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Biaxin

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Biaxin, Biaxin XL

Biaxin, Biaxin XL

Biaxin Side Effects Center

Pharmacy Editor: Eni Williams, PharmD, PhD

Biaxin (Clarithromycin) is a medication belonging to the drug class, macrolide antibiotics. Biaxin is available as a generic called clarithromycin. Biaxin is prescribed for certain bacterial infections including skin and middle ear infections, tonsillitis, throat infections, laryngitis, pneumonia, and tuberculosis. Common side effects of Biaxin include nausea, diarrhea, abnormal taste, dyspepsia, abdominal pain, and headache.

Biaxin adult dose is 250mg to 500mg twice daily or 1000mg once daily (extended release) and dosage in children is based on the weight. Drug interactions of Biaxin include terfenadine (Seldane), astemizole (Hismanal), loratadine (Claritin), warfarin (Coumadin), carbamazepine (Tegretol), digoxin (Lanoxin), lovastatin (Mevacor), and phenytoin (Dilantin). The use of Biaxin should be avoided in pregnant women and breastfeeding mothers unless the risk outweighs the benefits.

Our Biaxin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Biaxin in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have a serious side effect such as:

  • uneven heartbeats, chest pain, shortness of breath;
  • diarrhea that is watery or bloody;
  • problems with your hearing; 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.

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

  • low fever, itching;
  • nausea, upper stomach pain, loss of appetite;
  • dark urine, clay colored stools; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • upset stomach, vomiting, diarrhea;
  • unusual or unpleasant taste in your mouth;
  • tooth discoloration;
  • headache;
  • 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.

Read the entire detailed patient monograph for Biaxin (Clarithromycin) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Biaxin Overview - Patient Information: Side Effects

SIDE EFFECTS: Diarrhea, nausea, vomiting, and changes in taste may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: hearing loss, mental/mood changes, muscle weakness, eye problems (such as drooping eyelids, blurred vision), slurred speech, persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing of eyes or skin.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

Get medical help right away if you have any very serious side effects, including: severe dizziness, fainting, fast/irregular heartbeat.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Biaxin (Clarithromycin)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Biaxin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most frequent and common adverse reactions related to clarithromycin therapy for both adult and pediatric populations are abdominal pain, diarrhea, nausea, vomiting and dysgeusia. These adverse reactions are consistent with the known safety profile of macrolide antibiotics.

There was no significant difference in the incidence of these gastrointestinal adverse reactions during clinical trials between the patient population with or without preexisting mycobacterial infections.

Adverse Reactions Observed During Clinical Trials of Clarithromycin

The following adverse reactions were observed in clinical trials with clarithromycin at a rate greater than or equal to 1%:

Gastrointestinal disorders

Diarrhea, vomiting, dyspepsia, nausea, abdominal pain

Hepatobiliary disorders

Liver function test abnormal

Immune System Disorders

Anaphylactoid reaction

Infection and Infestations

Candidiasis

Nervous system disorders

Dysgeusia, headache

Psychiatric disorders

Insomnia

Skin and subcutaneous tissue disorders

Rash

Other Adverse Reactions Observed During Clinical Trials of Clarithromycin

The following adverse reactions were observed in clinical trials with clarithromycin at a rate less than 1%:

Blood and Lymphatic System Disorders

Leukopenia, neutropenia, thrombocythemia, eosinophilia

Cardiac Disorders

Electrocardiogram QT prolonged, cardiac arrest, atrial fibrillation, extrasystoles, palpitations

Ear and Labyrinth Disorders

Vertigo, tinnitus, hearing impaired

Gastrointestinal Disorders

Stomatitis, glossitis, esophagitis, gastrooesophageal reflux disease, gastritis, proctalgia, abdominal distension, constipation, dry mouth, eructation, flatulence

General Disorders and Administration Site Conditions

Malaise, pyrexia, asthenia, chest pain, chills, fatigue

Hepatobiliary Disorders

Cholestasis, hepatitis

Immune System Disorders

Hypersensitivity

Infections and Infestations

Cellulitis, gastroenteritis, infection, vaginal infection

Investigations

Blood bilirubin increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, albumin globulin ratio abnormal

