Clarithromycin

Take clarithromycin exactly as directed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Clarithromycin comes as a tablet, an extended-release (long-acting) tablet, and a suspension (liquid) to take by mouth.

• The regular tablet and liquid are usually taken with or without food twice daily (every 12 hours), with a full glass of water.
• The extended-release tablet is usually taken with food once daily, swallowed whole. Do not chew, crush or split them.
• Take clarithromycin at around the same time(s) every day.
• Clarithromycin is usually taken for 7 to 14 days. Your doctor may tell you to take clarithromycin for a longer time depending on your condition.  
• Do not take more or less of it or take it more often than prescribed by your doctor.
• Shake the suspension well before each use to mix the medication evenly.

After the first few days of treatment, you should begin to feel better. Take clarithromycin until you finish the prescription, even if you feel better. If you stop taking clarithromycin too soon, or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

You should not use this medicine if you have a life-threatening heart rhythm disorder, a history of Long QT syndrome, low levels of potassium in your blood, if you have ever had jaundice or liver problems caused by taking clarithromycin, or if you have liver or kidney disease and are also taking colchicine.

Many other drugs can interact with clarithromycin. There are certain medicines that can cause life-threatening drug interactions with clarithromycin, Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

In the U.S.

• Biaxin
• Biaxin Filmtab
• Biaxin XL

Available Dosage Forms:

• Tablet
• Powder for Suspension
• Tablet, Extended Release

Therapeutic Class: Antibiotic

Chemical Class: Macrolide

It is very important that your doctor check the progress of you or your child at regular visits to make sure clarithromycin is working properly. Blood and urine tests may be needed to check for unwanted effects.

Do not use clarithromycin if you or your child are also using astemizole (Hismanal®), cisapride (Propulsid®), lovastatin (Mevacor®), pimozide (Orap®), simvastatin (Zocor®), terfenadine (Seldane®), or certain ergot medicines (eg, dihydroergotamine, ergotamine, D.H.E. 45®, Ergomar®, Ergostat®, or Migranal®). If you have kidney or liver disease, do not take clarithromycin together with colchicine (Colcrys®). Using these medicines together may increase the risk for more serious side effects.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Make sure your doctor knows if you are pregnant or planning to become pregnant. If you become pregnant while using clarithromycin, tell your doctor right away.

clarithromycin may cause serious allergic reactions, including anaphylaxis. This can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you or your child are using clarithromycin.

Serious skin reactions can occur with clarithromycin. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you or your child are using clarithromycin.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem, such as QT prolongation.

Clarithromycin may increase the risk for heart and blood vessel problems in patients with these conditions. It may occur a year or 10 years after the use of clarithromycin. Talk to your doctor if you have concerns about this risk.

clarithromycin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you or your child stop taking clarithromycin. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Make sure any doctor or dentist who treats you knows that you or your child are using clarithromycin. clarithromycin may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Important Administration Instructions

Clarithromycin Tablets, USP and Clarithromycin for Oral Suspension, USP may be given with or without food.

Clarithromycin Extended-Release Tablets should be taken with food. Swallow Clarithromycin Extended-Release Tablets whole; do not chew, break or crush Clarithromycin Extended-Release Tablets.

Adult Dosage

The recommended dosages of Clarithromycin Tablets, USP and Clarithromycin Extended-Release Tablets for the treatment of mild to moderate infections in adults are listed in Table 1.

Combination Dosing Regimens for H. pylori Infection

• Triple therapy: Clarithromycin Tablets, USP/lansoprazole/amoxicillin

  The recommended adult dosage is 500 mg Clarithromycin Tablets, USP, 30 mg lansoprazole, and 1 gram amoxicillin, all given every 12 hours for 10 or 14 days [see Indications and Usage (1.8) and Clinical Studies (14.3)].

• Triple therapy: Clarithromycin Tablets, USP/omeprazole/amoxicillin

  The recommended adult dosage is 500 mg Clarithromycin Tablets, USP, 20 mg omeprazole, and 1 gram amoxicillin; all given every 12 hours for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief [see Indications and Usage (1.8)and Clinical Studies (14.3)].

• Dual therapy: Clarithromycin Tablets, USP/omeprazole

  The recommended adult dosage is 500 mg Clarithromycin Tablets, USP given every 8 hours and 40 mg omeprazole given once every morning for 14 days. An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief [see Indications and Usage (1.8) andClinical Studies (14.3)].

