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Terbinafine Side Effects

Common Terbinafine Side Effects


The most commonly reported Terbinafine side effects (click to view or check a box to report):

Dysgeusia (85)
Ageusia (80)
Dizziness (61)
Rash (60)
Depression (57)
Nausea (51)
Malaise (47)
Pruritus (44)
Headache (41)
Anxiety (36)
Weight Decreased (33)
Urticaria (33)
Fatigue (32)
Liver Function Test Abnormal (32)
Erythema (32)
Paraesthesia (31)
Skin Exfoliation (29)
Myalgia (28)
Diarrhoea (28)
Panic Attack (27)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Terbinafine Side Effects Reported to FDA

The following Terbinafine reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Terbinafine on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Pancreatitis, Cholelithiasis, Gastrointestinal Inflammation, Liver Function Test Abnormal
This is a report of a 66-year-old male patient (weight: NA) from GB, suffering from the following symptoms/conditions: onychomycosis, who was treated with Terbinafine (dosage: 250 Mg, Unk, start time: Sep 24, 2013), combined with:
  • Covonia Bronchial (Unk Ukn, Unk)
  • Ibuprofen (Unk Ukn, Unk)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Pancreatitis
  • Cholelithiasis
  • Gastrointestinal Inflammation
  • Liver Function Test Abnormal
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Terbinafine treatment in male patients, resulting in pancreatitis side effect. The patient was hospitalized.

Blister, Rash Macular
This report suggests a potential Terbinafine (terbinafine) Blister, Rash Macular side effect(s) that can have serious consequences. A 31-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Terbinafine (terbinafine) (dosage: NA) starting Nov 20, 2013. Soon after starting Terbinafine (terbinafine) the patient began experiencing various side effects, including:
  • Blister
  • Rash Macular
Drugs used concurrently:
  • Betamethasone Valerate (betamethasone Valerate)
  • E45 (akwa Tears /01635801/)
  • Mometasone (mometasone)
Although Terbinafine (terbinafine) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as blister, may still occur.

Biliary Cirrhosis Primary, Urticaria, Tryptase Increased, Pruritus, Autoimmune Disorder, Hepatic Enzyme Increased
This Biliary Cirrhosis Primary, Urticaria, Tryptase Increased, Pruritus, Autoimmune Disorder, Hepatic Enzyme Increased problem was reported by a health professional from CH. A 29-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: antifungal treatment. On NS this consumer started treatment with Terbinafine (dosage: NA). The following drugs were being taken at the same time: NA. When commencing Terbinafine, the patient experienced the following unwanted symptoms/side effects:
  • Biliary Cirrhosis Primary
  • Urticaria
  • Tryptase Increased
  • Pruritus
  • Autoimmune Disorder
  • Hepatic Enzyme Increased
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as biliary cirrhosis primary, may become evident only after a product is in use by the general population.

Blister, Rash Macular, Rash Pustular
This is a report of a 31-year-old male patient (weight: NA) from GB. The patient developed the following symptoms/conditions: NA and was treated with Terbinafine (dosage: NA) starting Oct 25, 2013. Concurrently used drugs:
  • Betamethasone Valerate
  • E45
  • Mometasone
Soon after that, the consumer experienced the following side effects:
  • Blister
  • Rash Macular
  • Rash Pustular
This opens a possibility that Terbinafine treatment could cause the above reactions, including blister, and some male subjects may be more susceptible.


Blister, Rash Pustular, Rash Macular
A 31-year-old male patient (weight: NA) from GB with the following symptoms/conditions: NA started Terbinafine treatment (dosage: Unk Ukn, Unk) on Oct 25, 2013. Soon after starting Terbinafine treatment, the subject experienced various side effects, including:
  • Blister
  • Rash Pustular
  • Rash Macular
Concurrently used drugs:
  • Betamethasone Valerate (Unk Ukn, Unk)
  • E45 (Unk Ukn, Unk)
  • Mometasone (Unk Ukn, Unk)
  • Cetraben (Unk Ukn, Unk)
This finding indicates that some male patients could be more vulnerable to Terbinafine.

Subacute Cutaneous Lupus Erythematosus, Erythema Multiforme
A 78-year-old male patient from DK (weight: NA) experienced symptoms, such as: NA and was treated with Terbinafine(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Subacute Cutaneous Lupus Erythematosus
  • Erythema Multiforme
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Terbinafine efficacy:
  • Lansoprazole (Unk)


Epilepsy
In this report, Terbinafine was administered for the following condition: onychomycosis.A 56-year-old male consumer from GB (weight: NA) started Terbinafine treatment (dosage: NA) on Jul 03, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Epilepsy
A possible interaction with other drugs could have contributed to this reaction:
  • Sildenafil
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Terbinafine treatment could be related to the listed above side effect(s).

