adorable baby smiling with joy

Peds Calc

Pediatric Reference

Biaxin Side EffectsComprehensive Pediatric Safety Guide

Biaxin (clarithromycin) is generally well-tolerated in pediatric patients aged 6 months and older, with gastrointestinal effects being most common. Taste disturbance (dysgeusia) affects up to 16% of patients, making it one of the most frequent side effects. QT prolongation is a serious concern requiring cardiac monitoring in high-risk patients. While hepatotoxicity is rare, it can be severe when it occurs, particularly with higher doses. Safety and efficacy are not established in children under 6 months for bacterial infections.

5 Categories
24 Clinical Sources
Evidence-Based
Back to Biaxin Overview

Essential Information

1

Gastrointestinal Effects

The most common side effects include diarrhea (3%), nausea (3%), abdominal pain (3%), and vomiting (6%). C. difficile-associated diarrhea can occur during treatment or up to 2 months after completion, requiring immediate medical attention. Generally mild and self-limiting with standard therapeutic doses. Management: Give with food to reduce stomach upset, maintain hydration, avoid anti-diarrheal medications for severe cases. Monitoring: Watch for severe, bloody, or persistent diarrhea; report cramping, fever, or signs of dehydration immediately.

2

Taste Disturbances (Dysgeusia)

Metallic or abnormal taste occurs in up to 16% of patients, making it one of the most frequent side effects. Can significantly impact appetite and nutrition, especially in children. Usually reversible after treatment completion but may persist for days to weeks. Management: Encourage varied flavors, use sugar-free gum or mints, maintain good oral hygiene, ensure adequate nutrition despite taste changes. Monitoring: Report persistent taste changes lasting >2 weeks after completion or significant impact on eating.

3

QT Prolongation and Cardiac Effects

Clarithromycin can cause dangerous heart rhythm abnormalities including QT prolongation and torsade de pointes. Risk is higher in patients with existing heart conditions, electrolyte imbalances, or concurrent QT-prolonging medications. Can be life-threatening and requires immediate intervention. Management: Avoid in patients with known QT prolongation, monitor electrolytes, obtain baseline and follow-up ECGs in high-risk patients. Monitoring: Watch for palpitations, chest pain, fainting, or unusual fatigue; seek emergency care for cardiac symptoms.

4

Hepatotoxicity

Rare but potentially severe liver injury can occur, typically presenting as cholestatic hepatitis within one week of treatment initiation. More common with higher doses (1-2 g/day) and in patients with underlying liver disease. Fatal cases have been reported, particularly in elderly patients with comorbidities. Management: Monitor liver function tests in high-risk patients, discontinue immediately if liver injury suspected. Monitoring: Watch for jaundice, dark urine, right upper quadrant pain, unusual fatigue, or pale stools.

5

Drug Interactions and CYP3A4 Inhibition

Clarithromycin is a potent CYP3A4 inhibitor, leading to significant drug interactions with many commonly prescribed medications. Notable interactions include statins (muscle toxicity), colchicine (toxicity), and various cardiac medications. Can affect levels of other antibiotics and immunosuppressants. Management: Review all medications before prescribing, avoid contraindicated combinations, monitor for signs of drug toxicity. Monitoring: Watch for unusual symptoms when starting clarithromycin with other medications, report muscle pain, weakness, or other new symptoms.

Clinical Overview

Biaxin adverse effects in pediatric patients include gastrointestinal symptoms (3-6% incidence), taste disturbance (up to 16%), and rare but serious QT prolongation and hepatotoxicity. The medication has extensive drug interactions due to CYP3A4 inhibition. Most side effects are mild and reversible, but cardiac and hepatic complications require immediate attention.