Pediatric Dosage

The recommended daily dosage is 15 mg/kg/day divided every 12 hours for 10 days (up to the adult dose). Refer to dosage regimens for mycobacterial infections in pediatric patients for additional dosage information [see Dosage and Administration (2.5)].

Dosage Regimens for Mycobacterial Infections

For the treatment of disseminated infection due to Mycobacterium avium complex (MAC), Clarithromycin Tablets, USP and Clarithromycin for Oral Suspension, USP are recommended as the primary agents. Clarithromycin Tablets, USP and Clarithromycin for Oral Suspension, USP should be used in combination with other antimycobacterial drugs (e.g. ethambutol) that have shown in vitro activity against MAC or clinical benefit in MAC treatment [see Clinical Studies (14.1)].

Adult Patients

For treatment and prophylaxis of mycobacterial infections in adults, the recommended dose of Clarithromycin is 500 mg every 12 hours.

Pediatric Patients

For treatment and prophylaxis of mycobacterial infections in pediatric patients, the recommended dose is 7.5 mg/kg every 12 hours up to 500 mg every 12 hours. [See Use in Specific Populations (8.4) and Clinical Studies (14.1)].

Clarithromycin therapy should continue if clinical response is observed. Clarithromycin can be discontinued when the patient is considered at low risk of disseminated infection.

Dosage Adjustment in Patients with Renal Impairment

See Table 2 for dosage adjustment in patients with moderate or severe renal impairment with or without concomitant atazanavir or ritonavir-containing regimens [see Drug Interactions (7)].

Dosage Adjustment Due to Drug Interactions

Decrease the dose of Clarithromycin by 50 % when co-administered with atazanavir [see Drug Interactions (7)]. Dosage adjustments for other drugs when co-administered with Clarithromycin may be recommended due to drug interactions [see Drug Interactions (7)].

Reconstitution of Clarithromycin for Oral Suspension, USP

The supplied Clarithromycin for Oral Suspension, USP must be reconstituted with water prior to administration of Clarithromycin for oral suspension. Table 3 below indicates the volume of water to be added when reconstituting. To reconstitute:

1. Add half the volume of water to the bottle containing the Clarithromycin granules and shake vigorously.
2. Add the remainder of water to the bottle and shake.

Shake well before each use. After mixing, store at 15° to 30°C (59° to 86°F) and use within 14 days. Do not refrigerate.

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, discontinue Clarithromycin therapy immediately and institute appropriate treatment.

QT Prolongation

Clarithromycin has been associated with prolongation of the QT interval and infrequent cases of arrhythmia. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving Clarithromycin. Fatalities have been reported.

Avoid Clarithromycin in the following patients:

• patients with known prolongation of the QT interval, ventricular cardiac arrhythmia, including torsades de pointes
• patients receiving drugs known to prolong the QT interval [see also Contraindications (4.2)]
• patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.

Elderly patients may be more susceptible to drug-associated effects on the QT interval [see Use in Specific Populations (8.5)].

Hepatotoxicity

Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been reported with Clarithromycin. This hepatic dysfunction may be severe and is usually reversible. In some instances, hepatic failure with fatal outcome has been reported and generally has been associated with serious underlying diseases and/or concomitant medications. Symptoms of hepatitis can include anorexia, jaundice, dark urine, pruritus, or tender abdomen. Discontinue Clarithromycin immediately if signs and symptoms of hepatitis occur.

Serious Adverse Reactions Due to Concomitant Use with Other Drugs

Drugs metabolized by CYP3A4: Serious adverse reactions have been reported in patients taking Clarithromycin concomitantly with CYP3A4 substrates. These include colchicine toxicity with colchicine; rhabdomyolysis with simvastatin, lovastatin, and atorvastatin; hypoglycemia with disopyramide; hypotension and acute kidney injury with calcium channel blockers metabolized by CYP3A4 (e.g., verapamil, amlodipine, diltiazem, nifedipine). Most reports of acute kidney injury with calcium channel blockers metabolized by CYP3A4 involved elderly patients 65 years of age or older. Use Clarithromycin with caution when administered concurrently with medications that induce the cytochrome CYP3A4 enzyme. The use of Clarithromycin with simvastatin, lovastatin, ergotamine, or dihydroergotamine is contraindicated [see Contraindications (4.5,4.6) andDrug Interactions (7)].

