Eflornithine 11.5% cream
Requires a prescription from a doctor or prescriber
Safety information for pregnancy and breastfeeding
Pregnancy
Always consult your doctor or midwife before taking any medicine during pregnancy or while breastfeeding. Source: DrugBank (CC BY-NC 4.0).
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Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Eflornithine
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Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
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Suspected adverse reactions reported for Eflornithine
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5 branded products available
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View all licensed products for Eflornithine on the MHRA register
Vaniqa 11.5% cream
This is the NHS Drug Tariff indicative price used for reimbursement purposes. It may not reflect the price paid by patients or pharmacies.
View full Drug TariffSource: NHS Drug Tariff via NHSBSA. Derived from dm+d VMPP (Virtual Medicinal Product Pack) pricing data. Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
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Codes for healthcare professionals and prescribing systems
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SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 8 · Randomised trials: 15 · 1992–2026
Showing the 50 most relevant studies, sorted by most relevant.
Gerardo Priotto, Serena Kasparian, Wilfried Mutombo, et al.
The Lancet, 2009
Yang L, Wang Y, Hu S, et al.
2023
Godoy A, Montalvan-Sanchez D, Principe-Meneses FS, et al.
2025
BackgroundGastrointestinal (GI) tract malignancies represent a significant global health burden, being major contributors to cancer-related morbidity and mortality globally, with over 7.7 million cases reported. While aspirin is a well-studied chemopreventive agent for GI neoplasms, its use may be limited due to the underlying bleeding risk. Eflornithine (DFMO) is an inhibitor of the ornithine decarboxylase (ODC) which inhibits polyamine synthesis, and has shown promise as an alternative chemopreventive agent, particularly in animal studies and limited clinical trials.MethodsFollowing PRISMA guidelines, we conducted a systematic review of studies evaluating DFMO alone or in combination for chemoprevention in premalignant GI lesions including chronic gastritis, atrophic gastritis, intestinal metaplasia, and dysplasia. The protocol was registered in Prospero (CRD42022309307). Randomized controlled trials (RCTs) and cohort studies in English or Spanish were included.ResultsNine studies (six RCTs and three phase I-II trials) met inclusion criteria. Phase I-II trials involving Barrett's esophagus and gastric cancer did not report significant benefits. Phase III-IV trials combining DFMO with nonsteroidal anti-inflammatory drugs (NSAIDs) were associated with reductions in adenoma recurrence, size, and polyamine levels in high-risk GI cancer populations. Side effects included ototoxicity, reversible upon discontinuation, and mild GI events, both occurring at higher doses.ConclusionWhile aspirin remains a frontline chemopreventive agent for GI neoplasms, this review shows that phase III-IV trials suggest promising outcomes in combination with NSAIDs, warranting further investigation. Notably, DFMO's low cost and favorable toxicity profile may position it as a viable alternative, emphasizing the need for additional RCTs to delineate its efficacy and safety in GI cancer prevention. Further investigation into DFMO's optimal dosage, duration, and side effect management is essential to establish it as a safe and effective chemopreventive agent.
Abstract licence: CC BY-NC
Freddie Kansiime, Seraphine Adibaku, Charles Wamboga, et al.
Parasites & Vectors, 2018
Hidalgo J, Ortiz JF, Fabara SP, et al.
2021
Human African trypanosomiasis (HAT), or sleeping sickness disease, is an infection caused mainly by Trypanosoma brucei gambiense-human African trypanosomiasis (g-HAT) and is transmitted by tsetse flies. The disease goes through two stages: hemolymphatic and meningo-encephalic phases. The treatment for the second stage has changed from melarsoprol or eflornithine to nifurtimox-eflornithine combination therapy (NECT) and fexinidazole. We aimed to systematically review the literature on the efficacy and toxicity of fexinidazole and NECT. We used PubMed advanced strategy and Google Scholar databases, including clinical trials and observational studies on humans in the last 20 years in the English literature. Applying the inclusion/exclusion criteria, we reviewed eight studies. We used Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) and Meta-analysis of Observational Studies in Epidemiology (MOOSE) protocol. For assessing bias, we used the Cochrane Collaboration's tool for risk assessment of the clinical trials and the Robins-I tool for the observational studies. Overall, the clinical trials showed that NECT was non-inferior to eflornithine. The proportion of patients discharged alive is higher in patients treated with NECT vs. patients treated with eflornithine. Gastrointestinal complaints are a common side effect of NECT therapy, while fearful but relatively rare convulsions can also occur. The main limitation among the studies of NECT was the lack of blinding because most of them were open-label. Fexinidazole, the new oral medication showed is effective and safe for the treatment of g-HAT infection. Because of their convenience, fexinidazole is preferred over NECT therapy, oral vs. IV infusion in the first and second stages of the disease. Compared to older therapies, fexinidazole and NECT are more effective and safer than eflornithine and melarsoprol monotherapy.
