Disorders	68 (.99%)
Depressed Mood Disorders	67 (.98%)
Coronary Artery	65 (.95%)
Gastrointestinal Motility And Defec...	61 (.89%)
Body Temperature Conditions	58 (.85%)
Cardiac And Vascular Investigations	54 (.79%)
Musculoskeletal And Connective Tiss...	54 (.79%)
Retina, Choroid And Vitreous Hemorr...	53 (.77%)
Hepatic And Hepatobiliary	50 (.73%)
Sleep Disorders	50 (.73%)
Electrolyte And Fluid Balance Condi...	49 (.72%)
Decreased And Nonspecific Blood Pre...	47 (.69%)
Metabolic, Nutritional And Blood Ga...	47 (.69%)
Urinary Tract Signs	46 (.67%)
Skin Appendage Conditions	43 (.63%)
Joint	42 (.61%)
Mood Disorders	42 (.61%)
Headaches	39 (.57%)
Exocrine Pancreas Conditions	37 (.54%)
Heart Failures	36 (.53%)
Personality Disorders	36 (.53%)
Bone Disorders	35 (.51%)
Neuromuscular	35 (.51%)
Hematology Investigations	33 (.48%)
Appetite And General Nutritional	32 (.47%)
Central Nervous System Vascular	32 (.47%)
Glucose Metabolism Disorders	31 (.45%)
Lower Respiratory Tract Disorders	31 (.45%)
White Blood Cell	28 (.41%)
Abortions And Stillbirth	27 (.39%)
Toxicology And Therapeutic Drug Mon...	27 (.39%)
Platelet	25 (.37%)
Lifestyle Issues	23 (.34%)
Ocular Neuromuscular	23 (.34%)
Arteriosclerosis, Stenosis, Vascula...	22 (.32%)
Cardiac Disorder Signs	22 (.32%)
Gastrointestinal Conditions	22 (.32%)
Renal And Urinary Tract Investigati...	22 (.32%)
Bone And Joint Injuries	21 (.31%)
Cranial Nerve Disorders	20 (.29%)
Enzyme	20 (.29%)
Ocular Infections, Irritations And ...	20 (.29%)
Anemias Nonhemolytic And Marrow Dep...	19 (.28%)
Vascular	19 (.28%)
Breast	18 (.26%)
Oral Soft Tissue Conditions	18 (.26%)
Upper Respiratory Tract Disorders	17 (.25%)
Allergic Conditions	16 (.23%)
Bronchial Disorders	16 (.23%)
Inner Ear And Viiith Cranial Nerve	16 (.23%)
Therapeutic Procedures And Supporti...	16 (.23%)
Encephalopathies	15 (.22%)
Somatoform And Factitious	15 (.22%)
Psychiatric And Behavioural Symptom...	14 (.2%)
Angiedema And Urticaria	13 (.19%)
Embolism And Thrombosis	13 (.19%)
Peripheral Neuropathies	13 (.19%)
Pregnancy, Labour, Delivery And Pos...	13 (.19%)
Vascular Hypertensive	13 (.19%)
Eye	12 (.18%)
Procedural And Device Related Injur...	12 (.18%)
Schizophrenia And Other Psychotic	12 (.18%)
Acid-base	11 (.16%)
Bacterial Infectious	11 (.16%)
Increased Intracranial Pressure And...	11 (.16%)
Musculoskeletal And Connective Tiss...	10 (.15%)
Salivary Gland Conditions	10 (.15%)
Tissue	10 (.15%)
Tongue Conditions	10 (.15%)
Gallbladder	9 (.13%)
Gastrointestinal Hemorrhages	9 (.13%)
Hearing	9 (.13%)
Lipid Analyses	9 (.13%)
Sexual Dysfunctions, Disturbances A...	9 (.13%)
Viral Infectious	9 (.13%)
Benign Neoplasms Gastrointestinal	8 (.12%)
Changes In Physical Activity	8 (.12%)
Myocardial	8 (.12%)

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This graph shows the top categories of adverse events submitted to the FDA for Pregabalin, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Pregabalin is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.