Side Effect Categories

5 Systems

Gastrointestinal

4 documented effects

Total Sources: 8

Diarrhea

Incidence: 3% in clinical trials
Onset: Within 24-48 hours of first dose
Mild to Moderate (Grade 1-2)
2 sources
Duration

Usually resolves within days of treatment completion

Management

Maintain hydration; give with food; avoid anti-diarrheal medications if severe; probiotics may help

Monitoring Guidelines

Report severe, bloody, or persistent diarrhea >3 days; watch for signs of C. difficile infection

2 clinical sources• PubMed • Clinical Guidelines • FDA

Nausea and Vomiting

Incidence: Nausea: 3%; Vomiting: 6% in pediatric trials
Onset: Within hours of administration
Mild (Grade 1)
2 sources
Duration

Self-limited; resolves between doses

Management

Take with food; ensure adequate fluid intake; consider dose timing adjustments

Monitoring Guidelines

Report persistent vomiting preventing oral intake or signs of dehydration

2 clinical sources• PubMed • Clinical Guidelines • FDA

Abdominal Pain

Incidence: 3% in clinical trials
Onset: Variable during treatment course
Mild (Grade 1)
2 sources
Duration

Usually temporary and self-limiting

Management

Take with food; maintain regular meal schedule; avoid spicy foods

Monitoring Guidelines

Report severe or persistent abdominal pain, especially with fever

2 clinical sources• PubMed • Clinical Guidelines • FDA

C. difficile-Associated Diarrhea (CDAD)

Incidence: Rare; can occur up to 2 months after treatment completion
Onset: During treatment or up to 2 months after completion
Severe to Life-threatening (Grade 3-4)
2 sources
Duration

Requires specific antibiotic treatment; can be prolonged

Management

Discontinue clarithromycin immediately; specific antibiotic therapy; supportive care

Monitoring Guidelines

Watch for severe, watery, bloody diarrhea with fever, cramping, or abdominal pain

2 clinical sources• PubMed • Clinical Guidelines • FDA

Neurologic/Sensory

3 documented effects

Total Sources: 6

Taste Disturbance (Dysgeusia)

Incidence: Up to 16% of patients; most common side effect
Onset: Within days of starting treatment
Mild to Moderate (Grade 1-2)
2 sources
Duration

Usually resolves days to weeks after completion; may persist longer

Management

Encourage varied flavors; sugar-free gum/mints; maintain oral hygiene; ensure adequate nutrition

Monitoring Guidelines

Monitor food intake in children; report persistent taste changes >2 weeks after completion

2 clinical sources• PubMed • Clinical Guidelines • FDA

Headache

Incidence: Common in immunocompromised patients on higher doses
Onset: Variable during treatment
Mild (Grade 1)
2 sources
Duration

Usually resolves with continued therapy

Management

Ensure adequate rest and hydration; consider acetaminophen if needed

Monitoring Guidelines

Report persistent or severe headaches, especially with fever or neck stiffness

2 clinical sources• PubMed • Clinical Guidelines • FDA

Dizziness and Motion Sickness

Incidence: Less common (<1%)
Onset: Variable during treatment
Mild (Grade 1)
2 sources
Duration

Usually temporary

Management

Avoid activities requiring alertness; ensure proper hydration; consider dose timing

Monitoring Guidelines

Report persistent dizziness or balance problems

2 clinical sources• PubMed • Clinical Guidelines • FDA

Cardiac

2 documented effects

Total Sources: 4

QT Prolongation

Incidence: Infrequent but documented; higher risk with predisposing factors
Onset: Can occur at any time during treatment
Moderate to Severe (Grade 2-3)
2 sources
Duration

Usually reversible after discontinuation

Management

Monitor QTc interval; avoid in patients with known QT prolongation; maintain electrolyte balance

Monitoring Guidelines

Watch for palpitations, chest pain, fainting, or unusual fatigue; obtain ECG if risk factors

2 clinical sources• PubMed • Clinical Guidelines • FDA

Torsade de Pointes

Incidence: Rare; life-threatening arrhythmia associated with QT prolongation
Onset: Can occur suddenly during treatment
Life-threatening (Grade 4)
2 sources
Duration

Immediate intervention required; potentially fatal

Management

Emergency cardiac care; discontinue immediately; correct electrolytes; consider defibrillation

Monitoring Guidelines

Continuous cardiac monitoring for high-risk patients; immediate care for cardiac symptoms

2 clinical sources• PubMed • Clinical Guidelines • FDA

Hepatic

2 documented effects

Total Sources: 4

Cholestatic Hepatitis

Incidence: Rare; more common with higher doses (1-2 g/day)
Onset: Typically within one week of treatment initiation
Moderate to Severe (Grade 2-3)
2 sources
Duration

