DIRA 1.0: Atlas of Drug-induced Rhabdomyolysis

DIDANOSINE

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 didanosine. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to their seriousness, frequency of reporting, causal connection to didanosine, or a combination of these factors.
Blood and Lymphatic System Disorders - anemia, leukopenia, and thrombocytopenia.
Body as a Whole - abdominal pain, alopecia, anaphylactoid reaction, asthenia, chills/fever, pain.
Digestive Disorders - anorexia, dyspepsia, and flatulence.
Exocrine Gland Disorders - pancreatitis (including fatal cases) [see WARNINGS AND PRECAUTIONS (5.1)], sialoadenitis, parotid gland enlargement, dry mouth, and dry eyes.
Hepatobiliary Disorders - symptomatic hyperlactatemia/lactic acidosis and hepatic steatosis [see WARNINGS AND PRECAUTIONS (5.2)]; non-cirrhotic portal hypertension [see WARNINGS AND PRECAUTIONS (5.4)]; hepatitis and liver failure.
Metabolic Disorders - diabetes mellitus, elevated serum alkaline phosphatase level, elevated serum amylase level, elevated serum gamma-glutamyltransferase level, elevated serum uric acid level, hypoglycemia, and hyperglycemia.
Musculoskeletal Disorders - myalgia (with or without increases in creatine kinase), rhabdomyolysis including acute renal failure and hemodialysis, arthralgia, and myopathy.
Ophthalmologic Disorders - retinal depigmentation and optic neuritis [see WARNINGS AND PRECAUTIONS (5.6)].

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

Rhabdomyolysis

42894

Other ADRs

2754

14114525

Odds Ratio = 2.151

Drug Property Information

ATC Code(s):

J05AF02 - didanosine

J05AF - Nucleoside and nucleotide reverse transcriptase inhibitors
J05A - DIRECT ACTING ANTIVIRALS
J05 - ANTIVIRALS FOR SYSTEMIC USE
J - ANTIINFECTIVES FOR SYSTEMIC USE

Active Ingredient:didanosine

Active Ingredient UNII:K3GDH6OH08

Drugbank ID:DB00900

PubChem Compound:50599

CAS Number:69655-05-6

Dosage Form(s):capsule, delayed release

Route(s) Of Administrator:oral

Daily Dose:

400.0 mg/day J05AF02

Chemical Structure:

SMILE Code:
C1C[C@@H](O[C@@H]1CO)N2C=NC3=C2NC=NC3=O

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

1: [Severe lactic acidosis in HIV-infected patients treated with nucleosidic reverse transcriptase analogs: a report of 9 cases].

[Bonnet F,Bonarek M,Abridj A,Mercié P,Dupon M,Gemain M-C,Malvy D,Bernard N,Pellegrin J-L,Morlat P,Beylot J]
Rev Med Interne.2003 Jan;24(1):11-6. PMID: 12614853

2: Acute rhabdomyolysis in patients infected by human immunodeficiency virus.

[Chariot P,Ruet E,Authier F J,Lévy Y,Gherardi R]
Neurology.1994 Sep;44(9):1692-6. PMID: 7936298

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