💊 Antifungal (allylamine) · hepatotoxicity risk

Terbinafine: Nursing Drug Guide, Hepatotoxicity & Monitoring

Oral terbinafine can cause serious hepatotoxicity—including liver failure and death—with or without pre-existing liver disease. Before the first 250 mg dose, confirm pretreatment ALT/AST, trend LFTs through the full 6- or 12-week nail course, and hold immediately when transaminases climb or jaundice, persistent nausea, or right upper quadrant pain appears.

⏱️16 min read
📅Updated May 31, 2026
Pharmacist Reviewed
🚨 Serious hepatotoxicity — including liver failure and death

Oral terbinafine has caused liver failure requiring transplantation and fatal outcomes with or without pre-existing liver disease. Obtain pretreatment ALT and AST, monitor during therapy, and discontinue if biochemical or clinical liver injury develops. Do not start in chronic or active liver disease per labeling.

Quick facts

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Class
Allylamine antifungal
➡️
Route
Oral
📐
Usual adult dose
250 mg PO daily × 6 or 12 weeks
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Main risk
Hepatotoxicity

💡 Key takeaway

Obtain pretreatment ALT/AST before the first dose and trend LFTs during the full onychomycosis course. Hold and escalate when transaminases climb, nausea persists with right upper quadrant pain, or jaundice appears—hepatotoxicity can progress to liver failure even without prior liver disease.

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Most common brand names

Oral terbinafine is widely known by the brand name Lamisil and is available as oral tablets per institution formulary. Topical terbinafine products exist for dermatophyte infections but are not interchangeable with systemic oral therapy for nail disease.

Verify the MAR shows oral terbinafine 250 mg—not topical gel or cream—when systemic therapy is ordered for nail disease. Topical Lamisil products are a different formulation and duration.

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Why we give it — Indications

Oral terbinafine tablets are FDA-indicated for dermatophyte onychomycosis of the fingernails or toenails (tinea unguium). Labeling advises obtaining nail specimens (KOH, fungal culture, or biopsy) to confirm diagnosis before starting therapy.

Use Detail
Onychomycosis (fingernail) 250 mg once daily for 6 weeks; optimal visible nail improvement may lag months after mycological cure because healthy nail must grow out.
Onychomycosis (toenail) 250 mg once daily for 12 weeks per labeling.
Other dermatophyte infections (oral tablets) Not specified in the reviewed prescribing information for oral tablet use beyond onychomycosis. Topical terbinafine is used for limited athlete’s foot and ringworm in outpatient settings—do not assume oral and topical products are interchangeable.

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Safety and efficacy for onychomycosis have not been established in pediatric patients per the reviewed prescribing information.

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How it works

Terbinafine is an allylamine antifungal that inhibits squalene epoxidase, blocking ergosterol synthesis in fungal cell membranes and causing intracellular squalene accumulation. It is fungicidal against many dermatophytes. Terbinafine is also a CYP2D6 inhibitor, which contributes to clinically relevant drug interactions.

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Dosing overview

Oral terbinafine is given once daily without regard to meals. Match duration to nail versus skin infection and verify pretreatment liver tests before day 1.

Adults — fingernail onychomycosis
250 mg PO daily × 6 weeks
Immunocompetent adults with dermatophyte nail infection per labeling.
Adults — toenail onychomycosis
250 mg PO daily × 12 weeks
Long courses increase exposure time for hepatotoxicity—LFT monitoring matters throughout.
Pediatrics — onychomycosis
Not established
Safety and efficacy for onychomycosis not established in children per labeling.
Renal impairment (CrCl <50 mL/min or hepatic cirrhosis)
Clearance ~50% decreased
Renal dose adjustment protocol: Not specified in the reviewed prescribing information—coordinate with pharmacy; monitor LFTs closely.

Missed dose: Give when remembered unless near the next dose; do not double doses. For multi-week nail regimens, document missed doses and notify prescriber if adherence gaps are significant.

