Prescription medicine
Clarithromycin First approved as Biaxin
Clarithromycin (Biaxin) is a prescription medicine with an FDA approval on record since 1991. FDA's NDC Directory lists it from 26 generic labelers, and pharmacies paid $0.466 per clarithromycin 500 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the clarithromycin FDA label on DailyMed (effective April 9, 2026, Solaris Pharma Corporation); the NDA 50662 record on Drugs@FDA; every clarithromycin label on DailyMed.
Highlights of the record
FDA label of April 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageClarithromycin 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) Treatme
Forms and strengths
- 250 mg
- 500 mg
- 125 mg/5ml
- 250 mg/5ml
Film-coated tablet; tablet; film-coated extended-release tablet; for suspension.
On the market
- Earliest approval on file
- October 31, 1991 Biaxin, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 23 first May 25, 2004; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 26 of which 26 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.466 per tablet Clarithromycin 500 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2015 0 Class I among all firms' recalls; latest June 1, 2015
- FAERS reports
- 34,134 through July 30, 2026
What is clarithromycin used for?
From the label: indications and usageClarithromycin 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 and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. […]
Conditions named in the indications of clarithromycin's FDA labels, with every medicine labeled for each:
From other clarithromycin labelsAcid reflux and ulcers: The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.3) ].
FDA pharmacologic class: Macrolide Antimicrobial.
Source: FDA drug label (Clarithromycin), Solaris Pharma Corporation, effective April 9, 2026 (SPL set 4d42821d-ce7a-7d64-e063-6294a90a0875), via openFDA; the full label on DailyMed
Is there a generic for clarithromycin (Biaxin)?
The FDA approved the first generic clarithromycin on May 25, 2004. 23 generic applications are approved; 12 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists clarithromycin from 26 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1991 earliest approval on file
- 2004 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for clarithromycin (Biaxin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.466 per Clarithromycin 500 mg tablet, up 6% from $0.439 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Clarithromycin 500 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Clarithromycin 125 mg/5 mL sus | Generic | $0.939 per mL | n/a | -2% |
| Clarithromycin 250 mg tablet | Generic | $0.394 per tablet | $11.82 | -23% |
| Clarithromycin 250 mg/5 mL sus | Generic | $1.46 per mL | n/a | -5% |
| Clarithromycin 500 mg tablet | Generic | $0.466 per tablet | $13.97 | +6% |
| Clarithromycin ER 500 mg tablet | Generic | $1.92 per tablet | $57.55 | -48% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has clarithromycin been recalled?
The FDA's Enforcement Report lists 3 recalls naming clarithromycin since 2015: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 1, 2015 | Class II | American Health Packaging | CGMP Deviations: Firm did not adequately investigate customer complaints. |
| May 22, 2015 | Class II | Blenheim Pharmacal, Inc. | cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted … |
| April 22, 2015 | Class II | Wockhardt Usa Inc. | CGMP Deviations: Firm did not adequately investigate customer complaints. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the clarithromycin label say about other medicines?
The clarithromycin label names 59 other medicines in its interaction, contraindication or warning sections. The labels of 42 other medicines name clarithromycin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Alprazolam | drug interactions | Alprazolam Triazolam Triazolam, Alprazolam: Caution and appropriate dose adjustments should be considered when triazolam or alprazolam is co-administered with clarithromycin. |
| Amiodarone | drug interactions | Disopyramide Quinidine Dofetilide Amiodarone Sotalol Procainamide Not Recommended Disopyramide, Quinidine: |
| Amlodipine | drug interactions | Amlodipine Diltiazem Amlodipine, Diltiazem: [See Warnings and Precautions (5.4) ] |
| Atazanavir | drug interactions | Atazanavir; Use With Caution; Atazanavir: Both clarithromycin and atazanavir are substrates and inhibitors of CYP3A, and there is evidence of a bi-directional drug interaction (see in the table below) [see Pharmacokinetics ]. |
