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LAMIVUDINE

DIR ClassificationPostmarketing SurveillanceDrug Property InformationReference

DIR Classification


Classification:Less-DIR concern
Severity Score:1

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

  • ADVERSE REACTIONS
  • Postmarketing Experience
  • In addition to adverse reactions reported from clinical trials, the following adverse reactions have been reported during postmarketing use of lamivudine. Because these reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to lamivudine.
  • Body as a Whole: Redistribution/accumulation of body fat [see WARNINGS AND PRECAUTIONS (5.7)].
  • Endocrine and Metabolic: Hyperglycemia.
  • General: Weakness.
  • Hemic and Lymphatic: Anemia (including pure red cell aplasia and severe anemias progressing on therapy).
  • Hepatic and Pancreatic: Lactic acidosis and hepatic steatosis, posttreatment exacerbation of hepatitis B [see BOXED WARNING, Warnings and Precautions (5.1, 5.2)].
  • Hypersensitivity: Anaphylaxis, urticaria.
  • Musculoskeletal: Muscle weakness, CPK elevation, rhabdomyolysis.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
58
42854
Other ADRs
9321
14107958

Odds Ratio = 2.049

Drug Property Information



ATC Code(s):
  • J05AR02 - lamivudine
    • J05AR - "Antivirals for treatment of HIV infections, combinations"
    • J05A - DIRECT ACTING ANTIVIRALS
    • J05 - ANTIVIRALS FOR SYSTEMIC USE
    • J - ANTIINFECTIVES FOR SYSTEMIC USE
  • J05AR13 - lamivudine
    • J05AR - "Antivirals for treatment of HIV infections, combinations"
    • J05A - DIRECT ACTING ANTIVIRALS
    • J05 - ANTIVIRALS FOR SYSTEMIC USE
    • J - ANTIINFECTIVES FOR SYSTEMIC USE
  • J05AR12 - lamivudine
    • J05AR - "Antivirals for treatment of HIV infections, combinations"
    • J05A - DIRECT ACTING ANTIVIRALS
    • J05 - ANTIVIRALS FOR SYSTEMIC USE
    • J - ANTIINFECTIVES FOR SYSTEMIC USE
  • J05AR01 - lamivudine
    • J05AR - "Antivirals for treatment of HIV infections, combinations"
    • J05A - DIRECT ACTING ANTIVIRALS
    • J05 - ANTIVIRALS FOR SYSTEMIC USE
    • J - ANTIINFECTIVES FOR SYSTEMIC USE
  • J05AR05 - lamivudine
    • J05AR - "Antivirals for treatment of HIV infections, combinations"
    • J05A - DIRECT ACTING ANTIVIRALS
    • J05 - ANTIVIRALS FOR SYSTEMIC USE
    • J - ANTIINFECTIVES FOR SYSTEMIC USE
  • J05AR07 - lamivudine
    • J05AR - "Antivirals for treatment of HIV infections, combinations"
    • J05A - DIRECT ACTING ANTIVIRALS
    • J05 - ANTIVIRALS FOR SYSTEMIC USE
    • J - ANTIINFECTIVES FOR SYSTEMIC USE
  • J05AR04 - lamivudine
    • J05AR - "Antivirals for treatment of HIV infections, combinations"
    • J05A - DIRECT ACTING ANTIVIRALS
    • J05 - ANTIVIRALS FOR SYSTEMIC USE
    • J - ANTIINFECTIVES FOR SYSTEMIC USE
  • J05AF05 - lamivudine
    • J05AF - Nucleoside and nucleotide reverse transcriptase inhibitors
    • J05A - DIRECT ACTING ANTIVIRALS
    • J05 - ANTIVIRALS FOR SYSTEMIC USE
    • J - ANTIINFECTIVES FOR SYSTEMIC USE
  • J05AR16 - lamivudine
    • J05AR - "Antivirals for treatment of HIV infections, combinations"
    • J05A - DIRECT ACTING ANTIVIRALS
    • J05 - ANTIVIRALS FOR SYSTEMIC USE
    • J - ANTIINFECTIVES FOR SYSTEMIC USE
  • J05AR11 - lamivudine
    • J05AR - "Antivirals for treatment of HIV infections, combinations"
    • J05A - DIRECT ACTING ANTIVIRALS
    • J05 - ANTIVIRALS FOR SYSTEMIC USE
    • J - ANTIINFECTIVES FOR SYSTEMIC USE
Active Ingredient:lamivudine
Active Ingredient UNII:2T8Q726O95
Drugbank ID:DB00709
PubChem Compound:60825
CAS Number:134678-17-4
Dosage Form(s):solution
Route(s) Of Administrator:oral
Daily Dose:
  • 300.0 mg/day J05AF05
Chemical Structure:
SMILE Code:
C1[C@H](O[C@H](S1)CO)N2C=CC(=NC2=O)N