⏱️

Onset, peak, duration, and half-life

ParameterValueNursing relevance
AbsorptionWell absorbed orally; food does not significantly affect absorptionMay administer without regard to meals per labeling
DistributionHighly protein bound; accumulates in skin, nails, and fatClinical nail improvement may lag weeks after therapy ends—hepatotoxicity can occur during the active course
Half-lifeApproximately 36 hours in adults; prolonged in renal or hepatic impairmentReduced clearance in cirrhosis or CrCl <50 mL/min increases exposure—monitor liver enzymes
MetabolismExtensive hepatic metabolism; CYP2D6 inhibitorPrimary safety focus is hepatotoxicity and CYP2D6-mediated interactions
EliminationPrimarily nonrenal after first-pass metabolismRenal impairment still reduces clearance—pharmacy review when CrCl <50 mL/min

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Before you give it — Safety check

Pretreatment checks

  • Pretreatment ALT and AST required before initiating oral terbinafine
  • History of allergic reaction to oral terbinafine (including anaphylaxis)
  • Active or chronic liver disease—contraindicated per labeling
  • Concurrent fluconazole, warfarin, rifampin, cimetidine, and other CYP2D6 substrates

Contraindications

  • History of allergic reaction to oral terbinafine, including anaphylaxis
  • Chronic or active liver disease

Important interactions

Drug / class Effect Nursing action
Fluconazole Increases terbinafine levels Flag duplicate or overlapping azole/allylamine therapy; pharmacy review before co-administration
Warfarin Altered prothrombin time reported Monitor INR and bleeding cues when warfarin starts or continues with terbinafine
Rifampin / cimetidine Rifampin increases clearance; cimetidine decreases clearance Reconcile MAR changes with pharmacy when these drugs are added or stopped
CYP2D6 substrates (e.g., tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers) Terbinafine inhibits CYP2D6 Review medication list for toxicity risk when terbinafine is initiated

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➡️

Administration

Route: Oral tablet per medication administration policy

  • Confirm pretreatment ALT/AST on chart before first dose
  • May give with or without food
  • Verify 250 mg oral tablet—not topical product—on the MAR
  • Document week of therapy for long nail courses (6 or 12 weeks) to align with LFT monitoring schedule
⚠️ Hepatic safety before every dose in long courses

During 6- to 12-week regimens, review latest LFT results and symptoms (nausea, RUQ pain, dark urine, jaundice) before administering terbinafine. Hold pending prescriber or pharmacist review when liver injury is suspected.

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Expected therapeutic response

  • Gradual improvement in tinea skin lesions over weeks of daily therapy
  • For onychomycosis, healthy nail growth may not be visible until months after completing therapy—lack of early cosmetic change does not mean hepatotoxicity monitoring can stop mid-course
  • Mycologic cure is assessed by prescriber with follow-up examination or culture per plan
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Adverse effects

Adverse effectFrequency / severityNursing response
Headache, diarrhea, dyspepsia, abdominal pain, flatulence, nauseaCommon (>2% in clinical trials)Document and differentiate mild GI upset from hepatotoxicity when RUQ pain or LFT rise coexists
Rash, pruritus, taste disturbanceCommon; taste/smell loss may be permanentTeach reporting of new rash; stop drug and escalate for progressive or mucosal rash
Liver enzyme abnormalitiesCommon laboratory finding; may progress to serious injuryTrend LFTs; hold and notify prescriber when ALT/AST rise or symptoms suggest hepatitis
Hepatotoxicity / liver failureSerious; includes transplantation and deathDiscontinue immediately for clinical or biochemical liver injury per labeling
Stevens-Johnson syndrome / toxic epidermal necrolysisSerious dermatologic reactions reportedStop terbinafine; urgent escalation for allergic rash with systemic symptoms
Severe neutropeniaSerious hematologic reactionMonitor complete blood count when ordered; hold and notify for febrile neutropenia signs
Depressive symptoms, lupus erythematosusSerious post-marketing reportsScreen mood changes; notify prescriber for new depression or autoimmune symptoms

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☠️

Overdose, toxicity, and antidote

Accidental doses up to 5 g have been reported without serious adverse reactions. Overdose may cause nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache. Management is supportive; no specific antidote is listed in prescribing information.

