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Lamisil Oral Granules

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Lamisil Oral Granules

Lamisil Oral Granules Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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. Common side effects include headache, vomiting, diarrhea, nausea, upset stomach, stuffy/runny nose, cough, or temporary change or loss of taste.

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. 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. 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.

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.

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 Oral Granules 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 Oral Granules (Terbinafine Hydrochloride) »

What is Patient Information Overview?

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

Lamisil Oral Granules Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, vomiting, diarrhea, nausea, upset stomach, stuffy/runny nose, cough, 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.

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 Oral Granules (Terbinafine Hydrochloride)»

What is Prescribing information?

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

Lamisil Oral Granules FDA Prescribing Information: Side Effects
(Adverse Reactions)

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) »

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Lamisil Oral Granules - User Reviews

Lamisil Oral Granules 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 Oral Granules 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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