VERMOX
Generic: MEBENDAZOLE
Basic Information
Manufacturer
Janssen Pharmaceuticals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
a720c424-517a-461b-8e13-6c37caf8aa3f
Indications & Usage
1 INDICATIONS AND USAGE VERMOX™ CHEWABLE is indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm).
VERMOX™ CHEWABLE is an anthelmintic indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by: Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm) ( 1 ).
VERMOX™ CHEWABLE is an anthelmintic indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by: Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm) ( 1 ).
Adverse Reactions
6 ADVERSE REACTIONS Adverse reactions reported in clinical trials were anorexia, abdominal pain, diarrhea, flatulence, nausea, vomiting and rash.
( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc.
at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Studies Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed 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 safety of mebendazole was evaluated in 6276 adult and pediatric subjects one year of age and older who participated in 39 clinical trials for treatment of single or mixed parasitic infections of the gastrointestinal tract.
In these trials, the formulations, dosages and duration of mebendazole treatment varied.
Adverse reactions reported in mebendazole-treated subjects from the 39 clinical trials are shown in Table 1 below.
Table 1: Adverse Reactions Reported in Mebendazole-Treated Subjects from 39 Clinical Trials Includes mebendazole formulations, dosages and treatment duration other than VERMOX™ CHEWABLE 500 mg tablet Adverse Reaction(s) Gastrointestinal Disorders Anorexia Abdominal Pain Diarrhea Flatulence Nausea Vomiting Skin and Subcutaneous Tissue Disorders Rash Clinical Studies with Mebendazole Chewable 500 mg Tablet The safety profile of mebendazole chewable 500 mg tablets administered as a single dose was evaluated in 677 pediatric subjects aged 1 to 16 years and in 34 adults.
The safety profile was consistent with the known safety profile of mebendazole.
6.2 Postmarketing Experience The following adverse reactions have been identified in adult and pediatric patients postmarketing with mebendazole formulations and dosages other than the VERMOX™ CHEWABLE 500 mg tablet.
Because these reactions 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.
Table 2: Adverse Reactions Identified During Postmarketing Experience with Mebendazole Includes mebendazole formulations, dosages and treatment durations other than VERMOX™ CHEWABLE 500 mg tablet Adverse Reaction(s) Blood and Lymphatic System Disorders Agranulocytosis, Neutropenia Immune System Disorders Hypersensitivity including anaphylactic reactions Nervous System Disorders Convulsions, Dizziness Hepatobiliary Disorders Hepatitis, Abnormal liver tests Renal and Urinary Disorders Glomerulonephritis Skin and Subcutaneous Tissue Disorders Toxic epidermal necrolysis, Stevens-Johnson syndrome, Exanthema, Angioedema, Urticaria, Alopecia
( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc.
at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Studies Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed 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 safety of mebendazole was evaluated in 6276 adult and pediatric subjects one year of age and older who participated in 39 clinical trials for treatment of single or mixed parasitic infections of the gastrointestinal tract.
In these trials, the formulations, dosages and duration of mebendazole treatment varied.
Adverse reactions reported in mebendazole-treated subjects from the 39 clinical trials are shown in Table 1 below.
Table 1: Adverse Reactions Reported in Mebendazole-Treated Subjects from 39 Clinical Trials Includes mebendazole formulations, dosages and treatment duration other than VERMOX™ CHEWABLE 500 mg tablet Adverse Reaction(s) Gastrointestinal Disorders Anorexia Abdominal Pain Diarrhea Flatulence Nausea Vomiting Skin and Subcutaneous Tissue Disorders Rash Clinical Studies with Mebendazole Chewable 500 mg Tablet The safety profile of mebendazole chewable 500 mg tablets administered as a single dose was evaluated in 677 pediatric subjects aged 1 to 16 years and in 34 adults.
The safety profile was consistent with the known safety profile of mebendazole.
6.2 Postmarketing Experience The following adverse reactions have been identified in adult and pediatric patients postmarketing with mebendazole formulations and dosages other than the VERMOX™ CHEWABLE 500 mg tablet.
Because these reactions 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.
Table 2: Adverse Reactions Identified During Postmarketing Experience with Mebendazole Includes mebendazole formulations, dosages and treatment durations other than VERMOX™ CHEWABLE 500 mg tablet Adverse Reaction(s) Blood and Lymphatic System Disorders Agranulocytosis, Neutropenia Immune System Disorders Hypersensitivity including anaphylactic reactions Nervous System Disorders Convulsions, Dizziness Hepatobiliary Disorders Hepatitis, Abnormal liver tests Renal and Urinary Disorders Glomerulonephritis Skin and Subcutaneous Tissue Disorders Toxic epidermal necrolysis, Stevens-Johnson syndrome, Exanthema, Angioedema, Urticaria, Alopecia