Variable; most recover but some develop chronic injury

Management

Discontinue immediately if liver injury suspected; supportive care; monitor liver function

Monitoring Guidelines

Watch for jaundice, dark urine, right upper quadrant pain, unusual fatigue, pale stools

2 clinical sources• PubMed • Clinical Guidelines • FDA

Acute Liver Failure

Incidence: Very rare; fatal cases reported, particularly in elderly with comorbidities
Onset: Can occur rapidly after treatment initiation
Life-threatening (Grade 4)
2 sources
Duration

Life-threatening emergency requiring intensive care

Management

Emergency medical care; discontinue immediately; supportive care; consider liver transplant

Monitoring Guidelines

Monitor liver function tests in high-risk patients; immediate care for liver injury signs

2 clinical sources• PubMed • Clinical Guidelines • FDA

Dermatologic

1 documented effect

Total Sources: 2

Skin Rash

Incidence: Common in immunocompromised patients; specific pediatric rate not established
Onset: Days 3-7 of therapy
Mild to Moderate (Grade 1-2)
2 sources
Duration

Usually resolves after discontinuation

Management

Discontinue if severe; antihistamines for mild reactions; topical steroids per provider guidance

Monitoring Guidelines

Watch for widespread rash, fever, blistering, or signs of severe allergic reaction

2 clinical sources• PubMed • Clinical Guidelines • FDA

Risk Factors

Age under 6 months (safety not established for bacterial infections)

Sources: 2 references

Pre-existing cardiac conditions or family history of QT prolongation

Sources: 2 references

Electrolyte imbalances (hypokalemia, hypomagnesemia)

Sources: 2 references

Hepatic impairment or history of liver disease

Sources: 2 references

Concurrent use of QT-prolonging medications

Sources: 2 references

Renal impairment (dose adjustment required)

Sources: 2 references

Prevention & Safety Tips

Give with food to reduce GI upset; maintain good oral hygiene for taste disturbances; review all medications for interactions; monitor electrolytes if cardiac risk factors; avoid in patients under 6 months; complete full course even if symptoms improve; use sugar-free products to help with metallic taste

When to Contact Your Pediatrician

Important

📞 Call your pediatrician immediately if you notice any of these symptoms:

Signs of liver injury (jaundice, dark urine, right upper quadrant pain, unusual fatigue)

Cardiac symptoms (palpitations, chest pain, fainting, irregular heartbeat)

Severe or bloody diarrhea with fever or cramping

Signs of severe allergic reaction (widespread rash, difficulty breathing, swelling)

Severe muscle pain or weakness (if taking interacting medications)

Persistent taste changes affecting nutrition significantly

Signs of drug toxicity from interactions (unusual symptoms with other medications)

Comparison with Azithromycin

EffectBiaxinAzithromycin
Taste disturbanceUp to 16% (most common)Less common
QT prolongationDocumented riskLower but documented risk
Drug interactionsExtensive (CYP3A4 inhibitor)Fewer interactions

Important Drug Interactions

!

Statins (simvastatin, lovastatin)

Contraindicated; increased risk of severe muscle problems including rhabdomyolysis

!

Colchicine

Contraindicated in patients with kidney or liver disease; increased colchicine toxicity

!

QT-prolonging medications (cisapride, pimozide, terfenadine)

Contraindicated; additive risk of QT prolongation and torsade de pointes

!

Ergot alkaloids

Contraindicated; increased risk of ergot toxicity and vasospasm

!

Warfarin

Enhanced anticoagulant effect; monitor INR closely and adjust warfarin dose

Parent Communication Guide

Age-Appropriate Explanations

Infants (0-12 months)

Biaxin is not approved for babies under 6 months old. For older infants, watch closely for diarrhea, vomiting, or changes in feeding. The medicine may cause a metallic taste that makes your baby fussy during feedings.

Toddlers (1-3 years)

Your toddler may complain about a 'yucky' or 'metal' taste in their mouth - this happens to many children taking Biaxin. They might also have an upset tummy or loose stools. These usually get better after finishing the medicine.

Children (4-12 years)

Biaxin can make food taste metallic or weird - like having pennies in your mouth. Your child might also feel queasy or have diarrhea. Let them know these side effects are temporary and will go away after treatment.