| Atorvastatin | drug interactions | … thereby increasing the risk of toxicities from these drugs [See Contraindications and Warnings and Precautions ] Atorvastatin, Pravastatin, Fluvastatin: [See Warnings and Precautions ] |
| Bromocriptine | drug interactions | Other Drugs Metabolized by CYP3A: Alfentanil Bromocriptine Cilostazol Methylprednisole Vinblastine Phenobarbital St. John’s Wort Use With Caution There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with alfentanil, methylprednisolone, cilostazol, bromocriptine, vinblastine … |
| Carbamazepine | drug interactions | Carbamazepine; Use With Caution; Carbamazepine: Concomitant administration of single doses of clarithromycin and carbamazepine has been shown to result in increased plasma concentrations of carbamazepine. Blood level monitoring of carbamazepine may be considered. … |
| Cilostazol | drug interactions | Other Drugs Metabolized by CYP3A: Alfentanil Bromocriptine Cilostazol Methylprednisole Vinblastine Phenobarbital St. John’s Wort Use With Caution There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with alfentanil, methylprednisolone, cilostazol, bromocriptine, vinblastine … |
| Colchicine | contraindications | CONTRAINDICATIONS 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 … |
| Cyclosporine | drug interactions | Cyclosporine Use With Caution Cyclosporine: There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with cyclosporine. |
| Digoxin | drug interactions | Digoxin Use With Caution Digoxin: Digoxin is a substrate for P-glycoprotein (Pgp) and clarithromycin is known to inhibit Pgp. |
| Dihydroergotamine | contraindications | … renal or hepatic impairment (4.4) Lomitapide, lovastatin, and simvastatin (4.5) Ergot alkaloids (ergotamine or dihydroergotamine) (4.6) Lurasidone |
| Diltiazem | drug interactions | Amlodipine Diltiazem Amlodipine, Diltiazem: [See Warnings and Precautions (5.4) ] |
| Disopyramide | drug interactions | Disopyramide Quinidine Dofetilide Amiodarone Sotalol Procainamide Not Recommended Disopyramide, Quinidine: |
Every other medicine the clarithromycin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Dofetilide | drug interactions | Disopyramide Quinidine Dofetilide Amiodarone Sotalol Procainamide Not Recommended Disopyramide, Quinidine: |
| Efavirenz | drug interactions | Efavirenz Nevirapine Rifampicin Rifabutin Rifapentine; Use With Caution; Inducers of CYP3A enzymes, such as efavirenz, nevirapine, rifampicin, rifabutin, and rifapentine will increase the metabolism … |
| Ergotamine | contraindications | … (4.4) Lomitapide, lovastatin, and simvastatin (4.5) Ergot alkaloids (ergotamine or dihydroergotamine) (4.6) Lurasidone |
| Erythromycin | contraindications | Clarithromycin is contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibacterial drugs [see Warnings and Precautions (5.1) ]. |
| Etravirine | drug interactions | Etravirine Etravirine: Clarithromycin exposure was decreased by etravirine; however, concentrations of the active metabolite, 14-OH-clarithromycin, were increased. |
| Fluconazole | drug interactions | Fluconazole No Dose Adjustment Fluconazole: [see Pharmacokinetics (12.3) ] |
| Fluvastatin | drug interactions | … Contraindications and Warnings and Precautions ] Atorvastatin, Pravastatin, Fluvastatin: [See Warnings and Precautions ] |
| Itraconazole | drug interactions | Itraconazole; Use With Caution; Itraconazole: Both clarithromycin and itraconazole are substrates and inhibitors of CYP3A, potentially leading to a bi-directional drug interaction when administered … |
| Lomitapide | contraindications | … 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 |
| Lorazepam | drug interactions | Temazepam Nitrazepam Lorazepam; No Dose Adjustment; Temazepam, Nitrazepam, Lorazepam: For benzodiazepines which are not metabolized by CYP3A (e.g., temazepam, nitrazepam, lorazepam), a clinically … |
| Lovastatin | contraindications | … (4.3) Colchicine in renal or hepatic impairment (4.4) Lomitapide, lovastatin, and simvastatin (4.5) Ergot alkaloids (ergotamine or dihydroergotamine) (4.6) Lurasidone |
| Lurasidone | contraindications | … simvastatin (4.5) Ergot alkaloids (ergotamine or dihydroergotamine) (4.6) Lurasidone |
| Maraviroc | drug interactions | Maraviroc Maraviroc: Clarithromycin may result in increases in maraviroc exposures by inhibition of CYP3A metabolism. |
| Methylprednisolone | drug interactions | … reports of CYP3A based interactions of clarithromycin with alfentanil, methylprednisolone, cilostazol, bromocriptine, vinblastine, phenobarbital, and St. John’s Wort. |