Dysgeusia, Headache, Viith Nerve Paralysis
This is a report of the following Terbinafine (terbinafine) side effect(s):
  • Dysgeusia
  • Headache
  • Viith Nerve Paralysis
A 48-year-old female patient from GB (weight: NA) presented with the following condition: onychomycosis and received a treatment with Terbinafine (terbinafine) (dosage: NA) starting: Nov 15, 2013.The following concurrently used drugs could have generated interactions: NA.The patient was hospitalized.This report suggests that a Terbinafine (terbinafine) treatment could be associated with the listed above side effect(s).

Epilepsy
This Terbinafine report was submitted by a 56-year-old male consumer from GB (weight: NA). The patient was diagnosed with: onychomycosis and Terbinafine was administered (dosage: 250 Milligram Daily;) starting: Jul 03, 2013. The consumer developed a set of symptoms:
  • Epilepsy
Other drugs used simultaneously:
  • Sildenafil
Those unexpected symptoms could be linked to a Terbinafine treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Viith Nerve Paralysis, Headache, Dysgeusia
This is a report of a possible correlation between Terbinafine Hydrochloride use and the following symptoms/side effect(s):
  • Viith Nerve Paralysis
  • Headache
  • Dysgeusia
which could contribute to an assessment of Terbinafine Hydrochloride risk profile.A 48-year-old female consumer from GB (weight: NA) was suffering from onychomycosis and was treated with Terbinafine Hydrochloride (dosage: NA) starting Nov 15, 2013.Other concurrent medications: NA.The patient was hospitalized.

Depression, Catatonia
A 64-year-old male patient from NL (weight: NA) presented with the following symptoms: onychomycosis and after a treatment with Terbinafine (dosage: 1 Keer Per Dag 1 Stuk(s)) experienced the following side effect(s):
  • Depression
  • Catatonia
The treatment was started on Nov 26, 2013. Terbinafine was used in combination with the following drugs: NA.The patient was hospitalized.This report could alert potential Terbinafine consumers.

Hypersensitivity, Depression, Skin Disorder, Skin Exfoliation
In this report, a 64-year-old male patient from NL (weight: NA) was affected by a possible Terbinafine side effect.The patient was diagnosed with fungal infection. After a treatment with Terbinafine (dosage: 1 Keer Per Dag 1 Stuk(s), start date: Jan 14, 2011), the patient experienced the following side effect(s):
  • Hypersensitivity
  • Depression
  • Skin Disorder
  • Skin Exfoliation
The following simultaneously used drugs could have led to this reaction:
  • Simvastatine
  • Acetylsalicylzuur
The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Terbinafine treatment.

Viith Nerve Paralysis, Headache, Dysgeusia
This is a report of a 48-year-old female patient from GB (weight: NA), who used Terbinafine (dosage: NA) for a treatment of onychomycosis. After starting a treatment on Nov 15, 2013, the patient experienced the following side effect(s):
  • Viith Nerve Paralysis
  • Headache
  • Dysgeusia
The following drugs could possibly have interacted with the Terbinafine treatment NA.The patient was hospitalized.Taken together, these observations suggest that a Terbinafine treatment could be related to side effect(s), such as Viith Nerve Paralysis, Headache, Dysgeusia.

Epilepsy
This epilepsy side effect was reported by a health professional from GB. A 56-year-old male patient (weight:NA) experienced the following symptoms/conditions: onychomycosis. The patient was prescribed Terbinafine (dosage: 250 Mg, Qd), which was started on Jul 03, 2013. Concurrently used drugs:
  • Sildenafil (Unk Ukn, Unk)
When starting to take Terbinafine the consumer reported the following symptoms:
  • Epilepsy
These side effects may potentially be related to Terbinafine.

Viith Nerve Paralysis, Headache, Dysgeusia
This is a Terbinafine side effect report of a 48-year-old female patient (weight:NA) from GB, suffering from the following symptoms/conditions: onychomycosis, who was treated with Terbinafine (dosage:NA, start time: Nov 15, 2013), combined with: NA., and developed a serious reaction and a viith nerve paralysis side effect. The patient presented with:
  • Viith Nerve Paralysis
  • Headache
  • Dysgeusia
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Terbinafine treatment in female patients suffering from onychomycosis, resulting in viith nerve paralysis.

Stevens-johnson Syndrome, Eczema, Insomnia, Stress
This report suggests a potential Terbinafine stevens-johnson syndrome side effect(s) that can have serious consequences. A 78-year-old male patient from GB (weight:NA) was diagnosed with the following health condition(s): tinea infection and used Terbinafine (dosage: NA) starting Sep 14, 2013. Soon after starting Terbinafine the patient began experiencing various side effects, including:
  • Stevens-johnson Syndrome
  • Eczema
  • Insomnia
  • Stress
Drugs used concurrently:NA. Although Terbinafine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as stevens-johnson syndrome, may still occur.

