Drug Safety Information for HORIZANT (Gabapentin enacarbil)

Required post-approval safety study:

Conduct a double-blind, randomized, placebo-controlled, parallel group efficacy and safety evaluation trial in adolescents = 13 years to 17 years with moderate to severe symptoms of primary Restless Legs Syndrome. Due Date: 2024-10-31

Required post-approval safety study:

Conduct a long-term safety study of adolescents ages =13 years to 17 years with moderate to severe symptoms of primary Restless Legs Syndrome. The study must provide a descriptive analysis of safety data in pediatric patients during at least 12 months of continuous treatment with gabapentin enacarbil at individualized doses in association with the study described in PMR #1588-2. Due Date: 2025-07-31

Original FDA Drug Approval Date for HORIZANT: 2011-04-06

Adverse Drug Reactions for HORIZANT* (Gabapentin enacarbil)

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 HORIZANT
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective39
2Dizziness33
3Insomnia28
4Somnolence26
5Feeling abnormal16
6Fatigue15
7Nausea13
8Restless legs syndrome12
9Depression11
10Fall11
11Therapeutic response unexpected10
12Headache10
13Adverse event9
14Pruritus8
15Asthenia8
16Gait disturbance7
17Suicidal ideation7
18Off label use7
19Diarrhoea7
20Feeling drunk7

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

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

Reason # of FDA Reports
1Restless legs syndrome445
2Product used for unknown indication126
3Neuralgia20
4Neuropathy peripheral19
5Periodic limb movement disorder11
6Post herpetic neuralgia11
7Migraine11
8Muscle spasms10
9Nervous system disorder10
10Multiple sclerosis9

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


Types of Adverse Events for HORIZANT

Total Reports Filed with FDA: 820


Number of FDA Adverse Event Reports by Patient Age for HORIZANT

Total Reports Filed with FDA: 820*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Gabapentin enacarbil (Horizant)

Charts are based on 820 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 HORIZANT Reviews and Review Summary .

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.

Visit   DrugInformer.com more on HORIZANT's side effects.