Adolescents (13+ years)

This antibiotic commonly causes a metallic taste that can last for weeks. It also has many drug interactions, so don't take any other medications without checking first. Report any heart palpitations, severe stomach pain, or yellowing of skin immediately.

Common Parent Concerns

Q: My child won't eat because everything tastes bad

A: The metallic taste from Biaxin affects up to 16% of children and can significantly impact appetite. Try offering cold foods, citrus flavors, or sugar-free mints. Ensure they stay hydrated even if eating less. The taste will return to normal after stopping the medicine, though it may take a few weeks.

When to validate: Contact us if your child loses weight, shows signs of dehydration, or refuses all food for more than 24 hours.

Q: Can my child take other medications with Biaxin?

A: Biaxin interacts with many medications because it affects how the liver processes drugs. This includes common medications like some allergy medicines, stomach acid reducers, and even some vitamins. Always check with us or a pharmacist before giving any other medication, including over-the-counter drugs.

When to validate: Call immediately if your child is taking any heart medications, has muscle pain while on cholesterol medicine, or develops new symptoms after starting another medication.

Q: Should I worry about heart problems?

A: While rare, Biaxin can affect heart rhythm, especially in children with existing heart conditions or low potassium/magnesium levels. Most children have no cardiac issues, but it's important to watch for warning signs.

When to validate: Seek immediate care if your child has chest pain, racing heartbeat, dizziness, fainting, or says their heart feels 'funny' or 'fluttery'.

Q: The diarrhea won't stop even after finishing the antibiotic

A: Biaxin can cause a serious intestinal infection called C. difficile that may occur even 2 months after finishing treatment. This is different from regular antibiotic-related diarrhea and requires specific treatment.

When to validate: Contact us immediately for severe, watery, or bloody diarrhea, especially with fever, stomach cramps, or if it persists more than 3 days after completing Biaxin.

Clinical Decision Support

Severity Assessment Framework

Evidence-based clinical assessment framework for Biaxin adverse effects with focus on QT prolongation, hepatotoxicity, and drug interactions.

Mild (Grade 1)
Indicators: Metallic taste without significant nutritional impact, Mild GI symptoms (diarrhea <4 episodes/day), No cardiac symptoms or ECG changes, Normal liver function tests, No drug interaction symptoms
Action: Continue Biaxin with supportive measures: dietary counseling for taste disturbance, probiotics for GI symptoms, maintain hydration
Moderate (Grade 2)
Indicators: Taste disturbance affecting nutrition/weight, Diarrhea 4-6 episodes/day, QTc 450-480ms (age-adjusted), Mild transaminase elevation (<3x ULN), Symptoms suggesting drug interaction
Action: Increase monitoring frequency, obtain ECG if cardiac risk factors, check electrolytes (K+, Mg2+), review all medications for interactions, consider dose reduction if renal impairment
Severe (Grade 3-4)
Indicators: QTc >480ms or symptomatic arrhythmia, Severe diarrhea (>7 episodes/day) or C. difficile suspected, Transaminases >3x ULN or bilirubin elevation, Rhabdomyolysis if on statins, Signs of colchicine toxicity
Action: Discontinue Biaxin immediately, obtain urgent ECG and labs, correct electrolyte abnormalities, consider alternative antibiotic (fluoroquinolone or tetracycline for MRMP), hospitalize if cardiac arrhythmia or severe hepatotoxicity

Treatment Decision Guidelines

Immediate Discontinuation

  • QTc >500ms or increase >60ms from baseline
  • Torsade de pointes or ventricular arrhythmia
  • Acute hepatitis (jaundice, severe transaminase elevation)
  • Severe allergic reaction
  • Rhabdomyolysis (CK >10x ULN with muscle symptoms)
  • Severe C. difficile colitis

Consider Alternatives

  • Persistent fever >72 hours (possible MRMP)
  • Intolerable taste disturbance affecting nutrition
  • Moderate drug interaction symptoms
  • QTc 480-500ms without symptoms

Dose Modification

  • CrCl <30 mL/min: reduce dose by 50%
  • Mild hepatic impairment: monitor closely
  • Drug interactions requiring dose adjustment

Frequently Asked Questions

Parent and clinician concerns about Biaxin