Nifurtimox

Nifurtimox is an antiprotozoal drug [see Microbiology ( 12.4 )] .

• LAMPIT is indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi [see Clinical Studies ( 14 )]. LAMPIT is a nitrofuran antiprotozoal, indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis), caused by Trypanosoma cruzi .

• LAMPIT tablets are contraindicated in: • Patients with known hypersensitivity to nifurtimox or any of the excipients in LAMPIT [see Warnings and Precautions ( 5.4 )]. • Patients who consume alcohol during treatment [see Drug Interactions ( 7 )] • Known hypersensitivity to nifurtimox or to any of the excipients in LAMPIT.contraindicated

• LAMPIT tablets must be taken with food ( 2.1 ) Dosage of LAMPIT in Pediatric Patients (birth a to less than 18 years of age) (2.2) Body Weight Group Total Daily Dose of nifurtimox (mg/kg) 41 kg or greater 8 to 10 Less than 41 kg 10 to 20 a Term newborn with body weight greater than or equal to 2.5 kg • Administer LAMPIT tablets orally, three times daily with food for 60 days. ( 2.2 ) • Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with LAMPIT ( 2.3 , 8.3 ) . • See Full Prescribing Information for additional important administration instructions. ( 2.1 , 2.2 , 2.4, 2.5 ) 2.1 Important Administration Instructions • LAMPIT (30 mg and 120 mg) tablets are for oral use and must be taken with food. • LAMPIT tablets are dosed by body weight of the patient [see Dosage and Administration ( 2.2 )] . • LAMPIT (30 mg and 120 mg) tablets are functionally scored tablets which can be split into one-half (15 mg and 60 mg respectively) at the scored lines by hand. Do not break LAMPIT tablets mechanically with a tablet splitting device [see Dosage and Administration ( 2.4 ) and Instructions for Use] . • LAMPIT 30 mg and 120 mg tablets can be made into a slurry as an alternative method of administration for patients who cannot swallow the tablets [see Dosage and Administration ( 2.5 )] . • Discontinue consumption of alcohol during treatment with LAMPIT [see Contraindications ( 4 ) and Drug Interactions ( 7 )] . • Complete the full course of treatment to prevent recurrence of the infection.

• Potential for Genotoxicity and Carcinogenicity. ( 5.1 ) • Embryo-Fetal Toxicity: May cause fetal harm. Pregnancy testing is recommended for females of reproductive potential. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. Advise males to use condoms with female partners of reproductive potential. ( 2.3 , 5.2 , 8.1 , 8.3 ) • Worsening Neurological and Psychiatric Conditions: Patients with a history of brain injury, seizures, psychiatric disease, serious behavioral alterations may experience worsening of their conditions when receiving LAMPIT. Administer LAMPIT under close medical supervision in these patients or if neurological disturbances or psychiatric drug reactions occur. ( 5.3 ) • Hypersensitivity: Hypersensitivity reactions including hypotension, angioedema, dyspnea, pruritus, rash or other severe skin reactions have been reported with the use of nifurtimox, discontinuation of treatment is recommended. ( 5.4 ) • Decreased Appetite and Weight Loss: Check body weight every 14 days as dosage may need to be adjusted. ( 5.5 ) • Porphyria: Treatment with nitrofuran derivatives, such as LAMPIT, may precipitate acute attacks of porphyria. Administer LAMPIT under close medical supervision in patients with porphyria. ( 5.6 ) 5.1 Potential for Genotoxicity and Carcinogenicity Genotoxicity Genotoxicity of LAMPIT has been demonstrated in humans, in vitro in several bacterial species and mammalian cell systems, and in vivo in rodents [see Nonclinical Toxicology ( 13.1 )] .

The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling: • Potential for Genotoxicity, Carcinogenicity, and Mutagenicity [see Warnings and Precautions ( 5.1 )] • Worsening of Neurological and Psychiatric Conditions [see Warnings and Precautions ( 5.3 )] • Hypersensitivity [see Warnings and Precautions ( 5.4 )] • Decreased Appetite and Weight Loss [see Warnings and Precautions ( 5.5 )] • Porphyria [see Warnings and Precautions ( 5.6 )] The most frequently reported adverse reactions (≥5%) are vomiting, abdominal pain, headache, decreased appetite, nausea, pyrexia, and rash. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. The safety data described below reflect exposure to LAMPIT in one prospective, randomized, double-blind trial (Trial 1). 330 pediatric patients with serologic evidence of T. cruzi infection and without Chagas disease-related cardiac or gastrointestinal symptoms were randomly assigned in a 2:1 fashion to a 60-day (n=219) or a 30-day (n=111) LAMPIT treatment regimen and were followed up for one year after end of treatment. LAMPIT was administered three times a day with food using a body weight-based dosing.