Colchicine: Life-threatening and fatal drug interactions have been reported in patients treated with Clarithromycin and colchicine. Clarithromycin is a strong CYP3A4 inhibitor and this interaction may occur while using both drugs at their recommended doses. If co-administration of Clarithromycin and colchicine is necessary in patients with normal renal and hepatic function, reduce the dose of colchicine. Monitor patients for clinical symptoms of colchicine toxicity. Concomitant administration of Clarithromycin and colchicine is contraindicated in patients with renal or hepatic impairment [see Contraindications (4.4) and Drug Interactions (7)].

HMG-CoA Reductase Inhibitors (statins): Concomitant use of Clarithromycin with lovastatin or simvastatin is contraindicated [see Contraindications (4.5)] as these statins are extensively metabolized by CYP3A4, and concomitant treatment with Clarithromycin increases their plasma concentration, which increases the risk of myopathy, including rhabdomyolysis. Cases of rhabdomyolysis have been reported in patients taking Clarithromycin concomitantly with these statins. If treatment with Clarithromycin cannot be avoided, therapy with lovastatin or simvastatin must be suspended during the course of treatment.

Exercise caution when prescribing Clarithromycin with atorvastatin or pravastatin. In situations where the concomitant use of Clarithromycin with atorvastatin or pravastatin cannot be avoided, atorvastatin dose should not exceed 20 mg daily and pravastatin dose should not exceed 40 mg daily. Use of a statin that is not dependent on CYP3A metabolism (e.g. fluvastatin) can be considered. It is recommended to prescribe the lowest registered dose if concomitant use cannot be avoided.

Oral Hypoglycemic Agents/Insulin: The concomitant use of Clarithromycin and oral hypoglycemic agents and/or insulin can result in significant hypoglycemia. With certain hypoglycemic drugs such as nateglinide, pioglitazone, repaglinide and rosiglitazone, inhibition of CYP3A enzyme by Clarithromycin may be involved and could cause hypoglycemia when used concomitantly. Careful monitoring of glucose is recommended [see Drug Interactions (7)].

Quetiapine: Use quetiapine and Clarithromycin concomitantly with caution. Co-administration could result in increased quetiapine exposure and quetiapine related toxicities such as somnolence, orthostatic hypotension, altered state of consciousness, neuroleptic malignant syndrome, and QT prolongation. Refer to quetiapine prescribing information for recommendations on dose reduction if co-administered with CYP3A4 inhibitors such as Clarithromycin [see Drug Interactions (7)].

Oral Anticoagulants: There is a risk of serious hemorrhage and significant elevations in INR and prothrombin time when Clarithromycin is co-administered with warfarin. Monitor INR and prothrombin times frequently while patients are receiving Clarithromycin and oral anticoagulants concurrently [see Drug Interactions (7)].

Benzodiazepines: Increased sedation and prolongation of sedation have been reported with concomitant administration of Clarithromycin and triazolobenzodiazepines, such as triazolam and midazolam [see Drug Interactions (7)].

All-Cause Mortality in Patients With Coronary Artery Disease 1 to 10 Years After Clarithromycin Exposure

In one clinical trial evaluating treatment with Clarithromycin on outcomes in patients with coronary artery disease, an increase in risk of all-cause mortality one year or more after the end of treatment was observed in patients randomized to receive Clarithromycin.1 Clarithromycin for treatment of coronary artery disease is not an approved indication. The cause of the increased risk has not been established. Other epidemiologic studies evaluating this risk have shown variable results [see Adverse Reactions (6.1)]. Consider balancing this potential risk with the treatment benefits when prescribing Clarithromycin in patients who have suspected or confirmed coronary artery disease.

Clostridium difficile Associated Diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Clarithromycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Embryofetal Toxicity

Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate. If Clarithromycin is used during pregnancy, or if pregnancy occurs while the patient is taking this drug, the patient should be apprised of the potential hazard to the fetus. Clarithromycin has demonstrated adverse effects on pregnancy outcome and/or embryo-fetal development in monkeys, rats, mice, and rabbits at doses that produced plasma levels 2 times to 17 times the serum levels achieved in humans treated at the maximum recommended human doses [see Use in Specific Populations (8.1)].

