Benznidazole

Last updated on RxList: 10/9/2019
Benznidazole Side Effects Center

Last reviewed on RxList 10/9/2019

Benznidazole tablets are a nitroimidazole antimicrobial indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis), caused by Trypanosoma cruzi. Common side effects of Benznidazole include:

For pediatric patients 2 to 12 years of age, the total daily dose of Benznidazole is 5 mg/kg to 8 mg/kg orally administered in two divided doses separated by approximately 12 hours for a duration of 60 days. Benznidazole may interact with disulfiram, alcohol alcoholic, and products containing propylene glycol. Tell your doctor all medications and supplements you use. Benznidazole is not recommended for use during pregnancy; it may harm a fetus. Benznidazole passes into breast milk. Because of the potential for adverse reactions in nursing infants, breastfeeding while using Benznidazole is not recommended.

Our Benznidazole Tablets 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.

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Benznidazole Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Stop using benznidazole and call your doctor at once if you have:

  • numbness, tingling, or burning pain in your hands or feet (may continue for several months); or
  • low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects may include:

  • low white blood cell counts;
  • rash or itching;
  • stomach pain, nausea, vomiting, loss of appetite;
  • headache; or
  • weight loss.

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 Benznidazole (Benznidazole Tablets, for Oral Use)

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Benznidazole Professional Information

SIDE EFFECTS

The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling:

Clinical Trials Experience

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.

Benznidazole was evaluated in two randomized, double-blind, placebo-controlled trials (Tril 11 and Trial 22) and one uncontrolled trial (Trial 33).

Trial 1 was conducted in pediatric patients 6 to 12 years of age with chronic indeterminate Chagas disease in Argentina. The chronic indeterminate form includes patients with serologic evidence of T. cruzi infection without symptoms of cardiac or gastrointestinal disease. A total of 106 patients were randomized to receive either benznidazole (5 mg/kg/day twice daily for 60 days; N= 55) or placebo (N=51) and followed for 4 years.

Trial 2 was conducted in pediatric patients 7 to 12 years of age with chronic indeterminate Chagas disease in Brazil. A total of 129 patients were randomized to receive either benznidazole (7.5 mg/kg/day twice daily for 60 days; N = 64) or placebo (N = 65) and followed for 3 years.

Trial 3 was an uncontrolled study in pediatric patients 2 to 12 years of age with chronic indeterminate Chagas disease. A total of 37 pediatric patients with Chagas disease were enrolled in this safety and pharmacokinetics study. Patients were treated with benznidazole 5 to 8 mg/kg/day twice daily for 60 days.

Adverse Reactions Leading To Discontinuation

In Trial 1, benznidazole was discontinued due to an adverse reaction in 5/55 (9%) patients. Some patients had more than one adverse reaction resulting in treatment discontinuation. The adverse reactions included abdominal pain, nausea, vomiting, rash, decreased appetite, headache, and transaminases increased.

Common Adverse Reactions In Pediatric Patients

The most frequently reported adverse reactions in pediatric patients treated with benznidazole in Trial 1 were abdominal pain (25%), rash (16%), decreased weight (13%), and headache (7%). Table 4 lists adverse reactions occurring at a rate of 1% or greater in pediatric patients with Chagas disease aged 6 to 12 years of age in Trial 1.

Table 4: Adverse Reactions Occurring in Pediatric Patients with Chagas Disease aged 6 to 12 Years in Trial 1

Body System Adverse Reaction Benznidazole
(N=55)
N (%)
Placebo
(N=51)
N (%)
Gastrointestinal Abdominal pain 14 (25) 4 (8)
Weight decreased 7 (13) 1 (2)
Nausea 3 (5) 1 (2)
Vomiting 3 (5) 0
Diarrhea 2 (4) 0
Decreased appetite 3 (5) 0
Skin and subcutaneous tissue Rash 9 (16) 0
Metabolism/Laboratory Transaminases increased 3 (5) 0
Nervous system Disorders Dizziness 2 (4) 2 (4)
Peripheral neuropathy 1 (2) 0
Tremor 1 (2) 0

In Trial 2, skin lesions were reported in 7 of 64 (11%) pediatric patients treated with benznidazole and in 2 of 65 patients receiving placebo. Adverse reactions reported in fewer than 5% of benznidazole-treated patients included nausea, anorexia, headache, abdominal pain and arthralgia.

In a subset of 19 pediatric patients 2 to 6 years of age treated with benznidazole in Trial 3, 6 patients (32%) had the following adverse reactions: rash, leukopenia, urticaria, eosinophilia, decreased appetite, and neutropenia. These adverse reactions were similar to those observed in the overall population of 37 patients.

Postmarketing Experience

The following adverse reactions have been identified during the use of other formulations of benznidazole outside of the United States. Because these reactions are reported 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 5: Adverse Reactions Reported in the Published Literature

Body System Adverse Reactions
Dermatological
Neurological (central and peripheral nervous system)
  • Paresthesia
  • Hypoesthesia
  • Headaches
  • Insomnia
  • Convulsions
  • Inability to concentrate
  • Amnesia, temporary
  • Disorientation, temporary
Gastrointestinal
Hepatobiliary disorders
Skeletal Muscle
General / Constitutional Symptoms
Lymphatic
Bone Marrow
Metabolism / Laboratory
  • Elevation of alkaline phosphatase
  • Elevation of bilirubin

Read the entire FDA prescribing information for Benznidazole (Benznidazole Tablets, for Oral Use)

© Benznidazole Patient Information is supplied by Cerner Multum, Inc. and Benznidazole Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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