Patients with Renal and or Hepatic Impairment: Administer LAMPIT under close medical supervision. ( 8.6 , 8. 7) 8.1 Pregnancy Risk Summary Based on animal studies, LAMPIT may cause fetal harm when administered to a pregnant woman. Published postmarketing reports on nifurtimox use during pregnancy are insufficient to inform a drug-associated risk of birth defects and miscarriage. There are risks to the fetus associated with Chagas disease ( see Clinical Considerations). Nifurtimox administered orally to pregnant rats, and rabbits during organogenesis was associated with reduced maternal body weights in rats, and abortions, reduced maternal weight gain, and reduced numbers of live fetuses in rabbits when nifurtimox was administered orally during organogenesis at doses approximately equal to the MRHD in rats and 2-times the MRHD in rabbits. An increased incidence of a fetal skeletal malformation (fusion of caudal vertebral bodies) occurred in rabbits at nifurtimox doses approximately 0.2 times the MRHD. In a pre-postnatal study, maternal body weights and fetal body weights of first-generation offspring were reduced at doses approximately equal to or 0.5 times the MRHD, respectively, and several male offspring in the nifurtimox treatment groups exhibited slightly small testes at doses ≥0.2 times the MRHD ( see Data) . Advise pregnant women of the potential risk to a fetus.

Metabolism

Absorption The mean (%CV) nifurtimox AUC estimates ranged between 1676-2670 µg∙h/L (19–32%) and C max estimates ranged between 425-568 µg/L (26–50%) following administration of single dose 120 mg nifurtimox with food in adult Chagas patients. No clinically significant differences in nifurtimox AUC or C max at the 120 mg dose were observed when using two tablet strengths (30 and 120 mg) or administered as whole or dissolved tablets under fed conditions.

• Aug 6, 2020NDANDA213464Bayer Healthcare

1. 1Nausea833%
2. 2Asthenia729%
3. 3Dysmetria625%
4. 4Vision Blurred625%
5. 5Diarrhoea313%
6. 6Pyrexia313%
7. 7Vomiting313%
8. 8Abdominal Pain28.3%
9. 9Drug Rash With Eosinophilia And Systemic Symptoms28.3%
10. 10Dyspnoea28.3%
11. 11Eosinophilia28.3%
12. 12Headache28.3%
13. 13Neuroblastoma28.3%
14. 14Oliguria28.3%
15. 15Pulmonary Haemorrhage28.3%

Recent PubMed references pinned to Nifurtimox as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Value of the Run-In Period to Evaluate the Safety of Conventional Trypanocidal Treatment: A Subanalysis of a Colombian Randomized Clinical Trial.
  The American journal of tropical medicine and hygiene · 2026 · Villar JC, Arango H, Sáenz-Pérez LD, et al.
  PMID 42013820DOI 10.4269/ajtmh.25-0198
• Therapeutic Potential of 3D-Printed Nifurtimox for Chagas Disease: Effects on Survival, Parasitemia Control and Immune Modulation.
  Tropical medicine & international health : TM & IH · 2026 · Menezes TP, Louise V, Pio S, et al.
  PMID 41582324DOI 10.1111/tmi.70085
• Mechanisms of resistance of Trypanosoma cruzi to benznidazole and nifurtimox: Molecular implications and multifaceted impact.
  Acta tropica · 2026 · Ochoa-Martínez P, López-Domínguez J, López-Monteon A, et al.
  PMID 41365456DOI 10.1016/j.actatropica.2025.107940
• Novel cosolvent systems for nifurtimox: improving solubility, trypanocidal efficacy, and stability.
  Therapeutic delivery · 2025 · Bedogni G, Azcarate F, Guerra L, et al.
  PMID 41306028DOI 10.1080/20415990.2025.2593815
• Engineering a nifurtimox nanosuspension: toward improved pharmaceutical attributes.
  Drug delivery and translational research · 2026 · Magi MS, Lopez-Vidal L, García MC, et al.
  PMID 41083754DOI 10.1007/s13346-025-01989-4
• Antitrypanosomal therapy for Chagas disease: A single center experience with adverse drug reactions and strategies for enhancing treatment completion.
  PLoS neglected tropical diseases · 2025 · Reifler K, Wheelock A, Hall SM, et al.
  PMID 40622934DOI 10.1371/journal.pntd.0013218
• Cutaneous reactions during treatment with Nifurtimox or Benznidazole among Trypanosoma cruzi seropositive adults without symptomatic cardiomyopathy: A safety sub analysis of a placebo-controlled randomised trial.
  Tropical medicine & international health : TM & IH · 2025 · Villar JC, Saavedra MF, Bermúdez PA, et al.
  PMID 40384408DOI 10.1111/tmi.14123
• Redefining the treatment of Chagas disease: a review of recent clinical and pharmacological data for a novel formulation of nifurtimox.
  PLoS neglected tropical diseases · 2025 · Altcheh J, Grossmann U, Stass H, et al.
  PMID 39999088DOI 10.1371/journal.pntd.0012849

