Clarithromycin

Clarithromycin is a macrolide antimicrobial drug [see Microbiology ( 12.4 )] .

• Clarithromycin is a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults ( 1.1 ) Acute Maxillary Sinusitis ( 1.2 ) Community-Acquired Pneumonia ( 1.3 ) Pharyngitis/Tonsillitis ( 1.4 ) Uncomplicated Skin and Skin Structure Infections ( 1.5 ) Acute Otitis Media in Pediatric Patients ( 1.6 ) Treatment and Prophylaxis of Disseminated Mycobacterial Infections ( 1.7 ) Helicobacter pylori Infection and Duodenal Ulcer Disease in Adults ( 1.8 ) Limitations of Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.ICD-10: H66.90, J02.9, J03.90, J18.9, J20.9, J32.9, K26.9

• Hypersensitivity to clarithromycin or any macrolide drug ( 4.1 ) Cisapride and pimozide ( 4.2 ) History of cholestatic jaundice/hepatic dysfunction with use of clarithromycin ( 4.3 ) Colchicine in renal or hepatic impairment ( 4.4 ) Lomitapide, lovastatin, and simvastatin ( 4.5 ) Ergot alkaloids (ergotamine or dihydroergotamine) ( 4.6 ) Lurasidone ( 4.7 ) 4.1 Hypersensitivity Clarithromycin tablets are contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibacterial drugs [see Warnings and Precautions ( 5.1 )] . 4.2 Cisapride and Pimozide Concomitant administration of clarithromycin tablets with cisapride and pimozide is contraindicated [see Drug Interactions ( 7 )] .contraindicated

Adults : clarithromycin tablets 250 mg or 500 mg every 12 hours for 7 to 14 days ( 2.2 ) H. pylori eradication (in combination with lansoprazole/amoxicillin, omeprazole/amoxicillin, or omeprazole): clarithromycin tablets 500 mg every 8 or 12 hours for 10 to 14 days. See full prescribing information (FPI) for additional information. ( 2.3 ) Pediatric Patients : clarithromycin 15 mg/kg/day divided every 12 hours for 10 days ( 2.4 ) Mycobacterial Infections : clarithromycin tablets 500 mg every 12 hours; clarithromycin tablets 7.5 mg/kg up to 500 mg every 12 hours in pediatric patients ( 2.5 ) Reduce dose in moderate renal impairment with concomitant atazanavir or ritonavir-containing regimens and in severe renal impairment ( 2.6 ) 2.1 Important Administration Instructions Clarithromycin tablets may be given with or without food. 2.2 Adult Dosage The recommended dosages of clarithromycin tablets for the treatment of mild to moderate infections in adults are listed in Table 1 . Table 1.

Severe Acute Hypersensitivity Reactions : Discontinue clarithromycin tablets if occurs ( 5.1 ) QT Prolongation : Avoid clarithromycin tablets in patients with known QT prolongation or receiving drugs known to prolong the QT interval, ventricular arrhythmia ( torsades de pointes ), hypokalemia/hypomagnesemia, significant bradycardia, or taking Class IA or III antiarrhythmics ( 5.2 ) Hepatotoxicity : Discontinue if signs and symptoms of hepatitis occur ( 5.3 ) Serious adverse reactions can occur due to drug interactions of clarithromycin tablets with colchicine, some lipid-lowering agents, some calcium channel blockers, and other drugs ( 5.4 ) Risk of all-cause mortality one year or more after the end of treatment in patients with coronary artery disease. Balance this potential risk with the treatment benefits when prescribing clarithromycin tablets in these patients ( 5.5 ) Clostridium difficile associated diarrhea (CDAD) : Evaluate if diarrhea occurs ( 5.6 ) Embryo-Fetal Toxicity : Based on animal findings, clarithromycin tablets is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate ( 5.7 ) Exacerbation of myasthenia gravis has been reported in patients receiving clarithromycin tablets therapy ( 5.8 ) 5.1 Severe Acute Hypersensitivity Reactions In the event of severe acute hypersensitivity reactions, such as anaphylaxis, Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), Henoch-Schonlein purpura, and acute generalized exanthematous pustulosis, di…

The following serious adverse reactions are described below and elsewhere in the labeling: Acute Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] QT Prolongation [see Warnings and Precautions ( 5.2 )] Hepatotoxicity [see Warnings and Precautions ( 5.3 )] Serious Adverse Reactions Due to Concomitant Use with Other Drugs [see Warnings and Precautions ( 5.4 )] Clostridium difficile Associated Diarrhea [see Warnings and Precautions ( 5.6 )] Exacerbation of Myasthenia Gravis [see Warnings and Precautions ( 5.8 )] Most frequent adverse reactions for both adult and pediatric populations in clinical trials: abdominal pain, diarrhea, nausea, vomiting, dysgeusia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Based on pooled data across all indications, the most frequent adverse reactions for both adult and pediatric populations observed in clinical trials are abdominal pain, diarrhea, nausea, vomiting and dysgeusia. Also reported were dyspepsia, liver function test abnormal, anaphylactic reaction, candidiasis, headache, insomnia, and rash.

