Lamisil Side Effects Center

Find Lowest Prices on

Medical Editor: John P. Cunha, DO, FACOEP

What Is Lamisil?

Lamisil (terbinafine hydrochloride) is an antifungal antibiotic used to treat infections caused by fungus that affect the fingernails or toenails (onychomycosis). Oral granules are used to treat a fungal infection of scalp hair follicles in children who are at least 4 years old. Lamisil is available in generic form.

What Are Side Effects of Lamisil?

Common side effects of Lamisil include

diarrhea,
stomach upset,
gas,
nausea,
stomach pain,
diarrhea,
headache,
dizziness,
spinning sensation,
mild skin rash,
itching, or
temporary unusual or unpleasant taste or loss of taste in your mouth.

Dosage for Lamisil

To treat fingernail onychomycosis the dose of Lamisil is one 250 mg tablet once daily for 6 weeks. For toenail onychomycosis, take one 250 mg tablet once daily for 12 weeks.

What Drugs, Substances, or Supplements Interact with Lamisil?

Lamisil may interact with cimetidine, rifampin, other antifungal antibiotics, blood thinners, heart rhythm medications, antidepressants, MAO inhibitors (MAOIs), or beta-blockers. Tell your doctor all medications you use.

Lamisil During Pregnancy and Breastfeeding

During pregnancy, Lamisil should be used only when prescribed. Fungal nail infection treatment can usually wait until after you have had your baby. This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug.

Additional Information

Our Lamisil (terbinafine hydrochloride) 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.

SLIDESHOW

Nail Disorders: What Nails Say About Your Health See Slideshow

Lamisil Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using terbinafine.

Some people taking terbinafine have developed severe liver damage leading to liver transplant or death. It is not clear whether terbinafine actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking terbinafine.

Call your doctor at once if you have symptoms of liver damage, such as nausea, upper stomach pain, vomiting, loss of appetite, tiredness, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.

Also call your doctor if you have:

changes in your sense of taste or smell;
depressed mood, sleep problems, lack of interest in daily activity, feeling anxious or restless;
pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
swelling, rapid weight gain, little or no urinating;
blood in your urine or stools;
weight loss due to taste changes or loss of appetite; or
skin sores, butterfly-shaped skin rash on your cheeks and nose (worsens in sunlight).

Common side effects may include:

diarrhea, nausea, gas, stomach pain or upset;
rash;
headache;
abnormal liver function tests.

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.

Lamisil Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most frequently reported adverse events observed in the 3 US/Canadian placebo-controlled trials are listed in the table below. The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia, and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. Changes in the ocular lens and retina have been reported following the use of Lamisil Tablets in controlled trials. The clinical significance of these changes is unknown. In general, the adverse events were mild, transient, and did not lead to discontinuation from study participation.

	Adverse Event		Discontinuation
	Lamisil Tablets (%) n=465	Placebo (%) n=137	Lamisil Tablets (%) n=465	Placebo (%) n=137
Headache	12.9	9.5	0.2	0.0
Gastrointestinal Symptoms:
Diarrhea	5.6	2.9	0.6	0.0
Dyspepsia	4.3	2.9	0.4	0.0
Abdominal Pain	2.4	1.5	0.4	0.0
Nausea	2.6	2.9	0.2	0.0
Flatulence	2.2	2.2	0.0	0.0
Dermatological Symptoms:
Rash	5.6	2.2	0.9	0.7
Pruritus	2.8	1.5	0.2	0.0
Urticaria	1.1	0.0	0.0	0.0
Liver Enzyme Abnormalities*	3.3	1.4	0.2	0.0
Taste Disturbance	2.8	0.7	0.2	0.0
Visual Disturbance	1.1	1.5	0.9	0.0
*Liver enzyme abnormalities ≥ 2x the upper limit of normal range.

Postmarketing Experience

The following adverse events have been identified during postapproval use of Lamisil Tablets. Because these events 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: Pancytopenia, agranulocytosis, severe neutropenia, thrombocytopenia, anemia [see WARNINGS AND PRECAUTIONS]

Immune system disorders: Serious hypersensitivity reactions e.g., angioedema and allergic reactions (including anaphylaxis), precipitation and exacerbation of cutaneous and systemic lupus erythematosus [see WARNINGS AND PRECAUTIONS], serum sickness-like reaction

Psychiatric disorders: Anxiety and depressive symptoms independent of taste disturbance have been reported with use of Lamisil Tablets. In some cases, depressive symptoms have been reported to subside with discontinuance of therapy and to recur with reinstitution of therapy [see WARNINGS AND PRECAUTIONS].

Nervous system disorders: Cases of taste disturbance, including taste loss, have been reported with the use of Lamisil Tablets. It can be severe enough to result in decreased food intake, weight loss, anxiety, and depressive symptoms. Cases of smell disturbance, including smell loss, have been reported with the use of Lamisil Tablets [see WARNINGS AND PRECAUTIONS]. Cases of paresthesia and hypoesthesia have been reported with the use of Lamisil Tablets.

Eye disorders: Visual field defects, reduced visual acuity

Ear and labyrinth disorders: Hearing impairment, vertigo, tinnitus

Vascular disorders: Vasculitis

Gastrointestinal disorders: Pancreatitis, vomiting

Hepatobiliary disorders: Cases of liver failure some leading to liver transplant or death [see WARNINGS AND PRECAUTIONS], idiosyncratic and symptomatic hepatic injury. Cases of hepatitis, cholestasis, and increased hepatic enzymes [see WARNINGS AND PRECAUTIONS] have been seen with the use of Lamisil Tablets.

Skin and subcutaneous tissue disorders: Serious skin reactions [e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome] [see WARNINGS AND PRECAUTIONS], acute generalized exanthematous pustulosis, psoriasiform eruptions or exacerbation of psoriasis, photosensitivity reactions, hair loss

Musculoskeletal and connective tissue disorders: Rhabdomyolysis, arthralgia, myalgia

General disorders and administration site conditions: Malaise, fatigue, influenza-like illness, pyrexia

Investigations: Altered prothrombin time (prolongation and reduction) in patients concomitantly treated with warfarin and increased blood creatine phosphokinase have been reported

Read the entire FDA prescribing information for Lamisil (Terbinafine)