| Midazolam | drug interactions | Midazolam; Use With Caution; Midazolam: When oral midazolam is co-administered with clarithromycin, dose adjustments may be necessary and possible prolongation and intensity of effect should be … |
| Nateglinide | drug interactions | Nateglinide Pioglitazone Repaglinide Rosiglitazone; Use With Caution; Nateglinide, Pioglitazone, Repaglinide, Rosiglitazone: [See Warnings and Precautions and Adverse Reactions ] |
| Nevirapine | drug interactions | Efavirenz Nevirapine Rifampicin Rifabutin Rifapentine; Use With Caution; Inducers of CYP3A enzymes, such as efavirenz, nevirapine, rifampicin, rifabutin, and rifapentine will increase the metabolism … |
| Nifedipine | drug interactions | Hypotension and peripheral edema were observed when clarithromycin was taken concomitantly with nifedipine [see Warnings and Precautions (5.4) ]. |
| Omeprazole | drug interactions | Omeprazole; No Dose Adjustment; Omeprazole: The mean 24-hour gastric pH value was 5.2 when omeprazole was administered alone and 5.7 when coadministered with clarithromycin as a result of increased … |
| Phenobarbital | drug interactions | Other Drugs Metabolized by CYP3A: Alfentanil Bromocriptine Cilostazol Methylprednisole Vinblastine Phenobarbital St. John’s Wort Use With Caution There have been spontaneous or published reports of … |
| Phenytoin | drug interactions | Hexobarbital Phenytoin Valproate; Use With Caution; There have been postmarketing reports of interactions of clarithromycin with drugs not thought to be metabolized by CYP3A, including hexobarbital … |
| Pimozide | contraindications | CONTRAINDICATIONS 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) … |
| Pioglitazone | drug interactions | Nateglinide Pioglitazone Repaglinide Rosiglitazone; Use With Caution; Nateglinide, Pioglitazone, Repaglinide, Rosiglitazone: [See Warnings and Precautions and Adverse Reactions ] |
| Pravastatin | drug interactions | … [See Contraindications and Warnings and Precautions ] Atorvastatin, Pravastatin, Fluvastatin: [See Warnings and Precautions ] |
| Procainamide | drug interactions | Disopyramide Quinidine Dofetilide Amiodarone Sotalol Procainamide Not Recommended Disopyramide, Quinidine: |
| Quetiapine | drug interactions | Pimozide Contraindicated Pimozide: [See Contraindications (4.2) ] Quetiapine Quetiapine: Quetiapine is a substrate for CYP3A4, which is inhibited by clarithromycin. |
| Quinidine | drug interactions | Disopyramide Quinidine Dofetilide Amiodarone Sotalol Procainamide Not Recommended Disopyramide, Quinidine: |
| Repaglinide | drug interactions | Nateglinide Pioglitazone Repaglinide Rosiglitazone; Use With Caution; Nateglinide, Pioglitazone, Repaglinide, Rosiglitazone: [See Warnings and Precautions and Adverse Reactions ] |
| Rifabutin | drug interactions | Rifabutin; Use With Caution; Rifabutin: Concomitant administration of rifabutin and clarithromycin resulted in an increase in rifabutin, and decrease in clarithromycin serum levels together with an … |
| Rifapentine | drug interactions | Efavirenz Nevirapine Rifampicin Rifabutin Rifapentine; Use With Caution; Inducers of CYP3A enzymes, such as efavirenz, nevirapine, rifampicin, rifabutin, and rifapentine will increase the metabolism … |
| Ritonavir | drug interactions | Ritonavir Etravirine; Ritonavir, Etravirine: (see in the table below) [see Pharmacokinetics ]. |
| Sildenafil | drug interactions | Phosphodiesterase inhibitors: Sildenafil Tadalafil Vardenafil Use With Caution Sildenafil, Tadalafil, Vardenafil: |
| Simvastatin | contraindications | … Colchicine in renal or hepatic impairment (4.4) Lomitapide, lovastatin, and simvastatin (4.5) Ergot alkaloids (ergotamine or dihydroergotamine) (4.6) Lurasidone |
| Sotalol | drug interactions | Disopyramide Quinidine Dofetilide Amiodarone Sotalol Procainamide Not Recommended Disopyramide, Quinidine: |
| Tacrolimus | drug interactions | Tacrolimus Tacrolimus: There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with tacrolimus. |
| Tadalafil | drug interactions | Phosphodiesterase inhibitors: Sildenafil Tadalafil Vardenafil Use With Caution Sildenafil, Tadalafil, Vardenafil: |
| Temazepam | drug interactions | Temazepam Nitrazepam Lorazepam; No Dose Adjustment; Temazepam, Nitrazepam, Lorazepam: For benzodiazepines which are not metabolized by CYP3A (e.g., temazepam, nitrazepam, lorazepam), a clinically … |
| Theophylline | drug interactions | Theophylline; Use With Caution; Theophylline: Clarithromycin use in patients who are receiving theophylline may be associated with an increase of serum theophylline concentrations [see … |