Metabolism and Nutrition Disorders

Anorexia, decreased appetite

Musculoskeletal and Connective Tissue Disorders

Myalgia, muscle spasms, nuchal rigidity

Nervous System Disorders

Dizziness, tremor, loss of consciousness, dyskinesia, somnolence

Psychiatric Disorders

Anxiety, nervousness

Renal and Urinary Disorders

Blood creatinine increased, blood urea increased

Respiratory, Thoracic and Mediastinal Disorders

Asthma, epistaxis, pulmonary embolism

Skin and Subcutaneous Tissue Disorders

Urticaria, dermatitis bullous, pruritus, hyperhidrosis, rash maculo-papular

In the acute exacerbation of chronic bronchitis and acute maxillary sinusitis studies overall gastrointestinal adverse events were reported by a similar proportion of patients taking either BIAXIN tablets or BIAXIN XL tablets; however, patients taking BIAXIN XL tablets reported significantly less severe gastrointestinal symptoms compared to patients taking BIAXIN tablets. In addition, patients taking BIAXIN XL tablets had significantly fewer premature discontinuations for drug-related gastrointestinal or abnormal taste adverse events compared to BIAXIN tablets.

In community-acquired pneumonia studies conducted in adults comparing clarithromycin to erythromycin base or erythromycin stearate, there were fewer adverse events involving the digestive system in clarithromycin-treated patients compared to erythromycin-treated patients (13% vs 32%; p < 0.01). Twenty percent of erythromycin-treated patients discontinued therapy due to adverse events compared to 4% of clarithromycin-treated patients.

In two U.S. studies of acute otitis media comparing clarithromycin to amoxicillin/potassium clavulanate in pediatric patients, there were fewer adverse events involving the digestive system in clarithromycin-treated patients compared to amoxicillin/potassium clavulanate-treated patients (21% vs. 40%, p < 0.001). One-third as many clarithromycin-treated patients reported diarrhea as did amoxicillin/potassium clavulanate-treated patients.

Post-Marketing Experience

The following adverse reactions have been identified during post approval use of clarithromycin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders

Thrombocytopenia, agranulocytosis

Cardiac Disorders

Torsades de pointes, ventricular tachycardia, ventricular arrhythmia

Ear and Labyrinth Disorders

Deafness was reported chiefly in elderly women and was usually reversible.

Gastrointestinal Disorders

Pancreatitis acute, tongue discoloration, tooth discoloration was reported and was usually reversible with professional cleaning upon discontinuation of the drug There have been reports of BIAXIN XL tablets in the stool, many of which have occurred in patients with anatomic (including ileostomy or colostomy) or functional gastrointestinal disorders with shortened GI transit times. In several reports, tablet residues have occurred in the context of diarrhea. It is recommended that patients who experience tablet residue in the stool and no improvement in their condition should be switched to a different clarithromycin formulation (e.g. suspension) or another antibacterial drug.

Hepatobiliary Disorders

Hepatic failure, jaundice hepatocellular. Adverse reactions related to hepatic dysfunction have been reported with clarithromycin (see WARNINGS -Hepatotoxicity).

Immune System Disorders

Anaphylactic reaction

Infections and Infestations

Pseudomembranous colitis

Investigations

Prothrombin time prolonged, white blood cell count decreased, international normalized ratio increased. Abnormal urine color has been reported, associated with hepatic failure.

Metabolism and Nutrition Disorders

Hypoglycemia has been reported in patients taking oral hypoglycemic agents or insulin.

Musculoskeletal and Connective Tissue Disorders

Myopathy, rhabdomyolysis was reported and in some of the reports, clarithromycin was administered concomitantly with statins, fibrates, colchicine or allopurinol (see CONTRAINDICATIONS and WARNINGS).

Nervous System Disorders

Convulsion, ageusia, parosmia, anosmia, paraesthesia

Psychiatric Disorders

Psychotic disorder, confusional state, depersonalization, depression, disorientation, manic behavior, hallucination, abnormal behavior, abnormal dreams. These disorders usually resolve upon discontinuation of the drug.

There are no data on the effect of clarithromycin on the ability to drive or use machines. The potential for dizziness, vertigo, confusion and disorientation, which may occur with the medication, should be taken into account before patients drive or use machines.

Renal and Urinary Disorders

Nephritis interstitial, renal failure

Skin and Subcutaneous Tissue Disorders

Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), Henoch-Schonlein purpura, acne

Vascular Disorders

Hemorrhage

There have been reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients (see WARNINGS and PRECAUTIONS).

Read the entire FDA prescribing information for Biaxin (Clarithromycin) »

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Biaxin, Biaxin XL - User Reviews

Biaxin, Biaxin XL User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Biaxin, Biaxin XL sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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