Exacerbation of Myasthenia Gravis

Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome has been reported in patients receiving Clarithromycin therapy.

Development of Drug Resistant Bacteria

Prescribing Clarithromycin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Carcinogenesis, Mutagenesis, Impairment of Fertility

The following in vitro mutagenicity tests have been conducted with Clarithromycin:

• Salmonella/Mammalian Microsomes Test
• Bacterial Induced Mutation Frequency Test
• In Vitro Chromosome Aberration Test
• Rat Hepatocyte DNA Synthesis Assay
• Mouse Lymphoma Assay
• Mouse Dominant Lethal Study
• Mouse Micronucleus Test

All tests had negative results except the in vitro chromosome aberration test which was positive in one test and negative in another. In addition, a bacterial reverse-mutation test (Ames test) has been performed on Clarithromycin metabolites with negative results.

Impairment of Fertility

Fertility and reproduction studies have shown that daily doses of up to 160 mg/kg/ to male and female rats caused no adverse effects on the estrous cycle, fertility, parturition, or number and viability of offspring. Plasma levels in rats after 150 mg/kg/day were twice the human serum levels.

Testicular atrophy occurred in rats at doses 7 times, in dogs at doses 3 times, and in monkeys at doses 8 times greater than the maximum human daily dose (on a body surface area basis).

Animal Toxicology and/or Pharmacology

Corneal opacity occurred in dogs at doses 12 times and in monkeys at doses 8 times greater than the maximum human daily dose (on a body surface area basis). Lymphoid depletion occurred in dogs at doses 3 times greater than and in monkeys at doses 2 times greater than the maximum human daily dose (on a body surface area basis).

• Antibiotic, Macrolide

Bronchitis, acute bacterial exacerbation: Treatment of acute bacterial exacerbation of chronic bronchitis in adults due to susceptible Haemophilus influenzae, H. parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.

Helicobacter pylori eradication: Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence as a component of combination therapy (triple therapy) in adults with H. pylori infection and duodenal ulcer disease (active or 5 year history of duodenal ulcer).

Limitations of use: Regimens that contain clarithromycin as the single antibacterial agent are more likely to be associated with the development of clarithromycin resistance. Clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin-resistant isolates (efficacy is reduced).

Mycobacterial infections, disseminated: Prophylaxis and treatment of disseminated mycobacterial infections due to Mycobacterium avium complex (MAC) in patients with advanced HIV infection.

Otitis media: Treatment of acute otitis media in pediatric patients due to susceptible H. influenzae, M. catarrhalis, or S. pneumoniae.

Pharyngitis/tonsillitis: Treatment of pharyngitis/tonsillitis due to susceptible Streptococcus pyogenes (alternative agent).

Pneumonia, community-acquired: Treatment of community-acquired pneumonia due to susceptible Mycoplasma pneumoniae, S. pneumoniae, or Chlamydophila pneumoniae (adult and pediatric patients) and H. influenzae, H. parainfluenzae, or M. catarrhalis (adults).

Sinusitis: Treatment of acute maxillary sinusitis due to susceptible H. influenzae, S. pneumoniae, or M. catarrhalis.

Skin/skin structure infections: Treatment of uncomplicated skin/skin structure infection due to susceptible Staphylococcus aureus or S. pyogenes.

Usual dosage range: Oral: 250 to 500 mg every 12 hours or 1000 mg (two 500 mg extended-release tablets) once daily for 7 to 14 days

Bronchitis, acute bacterial exacerbation: Oral:

M. catarrhalis and S. pneumoniae: 250 mg every 12 hours for 7 to 14 days or 1,000 mg (two 500 mg extended-release tablets) once daily for 7 days

H. influenzae: 500 mg every 12 hours for 7 to 14 days or 1,000 mg (two 500 mg extended-release tablets) once daily for 7 days

H. parainfluenzae: 500 mg every 12 hours for 7 days or 1,000 mg (two 500 mg extended-release tablets) once daily for 7 days

Bartonellosis in HIV-infected patients (excluding CNS infections and endocarditis) (off-label use; HHS [OI adult 2015]): Oral:

