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Biaxin: Uses, Dosage & Safety Information

Biaxin

Biaxin
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Biaxin

Clarithromycin
Biaxin is a brand name for the prescription antibiotic clarithromycin. It is a macrolide-class antibiotic used to treat various bacterial infections, including those affecting the respiratory tract and skin. It is also used in combination therapy for Helicobacter pylori eradication.
  • ActiveIngredient: Clarithromycin
  • DosageForm: Tablet; extended-release tablet; oral suspension
  • Dosage: 250 mg, 500 mg (tablets); 500 mg (extended-release tablets); 125 mg/5 mL, 250 mg/5 mL (oral suspension)
  • Indications: Bronchitis exacerbation, maxillary sinusitis, community-acquired pneumonia, pharyngitis and tonsillitis, uncomplicated skin infections, acute otitis media in children, disseminated mycobacterial infection, H. pylori with duodenal ulcer
  • Manufacturer: Generic: PD-Rx, Rising Pharma and others. Brand Biaxin discontinued
  • Storage: Store as directed on the dispensed container; keep out of reach of children
  • Drug Status: Discontinued
Drug Status: Discontinued
Description

What is Biaxin?

A risk that appears after the course ends
In people with coronary artery disease, clarithromycin has been linked to higher all-cause mortality a year or more after treatment. The labelling asks prescribers to weigh this against the benefit before choosing it for such patients.1

Biaxin was the original brand of clarithromycin, a prescription macrolide antibacterial. The brand is no longer marketed; clarithromycin is supplied as generic tablets, extended-release tablets and oral suspension.24

Clarithromycin strongly inhibits the liver enzyme CYP3A, so it raises the levels of many drugs cleared by that enzyme. For several of them, including two statins, ergot alkaloids and lurasidone, the combination is contraindicated rather than merely cautioned.1

It treats respiratory, throat and skin infections, mycobacterial infections and, in combination regimens, Helicobacter pylori with duodenal ulcer disease.

General Instructions

How to Take Biaxin

Every 12 hours, with or without food

Clarithromycin tablets can be taken with or without food, at evenly spaced times.1

How much

Adults usually take 250 mg or 500 mg every 12 hours for 7 to 14 days. For H. pylori, 500 mg is given every 8 or 12 hours for 10 to 14 days with other medicines. Children take 15 mg per kg a day in two doses for 10 days, and mycobacterial infections are treated with 500 mg every 12 hours in adults.1

Before the first dose

Bring your full medicine list, because many common drugs interact.

Storage

Store at 20° to 25°C (68° to 77°F).1

Before you start

Tell your prescriber about every medicine you take and whether any of these apply to you: macrolide hypersensitivity; cisapride and pimozide; lomitapide, lovastatin and simvastatin; ergot alkaloids; lurasidone. Each is a reason the labelling rules out Biaxin; the details are under Critical Warnings.

What not to do

Do not stop early when symptoms improve, and do not start any new medicine during the course without checking.

Side Effects

What Are the Side Effects of Biaxin?

Across indications, the most frequent reactions in adults and children were abdominal pain, diarrhoea, nausea, vomiting and an altered sense of taste.1

Reactions in the Labelling
FrequencyEffectNotes
Most frequent in trialsAbdominal pain, diarrhoea, nausea, vomitingAdults and children
Most frequent in trialsAltered or metallic taste (dysgeusia)Adults and children
Frequency not stated in labellingIrregular heartbeat from QT prolongationSerious
Frequency not stated in labellingLiver injurySerious; sometimes fatal

Source: 1

Seek immediate medical attention if:
  • Fast or irregular heartbeat, or fainting
  • Yellowing of the skin or eyes, or dark urine
  • Swelling of the face or throat, or a blistering rash
  • Severe or bloody diarrhoea
Uses

What is Biaxin Used For?

Eight licensed indications, all for mild to moderate infections caused by designated susceptible bacteria.

