DIRA 1.0: Atlas of Drug-induced Rhabdomyolysis

GABAPENTIN

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Less-DIR concern

Severity Score:1

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

ADVERSE REACTIONS
Postmarketing and Other Experience
In addition to the adverse experiences reported during clinical testing of gabapentin, the following adverse experiences have been reported in patients receiving marketed gabapentin. These adverse experiences have not been listed above and data are insufficient to support an estimate of their incidence or to establish causation. The listing is alphabetized: angioedema, blood glucose fluctuation, breast enlargement, elevated creatine kinase, elevated liver function tests, erythema multiforme, fever, hyponatremia, jaundice, movement disorder, rhabdomyolysis, Stevens-Johnson syndrome.
Adverse events following the abrupt discontinuation of gabapentin have also been reported. The most frequently reported events were anxiety, insomnia, nausea, pain, and sweating.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

Rhabdomyolysis

143

42769

Other ADRs

40669

14076610

Odds Ratio = 1.158

Drug Property Information

ATC Code(s):

N03AX12 - gabapentin

N03AX - Other antiepileptics
N03A - ANTIEPILEPTICS
N03 - ANTIEPILEPTICS
N - NERVOUS SYSTEM

Active Ingredient:gabapentin

Active Ingredient UNII:6CW7F3G59X

Drugbank ID:DB00996

PubChem Compound:3446

CAS Number:60142-96-3

Dosage Form(s):solution

Route(s) Of Administrator:oral

Daily Dose:

1800.0 mg/day N03AX12

Chemical Structure:

SMILE Code:
C1CCC(CC1)(CC(=O)O)CN

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

1: Radiologic Findings in Gabapentin-Induced Myositis.

[Coupal Tyler Michael,Chang David Ross,Pennycooke Kevin,Ouellette Hugue Alcide,Munk Peter Loren]
J Radiol Case Rep.2017 Apr 30;11(4):30-37. doi: 10.3941/jrcr.v11i4.3092. eCollection 2017 Apr. PMID: 28567183

2: A case of gabapentin-induced rhabdomyolysis requiring renal replacement therapy.

[Choi Min Seok,Jeon Howook,Kim Hyo Suk,Jang Bo Hyun,Lee Yoon Hee,Park Hoon Suk,Kim HyungWook,Jin Dong Chan]
Hemodial Int.2017 Jan;21(1):E4-E8. doi: 10.1111/hdi.12458. Epub 2016 Jul 8. PMID: 27389284

3: Trimethoprim-Sulfamethoxazole-Induced Rhabdomyolysis; Gabapentin-Induced Hypoglycemia in Diabetic and Nondiabetic Patients; Purple Glove Syndrome After Oral Phenytoin Administration; Acute Dystonic Reaction After Methylphenidate Initiation; Serotonin Syndrome with Vilazodone Monotherapy; Cabozantinib-Associated Dermatologic Adverse Reactions.

[Mancano Michael A]
Hosp Pharm.2015 Sep;50(8):662-6. doi: 10.1310/hpj5008-662. Epub 2015 Sep 16. PMID: 26715798

4: N,N-Dimethyltryptamine-Induced Psychosis.

[Paterson Neil E,Darby W Connor,Sandhu Preetpal S]
Clin Neuropharmacol.2015 Jul-Aug;38(4):141-3. doi: 10.1097/WNF.0000000000000078. PMID: 26166234

5: [Rhabdomyolysis from gabapentin: a case report].

[Falconi Daniela,Tattoli Fabio,Brunetti Carlo,De Prisco Ornella,Gherzi Maurizio,Marazzi Federico,Marengo Marita,Serra Ilaria,Tamagnone Michela,Formica Marco]
G Ital Nefrol.2015 Mar-Apr;32(2). pii: gin/32.2.37. PMID: 26005946

6: Rhabdomyolysis in a multiple myeloma patient secondary to concurrent treatment with lenalidomide and pravastatin and to lenalidomide alone.

[Shahan Jaime L,Panu Lori D,Hildebrandt Gerhard C]
Int J Hematol.2012 Dec;96(6):818-9. doi: 10.1007/s12185-012-1226-3. Epub 2012 Nov 28. PMID: 23188472

7: Gabapentin-induced rhabdomyolysis in a patient with diabetic neuropathy.

[Bilgir Oktay,Calan Mehmet,Bilgir Ferda,Kebapçilar Levent,Yüksel Arif,Yildiz Yasar,Sari Ismail]
Intern Med.2009;48(12):1085-7. Epub 2009 Jun 15. PMID: 19525604

8: Gabapentin-induced severe myopathy.

[Tuccori Marco,Lombardo Giuseppe,Lapi Francesco,Vannacci Alfredo,Blandizzi Corrado,Del Tacca Mario]
Ann Pharmacother.2007 Jul;41(7):1301-5. Epub 2007 Jun 12. PMID: 17565043

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