LYRICA

Adverse Events

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Lyrica Adverse Events Reported to the FDA Over Time

How are Lyrica adverse event reports trending over time?

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

Most Common Lyrica Adverse Events Reported to the FDA

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

Dizziness	5175 (2.69%)
Weight Increased	4957 (2.58%)
Drug Ineffective	4921 (2.56%)
Pain	4776 (2.48%)
Somnolence	4012 (2.09%)
Oedema Peripheral	3502 (1.82%)
Vision Blurred	3065 (1.59%)
Feeling Abnormal	2474 (1.29%)
Fatigue	2128 (1.11%)
Nausea	2126 (1.11%)
Fall	2092 (1.09%)
	Show More
Headache	2048 (1.07%)
Insomnia	2027 (1.05%)
Gait Disturbance	1885 (.98%)
Malaise	1879 (.98%)
Confusional State	1668 (.87%)
Pain In Extremity	1659 (.86%)
Dyspnoea	1566 (.81%)
Tremor	1491 (.78%)
Depression	1417 (.74%)
Dry Mouth	1203 (.63%)
Withdrawal Syndrome	1203 (.63%)
Balance Disorder	1201 (.62%)
Hypoaesthesia	1183 (.62%)
Asthenia	1162 (.6%)
Convulsion	1107 (.58%)
Disturbance In Attention	1092 (.57%)
Anxiety	1088 (.57%)
Rash	1082 (.56%)
Memory Impairment	1078 (.56%)
Diarrhoea	1075 (.56%)
Paraesthesia	1041 (.54%)
Loss Of Consciousness	966 (.5%)
Muscle Spasms	954 (.5%)
Myalgia	944 (.49%)
Vomiting	943 (.49%)
Drug Interaction	929 (.48%)
Weight Decreased	902 (.47%)
Arthralgia	887 (.46%)
Suicidal Ideation	873 (.45%)
Constipation	855 (.44%)
Joint Swelling	847 (.44%)
Muscular Weakness	845 (.44%)
Speech Disorder	827 (.43%)
Hypertension	820 (.43%)
Amnesia	814 (.42%)
Pruritus	793 (.41%)
Hyperhidrosis	785 (.41%)
Back Pain	747 (.39%)
Activities Of Daily Living Impaired	730 (.38%)
Visual Impairment	716 (.37%)
Oedema	715 (.37%)
Burning Sensation	712 (.37%)
Death	703 (.37%)
Fibromyalgia	683 (.36%)
Hypersensitivity	658 (.34%)
Visual Acuity Reduced	654 (.34%)
Blood Pressure Increased	641 (.33%)
Swelling Face	641 (.33%)
Diplopia	637 (.33%)
Hallucination	629 (.33%)
Swelling	628 (.33%)
Palpitations	618 (.32%)
Feeling Drunk	600 (.31%)
Dysarthria	586 (.3%)
Neuralgia	565 (.29%)
Agitation	558 (.29%)
Disorientation	541 (.28%)
Blood Glucose Increased	532 (.28%)
Decreased Appetite	517 (.27%)
Chest Pain	515 (.27%)
Dyskinesia	502 (.26%)
Neuropathy Peripheral	501 (.26%)
Condition Aggravated	491 (.26%)
Dysphagia	488 (.25%)
Muscle Twitching	485 (.25%)
Abdominal Pain Upper	482 (.25%)
Cerebrovascular Accident	476 (.25%)
Thinking Abnormal	470 (.24%)
Pyrexia	465 (.24%)
Vertigo	465 (.24%)
Abdominal Distension	462 (.24%)
Euphoric Mood	458 (.24%)
Drug Effect Decreased	450 (.23%)
Nervousness	445 (.23%)
Abasia	444 (.23%)
Sedation	441 (.23%)
Drug Withdrawal Syndrome	440 (.23%)
Overdose	438 (.23%)
Road Traffic Accident	438 (.23%)
Alopecia	431 (.22%)
Coordination Abnormal	425 (.22%)
Sleep Disorder	413 (.21%)
Pneumonia	411 (.21%)
Dysstasia	410 (.21%)
Diabetes Mellitus	405 (.21%)
Impaired Driving Ability	405 (.21%)
Syncope	405 (.21%)
Erythema	396 (.21%)
Irritability	396 (.21%)
Abnormal Behaviour	391 (.2%)

Share/Embed Graph Export Data

This graph shows the top adverse events submitted to the FDA for Lyrica, 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 Lyrica 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 Lyrica

