DIRA 1.0: Atlas of Drug-induced Rhabdomyolysis

TENOFOVIR DISOPROXIL FUMARATE

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 Experience
The following adverse reactions have been identified during postapproval use of VIREAD. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders
allergic reaction, including angioedema
Metabolism and Nutrition Disorders
lactic acidosis, hypokalemia, hypophosphatemia
Respiratory, Thoracic, and Mediastinal Disorders
dyspnea
Gastrointestinal Disorders
pancreatitis, increased amylase, abdominal pain
Hepatobiliary Disorders
hepatic steatosis, hepatitis, increased liver enzymes (most commonly AST, ALT gamma GT)
Skin and Subcutaneous Tissue Disorders
rash
Musculoskeletal and Connective Tissue Disorders
rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, myopathy
Renal and Urinary Disorders
acute renal failure, renal failure, acute tubular necrosis, Fanconi syndrome, proximal renal tubulopathy, interstitial nephritis (including acute cases), nephrogenic diabetes insipidus, renal insufficiency, increased creatinine, proteinuria, polyuria
General Disorders and Administration Site Conditions
asthenia
The following adverse reactions, listed under the body system headings above, may occur as a consequence of proximal renal tubulopathy: rhabdomyolysis, osteomalacia, hypokalemia, muscular weakness, myopathy, hypophosphatemia.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

Rhabdomyolysis

142

42770

Other ADRs

18353

14098926

Odds Ratio = 2.551

Drug Property Information

ATC Code(s): N/A

Active Ingredient:tenofovir disoproxil fumarate

Active Ingredient UNII:OTT9J7900I

Drugbank ID:DB00300

PubChem Compound:5481350

CAS Number:201341-05-1

Dosage Form(s):powder; tablet, coated

Route(s) Of Administrator:oral

Daily Dose:

245.0 mg/day J05AF07

Chemical Structure:

SMILE Code:
C[C@H](CN1C=NC2=C1N=CN=C2N)OCP(=O)(OCOC(=O)OC(C)C)OCOC(=O)OC(C)C

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

1: A 68-year old male presenting with rhabdomyolysis-associated acute kidney injury following concomitant use of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate and pravastatin/fenofibrate: a case report.

[Suttels Veronique,Florence Eric,Leys John,Vekemans Marc,Van den Ende Jef,Vlieghe Erika,Kenyon Chris]
J Med Case Rep.2015 Sep 8;9:190. doi: 10.1186/s13256-015-0671-z. PMID: 26347243

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