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Lamisil (Terbinafine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Lamisil (Terbinafine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (169)
Death (15)
Life Threatening Events (6)
Disability (4)

Reports by Reaction Type

Alanine Aminotransferase Increased (17)Aspartate Aminotransferase Increased (16)Malaise (14)Pyrexia (13)Rash (12)Hepatic Function Abnormal (10)Pruritus (10)Off Label Use (9)Fatigue (9)Ageusia (9)Asthenia (9)Drug Interaction (8)

Below are a few examples of reports where side effects / adverse reactions may be related to Lamisil (Terbinafine). For a complete list or a specific selection of reports, please use the links above.

Possible Lamisil side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-27

Patient: female, weighing 65.0 kg (143.0 pounds)

Reactions: Depression, Enzyme Inhibition

Drug(s) suspected as cause:
Lamisil

Other drugs received by patient: Lisinopril



Possible Lamisil side effects in

Reported by a pharmacist from United Kingdom on 2012-08-24

Patient:

Reactions: Enzyme Inhibition

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-24

Patient:

Reactions: Enzyme Inhibition

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in 72 year old male

Reported by a pharmacist from Japan on 2012-08-24

Patient: 72 year old male

Reactions: Hypoacusis, Sudden Hearing Loss, Local Swelling

Drug(s) suspected as cause:
Lamisil
    Administration route: Oral
    Indication: Onychomycosis
    Start date: 2011-10-23

Lamisil
    Dosage: 125 mg,
    Start date: 2011-10-28

Other drugs received by patient: Antibiotics; Antibiotics



Possible Lamisil side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Application Site Discolouration, Contusion, Drug Ineffective FOR Unapproved Indication, Mean Platelet Volume Decreased, Rebound Effect, Lethargy, Drug Administered AT Inappropriate Site, RED Blood Cell Count Increased, Laceration, Cognitive Disorder, Sensation of Pressure, Body Tinea, Incorrect Drug Administration Duration, Impaired Healing, Visual Impairment, Memory Impairment, Blood Pressure Decreased

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in 78 year old male

Reported by a physician from Germany on 2012-08-20

Patient: 78 year old male

Reactions: Anxiety, Medication Error, Depression, Depressed Mood

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: male

Reactions: Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Drug Interaction, Hepatic Enzyme Increased

Drug(s) suspected as cause:
Lamisil

Other drugs received by patient possibly interacting with the suspect drug:
Gilenya
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2012-02-22
    End date: 2012-06-04



Possible Lamisil side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: male

Reactions: Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Drug Interaction, Hepatic Enzyme Increased

Drug(s) suspected as cause:
Lamisil

Other drugs received by patient possibly interacting with the suspect drug:
Gilenya
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2012-02-22
    End date: 2012-06-04



Possible Lamisil side effects in 68 year old male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: 68 year old male

Reactions: Off Label Use, Vision Blurred

Drug(s) suspected as cause:
Lamisil

Other drugs received by patient: Probiotics NOS; Remicade



Possible Lamisil side effects in

Reported by a pharmacist from United Kingdom on 2012-08-14

Patient:

Reactions: Enzyme Inhibition

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in

Reported by a pharmacist from United Kingdom on 2012-08-14

Patient:

Reactions: Enzyme Inhibition

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in 59 year old female

Reported by a pharmacist from Japan on 2012-08-13

Patient: 59 year old female

Reactions: Hepatitis C

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in 41 year old female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: 41 year old female, weighing 59.0 kg (129.7 pounds)

Reactions: Ageusia

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in

Reported by a pharmacist from Japan on 2012-08-07

Patient:

Reactions: Haematuria

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in 76 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-07

Patient: 76 year old female, weighing 52.6 kg (115.8 pounds)

Reactions: Photosensitivity Reaction, Autoimmune Disorder, Pruritus, Urticaria, Rash

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: male

Reactions: Ageusia, Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lamisil

Other drugs received by patient: Warfarin; Digoxin; Terazosin Hydrochloride; Furosemide; Mirtazapine; Levothyroxine Sodium; Atenolol



Possible Lamisil side effects in 50 year old female

Reported by a physician from Japan on 2012-08-02

Patient: 50 year old female

Reactions: Viral Infection, Malaise, Liver Function Test Abnormal, Pyrexia

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in male

Reported by a consumer/non-health professional from Australia on 2012-08-02

Patient: male

Reactions: Oral Mucosal Blistering, Acne, Malaise, Staphylococcal Infection, Oral Pain, Skin Mass, Neutropenia, Feeling Abnormal, Inflammation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in 78 year old male

Reported by a physician from Germany on 2012-08-02

Patient: 78 year old male

Reactions: Anxiety, Medication Error, Depression, Depressed Mood

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in male

Reported by a pharmacist from Japan on 2012-07-27

Patient: male

Reactions: Hypoaesthesia

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-24

Patient: female, weighing 94.8 kg (208.6 pounds)

Reactions: Abdominal Discomfort, Nausea, Diarrhoea, Abdominal Pain Upper

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in 72 year old male

Reported by a physician from Japan on 2012-07-24

Patient: 72 year old male

Reactions: Hypoaesthesia

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in 64 year old male

Reported by a pharmacist from Canada on 2012-07-23

Patient: 64 year old male, weighing 86.0 kg (189.2 pounds)

Reactions: Death, Duodenitis, Renal Failure, Hepatotoxicity, Sepsis, Hepatic Cirrhosis

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Lamisil

Other drugs received by patient: Glyburide; Metformin Hydrochloride; Aspirin; Lipitor



Possible Lamisil side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: male, weighing 86.2 kg (189.6 pounds)

Reactions: Ageusia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in female

Reported by a physician from United States on 2012-07-16

Patient: female

Reactions: Localised Infection, Limb Injury, Wound Secretion

Drug(s) suspected as cause:
Lamisil

Other drugs received by patient: Prozac; Vivelle-DOT



Possible Lamisil side effects in female

Reported by a consumer/non-health professional from Canada on 2012-07-12

Patient: female

Reactions: Vomiting, Palpitations, Hypoaesthesia, Paraesthesia

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in

Reported by a individual with unspecified qualification from United States on 2012-07-09

Patient:

Reactions: Medication Error, Wrong Drug Administered, Dizziness, Drug Dispensing Error

Drug(s) suspected as cause:
Lamisil

Lamotrigine
    Dosage: tablet oral
    Administration route: Oral



Possible Lamisil side effects in male

Reported by a pharmacist from Japan on 2012-07-09

Patient: male

Reactions: Hypoaesthesia

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in 52 year old male

Reported by a pharmacist from United States on 2012-07-09

Patient: 52 year old male, weighing 90.2 kg (198.4 pounds)

Reactions: Jaundice, Dyspnoea, Renal Disorder, Skin Exfoliation, Drug Hypersensitivity, Chromaturia, Drug Rash With Eosinophilia and Systemic Symptoms, Liver Disorder, Acute Generalised Exanthematous Pustulosis, Dermatitis, Oral Pain, Oliguria, Rash Erythematous

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lamisil



Possible Lamisil side effects in female

Reported by a physician from Australia on 2012-07-06

Patient: female

Reactions: Hypoaesthesia

Drug(s) suspected as cause:
Lamisil

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