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

Neurological	22041 (11.46%)
Therapeutic And Nontherapeutic Effe...	7522 (3.91%)
Physical Examination Topics	6254 (3.25%)
Gastrointestinal Signs	5964 (3.1%)
Vision	5751 (2.99%)
Epidermal And Dermal Conditions	5719 (2.97%)
Muscle	4613 (2.4%)
Injuries	4134 (2.15%)
Musculoskeletal And Connective Tiss...	4055 (2.11%)
Mental Impairment	3821 (1.99%)
Respiratory	3742 (1.95%)
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Sleep Disorders	3230 (1.68%)
Movement Disorders	3153 (1.64%)
Anxiety Disorders	3098 (1.61%)
Joint	2754 (1.43%)
Psychiatric	2439 (1.27%)
Headaches	2415 (1.26%)
Deliria	2387 (1.24%)
Gastrointestinal Motility And Defec...	2325 (1.21%)
Infections - Pathogen Unspecified	2225 (1.16%)
Lifestyle Issues	1951 (1.01%)
Depressed Mood Disorders	1826 (.95%)
Cardiac And Vascular Investigations	1763 (.92%)
Skin Appendage Conditions	1729 (.9%)
Urinary Tract Signs	1727 (.9%)
Medication Errors	1716 (.89%)
Mood Disorders	1714 (.89%)
Seizures	1711 (.89%)
Cardiac Arrhythmias	1646 (.86%)
Disturbances In Thinking	1604 (.83%)
Suicidal And Self-injurious Behavio...	1349 (.7%)
Eye	1339 (.7%)
Appetite And General Nutritional	1302 (.68%)
Salivary Gland Conditions	1282 (.67%)
Oral Soft Tissue Conditions	1179 (.61%)
Allergic Conditions	1143 (.59%)
Renal Disorders	1130 (.59%)
Hematology Investigations	1116 (.58%)
Metabolic, Nutritional And Blood Ga...	1111 (.58%)
Electrolyte And Fluid Balance Condi...	1056 (.55%)
Cardiac Disorder Signs	984 (.51%)
Bone And Joint Injuries	980 (.51%)
Hepatobiliary	918 (.48%)
Personality Disorders	915 (.48%)
Vascular Hypertensive	905 (.47%)
Peripheral Neuropathies	897 (.47%)
Central Nervous System Vascular	893 (.46%)
Hepatic And Hepatobiliary	891 (.46%)
Glucose Metabolism Disorders	789 (.41%)
Fatal Outcomes	775 (.4%)
Renal And Urinary Tract Investigati...	768 (.4%)
Inner Ear And Viiith Cranial Nerve	747 (.39%)
Upper Respiratory Tract Disorders	727 (.38%)
Tongue Conditions	658 (.34%)
Decreased And Nonspecific Blood Pre...	646 (.34%)
Lipid Analyses	601 (.31%)
Musculoskeletal And Connective Tiss...	598 (.31%)
Viral Infectious	584 (.3%)
Coronary Artery	573 (.3%)
Bronchial Disorders	546 (.28%)
Heart Failures	545 (.28%)
Body Temperature Conditions	536 (.28%)
Ocular Infections, Irritations And ...	535 (.28%)
Therapeutic Procedures And Supporti...	535 (.28%)
Water, Electrolyte And Mineral	528 (.27%)
Sleep Disturbances	501 (.26%)
Bone Disorders	485 (.25%)
Angiedema And Urticaria	484 (.25%)
Psychiatric And Behavioural Symptom...	482 (.25%)
Lower Respiratory Tract Disorders	470 (.24%)
Vascular	465 (.24%)
Dental And Gingival Conditions	453 (.24%)
Hearing	414 (.22%)
Enzyme	410 (.21%)
Cranial Nerve Disorders	401 (.21%)
Gastrointestinal Conditions	401 (.21%)
Changes In Physical Activity	383 (.2%)
Anemias Nonhemolytic And Marrow Dep...	381 (.2%)
White Blood Cell	378 (.2%)
Chemical Injury And Poisoning	361 (.19%)
Arteriosclerosis, Stenosis, Vascula...	330 (.17%)
Sexual Function And Fertility	325 (.17%)
Bacterial Infectious	324 (.17%)
Schizophrenia And Other Psychotic	324 (.17%)
Ocular Neuromuscular	322 (.17%)
Communication Disorders	304 (.16%)
Toxicology And Therapeutic Drug Mon...	299 (.16%)
Bone And Joint Therapeutic Procedur...	284 (.15%)
Neuromuscular	269 (.14%)
Breast	268 (.14%)
Manic And Bipolar Mood Disorders	267 (.14%)
Anterior Eye Structural Change, Dep...	260 (.14%)
Gastrointestinal Hemorrhages	253 (.13%)
Sexual Dysfunctions, Disturbances A...	253 (.13%)
Vascular Hemorrhagic	245 (.13%)
Embolism And Thrombosis	240 (.12%)
Skin Vascular Abnormalities	233 (.12%)
Miscellaneous And Site Unspecified ...	229 (.12%)
Ocular Structural Change, Deposit A...	225 (.12%)
Thyroid Gland	217 (.11%)
Spinal Cord And Nerve Root	203 (.11%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Lyrica, 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 Lyrica 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.