  • Acute bacterial exacerbation of chronic bronchitis, in adults
  • Acute maxillary sinusitis
  • Community-acquired pneumonia
  • Pharyngitis and tonsillitis
  • Uncomplicated skin and skin structure infections
  • Acute otitis media, in children
  • Disseminated mycobacterial infection — both treatment and prevention
  • Helicobacter pylori infection with duodenal ulcer disease, in adults

The label carries the standard stewardship limitation: use it only where infection is proven or strongly suspected to be bacterial, to limit resistance.

Safety Advice

Interactions Alcohol:

Consult your doctor
The label sets no alcohol restriction for clarithromycin. The practical question is usually the infection being treated and the other medicines involved, which is a conversation with the prescriber rather than a rule about the drink.

Interactions Other Medications:

Unsafe
This is the drug’s defining risk. Cisapride, pimozide, lurasidone, lomitapide, lovastatin, simvastatin and ergot alkaloids are contraindicated outright, and colchicine is contraindicated where kidney or liver function is impaired. Clarithromycin inhibits CYP3A, so concentrations of drugs cleared by that enzyme rise.

Special Groups Pregnancy:

Unsafe
Based on animal findings, clarithromycin is not recommended in pregnancy except where no alternative therapy is appropriate. If pregnancy occurs during treatment, the label directs that the patient be told of the potential hazard to the fetus.

Special Groups Breastfeeding:

Consult your doctor
The prescribing information does not establish a breastfeeding recommendation. With a course of a week or two, timing and monitoring are decided with the prescriber.

Special Groups Elderly:

Use with caution
Age brings more co-prescribed medicines and more cardiac risk, and both matter here: QT prolongation is avoided in patients already at risk, and the interaction list is long. Renal function also affects the colchicine contraindication.

Special Groups Children:

Safe if prescribed
Safety and effectiveness are established from six months of age for the licensed paediatric indications, dosed at 15 mg/kg per day divided every 12 hours for 10 days.

Effects on Activities Driving:

Use with caution
Nausea, malaise and headache are among the most frequent reactions. More important is what QT prolongation can do: fainting or palpitations while driving is the scenario worth avoiding, and either means stopping to get checked.

Effects on Activities Operating Machinery:

Use with caution
The same reasoning applies. Malaise and dizziness are common enough that tasks punishing a lapse in attention are better deferred until the course is finished.
Concerns

The Biaxin brand is no longer the route of supply; clarithromycin reaches patients as a generic tablet, extended-release tablet or suspension from several manufacturers.2 The one branded product still containing it is Voquezna Triple Pak, a combination pack for H. pylori.

The practical concern is the medicine list rather than the antibiotic: seven contraindicated combinations mean a pharmacy check before the first dose matters more here than with most antibacterials.

Warnings

Critical Warnings for Biaxin Use

Macrolide hypersensitivity

Contraindicated: Hypersensitivity to clarithromycin or any macrolide.1

Cisapride and pimozide

Contraindicated: Concomitant cisapride or pimozide.1

Previous clarithromycin-related liver injury

Contraindicated: History of cholestatic jaundice or hepatic dysfunction with clarithromycin.1

Colchicine in kidney or liver impairment

Contraindicated: Colchicine in people with renal or hepatic impairment.1

Lomitapide, lovastatin and simvastatin

Contraindicated: Concomitant lomitapide, lovastatin or simvastatin.1

Ergot alkaloids

Contraindicated: Ergotamine or dihydroergotamine.1

Lurasidone

Contraindicated: Concomitant lurasidone.1

QT prolongation

Clarithromycin has been associated with QT prolongation and rare torsade de pointes.1

See Interactions.

