VERMOX SIDE EFFECTS

  • Generic Name: mebendazole
  • Brand Name: Vermox
  • Drug Class: Anthelmintics
Last updated on MDtodate: 10/7/2022

SIDE EFFECTS

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*

Adverse Reaction(s)
Gastrointestinal Disorders
Anorexia
Abdominal Pain
Diarrhea
Flatulence
Nausea
Vomiting
Skin and Subcutaneous Tissue Disorders
Rash
* Includes mebendazole formulations, dosages and treatment duration other than VERMOX™ CHEWABLE 500 mg tablet

 

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.

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*

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
* Includes mebendazole formulations, dosages and treatment durations other than VERMOX™ CHEWABLE 500 mg tablet

 

SRC: NLM .