Common Uses of Lyrica According to Those Reporting Adverse Events

Why are people taking Lyrica, according to those reporting adverse events to the FDA?

Fibromyalgia	6691
Neuralgia	5915
Pain	4120
Neuropathy Peripheral	3305
Diabetic Neuropathy	1656
Ill-defined Disorder	1514
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Back Pain	1271
Post Herpetic Neuralgia	1162
Pain In Extremity	1037
Product Used For Unknown Indication	993
Drug Use For Unknown Indication	970
Nerve Injury	698
Herpes Zoster	692
Trigeminal Neuralgia	525
Sciatica	502
Neuropathy	496
Anxiety	405
Hypoaesthesia	393
Epilepsy	378
Convulsion	344
Arthralgia	330
Generalised Anxiety Disorder	315
Polyneuropathy	315
Paraesthesia	306
Complex Regional Pain Syndrome	257
Burning Sensation	248
Neck Pain	220
Depression	220
Headache	216
Intervertebral Disc Protrusion	205
Arthritis	201
Myalgia	175
Muscle Spasms	162
Spinal Column Stenosis	159
Restless Legs Syndrome	147
Migraine	146
Multiple Sclerosis	131
Musculoskeletal Pain	131
Nerve Compression	127
Osteoarthritis	122
Back Disorder	113
Procedural Pain	111
Anxiety Disorder	100
Pain Management	98
Radiculopathy	95
Rheumatoid Arthritis	93
Nervous System Disorder	92
Sleep Disorder	90
Cancer Pain	88
Bone Pain	84
Lumbar Radiculopathy	73

Drug Labels

Label	Labeler	Effective
Lyrica	Physicians Total Care, Inc.	30-DEC-09
Lyrica	Lake Erie Medical DBA Quality Care Products LLC	13-AUG-10
Lyrica	Rebel Distributors Corp	28-DEC-10
Lyrica	Unit Dose Services	12-JUL-11
Lyrica	Unit Dose Services	12-JUL-11
Lyrica	PD-Rx Pharmaceuticals, Inc.	12-JUL-11
Lyrica	PD-Rx Pharmaceuticals, Inc.	12-JUL-11
Lyrica	Unit Dose Services	12-JUL-11
Lyrica	PD-Rx Pharmaceuticals, Inc.	12-JUL-11
Lyrica	PD-Rx Pharmaceuticals, Inc.	12-JUL-11
Lyrica	Unit Dose Services	12-JUL-11
Lyrica	Unit Dose Services	12-JUL-11
Lyrica	Unit Dose Services	12-JUL-11
Lyrica	PD-Rx Pharmaceuticals, Inc.	12-JUL-11
Lyrica	Unit Dose Services	12-JUL-11
Lyrica	H.J. Harkins Company, Inc.	17-OCT-11
Lyrica	Lake Erie Medical & Surgical Supply, DBA Quality Care Products, LLC	16-NOV-11
Lyrica	Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC	12-DEC-11
Lyrica	Lake Erie Medical DBA Quality Care Products LLC	13-DEC-11
Lyrica	Cardinal Health	19-JAN-12
Lyrica	Rebel Distributors Corp	24-JAN-12
Lyrica	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	06-FEB-12
Lyrica	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	08-FEB-12
Lyrica	STAT Rx USA LLC	01-MAR-12
Lyrica	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	19-MAR-12
Lyrica	Lake Erie Medical DBA Quality Care Products LLC	30-MAY-12
Lyrica	Parke-Davis Div of Pfizer Inc	22-JUN-12
Lyrica	St Marys Medical Park Pharmacy	10-AUG-12
Lyrica	Bryant Ranch Prepack	12-OCT-12
Lyrica	Bryant Ranch Prepack	23-OCT-12
Lyrica	U.S. Pharmaceuticals	30-NOV-12
Lyrica	Bryant Ranch Prepack	17-JAN-13
Lyrica	Bryant Ranch Prepack	18-JAN-13
Lyrica	STAT Rx USA LLC	08-FEB-13
Lyrica	Cardinal Health	23-APR-13
Lyrica	Bryant Ranch Prepack	25-APR-13
Lyrica	Bryant Ranch Prepack	25-APR-13
Lyrica	A-S Medication Solutions LLC	02-MAY-13
Lyrica	A-S Medication Solutions LLC	02-MAY-13

Lyrica Case Reports

What Lyrica safety concerns are being reported by doctors and researchers in the medical literature?

About Results

This report contains aggregated drug side effects and adverse events for Lyrica. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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