Nursing actions

  • Stop further doses and notify prescriber, pharmacist, and poison control or toxicology services per facility protocol
  • Monitor mental status, liver function, and vital signs
  • Provide supportive care for GI and neurologic symptoms
📞Escalation

Contact local poison control or medical toxicology services for large ingestions or when hepatic injury is suspected after overdose.

Antidote: Not specified in the reviewed prescribing information — treatment is supportive.

⚠️

Why cosmetic nail delay does not mean treatment failure

Healthy nail growth may not look improved for months after completing oral terbinafine—lack of early cosmetic change does not justify stopping therapy early or skipping LFT monitoring mid-course. Finish the full 6- or 12-week order unless hepatotoxicity or prescriber hold rules apply.

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Look-alike / sound-alike and error prevention

  • Terbinafine vs terbutaline — sound-alike risk; verify antifungal indication on MAR
  • Oral Lamisil vs topical terbinafine — onychomycosis requires oral systemic therapy; topical products are not equivalent for nail infection
  • Terbinafine vs itraconazole / fluconazole — different antifungal classes and monitoring profiles; confirm correct agent on order
  • 250 mg daily × 6 weeks vs × 12 weeks — fingernail versus toenail duration errors extend hepatotoxicity exposure
  • Perform medication reconciliation to catch duplicate systemic antifungals or interacting CYP drugs
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Practical bedside notes

TopicBedside guidance
Before first doseConfirm pretreatment ALT/AST, allergy history, and absence of chronic/active liver disease
Week 8 of 12-week toenail courseHigh-risk window for delayed hepatotoxicity—review latest LFTs and GI symptoms before each dose
Taste changesCommon; may be permanent—document and notify prescriber if distressing or affecting intake
Renal impairmentClearance decreased when CrCl <50 mL/min—pharmacy review; no specific adjustment table in labeling
Ask pharmacy whenUnclear duration, interacting fluconazole or warfarin, rising LFTs, or CrCl decline during therapy

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Red flags — Stop and act

Stop oral terbinafine and escalate when serious hepatotoxicity or other life-threatening reactions develop.

  • Jaundice, dark urine, clay-colored stools, or persistent RUQ pain with rising ALT/AST
  • Clinical hepatitis, ascites, or signs of liver failure
  • Stevens-Johnson syndrome or toxic epidermal necrolysis (mucosal involvement, widespread painful rash)
  • Anaphylaxis or angioedema after prior terbinafine exposure
  • Severe neutropenia or febrile illness with low white cell count
  • New severe depressive symptoms or suicidal ideation
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High-risk populations

Population Considerations
Any patient without baseline LFTs Do not start until pretreatment ALT and AST are available per labeling
Hepatic cirrhosis or CrCl <50 mL/min Clearance approximately 50% decreased—heightened hepatotoxicity and exposure risk; pharmacy coordination essential
Concurrent fluconazole or CYP2D6 substrates Increased terbinafine levels or substrate toxicity—interaction review at start and on MAR changes
Pregnancy Older labels used pregnancy category B; follow current product label—generally do not initiate during pregnancy unless clearly needed per prescriber
Lactation Present in breast milk at ~7:1 milk:plasma ratio; not recommended in nursing mothers
Pediatric onychomycosis Safety and efficacy not established—avoid off-label use without specialist plan

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Monitoring and documentation

Monitor

  • Pretreatment ALT and AST (and full liver function tests when ordered) before therapy begins
  • Periodic LFTs during therapy per prescriber and labeling recommendations
  • Clinical signs of liver injury: nausea, RUQ pain, jaundice, fatigue, dark urine
  • CBC when neutropenia is suspected; mood and rash symptoms throughout long courses

Document

  • Baseline and follow-up LFT values with dates
  • Week of therapy (especially toenail 12-week courses)
  • Hold events, prescriber notification, and patient teaching on hepatotoxicity warning signs
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Patient teaching