Pulse Pressure Increased, Arteritis, Muscle Spasms, Pain Of Skin, Headache
This pulse pressure increased problem was reported by a health professional from GB. A 62-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): onychomycosis.On Dec 30, 2013 a consumer started treatment with Terbinafine (dosage: 250 Mg, Unk). The following drugs/medications were being taken at the same time:
  • Amitriptyline (10 Mg, Qd At Night)
When commencing Terbinafine, the patient experienced the following unwanted symptoms /side effects:
  • Pulse Pressure Increased
  • Arteritis
  • Muscle Spasms
  • Pain Of Skin
  • Headache
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as pulse pressure increased, may become evident only after a product is in use by the general population.

Dysgeusia, Ageusia, Food Aversion, Aptyalism, Dysphagia, Oropharyngeal Pain
This is a Terbinafine Hcl side effect report of a 65-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Terbinafine Hcl (dosage: NA) starting Oct 04, 2013. Concurrently used drugs:
  • Estradiol
  • Diltiazem Hcl
  • Hydrochlorothiazide
  • Baby Aspirin
  • Citracal D
  • Centrum Specialist Heart
Soon after that, the consumer experienced the following of symptoms:
  • Dysgeusia
  • Ageusia
  • Food Aversion
  • Aptyalism
  • Dysphagia
  • Oropharyngeal Pain
This opens a possibility that Terbinafine Hcl could cause dysgeusia and that some female patients may be more susceptible.

Rash, Excoriation, Dry Skin, Erythema
A 88-year-old female patient (weight: NA) from GB with the following symptoms: fungal infection started Terbinafine (terbinafine) treatment (dosage: NA) on Dec 19, 2013. Soon after starting Terbinafine (terbinafine) treatment, the consumer experienced several side effects, including:
  • Rash
  • Excoriation
  • Dry Skin
  • Erythema
. Concurrently used drugs:
  • Aspirin (acetylsalicylic Acid)
  • Diprobase (diprobase)
  • E45 (akwa Tears)
  • Enalapril (enalapril)
  • Flucloxacillin ( Flucloxacillin)
  • Metformin (metformin)
  • Miconazole (miconazole)
  • Paracetamol (paracetamol)
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Terbinafine (terbinafine) side effects, such as rash.

Arteritis, Pain, Headache, Pulse Pressure Increased, Pain Of Skin, Muscle Spasms
This arteritis side effect was reported by a physician from GB. A 62-year-old female patient (weight:NA) experienced the following symptoms/conditions: onychomycosis.The patient was prescribed Terbinafine (dosage: NA), which was started on Dec 30, 2013. Concurrently used drugs:
  • Amitriptyline
.When starting to take Terbinafine the consumer reported symptoms, such as:
  • Arteritis
  • Pain
  • Headache
  • Pulse Pressure Increased
  • Pain Of Skin
  • Muscle Spasms
These side effects may potentially be related to Terbinafine.

Dermatitis Exfoliative, Arthralgia, Erythema, Renal Failure Acute, Renal Impairment, Local Swelling
This is a report of a 77-year-old male patient (weight: NA) from GB, suffering from the following symptoms/conditions: onychomycosis, who was treated with Terbinafine (dosage: NA, start time: Aug 19, 2013), combined with:
  • Flucloxacillin
  • Penicillin V
  • Atorvastatin
  • Clopidogrel
  • Metformin
and developed a serious reaction and side effect(s). The consumer presented with:
  • Dermatitis Exfoliative
  • Arthralgia
  • Erythema
  • Renal Failure Acute
  • Renal Impairment
  • Local Swelling
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Terbinafine treatment in male patients, resulting in dermatitis exfoliative side effect. The patient was hospitalized and became disabled.

Erythema, Dry Skin, Excoriation
This report suggests a potential Terbinafine Erythema, Dry Skin, Excoriation side effect(s) that can have serious consequences. A 88-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: fungal infection and used Terbinafine (dosage: NA) starting Dec 17, 2013. Soon after starting Terbinafine the patient began experiencing various side effects, including:
  • Erythema
  • Dry Skin
  • Excoriation
Drugs used concurrently:
  • Aspirin
  • Diprobase
  • E45
  • Enalapril
  • Flucloxacillin
  • Metformin
  • Miconazole
  • Paracetamol
The patient was hospitalized. Although Terbinafine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as erythema, may still occur.

