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Gabapen Adverse Events Reported to the FDA Over Time

How are Gabapen adverse event reports trending over time?

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

Most Common Gabapen Adverse Events Reported to the FDA

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

Somnolence
82 (5.85%)
Convulsion
36 (2.57%)
Dizziness
32 (2.28%)
Fall
32 (2.28%)
Epilepsy
27 (1.93%)
Altered State Of Consciousness
24 (1.71%)
Delirium
22 (1.57%)
Drug Ineffective
21 (1.5%)
Pyrexia
21 (1.5%)
Depressed Level Of Consciousness
18 (1.28%)
Weight Increased
16 (1.14%)
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Gamma-glutamyltransferase Increased
15 (1.07%)
Hepatic Function Abnormal
15 (1.07%)
Loss Of Consciousness
14 (1%)
Blood Creatine Phosphokinase Increa...
13 (.93%)
Hallucination
13 (.93%)
Anticonvulsant Drug Level Decreased
12 (.86%)
Nausea
12 (.86%)
Renal Impairment
12 (.86%)
Urine Output Decreased
12 (.86%)
Drug Eruption
11 (.78%)
Respiratory Depression
11 (.78%)
Drug Interaction
10 (.71%)
Oedema
10 (.71%)
Platelet Count Decreased
10 (.71%)
Pneumonia
10 (.71%)
Status Epilepticus
10 (.71%)
Blood Potassium Increased
9 (.64%)
Grand Mal Convulsion
9 (.64%)
Overdose
9 (.64%)
Rhabdomyolysis
9 (.64%)
Blood Creatinine Increased
8 (.57%)
Death
8 (.57%)
Dysstasia
8 (.57%)
Hypoaesthesia
8 (.57%)
Pain
8 (.57%)
Pruritus
8 (.57%)
Rash
8 (.57%)
Urinary Incontinence
8 (.57%)
Anxiety
7 (.5%)
Asthenia
7 (.5%)
Dysarthria
7 (.5%)
Dyspnoea
7 (.5%)
Eosinophil Count Increased
7 (.5%)
Face Oedema
7 (.5%)
Neuroleptic Malignant Syndrome
7 (.5%)
Weight Decreased
7 (.5%)
White Blood Cell Count Decreased
7 (.5%)
Withdrawal Syndrome
7 (.5%)
Abasia
6 (.43%)
Agitation
6 (.43%)
Anuria
6 (.43%)
Headache
6 (.43%)
Interstitial Lung Disease
6 (.43%)
Neoplasm Progression
6 (.43%)
Proteinuria
6 (.43%)
Renal Failure Acute
6 (.43%)
White Blood Cell Count Increased
6 (.43%)
Abnormal Behaviour
5 (.36%)
Alanine Aminotransferase Increased
5 (.36%)
Blood Glucose Increased
5 (.36%)
Cardiac Failure
5 (.36%)
Cardio-respiratory Arrest
5 (.36%)
Cerebral Infarction
5 (.36%)
Diplopia
5 (.36%)
Face Injury
5 (.36%)
Glycosylated Haemoglobin Increased
5 (.36%)
Hyperkalaemia
5 (.36%)
Liver Disorder
5 (.36%)
Malignant Neoplasm Progression
5 (.36%)
Miosis
5 (.36%)
Muscular Weakness
5 (.36%)
Pneumonia Aspiration
5 (.36%)
Tachycardia
5 (.36%)
Vision Blurred
5 (.36%)
Agranulocytosis
4 (.29%)
Arrhythmia
4 (.29%)
Atonic Seizures
4 (.29%)
Blood Cholesterol Increased
4 (.29%)
Blood Triglycerides Increased
4 (.29%)
Cervical Root Pain
4 (.29%)
Clonic Convulsion
4 (.29%)
Consciousness Fluctuating
4 (.29%)
Dialysis
4 (.29%)
Drug Exposure During Pregnancy
4 (.29%)
Drug Toxicity
4 (.29%)
Dysuria
4 (.29%)
Encephalitis
4 (.29%)
Gait Disturbance
4 (.29%)
Heart Rate Decreased
4 (.29%)
Herpes Zoster
4 (.29%)
Hypercholesterolaemia
4 (.29%)
Hypertriglyceridaemia
4 (.29%)
Hypoglycaemia
4 (.29%)
Metastatic Pain
4 (.29%)
Nephrotic Syndrome
4 (.29%)
Neuralgia
4 (.29%)
Pancreatitis Acute
4 (.29%)
Restlessness
4 (.29%)
Systemic Lupus Erythematosus
4 (.29%)
Therapeutic Agent Toxicity
4 (.29%)

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

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

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

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

Epilepsy
127
Pain
84
Cancer Pain
32
Partial Seizures
22
Neuralgia
20
Convulsion
14
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Analgesic Therapy
11
Drug Use For Unknown Indication
11
Pain In Extremity
10
Fibromyalgia
9
Hypoaesthesia
9
Post Herpetic Neuralgia
9
Trigeminal Neuralgia
6
Hernia Pain
5
Neuropathy Peripheral
5
Headache
4
Temporal Lobe Epilepsy
4
Pain Management
4
Back Pain
3
Prophylaxis
3
Diabetic Neuropathy
3
Facial Palsy
2
Multiple Myeloma
2
Post-traumatic Epilepsy
2
Lennox-gastaut Syndrome
2
Analgesia
2
Encephalitis
2
Abdominal Pain
2
Hypersomnia-bulimia Syndrome
1
Tonic Convulsion
1
Metastases To Bone
1
Procedural Pain
1
Arthralgia
1
Grand Mal Convulsion
1
Complex Regional Pain Syndrome
1
Product Used For Unknown Indication
1
Chest Pain
1
Eye Pain
1
Palliative Care
1
Ovarian Cancer Recurrent
1
Tremor
1
Multiple Sclerosis
1

Gabapen Case Reports

What Gabapen 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 Gabapen. 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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