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Neurontin Adverse Events Reported to the FDA Over Time

How are Neurontin adverse event reports trending over time?

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

Most Common Neurontin Adverse Events Reported to the FDA

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

Drug Ineffective
2792 (4.12%)
Pain
1372 (2.02%)
Suicidal Ideation
1055 (1.56%)
Depression
1023 (1.51%)
Somnolence
977 (1.44%)
Dizziness
932 (1.38%)
Suicide Attempt
834 (1.23%)
Feeling Abnormal
726 (1.07%)
Weight Increased
714 (1.05%)
Amnesia
686 (1.01%)
Convulsion
627 (.93%)
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Fatigue
626 (.92%)
Anxiety
617 (.91%)
Nausea
594 (.88%)
Completed Suicide
590 (.87%)
Headache
586 (.86%)
Insomnia
569 (.84%)
Fall
557 (.82%)
Pain In Extremity
526 (.78%)
Vision Blurred
526 (.78%)
Malaise
520 (.77%)
Thinking Abnormal
462 (.68%)
Oedema Peripheral
447 (.66%)
Confusional State
446 (.66%)
Condition Aggravated
439 (.65%)
Hypertension
434 (.64%)
Gait Disturbance
409 (.6%)
Tremor
405 (.6%)
Drug Ineffective For Unapproved Ind...
385 (.57%)
Asthenia
378 (.56%)
Memory Impairment
372 (.55%)
Loss Of Consciousness
359 (.53%)
Hypoaesthesia
348 (.51%)
Balance Disorder
336 (.5%)
Drug Interaction
330 (.49%)
Weight Decreased
316 (.47%)
Paraesthesia
301 (.44%)
Back Pain
294 (.43%)
Dyspnoea
292 (.43%)
Neuropathy Peripheral
291 (.43%)
Vomiting
289 (.43%)
Cerebrovascular Accident
281 (.41%)
Diarrhoea
278 (.41%)
Agitation
265 (.39%)
Overdose
259 (.38%)
Muscle Spasms
255 (.38%)
Rash
255 (.38%)
Drug Effect Decreased
239 (.35%)
Constipation
238 (.35%)
Neuralgia
235 (.35%)
Death
228 (.34%)
Burning Sensation
224 (.33%)
Injury
219 (.32%)
Disturbance In Attention
215 (.32%)
Hallucination
213 (.31%)
Chest Pain
212 (.31%)
Blood Pressure Increased
210 (.31%)
Arthralgia
209 (.31%)
Speech Disorder
209 (.31%)
Dry Mouth
206 (.3%)
Aggression
204 (.3%)
Hypersensitivity
201 (.3%)
Myocardial Infarction
194 (.29%)
Drug Hypersensitivity
193 (.28%)
Coma
188 (.28%)
Abnormal Behaviour
187 (.28%)
Activities Of Daily Living Impaired
187 (.28%)
Renal Failure
185 (.27%)
Diabetes Mellitus
184 (.27%)
Coordination Abnormal
183 (.27%)
Disorientation
181 (.27%)
Muscular Weakness
180 (.27%)
Myalgia
179 (.26%)
Pyrexia
179 (.26%)
Anger
178 (.26%)
Gun Shot Wound
177 (.26%)
Nervousness
177 (.26%)
Hyperhidrosis
174 (.26%)
Dyskinesia
169 (.25%)
Blood Cholesterol Increased
167 (.25%)
Pruritus
167 (.25%)
Road Traffic Accident
167 (.25%)
Dysphagia
166 (.25%)
Abasia
165 (.24%)
Fibromyalgia
163 (.24%)
Treatment Noncompliance
159 (.23%)
Abdominal Pain Upper
156 (.23%)
Alopecia
155 (.23%)
Irritability
152 (.22%)
Drug Withdrawal Syndrome
151 (.22%)
Heart Rate Increased
150 (.22%)
Nervous System Disorder
149 (.22%)
Swelling
144 (.21%)
Unevaluable Event
141 (.21%)
Impaired Work Ability
140 (.21%)
Migraine
139 (.21%)
Mental Disorder
138 (.2%)
Nerve Injury
137 (.2%)
Withdrawal Syndrome
136 (.2%)
Hypersomnia
134 (.2%)
Sedation
133 (.2%)

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

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

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This graph shows the top categories of adverse events submitted to the FDA for Neurontin, 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 Neurontin 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 Neurontin According to Those Reporting Adverse Events

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

Pain
2211
Neuropathy Peripheral
1769
Neuralgia
1733
Ill-defined Disorder
1002
Drug Use For Unknown Indication
884
Product Used For Unknown Indication
839
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Bipolar Disorder
679
Back Pain
659
Convulsion
649
Fibromyalgia
645
Diabetic Neuropathy
564
Pain In Extremity
503
Neuropathy
498
Depression
435
Nerve Injury
410
Epilepsy
387
Restless Legs Syndrome
294
Migraine
285
Anxiety
281
Trigeminal Neuralgia
261
Muscle Spasms
197
Multiple Sclerosis
190
Herpes Zoster
177
Post Herpetic Neuralgia
166
Neuropathic Pain
160
Hypoaesthesia
154
Headache
146
Paraesthesia
143
Arthralgia
132
Arthritis
111
Sciatica
100
Complex Regional Pain Syndrome
100
Neck Pain
93
Affective Disorder
86
Burning Sensation
84
Tremor
78
Intervertebral Disc Protrusion
76
Sleep Disorder
69
Insomnia
65
Mood Swings
59
Polyneuropathy
59
Nervous System Disorder
55
Nerve Compression
50
Back Disorder
50
Spinal Column Stenosis
48
Rheumatoid Arthritis
44
Partial Seizures
44
Movement Disorder
40
Musculoskeletal Pain
38
Attention Deficit/hyperactivity Dis...
38
Osteoarthritis
37

Drug Labels

LabelLabelerEffective
NeurontinSTAT RX USA LLC05-NOV-10
NeurontinCardinal Health26-MAY-11
NeurontinREMEDYREPACK INC. 17-SEP-12
NeurontinParke-Davis Div of Pfizer Inc29-MAR-13

Neurontin Case Reports

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

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About Results

This report contains aggregated drug side effects and adverse events for Neurontin. 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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