Orchitis, Dermatitis Exfoliative, Groin Pain, Renal Failure Acute, Hepatic Function Abnormal, Thrombocytopenia, Atrial Fibrillation, Respiratory Failure
This Orchitis, Dermatitis Exfoliative, Groin Pain, Renal Failure Acute, Hepatic Function Abnormal, Thrombocytopenia, Atrial Fibrillation, Respiratory Failure problem was reported by a pharmacist from GB. A 57-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: fungal infection. On Sep 24, 2013 this consumer started treatment with Terbinafine (dosage: NA). The following drugs were being taken at the same time:
  • Phenobarbital (phenobarbital)
When commencing Terbinafine, the patient experienced the following unwanted symptoms/side effects:
  • Orchitis
  • Dermatitis Exfoliative
  • Groin Pain
  • Renal Failure Acute
  • Hepatic Function Abnormal
  • Thrombocytopenia
  • Atrial Fibrillation
  • Respiratory Failure
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as orchitis, may become evident only after a product is in use by the general population.

Renal Failure Acute
This is a report of a 25-year-old male patient (weight: NA) from FR. The patient developed the following symptoms/conditions: NA and was treated with Terbinafine (dosage: NA) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Renal Failure Acute
The patient was hospitalized. This opens a possibility that Terbinafine treatment could cause the above reactions, including renal failure acute, and some male subjects may be more susceptible.

Dermatitis Exfoliative, Thrombocytopenia, Hepatic Function Abnormal, Respiratory Failure, Renal Failure Acute, Groin Pain, Orchitis, Atrial Fibrillation
A 57-year-old male patient (weight: NA) from GB with the following symptoms/conditions: fungal infection,epilepsy started Terbinafine treatment (dosage: 250 Milligram Daily; (note: 13 Of 28 Tablets Supplied Remain I.e. Not Taken)) on Sep 24, 2013. Soon after starting Terbinafine treatment, the subject experienced various side effects, including:
  • Dermatitis Exfoliative
  • Thrombocytopenia
  • Hepatic Function Abnormal
  • Respiratory Failure
  • Renal Failure Acute
  • Groin Pain
  • Orchitis
  • Atrial Fibrillation
Concurrently used drugs:
  • Phenobarbital
This finding indicates that some male patients could be more vulnerable to Terbinafine.

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Top 10 Terbinafine Side Effects for Women

Women Side EffectsReports
Dysgeusia 76
Ageusia 59
Malaise 40
Dizziness 39
Nausea 29
Weight Decreased 29
Headache 28
Pruritus 27
Depression 26
Rash 23

Top 10 Terbinafine Side Effects for Men

Men Side EffectsReports
Rash 35
Depression 31
Pancreatitis 25
Ageusia 21
Nausea 21
Liver Function Test Abnormal 20
Paraesthesia 20
Dizziness 19
Myalgia 18
Skin Exfoliation 18

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    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.


    Discuss Terbinafine Side Effects

    Did You Have a Terbinafine Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Terbinafine for You?

    Exceeded Expectations
    Effective
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    Terbinafine Safety Alerts, Active Ingredients, Usage Information

    NDC0363-2083
    TypeHUMAN OTC DRUG
    Proprietary NameTerbinafine Hydrochloride
    NameTerbinafine Hydrochloride
    Dosage FormCREAM
    RouteTOPICAL
    On market since20070702
    LabelerWalgreen Company
    Active Ingredient(s)TERBINAFINE HYDROCHLORIDE
    Strength(s)1
    Unit(s)g/100g
    Pharma Class

    More About Terbinafine

    Side Effects reported to FDA: 1036

    Terbinafine safety alerts: 2001 2000

    Reported deaths: 23

    Reported hospitalizations: 126

    Lamisil (terbinafine hydrochloride)

    Sporanox (itraconazole)

    Audience: Dermatologists and other healthcare professionals

    FDA is issuing a public health advisory concerning Sporanox and Lamisil, systemic drug therapies to treat onychomycosis (fungal nail infections). Healthcare professionals are notified of the possible association of serious cardiac adverse events with the administration of Sporanox and hepatic adverse events with the administration of both Sporanox and Lamisil. New labeling for both Sporanox and Lamisil recommends that healthcare providers obtain nail specimens for laboratory testing prior to prescribing the medications for onychomycosis to confirm the diagnosis. FDA's concerns do NOT apply to the over-the-counter versions of Lamisil, which are topical creams.

    [May 11, 2001 - Letter - Novartis Pharmaceuticals Corp.]
    [May 09, 2001 - Letter - Janssen Pharmaceutica Products, L.P.]
    [May 09, 2001 - Public Health Advisory - FDA]
    [May 09, 2001 - Questions and Answers - FDA]
    [May 09, 2001 - Revised Sporanox Capsules Label - Janssen Pharmaceutica Products, L.P.]

     

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