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

1: Rhabdomyolysis due to lamivudine re-administration in a patient with HBV-related hepatic failure caused by interruption of lamivudine and adefovir.

[Kim Soo Ki,Kim Soo Ryang,Imoto Susumu,Tohyama Madoka,Otono Yumi,Tamura Tomoko]
J Gastrointestin Liver Dis.2015 Dec;24(4):535-6. PMID: 26697584

2: Rhabdomyolysis due to Lamivudine administration in acute viral hepatitis B infection: a case report from Malaysia.

[Baharin Janudin,Sahari Narisa Sulaiman,Lim Sazlyna Mohd Sazlly]
Electron Physician.2014 Jul 1;6(3):863-7. doi: 10.14661/2014.863-867. eCollection 2014 Jul-Sep. PMID: 25763159

3: Tolerability of HIV postexposure prophylaxis with tenofovir/emtricitabine and lopinavir/ritonavir tablet formulation.

[Tosini William,Muller Philippe,Prazuck Thierry,Benabdelmoumen Ghania,Peyrouse Eric,Christian Bernard,Quertainmont Yann,Bouvet Elisabeth,Rabaud Christian]
AIDS.2010 Sep 24;24(15):2375-80. doi: 10.1097/QAD.0b013e32833dfad1. PMID: 20729709

4: Severe myositis on commencement of efavirenz, abacavir and lamivudine, in the absence of lactic acidosis or classical abacavir hypersensitivity.

[Parsonage Mirella Jane,Barlow Gavin,Lillie Patrick,Moss Peter,Adams Katherine,Thaker Hiten]
BMJ Case Rep.2009;2009. pii: bcr01.2009.1411. doi: 10.1136/bcr.01.2009.1411. Epub 2009 Jun 15. PMID: 21687032

5: Rhabdomyolysis due to Lamivudine administration in a liver transplant recipient.

[Adani Gian Luigi,Baccarani Umberto,Risaliti Andrea,Bresadola Fabrizio,Della Rocca Giorgio,Viale Pierluigi]
Am J Transplant.2005 Mar;5(3):634. PMID: 15707423

6: Anti-retrovirals and immunosuppressive drug interactions in a HIV-positive patient after liver transplantation.

[Antonini Mario,Ettorre Giuseppe Maria,Vennarecci Giovanni,D'Offizi Gianpiero,Narciso Pasquale,Del Nonno Franca,Perracchio Letizia,Visco Giuseppe,Santoro Eugenio]
Hepatogastroenterology.2004 May-Jun;51(57):646-8. PMID: 15143883

7: [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

8: Rhabdomyolytic syndrome during the lamivudine therapy for acute exacerbation of chronic type B hepatitis.

[Yahagi Kaichiro,Ueno Yoshiyuki,Mano Yutaka,Shimosegawa Tooru]
Liver Transpl.2002 Dec;8(12):1198-9. PMID: 12474162

9: From the Centers for Disease Control and Prevention. Serious adverse events attributed to nevirapine regimens for postexposure prophylaxis after HIV exposures--worldwide, 1997-2000.


JAMA.2001 Jan 24-31;285(4):402-3. PMID: 11263401

10: Serious adverse events attributed to nevirapine regimens for postexposure prophylaxis after HIV exposures--worldwide, 1997-2000.

[Centers for Disease Control and Prevention (CDC)]
MMWR Morb Mortal Wkly Rep.2001 Jan 5;49(51-52):1153-6. PMID: 11198946

11: [Rhabdomyolysis in antiretroviral therapy with Lamivudin].

[Mendila M,Walter G F,Stoll M,Schmidt R E]
Dtsch Med Wochenschr.1997 Aug 15;122(33):1003-6. PMID: 9296927

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