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PREGABALIN
DIR Classification
Classification:Less-DIR concern
Severity Score:1
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- WARNINGS AND PRECAUTIONS
- Creatine Kinase Elevations
- LYRICA treatment was associated with creatine kinase elevations. Mean changes in creatine kinase from baseline to the maximum value were 60 U/L for LYRICA-treated patients and 28 U/L for the placebo patients. In all controlled trials across multiple patient populations, 1.5% of patients on LYRICA and 0.7% of placebo patients had a value of creatine kinase at least three times the upper limit of normal. Three LYRICA treated subjects had events reported as rhabdomyolysis in premarketing clinical trials. The relationship between these myopathy events and LYRICA is not completely understood because the cases had documented factors that may have caused or contributed to these events. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if these muscle symptoms are accompanied by malaise or fever. Discontinue treatment with LYRICA if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
253
42659
Other ADRs
89711
14027568
Odds Ratio = 0.928
Drug Property Information
ATC Code(s):
- N03AX16 - pregabalin
- N03AX - Other antiepileptics
- N03A - ANTIEPILEPTICS
- N03 - ANTIEPILEPTICS
- N - NERVOUS SYSTEM
Active Ingredient:pregabalin
Active Ingredient UNII:55JG375S6M
Drugbank ID:DB00230
PubChem Compound:5486971
CAS Number:148553-50-8
Dosage Form(s):capsule
Route(s) Of Administrator:oral
Daily Dose:
- 300.0 mg/day N03AX16
Chemical Structure: 
SMILE Code:
CC(C)C[C@@H](CC(=O)O)CN
CC(C)C[C@@H](CC(=O)O)CN
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
1: Pregabalin- and azithromycin-induced rhabdomyolysis with purpura: An unrecognized interaction: A case report.
[Kato Kazuya,Iwasaki Yoshiaki,Onodera Kazuhiko,Higuchi Mineko,Kato Kimitaka,Kato Yurina,Tsutsui Masato,Taniguchi Masahiko,Furukawa Hiroyuki]Int J Surg Case Rep.2016;26:221-3. doi: 10.1016/j.ijscr.2016.07.007. Epub 2016 Jul 14. PMID: 27521491
2: Pregabalin-associated rhabdomyolysis.
[Gunathilake Roshan,Boyce Laura E,Knight Anne T]Med J Aust.2013 Nov 4;199(9):624-5. PMID: 24182230
3: Pregabalin and simvastatin: first report of a case of rhabdomyolysis.
[Kaufman Michele B,Choy Mary]P T.2012 Oct;37(10):579-95. PMID: 23115467
4: Gemfibrozil-induced myositis in a patient with normal renal function.
[Hahn Martin,Sriharan Kalavally,McFarland M Shawn]Ann Pharmacother.2010 Jan;44(1):211-4. doi: 10.1345/aph.1M411. Epub 2009 Nov 24. PMID: 19934390
5: Pregabalin does not impact peripheral nerve regeneration after crush injury.
[Whitlock Elizabeth L,Moradzadeh Arash,Hunter Daniel A,Mackinnon Susan E]J Reconstr Microsurg.2007 Jul;23(5):263-8. PMID: 17876729
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