  • Take 250 mg once daily for the full ordered weeks—even if nails still look abnormal early in therapy
  • Report yellow skin or eyes, dark urine, persistent nausea, abdominal pain, unusual bruising, severe rash, or mood changes immediately
  • Taste or smell changes can occur and may not resolve after stopping the drug
  • Do not start if pregnant or breastfeeding without prescriber discussion; labeling does not recommend initiation in pregnancy or nursing
  • Tell all clinicians you take terbinafine before new prescriptions are added

The Hold Rule

Do not give and contact the prescriber or pharmacist when:

The Hold Rule — When to pause and clarify
  • History of anaphylaxis or serious allergic reaction to oral terbinafine
  • Active or chronic liver disease (contraindication)
  • Biochemical liver injury: rising ALT/AST attributable to terbinafine
  • Clinical hepatitis, jaundice, or persistent nausea with RUQ pain pending prescriber review
  • Stevens-Johnson syndrome, toxic epidermal necrolysis, or severe neutropenia
  • Pretreatment ALT/AST not available before the first scheduled dose

Hold parameters may vary by institutional protocol. Follow prescriber orders, pharmacy guidance, and facility policy.

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Clinical practice integration and workflow

Safe oral terbinafine therapy centers on pretreatment liver assessment and early recognition of hepatotoxicity during long nail regimens.

1. Check-before-you-give protocol

  • Confirm pretreatment ALT/AST documented before dose 1
  • Verify 250 mg oral tablet, indication, and week of 6- or 12-week course
  • Review latest LFT trend and GI/hepatic symptoms before each dose in long courses
  • Screen MAR for fluconazole, warfarin, rifampin, and CYP2D6 substrates

2. High-alert and safety badge

Hepatotoxicity monitoring required

Oral terbinafine carries a serious hepatotoxicity warning: liver failure, transplantation, and death have occurred with and without pre-existing liver disease. Treat LFT monitoring and hold rules with high-alert-level discipline.

3. Clinical workflow: hold and question rules

  • Hold when ALT/AST rise above baseline with compatible symptoms until prescriber review
  • Hold first dose if pretreatment LFTs are missing or show active liver disease
  • Do not restart without prescriber and pharmacy plan after suspected hepatotoxicity

4. Critical teach-back questions

  • “What liver warning signs will you report while taking terbinafine?” Yellow skin or eyes, dark urine, persistent nausea, right upper abdominal pain, unusual fatigue.
  • “Why must you finish the full weeks ordered even if the nail still looks infected?” Dermatophyte eradication requires the full course; stopping early increases treatment failure and does not eliminate hepatotoxicity risk during the remaining exposure if restarted.

5. Care coordination

Pharmacist: Pretreatment LFT review, interaction screening (fluconazole, warfarin, CYP2D6 drugs), and hold or discontinuation planning when transaminases rise

Primary prescriber / dermatology: Confirm mycologic indication, course duration (6 vs 12 weeks), and alternative therapy if hepatotoxicity develops

🧠 Quick mental checklist

  • Are pretreatment ALT and AST on the chart?
  • Which week of the 6- or 12-week course is this?
  • What do today’s LFT trends and GI symptoms show?
  • Are fluconazole, warfarin, or CYP2D6 drugs on the MAR?
  • Has the patient reported jaundice, rash, taste loss, or mood changes?
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Terbinafine NCLEX practice questions

Practice NCLEX-style clinical judgment practice for terbinafine hepatotoxicity using a tabbed case (MAR, labs, vitals, nursing notes) for week 8 of toenail onychomycosis therapy with rising ALT/AST, then work through priority action, cue recognition, trend interpretation, matrix urgency, clinical judgment, and documentation cloze—recognise cues → analyse → prioritise → act → evaluate outcomes.

Select a tab to view MAR, labs, vitals, and nursing note details for this case.

Medication administration record — today (week 8)
  • Terbinafine 250 mg PO daily — week 8 of 12-week toenail onychomycosis course
  • Acetaminophen 500 mg PO PRN mild headache — used once yesterday
  • No warfarin or fluconazole on MAR
  • Multivitamin PO daily — home medication
Question 1 — Priority action

After reviewing the case tabs, what is the nurse’s best FIRST action before the scheduled terbinafine dose?

Question 2 — Recognize cues

Which findings from the case tabs increase concern for terbinafine hepatotoxicity? Select all that apply.