Dosage

Dosage

Clarithromycin Products
FormulationActive IngredientsClinical Note
Tablets 250 mg, 500 mgClarithromycinFilm-coated; generic
Extended-release tablets and oral suspensionClarithromycinSeparate labelling
Severe renal impairment (creatinine clearance below 30 mL/min)ClarithromycinReduce the dose by 50%
Moderate renal impairment with atazanavir or ritonavirClarithromycinReduce the dose by 50%; further reduction in severe impairment
Hepatic impairmentClarithromycinNo separate adjustment stated; colchicine is contraindicated with clarithromycin in liver or kidney impairment

Source: 1

Exceeding the dose
Overdose mainly causes stomach pain, vomiting, nausea and diarrhoea; treatment removes unabsorbed drug and is supportive. Seek medical help.1
Interactions

What Does Biaxin Interact With?

Clarithromycin inhibits CYP3A. Anything cleared by that enzyme can accumulate, and for several drugs the label does not offer a dose adjustment — it forbids the combination.1

Significant Interactions
Interacting SubstanceEffect and RiskSeverityDocumentation
Cisapride, pimozide, lurasidoneRaised concentrations; contraindicated outrightContraindicatedExcellent
Lovastatin, simvastatinRaised statin exposure with risk of myopathy and rhabdomyolysis; contraindicatedContraindicatedExcellent
Ergotamine, dihydroergotamineAcute ergot toxicity; contraindicatedContraindicatedExcellent
LomitapideContraindicatedContraindicatedExcellent
Colchicine, in renal or hepatic impairmentColchicine toxicity; contraindicated in that settingContraindicatedExcellent
Carbamazepine and other narrow-margin CYP3A substratesElevated concentrations; used with caution and dose adjustmentMajorExcellent
QT-prolonging drugs, Class IA and III antiarrhythmicsAdditive QT prolongationMajorExcellent
Some calcium channel blockersSerious reactions reported with the combinationMajorGood

Source:

▶Clinical detailstechnical detail

Clarithromycin is both a substrate and a mechanism-based inhibitor of CYP3A4. Inhibition is not competitive and reversible in the usual sense: a reactive metabolite forms a complex with the enzyme, so activity recovers only as new enzyme is synthesised. That is why interaction effects can persist after the antibiotic is stopped.

The consequence is dose-independent in practice. For a substrate with a narrow therapeutic margin — colchicine, some statins, ergot alkaloids — the resulting rise in exposure can be several-fold, which is why the label contraindicates the combination rather than suggesting a reduced dose.

FAQs
Dysgeusia — altered or metallic taste — is among the most frequently reported reactions in trials, and it is one of the commonest reasons people ask about this drug. It reflects the medicine rather than the infection, and it fades once the course ends. Taking the dose with food does not remove it but often makes it easier to tolerate.
Cisapride, pimozide, lurasidone, lomitapide, lovastatin, simvastatin and ergot alkaloids are contraindicated outright, and colchicine is contraindicated where kidney or liver function is impaired. Clarithromycin inhibits CYP3A, so it raises concentrations of drugs cleared by that enzyme. This is a check to make before the first dose, not after.
Not as a brand. The name persists in conversation, but supply is generic clarithromycin from several manufacturers, as immediate-release tablets, extended-release tablets and oral suspension. The only branded product still containing it is Voquezna Triple Pak, used for Helicobacter pylori eradication.
In people with coronary artery disease it has been linked to higher all-cause mortality a year or more later, so prescribers weigh that risk before using it.
Yes. It can prolong the QT interval, and rare cases of torsade de pointes have been reported.
Evidence and Reported Data

Evidence scope

What we know
  • Eight indications with defined regimens; paediatric use established from six months of age.
  • Seven contraindicated drug combinations are named specifically, not left to judgement.
  • The mechanism behind them is understood: CYP3A inhibition raising concentrations of co-administered drugs.
What remains uncertain
  • Why all-cause mortality rose a year or more after treatment in coronary artery disease is not explained by the label; the finding is stated, not accounted for.
  • Human pregnancy data are limited; the recommendation against use rests on animal findings.
  • How often QT prolongation becomes clinically significant is not quantified.

