Paromomycin
/api/v1/drug/paromomycinMechanism of action
Sourced from openFDAMechanism-of-action class: Protein Synthesis Inhibitors.
Indications
Sourced from openFDA- Paromomycin sulfate is indicated for intestinal amebiasis–acute and chronic (NOTE-It is not effective in extraintestinal amebiasis); management of hepatic coma–as adjunctive therapy. To reduce the development of drug-resistant bacteria and maintain the effectiveness of HUMATIN™ Capsules and other antibacterial drugs, HUMATIN™ Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
Contraindications
Sourced from openFDA- Paromomycin sulfate is contraindicated in individuals with a history of previous hypersensitivity reactions to it. It is also contraindicated in intestinal obstruction.contraindicated
Dosage & administration
Sourced from openFDAIntestinal amebiasis: Adults and Pediatric Patients: Usual dose—25 to 35 mg/kg body weight daily, administered in three doses with meals, for five to ten days. Management of hepatic coma: Adults: Usual dose—4 g daily in divided doses, given at regular intervals for five to six days.
Adverse reactions
Sourced from openFDANausea, abdominal cramps, and diarrhea have been reported in patients on doses over 3 g daily. To report SUSPECTED ADVERSE REACTIONS, Waylis Therapeutics LLC at 844-200-7910 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Approval history
Sourced from openFDA- Dec 14, 2007ANDAANDA065173Heritage
FAERS reports
- 1Diarrhoea2121%
- 2Abdominal Pain Upper109.8%
- 3Vomiting87.8%
- 4Nausea76.9%
- 5Tinnitus76.9%
- 6Abdominal Pain65.9%
- 7Anaemia65.9%
- 8Asthenia65.9%
- 9Dysphagia65.9%
- 10Pain65.9%
- 11Rash65.9%
- 12Urinary Tract Infection65.9%
- 13Blood Creatinine Increased54.9%
- 14Dyspepsia54.9%
- 15Fluid Retention54.9%
Literature
Recent PubMed references pinned to Paromomycin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Antileishmanial and Immunomodulatory Activity of Paclitaxel and Docetaxel Combined with Miltefosine and Paromomycin.International journal of molecular sciences · 2026 · Melcón-Fernández E, Balaña-Fouce R, García-Estrada C, et al.PMID 41977242DOI 10.3390/ijms27073055
- The adverse effects of paromomycin on early cardiovascular development in zebrafish (Danio rerio).Aquatic toxicology (Amsterdam, Netherlands) · 2026 · Lin Y, Lei Y, Zhong Y, et al.PMID 41905306DOI 10.1016/j.aquatox.2026.107795
- Skin pharmacokinetics and pharmacodynamics in patients with post-kala-azar dermal leishmaniasis.International journal of antimicrobial agents · 2026 · Chu WY, Singh OP, Sundar S, et al.PMID 41519406DOI 10.1016/j.ijantimicag.2026.107713
- The Efficacy of Topical Paromomycin-Gentamicin versus Topical Paromomycin Alone in The Treatment of Cutaneous Leishmaniasis: A meta-analysis of randomized controlled trials.Sultan Qaboos University medical journal · 2025 · Alshaikh T, Jihad M, Jomaa A, et al.PMID 41425839DOI 10.18295/2075-0528.2931
- Efficacy of topical hydrophilic gel of paromomycin combined with systemic or locally administered leishmanicidal drugs for treatment of experimental leishmaniasis caused by Leishmania (Viannia) braziliensis.The Journal of antimicrobial chemotherapy · 2025 · Alves LL, Pinheiro Rosa DC, Freire ML, et al.PMID 41054941DOI 10.1093/jac/dkaf362
- Synergistic Effect of Copper Nanoparticles and Paromomycin in the Treatment of Cutaneous Leishmaniasis.Parasite immunology · 2025 · Heidari-Kharaji M, Rodrigues P, Ferreira C, et al.PMID 40686227DOI 10.1111/pim.70017
- Paromomycin is a more effective selection agent than kanamycin in Arabidopsis harboring the neomycin phosphotransferase II transgene.PloS one · 2025 · Goodman CP, Padgett VN, Evans ER, et al.PMID 40561069DOI 10.1371/journal.pone.0325322