Select all that apply

Question 3 — Trend interpretation

After 48 hours, updated data show:

Trend snapshot
ALT 128 → 186 U/L; AST 115 → 164 U/L
Bilirubin 1.1 → 2.4 mg/dL; new scleral icterus
Persistent nausea and RUQ pain; terbinafine still listed active on MAR
Patient afebrile; BP stable

Select all that apply — which nursing actions are appropriate now?

Question 4 — Matrix judgment

For each finding, select the best nursing urgency category (one per row).

Finding Expected Concerning Requires immediate follow-up
Week 2 terbinafine; ALT/AST within baseline; no GI or jaundice symptoms
Week 8; ALT 42 → 128 U/L and AST 38 → 115 U/L with nausea and RUQ tenderness
New pruritic rash without mucosal involvement on day 10 terbinafine
Jaundice, confusion, INR rising, bilirubin climbing after continued terbinafine despite prior LFT rise

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Question 5 — Clinical judgment

Which pre-administration assessment is required by prescribing information before starting oral terbinafine for onychomycosis?

Question 6 — Documentation cloze

Before the first oral terbinafine dose, the nurse confirms because hepatotoxicity can occur with or without pre-existing liver disease.

Answer key & rationale

Frequently asked questions

Why do nurses need pretreatment liver tests before oral terbinafine?

Prescribing information requires pretreatment ALT and AST because oral terbinafine has caused serious hepatotoxicity, including liver failure and death, with or without pre-existing liver disease. Baseline transaminases identify patients who should not start therapy and provide a reference for detecting drug-related liver injury during treatment.

When should a nurse hold oral terbinafine?

Hold and notify the prescriber or pharmacist for hypersensitivity or anaphylaxis, clinical signs of liver injury, rising ALT or AST attributable to terbinafine, jaundice, persistent nausea with right upper quadrant pain, Stevens-Johnson syndrome or toxic epidermal necrolysis, and severe neutropenia. Chronic or active liver disease is a contraindication per labeling.

How long is terbinafine given for onychomycosis?

For immunocompetent adults, labeling recommends terbinafine 250 mg once daily for 6 weeks for fingernail onychomycosis and 12 weeks for toenail onychomycosis. Nurses should verify the indication matches the ordered duration and reinforce that laboratory monitoring continues for the full course.

Does terbinafine interact with fluconazole or warfarin?

Fluconazole can increase terbinafine exposure. Terbinafine inhibits CYP2D6 and may alter prothrombin time with warfarin. Rifampin increases terbinafine clearance and cimetidine decreases clearance. Reconcile interacting drugs at admission and when new prescriptions are added.

Is oral terbinafine safe in pregnancy and breastfeeding?

Older labeling classified terbinafine as pregnancy category B; current counseling should follow the product label and prescriber risk–benefit assessment. Oral terbinafine is generally not initiated during pregnancy unless clearly needed. Terbinafine is present in breast milk at approximately seven times the plasma concentration and is not recommended in nursing mothers per prescribing information and LactMed.

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References

  1. U.S. National Library of Medicine. Terbinafine hydrochloride tablets — Full prescribing information. DailyMed.
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e0b309a5-bebe-c6da-2847-bda21aa488b1
  2. Drugs and Lactation Database (LactMed). Terbinafine. Bethesda (MD): National Institute of Child Health and Human Development.
    https://www.ncbi.nlm.nih.gov/books/NBK501168/
  3. National Institute of Diabetes and Digestive and Kidney Diseases. LiverTox. Terbinafine.
    https://www.ncbi.nlm.nih.gov/books/NBK548617/
  4. U.S. National Library of Medicine. MedlinePlus. Terbinafine.
    https://medlineplus.gov/druginfo/meds/a601014.html
  5. U.S. Food and Drug Administration. MedWatch: FDA Safety Information and Adverse Event Reporting Program.
    https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
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Review and transparency

This medication guide is written and reviewed using NurseOnShift editorial and clinical review standards.

Educational use only. This content does not replace clinical judgment, prescriber orders, pharmacist guidance, product labeling, or institutional protocols.