The 10 most recently updated of 19 ClinicalTrials.gov registrations naming Nifurtimox as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health
  Not yet recruiting · Observational · 50 enrolled · Bayer
  NCT05477953updated 2026-05-18
• A Study to Learn How Well Nifurtimox Works and How Safe it is in Children Aged 0 to 17 Years With Chagas' Disease, an Inflammatory, Infectious Disease Caused by the Parasite Trypanosoma Cruzi
  Completed · Phase 3 · Interventional · 330 enrolled · Bayer
  NCT02625974updated 2024-08-19
• Study of Nifurtimox to Treat Refractory or Relapsed Neuroblastoma or Medulloblastoma
  Completed · Phase 2 · Interventional · 112 enrolled · Giselle Sholler
  NCT00601003updated 2024-08-06
• New Therapies and Biomarkers for Chagas Infection
  Completed · Phase 2 · Interventional · 450 enrolled · University of Texas, El Paso
  NCT03981523updated 2024-07-17
• Nifurtimox Versus Benznidazole Effectiveness and Tolerance for Chagas Disease Treatment
  Unknown · Observational · 900 enrolled · Hospital de Niños R. Gutierrez de Buenos Aires
  NCT04274101updated 2023-03-01
• Study on Benefits of Therapy With Nifurtimox in Chagas Disease, a Parasitic Illness Mostly Transmitted to Humans by a Bug, Using Information From Patient Medical Records in Argentina
  Completed · Observational · 3,000 enrolled · Bayer
  NCT03784391updated 2021-04-08
• Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients - Dietary Habits Study
  Completed · Phase 1 · Interventional · 36 enrolled · Bayer
  NCT03334838updated 2020-12-30
• Study to Assess Bioequivalence of a New Nifurtimox Oral Tablet Formulation
  Completed · Phase 1 · Interventional · 24 enrolled · Bayer
  NCT03708133updated 2020-06-11
• Study Will Evaluate the Relative Bioavailability, Safety, and Tolerability of Single Doses of Nifurtimox 30 mg Tablets Exhibiting Different in Vitro Dissolution Characteristics, and to Evaluate the Relative Bioavailability of Nifurtimox 30 mg and 120 mg
  Completed · Phase 1 · Interventional · 48 enrolled · Bayer
  NCT03350295updated 2019-12-12
• Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2
  Completed · Phase 2 · Phase 3 · Interventional · 394 enrolled · Drugs for Neglected Diseases
  NCT01685827updated 2018-02-20

Frequently asked questions

How does Nifurtimox work?

Nifurtimox is an antiprotozoal drug [see Microbiology ( 12.4 )] .

What is Nifurtimox used for?

According to FDA labeling, Nifurtimox carries indications including: LAMPIT is indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi [see Clinical Studies ( 14 )]. LAMPIT is a nitrofuran antiprotozoal, indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis), caused by Trypanosoma cruzi .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Nifurtimox?

Nifurtimox is classified as Nitrofuran derivatives.

What are the brand names for Nifurtimox?

Nifurtimox is marketed under brand names including Lampit.

What are the contraindications for Nifurtimox?

Nifurtimox labeling lists contraindications including: LAMPIT tablets are contraindicated in: • Patients with known hypersensitivity to nifurtimox or any of the excipients in LAMPIT [see Warnings and Precautions ( 5.4 )]. • Patients who consume alcohol during treatment [see Drug Interactions ( 7 )] • Known hypersensitivity to nifurtimox or to any of the excipients in LAMPIT.. Always consult the full prescribing information and a clinician.