- Solid Lipid Nanoparticles Encapsulated With Paromomycin: An Effective Oral Formulation Against Leishmania major in Mouse Model.Parasite immunology · 2025 · Heidari-Kharaji M, Rodrigues P, Petersen C, et al.PMID 39988879DOI 10.1111/pim.70002
Clinical trials
The 10 most recently updated of 37 ClinicalTrials.gov registrations naming Paromomycin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Study Comparing Several Drugs to Understand Which Work Against Cutaneous Leishmaniasis (CL)Not yet recruiting · Phase 3 · Interventional · 900 enrolled · Institute of Tropical Medicine, BelgiumNCT07463040updated 2026-03-10
- LXE408 for Treatment of Visceral Leishmaniasis in Ethiopia, a Proof of Concept StudyCompleted · Phase 2 · Interventional · 52 enrolled · Drugs for Neglected DiseasesNCT05957978updated 2025-12-18
- A Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral LeishmaniasisActive not recruiting · Observational · 216 enrolled · University of YorkNCT04342715updated 2025-07-24
- Paromomycin or Metronidazole for Symptomatic Dientamoeba Fragilis in AdultsRecruiting · Interventional · 60 enrolled · Sheba Medical CenterNCT06907498updated 2025-04-02
- Miltefosine/Paromomycin Phase III Trial for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern AfricaCompleted · Phase 3 · Interventional · 439 enrolled · Drugs for Neglected DiseasesNCT03129646updated 2024-02-29
- Clinical Evaluation of a New Form of Cancer Therapy (Atavistic Chemotherapy) Based on the Principles of Atavistic Metamorphosis (2011)Unknown · Phase 2 · Interventional · 250 enrolled · Dr. Frank Arguello Cancer ClinicNCT02366884updated 2022-04-06
- A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3Completed · Phase 2 · Interventional · 68 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)NCT00000771updated 2021-11-04
- Patients Response to Early Switch To Oral:Osteomyelitis StudyTerminated · Early phase 1 · Interventional · 11 enrolled · Julio RamirezNCT02099240updated 2021-04-06
- A Study to Evaluate the Efficacy and Tolerance of WR279,396 for Old World Cutaneous LeishmaniasisCompleted · Phase 2 · Interventional · 48 enrolled · U.S. Army Medical Research and Development CommandNCT01536795updated 2021-02-12
- Topical Paromomycin for Cutaneous Leishmaniasis in BoliviaCompleted · Phase 2 · Phase 3 · Interventional · 80 enrolled · Fundacion Nacional de DermatologiaNCT03096457updated 2021-02-02
Pharmacogenomics
CPIC-curated drug–gene pairs for Paromomycin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.
- MT-RNR1CPIC A
Frequently asked questions
- How does Paromomycin work?
- Mechanism-of-action class: Protein Synthesis Inhibitors.
- What is Paromomycin used for?
- According to FDA labeling, Paromomycin carries indications including: Paromomycin sulfate is indicated for intestinal amebiasis–acute and chronic (NOTE-It is not effective in extraintestinal amebiasis); management of hepatic coma–as adjunctive therapy. To reduce the development of drug-resistant bacteria and maintain the effectiveness of HUMATIN™ Capsules and other antibacterial drugs, HUMATIN™ Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Paromomycin?
- Paromomycin is classified as Antibiotics, Antiprotozoal, Protein Synthesis Inhibitors, Decreased Protein Synthesis.
- What are the brand names for Paromomycin?
- Paromomycin is marketed under brand names including Humatin.
- What are the contraindications for Paromomycin?
- Paromomycin labeling lists contraindications including: Paromomycin sulfate is contraindicated in individuals with a history of previous hypersensitivity reactions to it. It is also contraindicated in intestinal obstruction.. Always consult the full prescribing information and a clinician.
paromomycin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.