Lamisil Oral Granules

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 10/6/2021
Lamisil Oral Granules Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Are Lamisil Oral Granules?

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

What Are Side Effects of Lamisil Oral Granules?

Common side effects of Lamisil Oral Granules include headache, nausea, vomiting, diarrhea, gas, nausea, upset stomach, stomach pain, stuffy or runny nose, cough, dizziness or spinning sensation, skin rash or itching, or unusual or unpleasant taste in your mouth or loss of taste.

Dosage for Lamisil Oral Granules

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

What Drugs, Substances, or Supplements Interact with Lamisil Oral Granules?

Lamisil Oral Granules may interact with cimetidine, cyclosporine, rifampin, other antifungal medicines, blood thinners, heart rhythm medications, antidepressants, MAO inhibitors, or beta-blockers. Tell your doctor all medications and supplements you use.

Lamisil Oral Granules During Pregnancy and Breastfeeding

During pregnancy, Lamisil Oral Granules should be used only if prescribed. This medication passes into breast milk and may have undesirable effects on a nursing infant. Breastfeeding is not recommended while using Lamisil Oral Granules.

Additional Information

Our Lamisil Oral Granules (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.

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Lamisil Oral Granules 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.

Read the entire detailed patient monograph for Lamisil Oral Granules (Terbinafine Hydrochloride)

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Lamisil Oral Granules Professional Information

SIDE EFFECTS

Clinical Studies 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.

Lamisil (terbinafine hydrochloride) Oral Granules

The data described below reflect exposure to terbinafine including 1042 subjects exposed for a median of 42 days. Lamisil Oral Granules (terbinafine hydrochloride) was studied in 2 active-controlled trials (n=1042). The population was children aged 4 to 12 years old, 64% male and 36% female, 21% Caucasian, 47% Black, 32% Other. Baseline disease (dermatophyte) characteristics of subjects included 49% having T. tonsurans, 15% T. violaceum, 15% M. canis, 2% M. audouinii, and 1% others. Subjects received once daily, for 6 weeks, oral doses of Lamisil Oral Granules (terbinafine hydrochloride) based on body weight: < 25kg 125 mg/day, 25-35kg 187.5 mg/day, and > 35kg 250 mg/day. Adverse events reported in the 2 trials are listed in the table below.

Table 2 Adverse Events ( ≥ 1%) in the Tinea Capitis Trials

  Lamisil®
Oral Granules (%)
N=1042
Griseofulvin oral
suspension (%)
N=507
Nasopharyngitis 10 11
Headache 7 8
Pyrexia 7 6
Cough 6 5
Vomiting 5 5
Upper respiratory tract infection 5 5
Upper abdominal pain 4 4
Diarrhea 3 4
Influenza 2 1
Abdominal pain 2 1
Pharyngolaryngeal pain 2 2
Nausea 2 2
Rash 2 2
Rhinorrhea 2 0
Nasal congestion 2 1
Pruritus 1 1
Toothache 1 1

In the pooled pivotal trials, 2% (17/1042) of subjects in the terbinafine group and 2% (6/507) in the griseofulvin group experienced discontinuation of study drug due to adverse events. The most common categories of adverse events causing discontinuation in those exposed to terbinafine included gastrointestinal disorders, skin and subcutaneous disorders, and infections and infestations.

No ophthalmologic safety signal was identified in the pooled pivotal trials. Ophthalmologic assessments included dilated fundoscopy to assess for refractile bodies in the retina, visual acuity assessment, and color vision testing. Of the 940 subjects in the terbinafine group and 471 subjects in the griseofulvin group who completed dilated fundoscopy at post-treatment visits, none of the subjects were found to have refractile bodies of the retina at baseline or end of treatment. For visual acuity, 1% (11/837) of subjects treated with terbinafine and 2% (7/426) of subjects treated with griseofulvin showed a doubling of visual angle after 6 weeks of treatment, while 2% (15/837) treated with terbinafine and 3% (12/426) treated with griseofulvin showed a halving of the visual angle after 6 weeks of treatment. Of subjects who completed yellow-blue color vision assessment for acquired defects, 5% (13/262) of subjects treated with terbinafine and 6% (8/129) of subjects treated with griseofulvin had color confusion on more than one symbol at week 6 than at baseline, while 13% (33/262) of subjects treated with terbinafine and 13% (17/129) of subjects treated with griseofulvin identified more symbols correctly at week 6 than at baseline.

Lamisil (terbinafine hydrochloride) Tablets

Adverse events reported in three US/Canadian placebo-controlled trials included diarrhea (6%), rashes (6%), dyspepsia (4%), nausea (3%), liver abnormalities (3%), pruritus (3%), taste disturbances (3%), abdominal pain (2%), and urticaria (1%).

Changes in the ocular lens and retina have been reported following the use of Lamisil Tablets in clinical trials in adult subjects with onychomycosis. The clinical significance of these changes is unknown.

Postmarketing Experience

The following adverse events have been identified during postapproval use of Lamisil. 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.

Adverse events reported with oral terbinafine use include: idiosyncratic and symptomatic hepatic injury and, cases of liver failure, some leading to death or liver transplant, serious skin reactions, severe neutropenia, thrombocytopenia, agranulocytosis, pancytopenia, anemia, angioedema and allergic reactions (including anaphylaxis) [see Warnings and PRECAUTIONS].

Psoriasiform eruptions or exacerbation of psoriasis, acute generalized exanthematous pustulosis and precipitation and exacerbation of cutaneous and systemic lupus erythematosus have been reported. Oral terbinafine may cause taste disturbance (including taste loss) which usually recovers within several weeks after discontinuation of the drug. There have been reports of prolonged (greater than one year) taste disturbance. Taste disturbances have been reported to be severe enough to result in decreased food intake leading to significant and unwanted weight loss.

Other adverse reactions which have been reported include malaise, fatigue, arthralgia, myalgia, vomiting, acute pancreatitis, rhabdomyolysis, reduced visual acuity, visual field defects, and hair loss. Adverse events reported spontaneously since the drug was marketed include altered prothrombin time (prolongation and reduction) in patients concomitantly treated with warfarin.

Read the entire FDA prescribing information for Lamisil Oral Granules (Terbinafine Hydrochloride)

© Lamisil Oral Granules Patient Information is supplied by Cerner Multum, Inc. and Lamisil Oral Granules Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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