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Lamisil

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Lamisil

Lamisil Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Lamisil (terbinafine hydrochloride) is 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. It is an antifungal antibiotic. This medication is available in generic form. Common side effects include diarrhea, stomach upset, or temporary change or loss of taste.

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. 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. 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.

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.

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.

Lamisil in Detail - Patient Information: Side Effects

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

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, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.

Stop taking terbinafine and call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • joint pain or swelling, swollen glands, patchy skin color, or a butterfly-shaped skin rash over your cheeks and nose;
  • changes in mood or behavior;
  • hearing problems;
  • weight loss due to taste changes;
  • raised, silvery flaking of the skin; 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.

Less serious side effects may include:

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

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 Lamisil (Terbinafine) »

What is Patient Information Overview?

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

Lamisil Overview - Patient Information: Side Effects

SIDE EFFECTS: Diarrhea, stomach upset, or temporary change or loss of 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.

Get medical help right away if you have any very serious side effects, including: new signs of infection (such as fever, chills, persistent sore throat), swollen lymph glands, vision changes, mouth sores, unusual change in the amount of urine, pink/bloody urine, chest pain, fast/irregular heartbeat, unusual tiredness, persistent dry cough, trouble breathing.

This drug has rarely caused very serious (possibly fatal) liver disease. Get medical help right away if you develop symptoms of liver disease, including: persistent nausea/vomiting, loss of appetite, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.

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 Lamisil (Terbinafine)»

What is Prescribing information?

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

Lamisil FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 post-approval 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: 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, and depressive symptoms. Cases of smell disturbance, including smell loss, have been reported with the use of Lamisil Tablets [see WARNINGS AND PRECAUTIONS]

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

Skin and subcutaneous tissue disorders: Serious skin reactions [e.g., Stevens - Johnson syndrome, toxic epidermal necrolysis, 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) »

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Lamisil - User Reviews

Lamisil 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 Lamisil 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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