Drug Safety Information for GABAPENTIN (Gabapentin)

FDA Safety Communication for GABAPENTIN (GABAPENTIN) Rx Drug: FDA Link

serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors Drug Safety Communication

Safety-related Labeling Changes for NEURONTIN (GABAPENTIN) Rx Drug: FDA Link

Safety-related Labeling Changes for HORIZANT (GABAPENTIN ENACARBIL) Rx Drug: FDA Link

Safety-related Labeling Changes for GRALISE (GABAPENTIN) Rx Drug: FDA Link

Adverse Drug Reactions for GABAPENTIN* (Gabapentin)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with GABAPENTIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective*7377
2Pain5554
3Nausea*5109
4Fatigue*4345
5Dizziness*4102
6Headache3908
7Fall3600
8Dyspnoea3491
9Depression*3449
10Diarrhoea3352
11Asthenia3134
12Pain in extremity3072
13Vomiting3063
14Insomnia*2728
15Anxiety2705
16Somnolence*2666
17Malaise2449
18Pneumonia2361
19Arthralgia2350
20Back pain2336

* This side effect also appears in "Top 10 Side Effects of GABAPENTIN " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking GABAPENTIN
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication35194
2Neuralgia*19941
3Neuropathy peripheral*17229
4Pain*17052
5Fibromyalgia*5988
6Convulsion4908
7Diabetic neuropathy4240
8Back pain*4097
9Epilepsy2979
10Restless legs syndrome*2952

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for GABAPENTIN

Total Reports Filed with FDA: 426116


Number of FDA Adverse Event Reports by Patient Age for GABAPENTIN

Total Reports Filed with FDA: 426116*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Gabapentin (Apo-gabapentin, Novo-gabapentin, Pms-gabapentin, Neurontin, Gabapentin hexal, Gralise, Gabapentin)

Charts are based on 426116 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and GABAPENTIN Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.