Treatment (alternative to preferred): 500 mg twice daily for at least 3 months

Long-term suppressive therapy: 500 mg twice daily; may discontinue if completed 3 to 4 months therapy and CD4 >200 cells/mm3 for at least 6 months. Note: Some clinicians would discontinue only if Bartonella titers have also decreased four-fold

H. pylori eradication: Oral: 500 mg every 12 hours for 10 to 14 days as part of a combination regimen.

Lyme disease (off-label use): Oral: 500 mg twice daily for 14 to 21 days (not recommended for pregnant women) (Wormser 2006)

Mycobacterial infection, disseminated (prophylaxis and treatment): Oral:

Manufacturer's labeling: 500 mg twice daily (use with other antimycobacterial drugs, eg, ethambutol or rifampin). Continue therapy if clinical response is observed; may discontinue when patient is considered at low risk of disseminated infection.

Alternate dosing: Mycobacterium avium complex disease (MAC) in HIV-infected patients (HHS [OI adult 2017]):

Primary prophylaxis (patients with CD4 count <50 cells/mm3): 500 mg twice daily; may discontinue when CD4 count >100 cells/mm3 for ≥3 months in response to ART. Note: If effective ART is initiated immediately and viral suppression is achieved, some experts do not recommend routine initiation of MAC primary prophylaxis, regardless of initial CD4 count (IAS-USA [Gunthard 2016]).

Treatment and chronic maintenance therapy: 500 mg twice daily plus ethambutol; consider additional agents (eg, rifabutin, aminoglycoside, fluoroquinolone) for CD4 <50 cells/mm3, high mycobacterial load, or ineffective antiretroviral therapy; may discontinue chronic maintenance if no signs/symptoms of MAC disease, have maintained a CD4 count >100 cells/mm3 for >6 months in response to ART, and completed at least 12 months of therapy

Pertussis (off-label use): Oral: 500 mg twice daily for 7 days (CDC 2005)

Pharyngitis, tonsillitis (alternative agent): Oral: 250 mg every 12 hours for 10 days (IDSA [Shulman 2012]).

Pneumonia, community-acquired: Oral:

Manufacturer's labeling:

C. pneumoniae, M. pneumoniae, and S. pneumoniae: 250 mg every 12 hours for 7 to 14 days or 1,000 mg (two 500 mg extended-release tablets) once daily for 7 days

H. influenzae: 250 mg every 12 hours for 7 days or 1,000 mg (two 500 mg extended-release tablets) once daily for 7 days

H. parainfluenzae and M. catarrhalis: 1000 mg (two 500 mg extended-release tablets) once daily for 7 days

Alternate dosing:

Outpatient empiric therapy: 500 mg twice daily for 5 days, in combination with a beta-lactam (Lim 2009; Mandell 2007)

Prophylaxis against infective endocarditis (off-label use): Oral: 500 mg 30 to 60 minutes prior to procedure. Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA (Wilson 2007).

Sinusitis: Oral: 500 mg every 12 hours for 14 days or 1,000 mg (two 500 mg extended-release tablets) once daily for 14 days

Skin and skin structure infection, uncomplicated: Oral: 250 mg every 12 hours for 7 to 14 days

Dosage adjustment for concomitant therapy: Atazanavir: Decrease clarithromycin dose by 50%.

Refer to adult dosing.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe stomach pain, nausea, vomiting, or diarrhea.

Get emergency medical help if you have any of these signs of an allergic reaction to clarithromycin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• headache with chest pain and severe dizziness, fast or pounding heartbeats, shortness of breath, fainting;

• diarrhea that is watery or bloody;

• fever, swollen glands, body aches, flu symptoms, new or worsening cough;

• skin rash, easy bruising or bleeding, severe tingling, numbness, pain, muscle weakness;

• problems with your hearing;

• signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Older adults may be more likely to have heart rhythm side effects, including a life-threatening fast heart rate.

Clarithromycin may also cause severe liver symptoms. Stop taking clarithromycin and call your doctor at once if you have any of these liver symptoms:

• itching, tired feeling;

• nausea, upper stomach pain, loss of appetite;

• dark urine, clay colored stools; or

• jaundice (yellowing of the skin or eyes).

Common clarithromycin side effects may include:

• stomach pain, indigestion, gas;

• vomiting, mild diarrhea;

• unusual or unpleasant taste in your mouth;

• headache, sleep problems (insomnia);

• mild itching or rash; or

• vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.