Geriatric : Increased risk of torsades de pointes ( 8.5 ) 8.1 Pregnancy Risk Summary Based on findings from animal studies, clarithromycin tablets are not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate. If pregnancy occurs while taking clarithromycin tablets, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions ( 5.7 )]. Limited data from a small number of published human studies with clarithromycin tablets use during pregnancy are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, administration of oral clarithromycin to pregnant mice, rats, rabbits, and monkeys during the period of organogenesis produced malformations in rats (cardiovascular anomalies) and mice (cleft palate) at clinically relevant doses based on body surface area comparison. Fetal effects in mice, rats, and monkeys (e.g., reduced fetal survival, body weight, body weight gain) and implantation losses in rabbits were generally considered to be secondary to maternal toxicity (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Metabolism

Absorption Clarithromycin Tablets The absolute bioavailability of 250 mg clarithromycin tablets was approximately 50%. For a single 500 mg dose of clarithromycin, food slightly delays the onset of clarithromycin absorption, increasing the peak time from approximately 2 to 2.5 hours.

Overdosage of clarithromycin tablets can cause gastrointestinal symptoms such as abdominal pain, vomiting, nausea, and diarrhea. Treat adverse reactions accompanying overdosage by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum concentrations are not expected to be appreciably affected by hemodialysis or peritoneal dialysis.

• Jun 24, 2004ANDAANDA065145Actavis Labs Fl Inc
• Aug 25, 2005ANDAANDA065136Sandoz
• Oct 18, 2005ANDAANDA065144Sandoz
• Aug 20, 2007ANDAANDA065384Chartwell
• Sep 4, 2007ANDAANDA065283Sandoz
• Jul 25, 2012ANDAANDA065489Aurobindo
• Sep 28, 2015ANDAANDA203584Hec Pharm
• May 3, 2022NDANDA215152Phathom

1. 1Drug Interaction2,9508.7%
2. 2Drug Ineffective2,5237.5%
3. 3Nausea2,2736.7%
4. 4Dyspnoea2,0005.9%
5. 5Diarrhoea1,9865.9%
6. 6Malaise1,6835.0%
7. 7Pyrexia1,6414.9%
8. 8Off Label Use1,5804.7%
9. 9Headache1,5784.7%
10. 10Vomiting1,4954.4%
11. 11Rash1,2713.8%
12. 12Pneumonia1,2453.7%
13. 13Dizziness1,2023.6%
14. 14Fatigue1,1803.5%
15. 15Abdominal Pain1,0383.1%

Recent PubMed references pinned to Clarithromycin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Pharmacokinetic Drug-Drug Interactions of DA-8010 with Clarithromycin or Rifampicin: Influence of CYP2D6 Phenotype on the Extent of These Interactions.
  Drug design, development and therapy · 2026 · Lee S, Won H, Yu KS, et al.
  PMID 42094211DOI 10.2147/DDDT.S592783
• QcrB inhibitor Q203 (Telacebec) can synergize with clofazimine and clarithromycin to control a Mycobacterium avium infection.
  PloS one · 2026 · Cheng Y, Mulvey K, Moraski GC, et al.
  PMID 42013119DOI 10.1371/journal.pone.0344608
• Molecular pathways driving clarithromycin benefit in community-acquired pneumonia: analysis of the ACCESS randomised trial.
  EBioMedicine · 2026 · Stylianakis E, Kakavoulis N, Foutadakis S, et al.
  PMID 41934919DOI 10.1016/j.ebiom.2026.106240
• Polydopamine-mediated multi-stage delivery for precise local therapy of Helicobacter pylori-infected gastric ulcers.
  Journal of controlled release : official journal of the Controlled Release Society · 2026 · Kim H, Kwak D, Lee J, et al.
  PMID 41921837DOI 10.1016/j.jconrel.2026.114869
• [The application of genotypic resistance testing for clarithromycin and levofloxacin in different types of Helicobacter pylori infected patients based on gastric mucosal samples].
  Zhonghua nei ke za zhi · 2026 · Ma LL, Li CL, Zhang YX, et al.
  PMID 41834619DOI 10.3760/cma.j.cn112138-20250904-00521
• Clarithromycin-based therapy with adjunctive photobiomodulation and microwave treatment for cutaneous Mycobacterium marinum infection.
  Photodiagnosis and photodynamic therapy · 2026 · Su Y, Zhao W, Yang Y, et al.
  PMID 41812906DOI 10.1016/j.pdpdt.2026.105432
• Effects of Successful Versus Delayed/Failed Helicobacter pylori Eradication Therapy on Subsequent Fracture Risk: a Population-Based Cohort Study.
  Journal of gastroenterology and hepatology · 2026 · Tan JT, Mao X, Cheung CL, et al.
  PMID 41796978DOI 10.1111/jgh.70310
• Exosome-Based Detection of Helicobacter pylori Infection and Clarithromycin Resistance in Children.
  Helicobacter · 2026 · Song M, Zeng J, Yao Z, et al.
  PMID 41781337DOI 10.1111/hel.70113