| Tolterodine | drug interactions | Lurasidone Lurasidone: [See Contraindications (4.7) ] Antispasmodics: Tolterodine (patients deficient in CYP2D6 activity) Use With Caution Tolterodine: |
| Triazolam | drug interactions | Alprazolam Triazolam Triazolam, Alprazolam: Caution and appropriate dose adjustments should be considered when triazolam or alprazolam is co-administered with clarithromycin. |
| Vardenafil | drug interactions | Phosphodiesterase inhibitors: Sildenafil Tadalafil Vardenafil Use With Caution Sildenafil, Tadalafil, Vardenafil: |
| Verapamil | drug interactions | Verapamil; Use With Caution; Verapamil: Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent verapamil, [see Warnings and Precautions ]. |
| Vinblastine | drug interactions | Other Drugs Metabolized by CYP3A: Alfentanil Bromocriptine Cilostazol Methylprednisole Vinblastine Phenobarbital St. John’s Wort Use With Caution There have been spontaneous or published reports of … |
| Warfarin | drug interactions | Warfarin; Use With Caution; Oral anticoagulants: Spontaneous reports in the postmarketing period suggest that concomitant administration of clarithromycin and oral anticoagulants may potentiate the … |
| Zidovudine | drug interactions | Zidovudine; Zidovudine: Simultaneous oral administration of clarithromycin immediate-release tablets and zidovudine to HIV-infected adult patients may result in decreased steady-state zidovudine … |
Other labels that name clarithromycin
- Alosetron
- Anagrelide
- Aripiprazole
- Aripiprazole lauroxil
- Avanafil
- Brincidofovir
- Budesonide
- Cabazitaxel
- Cabozantinib
- Calcifediol
- Cobicistat
- Dabigatran
- Darifenacin
- Deflazacort
- Dexamethasone
- Doxazosin
- Dronabinol
- Dronedarone
- Drospirenone and ethinyl estradiol
- Drospirenone and ethinyl estradiol and levomefolate
- Erlotinib
- Esomeprazole
- Estradiol
- Estrogens conjugated
- Everolimus
- Fesoterodine
- Fluticasone
- Glimepiride
- Glyburide
- Hydrocortisone
- Irinotecan
- Ivacaftor
- Lansoprazole
- Lemborexant
- Levomilnacipran
- Mifepristone
- Mometasone
- Naldemedine
- Naloxegol
- Nimodipine
- Nirmatrelvir and ritonavir
- Osilodrostat
- Paclitaxel
- Palbociclib
- Paricalcitol
- Rabeprazole
- Ranolazine
- Rilpivirine
- Rivaroxaban
- Salmeterol
- Saxagliptin
- Silodosin
- Sirolimus
- Suvorexant
- Talazoparib
- Temsirolimus
- Thiotepa
- Ticagrelor
- Trabectedin
- Trastuzumab emtansine
- Trazodone
- Ubrogepant
- Umeclidinium and vilanterol
- Upadacitinib
- Vandetanib
- Vilazodone
- Voclosporin
- Vonoprazan
Source: FDA drug label (Clarithromycin), Solaris Pharma Corporation, effective April 9, 2026 (SPL set 4d42821d-ce7a-7d64-e063-6294a90a0875), via openFDA; the full label on DailyMed
What do FAERS reports show for clarithromycin?
The FDA Adverse Event Reporting System holds 34,134 reports that list clarithromycin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,961 are coded as a death and 13,494 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as clarithromycin?
23 other medicines are given the same way (oral) and in the same FDA class as clarithromycin or labeled mainly for the same use (bacterial infections), the same class first. Bacterial infections lists all 51 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Azithromycin | Bacterial infections | 47 labelers | $0.266 per tablet 250 mg tablet | A presentation being discontinued |
| Erythromycin | Bacterial infections | 22 labelers | $1.96 per tablet 250 mg tablet | No current entry |
| Amoxicillin | Acid reflux and ulcers, Bacterial infections | 38 labelers | $0.0788 per capsule 500 mg capsule | No current entry |
| Cephalexin | Bacterial infections | 36 labelers | $0.120 per capsule 500 mg capsule | No current entry |
| Metronidazole | Bacterial infections | 40 labelers | $0.102 per tablet 250 mg tablet | In shortage |
| Clindamycin | Bacterial infections | 40 labelers | $0.103 per capsule 150 mg capsule | In shortage |
| Sulfamethoxazole and trimethoprim | Bacterial infections | 42 labelers | $0.0448 per tablet Sulfamethoxazole-tmp ds tablet | No current entry |
| Levofloxacin | Bacterial infections | 35 labelers | $0.259 per tablet 750 mg tablet | No current entry |
Every medicine labeled for the same conditions as clarithromycin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does clarithromycin compare with medicines for the same use?
15 side-by-side pages set clarithromycin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to clarithromycin
- 23 medicines for the same use
- Other macrolides
- the pharmacologic class, with prices and generics
- Clarithromycin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other