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Pediatric Reference

Terbinafine Side EffectsComprehensive Pediatric Safety Guide

Terbinafine is generally well tolerated, but treatment courses last several weeks so proactive monitoring helps catch rare hepatic or taste disturbances early.

5 Categories
9 Clinical Sources
Evidence-Based
Back to Terbinafine Overview

Essential Information

1

Check baseline liver function when risk factors exist and counsel families about jaundice or dark urine.

2

Encourage children to report taste changes or food aversions, which can affect nutrition during long courses.

3

Advise stopping the medication and seeking care for severe rash, blistering, or swelling.

Clinical Overview

Gastrointestinal upset, headache, and mild skin rashes are the most common effects. Clinically significant liver injury and taste or smell disturbances are uncommon but important for families to understand.

Side Effect Categories

5 Systems

Gastrointestinal

1 documented effect

Total Sources: 2

Nausea, abdominal discomfort, diarrhea

Incidence: Common
Onset: Early in therapy
mild
2 sources
Duration

Not specified

Management

Give with food, small frequent meals, hydration

Monitoring Guidelines

Call if vomiting prevents dosing or if symptoms persist >48 hours

2 clinical sources• PubMed • Clinical Guidelines • FDA

Hepatic

2 documented effects

Total Sources: 3

Elevated liver enzymes

Incidence: Uncommon
Onset: Usually within the first 4 to 6 weeks
moderate
1 sources
Duration

Not specified

Management

Check laboratory values; discontinue if ALT/AST exceed 2-3x upper limit with symptoms

Monitoring Guidelines

Educate parents about jaundice, pruritus, dark urine

1 clinical sources• PubMed • Clinical Guidelines • FDA

Serious hepatic injury

Incidence: Rare
Onset: Variable; most reports within first 6 weeks
severe
2 sources
Duration

Not specified

Management

Stop therapy immediately; refer for urgent evaluation

Monitoring Guidelines

Watch for fatigue, anorexia, abdominal pain, jaundice

2 clinical sources• PubMed • Clinical Guidelines • FDA

Neurologic/Sensory

2 documented effects

Total Sources: 2

Taste disturbance (dysgeusia)

Incidence: Uncommon
Onset: Typically after several weeks
mild to moderate
1 sources
Duration

Not specified

Management

Encourage hydration and oral hygiene; discontinue if persistent or associated with anorexia

Monitoring Guidelines

Monitor weight and intake during prolonged therapy

1 clinical sources• PubMed • Clinical Guidelines • FDA

Smell disturbance (dysosmia)

Incidence: Rare
Onset: Not specified
moderate
1 sources
Duration

Not specified

Management

Assess impact on eating; consider discontinuation

Monitoring Guidelines

Monitor for symptom escalation or new adverse effects.

1 clinical sources• PubMed • Clinical Guidelines • FDA

Dermatologic

1 documented effect

Total Sources: 1

Rash or urticaria

Incidence: Uncommon
Onset: Not specified
variable
1 sources
Duration

Not specified

Management

Stop drug and seek care for widespread rash, mucosal involvement, or blistering

Monitoring Guidelines

Monitor for symptom escalation or new adverse effects.

1 clinical sources• PubMed • Clinical Guidelines • FDA

Hematologic

1 documented effect

Total Sources: 1

Neutropenia

Incidence: Rare
Onset: Not specified
moderate
1 sources
Duration

Not specified

Management

Check complete blood count if fever or sore throat develops; discontinue if neutropenia confirmed

Monitoring Guidelines

Monitor for symptom escalation or new adverse effects.

1 clinical sources• PubMed • Clinical Guidelines • FDA

Parent Communication Guide

Age-Appropriate Explanations

Infants (0-12 months)

Let us know if feedings drop off or urine turns dark.

Toddlers (1-3 years)

Tell your grown-up if your tummy hurts a lot or food tastes funny.

Children (4-12 years)

If you notice weird tastes, bumps, or yellow eyes, we want to hear right away.

Adolescents (13+ years)

Report taste changes, fatigue, or dark urine promptly; do not combine terbinafine with alcohol or vaping substances.

Common Parent Concerns

Q: Course feels long

A: Explain that scalp fungus lives in hair follicles, so we need the full course to prevent relapse.

When to validate: Set calendar reminders and use weekly check-ins.

Q: Child dislikes taste

A: Take with food, use flavored chasers, or ask about granules mixed with soft food.

When to validate: Call if intake drops or weight changes.

Clinical Decision Support

Severity Assessment Framework

Guide for clinicians to triage terbinafine adverse effects.

Mild
Indicators: Transient GI upset, Mild headache
Action: Continue therapy with supportive care
Moderate
Indicators: Persistent taste disturbance, Rash without systemic symptoms
Action: Reassess risk-benefit, consider labs or dermatology consult
Severe
Indicators: Elevated liver enzymes with symptoms, Blistering rash, Neutropenia
Action: Stop drug, arrange urgent evaluation, consider alternative antifungal

Treatment Decision Guidelines

Immediate Discontinuation

  • • Hepatic injury signs
  • • Severe cutaneous adverse reactions
  • • Hematologic abnormalities

Consider Alternatives

  • • Intractable dysgeusia
  • • Adherence failure

Dose Modification

  • • Mild GI upset responsive to food

Clinical References

Terbinafine Hydrochloride Tablets — DailyMed•U.S. National Library of Medicine (2024)Label
Terbinafine for fungal infections•Medicines for Children (2024)Patient education
Terbinafine•StatPearls Publishing (2025)Review
Public Health Advisory: Lamisil (terbinafine) Oral Granules•U.S. Food and Drug Administration (2010)Safety communication

Frequently Asked Questions

Parent and clinician concerns about Terbinafine