Source: 1

What has been reported to the FDA

As of the FAERS data cut of 30 July 2026, the FDA Adverse Event Reporting System held 37,384 reports naming clarithromycin, of which 33,968 were classed as serious — 91% of the total. A further 5,801 reports name the brand Biaxin.3

Most Reported Terms
Coded termReports
Drug interaction3,226
Drug ineffective2,694
Nausea2,521
Dyspnoea2,229
Diarrhoea2,205
Malaise1,853
How to read this table

FAERS records what was reported, not what the medicine caused, and has no denominator – no count can become a rate.

Figures above are the counts held at the 30 July 2026 data cut, retrieved on 2 September 2026; they do not update between cuts.

Population note: the most frequent term is not a symptom at all — “drug interaction” heads the list, which matches a CYP3A inhibitor with seven contraindicated combinations. The 91% serious proportion is high partly because interaction reports are serious by definition when they involve hospitalisation. Reports name the product, not the culprit.

Who was this medicine studied in?

Adult and paediatric trials underpin the licensed indications, with paediatric safety and effectiveness established from six months of age.1 No Drug Trials Snapshot exists: clarithromycin was approved long before that programme began, and current supply is generic.25

Who this is and is not appropriate for

It is not appropriate for anyone hypersensitive to any macrolide, anyone with previous cholestatic jaundice or hepatic dysfunction on clarithromycin, or anyone taking cisapride, pimozide, lurasidone, lomitapide, lovastatin, simvastatin or an ergot alkaloid. Colchicine is contraindicated where kidney or liver function is impaired.1

In coronary artery disease it may still be appropriate, but the label asks for an explicit weighing of the long-term mortality signal against the benefit — a conversation worth having before the prescription rather than after.

Where to report and verify

Routing to Official Registries
What you needWhere to go
Report a side effectFDA MedWatch
Pregnancy-specific dataMotherToBaby
Full prescribing informationDailyMed
Verify a pharmacy websiteFDA BeSafeRx · LegitScript
References

References

  1. FDA Prescribing Information, clarithromycin tablets USP (ANDA 065136) — Indications and Usage, Dosage and Administration 2.1–2.6, Dosage Forms and Strengths, Contraindications 4.1–4.7, Warnings and Precautions 5.1–5.8, Adverse Reactions 6.1, Drug Interactions 7, Overdosage
    Label effective 2025-10-15 · Accessed 2026-09-28
    Used for: indications, dosing, renal table, contraindications, warnings, reactions, interactions.
    dailymed.nlm.nih.gov — DailyMed
  2. Drugs@FDA — clarithromycin applications, including Biaxin
    Records · Accessed 2026-09-28
    Used for: brand status and current supply.
    accessdata.fda.gov — Drugs@FDA
  3. openFDA — FDA Adverse Event Reporting System, drug event query for clarithromycin
    Data cut 2026-07-30 · Accessed 2026-09-28
    Used for: report totals, serious counts and most reported terms.
    open.fda.gov — openFDA
  4. FDA Orange Book — clarithromycin
    Current edition · Accessed 2026-09-28
    Used for: reference-standard and generic availability.
    accessdata.fda.gov — Orange Book
  5. FDA — Drug Trials Snapshots programme scope
    Programme current · Accessed 2026-09-28
    Used for: confirmation that Snapshots cover novel drugs approved from 2015.
    fda.gov — Drug Trials Snapshots

Review cycle. Clinical review completed 28 September 2026. Next review due by 28 September 2027, or earlier if the labelling is revised.

Disclaimer

Disclaimer: The information on this site is provided for informational purposes only and is not medical advice. It does not replace professional medical consultation, diagnosis, or treatment. Do not self-medicate based on the information presented on this site. Always consult with a doctor or other qualified healthcare professional before making any decisions about your health.