Drug Safety Information for HORIZANT (Gabapentin enacarbil)
Safety-related Labeling Changes for HORIZANT (GABAPENTIN ENACARBIL) Rx Drug: FDA Link
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 | |
---|---|---|
1 | Drug ineffective | 39 |
2 | Dizziness | 33 |
3 | Insomnia | 28 |
4 | Somnolence | 26 |
5 | Feeling abnormal | 16 |
6 | Fatigue | 15 |
7 | Nausea | 13 |
8 | Restless legs syndrome | 12 |
9 | Depression | 11 |
10 | Fall | 11 |
11 | Therapeutic response unexpected | 10 |
12 | Headache | 10 |
13 | Adverse event | 9 |
14 | Pruritus | 8 |
15 | Asthenia | 8 |
16 | Gait disturbance | 7 |
17 | Suicidal ideation | 7 |
18 | Off label use | 7 |
19 | Diarrhoea | 7 |
20 | Feeling drunk | 7 |
* 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 | |
---|---|---|
1 | Restless legs syndrome | 445 |
2 | Product used for unknown indication | 126 |
3 | Neuralgia | 20 |
4 | Neuropathy peripheral | 19 |
5 | Periodic limb movement disorder | 11 |
6 | Post herpetic neuralgia | 11 |
7 | Migraine | 11 |
8 | Muscle spasms | 10 |
9 | Nervous system disorder | 10 |
10 | Multiple sclerosis | 9 |
*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 .
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.