The 10 most recently updated of 556 ClinicalTrials.gov registrations naming Clarithromycin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance
  Recruiting · Phase 4 · Interventional · 60 enrolled · National Taiwan University Hospital
  NCT07514364updated 2026-06-10
• Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Gastric Cancer
  Recruiting · Phase 2 · Interventional · 180 enrolled · Sixth Affiliated Hospital, Sun Yat-sen University
  NCT06510010updated 2026-06-10
• Study to Evaluate the Preliminary Efficacy of SKB264 and the Effect of Clarithromycin on the PK of SKB264 in OC
  Active not recruiting · Phase 2 · Interventional · 20 enrolled · Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
  NCT07341100updated 2026-06-01
• A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants
  Completed · Phase 1 · Interventional · 26 enrolled · Eli Lilly and Company
  NCT05469126updated 2026-05-27
• The Clinical Trail to Evaluate the Efficacy and Safety of Anaprazole Sodium Enteric-coated Tablets Combined With Bismuth-containing Quadruple Therapy in Eradicating Helicobacter Pylori
  Not yet recruiting · Phase 3 · Interventional · 556 enrolled · Xuanzhu Biopharmaceutical Co., Ltd.
  NCT07606833updated 2026-05-26
• A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab
  Active not recruiting · Phase 2 · Interventional · 11 enrolled · Weill Medical College of Cornell University
  NCT04302324updated 2026-05-20
• Enhanced Treatment Strategy for Disseminated MAC Infection in HIV Patients: A Randomized Controlled Trial
  Not yet recruiting · Interventional · 124 enrolled · Shanghai Public Health Clinical Center
  NCT07585461updated 2026-05-13
• Finding the Optimal Regimen for Mycobacterium Abscessus Treatment
  Recruiting · Phase 2 · Phase 3 · Interventional · 300 enrolled · The University of Queensland
  NCT04310930updated 2026-05-11
• Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
  Recruiting · Phase 3 · Interventional · 700 enrolled · Yale University
  NCT03907046updated 2026-05-08
• Effect of Triple Versus Quadruple Therapy for Treating Helicobacter Pylori Infection
  Enrolling by invitation · Interventional · 66 enrolled · Akil Al Islam
  NCT07010744updated 2026-05-07

Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

• ErythromycinMacrolide98%
• AzithromycinMacrolide Antimicrobial92%
• TacrolimusAgents for dermatitis, excluding corticosteroids77%

Frequently asked questions

How does Clarithromycin work?

Clarithromycin is a macrolide antimicrobial drug [see Microbiology ( 12.4 )] .

What is Clarithromycin used for?

According to FDA labeling, Clarithromycin carries indications including: Clarithromycin is a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults ( 1.1 ) Acute Maxillary Sinusitis ( 1.2 ) Community-Acquired Pneumonia ( 1.3 ) Pharyngitis/Tonsillitis ( 1.4 ) Uncomplicated Skin and Skin Structure Infections ( 1.5 ) Acute Otitis Media in Pediatric Patients ( 1.6 ) Treatment and Prophylaxis of Disseminated Mycobacterial Infections ( 1.7 ) Helicobacter pylori Infection and Duodenal Ulcer Disease in Adults ( 1.8 ) Limitations of Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Clarithromycin?

Clarithromycin is classified as Macrolides, Macrolide Antimicrobial, Cytochrome P450 3A Inhibitors, Cytochrome P450 3A4 Inhibitors, Hydroxymethylglutaryl-CoA Reductase Inhibitors, P-Glycoprotein Inhibitors, Protein Synthesis Inhibitors, Decreased Protein Synthesis.

What are the brand names for Clarithromycin?

Clarithromycin is marketed under brand names including Biaxin.

What are the contraindications for Clarithromycin?

Clarithromycin labeling lists contraindications including: Hypersensitivity to clarithromycin or any macrolide drug ( 4.1 ) Cisapride and pimozide ( 4.2 ) History of cholestatic jaundice/hepatic dysfunction with use of clarithromycin ( 4.3 ) Colchicine in renal or hepatic impairment ( 4.4 ) Lomitapide, lovastatin, and simvastatin ( 4.5 ) Ergot alkaloids (ergotamine or dihydroergotamine) ( 4.6 ) Lurasidone ( 4.7 ) 4.1 Hypersensitivity Clarithromycin tablets are contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibacterial drugs [see Warnings and Precautions ( 5.1 )] . 4.2 Cisapride and Pimozide Concomitant administration of clarithromycin tablets with cisapride and pimozide is contraindicated [see Drug Interactions ( 7 )] .. Always consult the full prescribing information and a clinician.