GABAPENTIN

Gabapentin Adverse Events Reported to the FDA Over Time

How are Gabapentin adverse event reports trending over time?

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

Most Common Gabapentin Adverse Events Reported to the FDA

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

Drug Ineffective	1209 (3.36%)
Completed Suicide	810 (2.25%)
Pain	561 (1.56%)
Dizziness	559 (1.56%)
Somnolence	458 (1.27%)
Headache	387 (1.08%)
Nausea	336 (.94%)
Confusional State	333 (.93%)
Feeling Abnormal	321 (.89%)
Drug Interaction	311 (.87%)
Convulsion	297 (.83%)
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Weight Increased	292 (.81%)
Fatigue	285 (.79%)
Fall	268 (.75%)
Tremor	267 (.74%)
Depression	263 (.73%)
Pain In Extremity	252 (.7%)
Malaise	250 (.7%)
Anxiety	247 (.69%)
Insomnia	246 (.68%)
Suicidal Ideation	246 (.68%)
Cardiac Arrest	243 (.68%)
Oedema Peripheral	226 (.63%)
Condition Aggravated	222 (.62%)
Diarrhoea	217 (.6%)
Dyspnoea	216 (.6%)
Respiratory Arrest	215 (.6%)
Asthenia	209 (.58%)
Vision Blurred	205 (.57%)
Death	202 (.56%)
Amnesia	192 (.53%)
Hypoaesthesia	184 (.51%)
Vomiting	180 (.5%)
Constipation	178 (.5%)
Loss Of Consciousness	173 (.48%)
Gait Disturbance	172 (.48%)
Drug Toxicity	170 (.47%)
Paraesthesia	167 (.46%)
Memory Impairment	161 (.45%)
Muscle Spasms	161 (.45%)
Rash	160 (.45%)
Renal Failure Acute	158 (.44%)
Pyrexia	156 (.43%)
Weight Decreased	151 (.42%)
Abdominal Pain	147 (.41%)
Pruritus	146 (.41%)
Agitation	145 (.4%)
Disturbance In Attention	143 (.4%)
Drug Effect Decreased	141 (.39%)
Chest Pain	137 (.38%)
Myalgia	137 (.38%)
Arthralgia	134 (.37%)
Overdose	134 (.37%)
Sedation	131 (.36%)
Myoclonus	128 (.36%)
Drug Withdrawal Syndrome	127 (.35%)
Back Pain	126 (.35%)
Drug Abuse	125 (.35%)
Cardio-respiratory Arrest	121 (.34%)
Hypotension	120 (.33%)
Balance Disorder	119 (.33%)
Disorientation	118 (.33%)
Suicide Attempt	118 (.33%)
Hallucination	116 (.32%)
Dyskinesia	114 (.32%)
Hyperhidrosis	114 (.32%)
Hypertension	111 (.31%)
Speech Disorder	102 (.28%)
Intentional Drug Misuse	100 (.28%)
Withdrawal Syndrome	100 (.28%)
Hypersensitivity	99 (.28%)
Neuralgia	99 (.28%)
Dysarthria	98 (.27%)
Rhabdomyolysis	97 (.27%)
Abdominal Pain Upper	96 (.27%)
Joint Swelling	95 (.26%)
Poisoning	94 (.26%)
Coma	92 (.26%)
Lethargy	91 (.25%)
Activities Of Daily Living Impaired	90 (.25%)
Sleep Disorder	90 (.25%)
Intentional Overdose	89 (.25%)
Depressed Level Of Consciousness	88 (.24%)
Mental Status Changes	88 (.24%)
Dry Mouth	87 (.24%)
Multiple Drug Overdose Intentional	87 (.24%)
Abdominal Discomfort	86 (.24%)
Drug Dependence	84 (.23%)
Diplopia	82 (.23%)
Coordination Abnormal	81 (.23%)
Restlessness	81 (.23%)
Cognitive Disorder	80 (.22%)
Oedema	80 (.22%)
Dysphagia	79 (.22%)
Muscular Weakness	79 (.22%)
Burning Sensation	78 (.22%)
Muscle Twitching	76 (.21%)
Alopecia	75 (.21%)
Neuropathy Peripheral	74 (.21%)
Renal Failure	74 (.21%)
Aggression	73 (.2%)

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

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

Neurological	3451 (9.6%)
Therapeutic And Nontherapeutic Effe...	2068 (5.76%)
Suicidal And Self-injurious Behavio...	1221 (3.4%)
Gastrointestinal Signs	1154 (3.21%)
Respiratory	882 (2.45%)
Epidermal And Dermal Conditions	795 (2.21%)
Movement Disorders	786 (2.19%)
Medication Errors	698 (1.94%)
Muscle	679 (1.89%)
Cardiac Arrhythmias	661 (1.84%)
Mental Impairment	642 (1.79%)
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Injuries	623 (1.73%)
Musculoskeletal And Connective Tiss...	609 (1.69%)
Anxiety Disorders	599 (1.67%)
Psychiatric	597 (1.66%)
Sleep Disorders	533 (1.48%)
Deliria	531 (1.48%)
Physical Examination Topics	531 (1.48%)
Gastrointestinal Motility And Defec...	506 (1.41%)
Seizures	478 (1.33%)
Infections - Pathogen Unspecified	463 (1.29%)
Vision	458 (1.27%)
Headaches	428 (1.19%)
Chemical Injury And Poisoning	409 (1.14%)
Hematology Investigations	390 (1.09%)
Renal Disorders	377 (1.05%)
Depressed Mood Disorders	374 (1.04%)
Joint	358 (1%)
Lifestyle Issues	346 (.96%)
Mood Disorders	318 (.88%)
Disturbances In Thinking	317 (.88%)
Cardiac And Vascular Investigations	287 (.8%)
Skin Appendage Conditions	278 (.77%)
Urinary Tract Signs	265 (.74%)
Hepatic And Hepatobiliary	254 (.71%)
Hepatobiliary	237 (.66%)
Fatal Outcomes	221 (.62%)
Allergic Conditions	207 (.58%)
Electrolyte And Fluid Balance Condi...	199 (.55%)
Peripheral Neuropathies	198 (.55%)
Personality Disorders	196 (.55%)
Bone And Joint Injuries	189 (.53%)
Decreased And Nonspecific Blood Pre...	186 (.52%)
Appetite And General Nutritional	182 (.51%)
Metabolic, Nutritional And Blood Ga...	172 (.48%)
Product Quality Issues	172 (.48%)
Body Temperature Conditions	165 (.46%)
Oral Soft Tissue Conditions	158 (.44%)
Gastrointestinal Hemorrhages	151 (.42%)
White Blood Cell	150 (.42%)
Water, Electrolyte And Mineral	149 (.41%)
Central Nervous System Vascular	139 (.39%)
Eye	135 (.38%)
Dental And Gingival Conditions	134 (.37%)
Renal And Urinary Tract Investigati...	130 (.36%)
Therapeutic Procedures And Supporti...	128 (.36%)
Cardiac Disorder Signs	126 (.35%)
Vascular Hypertensive	119 (.33%)
Neuromuscular	117 (.33%)
Changes In Physical Activity	114 (.32%)
Lower Respiratory Tract Disorders	110 (.31%)
Viral Infectious	108 (.3%)
Toxicology And Therapeutic Drug Mon...	106 (.29%)
Enzyme	104 (.29%)
Sexual Dysfunctions, Disturbances A...	103 (.29%)
Salivary Gland Conditions	101 (.28%)
Glucose Metabolism Disorders	97 (.27%)
Sleep Disturbances	96 (.27%)
Upper Respiratory Tract Disorders	94 (.26%)
Bone Disorders	93 (.26%)
Psychiatric And Behavioural Symptom...	93 (.26%)
Musculoskeletal And Connective Tiss...	92 (.26%)
Lipid Analyses	91 (.25%)
Anemias Nonhemolytic And Marrow Dep...	90 (.25%)
Procedural And Device Related Injur...	90 (.25%)
Coronary Artery	88 (.24%)
Ocular Structural Change, Deposit A...	85 (.24%)
Ocular Neuromuscular	84 (.23%)
Platelet	80 (.22%)
Sexual Function And Fertility	80 (.22%)
Skin Vascular Abnormalities	80 (.22%)
Vascular	80 (.22%)
Bronchial Disorders	75 (.21%)
Inner Ear And Viiith Cranial Nerve	75 (.21%)
Tongue Conditions	74 (.21%)
Encephalopathies	72 (.2%)
Heart Failures	72 (.2%)
Angiedema And Urticaria	71 (.2%)
Protein And Chemistry Analyses	65 (.18%)
Gastrointestinal Conditions	64 (.18%)
Bacterial Infectious	62 (.17%)
Cranial Nerve Disorders	61 (.17%)
Bladder And Bladder Neck Disorders	58 (.16%)
Hematological And Lymphoid Tissue T...	58 (.16%)
Administration Site Reactions	44 (.12%)
Arteriosclerosis, Stenosis, Vascula...	44 (.12%)
Communication Disorders	44 (.12%)
Acid-base	43 (.12%)
Investigations, Imaging And Histopa...	43 (.12%)
Bone And Joint Therapeutic Procedur...	42 (.12%)
Breast	42 (.12%)

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