Abstract licence: CC BY
G. Priotto, S. Kasparian, D. Ngouama, et al.
Clinical Infectious Diseases, 2007
Hidalgo J, Tirupathi R, Ortiz J, et al.
2021
Morgan DR, Dominguez RL, Norwood DA, et al.
2026
- Helicobacter Infections
- Stomach Neoplasms
- Precancerous Conditions
Nawaz MU, Baig MB, Shahid SM, et al.
2025
BackgroundIdiopathic facial hirsutism (IFH) exerts a measurable negative impact on psychosocial well-being, even in the absence of identifiable endocrine dysfunction. Although light-based epilation technologies offer durable hair reduction, treatment-resistant regrowth remains a clinical challenge. Adjunctive topical therapies that modulate follicular activity are under investigation to potentially enhance and prolong the efficacy of such interventions.ObjectiveThe objective of this study is to compare the efficacy and tolerability of six-month sessions of intense pulsed light (IPL) combined with a topical agent versus the same IPL protocol alone in Pakistani women with IFH.MethodsIn this open-label randomised controlled trial, 152 women aged 18-70 years were randomised 1:1 to combination therapy (n = 76) or IPL alone (n = 76). The primary outcome was the proportion of participants achieving ≥ 1‑grade reduction on the modified Ferriman-Gallwey (mFG) scale at week 24. Secondary outcomes included mean percentage terminal-hair reduction and patient satisfaction.ResultsBaseline characteristics were comparable. At week 24, 89.5 % of the combination group met the primary endpoint compared with 69.7 % receiving IPL alone (absolute risk difference 19.8 %, p = 0.003). Mean terminal-hair reduction was 90 % versus 59 % (p ConclusionAdding a topical agent to IPL significantly improves clinical and patient-reported outcomes in IFH without increasing toxicity. The regimen may offer a practical, hormone-free first-line strategy for South-Asian women seeking rapid, durable cosmetic benefits.
Abstract licence: CC BY
saba nasim, Saadiya Siddiqui, Shahbaz Aman, et al.
Pakistan Association of Dermatologists, 2024
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
3.5 hours
Mechanism
Eflornithine is an irreversible inhibitor of the enzyme ornithine decarboxylase…
Food interactions
1 warning
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
3.5 hours
Half-life
3.5 hours
Protein binding
[L49288]
Volume of distribution
24.3 L
[L49288]
Metabolism
[L49298]
Elimination
[L49298]
Clearance
5.3 L/h
[L49298]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
In 1960 and 2000, the FDA approved eflornithine under the brand names ORNIDYL and VANIQUA for the treatment of African trypanosomiasis and hirsutism, respectively, but has since been discontinued.[A262823][L49318] Subsequently, on December 14, 2023, the FDA approved eflornithine again but under the brand name IWILFIN as an oral maintenance therapy to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who have demonstrated at least a partial response to prior multiagent, multimodality therapy, including anti-GD2 immunotherapy. This approval is based on positive results obtained from a multi-site, single-arm, externally controlled study of children with high-risk neuroblastoma, where a 52% reduction in the risk of relapse and a 68% reduction in the risk of death were observed.[L49313]
[L49288]
It was also previously indicated for the treatment of female hirsutism and African trypanosomiasis but has since been discontinued.
[L49318]
Known interactions with other medicines. Always consult a healthcare professional.
Showing 38 of 38 interactions
Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
[L49298]
In a 2-year carcinogenicity study, once daily oral administration of eflornithine to female rats did not result in drug-related neoplasms at doses up to 600 mg/kg/day (10.5 times the human Cmax at the recommended clinical dose of 1152 ± 384 mg/m2).
[L49298]
Eflornithine was not mutagenic in the in vitro bacterial reverse mutation (Ames) assay.
[L49298]
Dedicated fertility studies were not conducted with eflornithine.
[L49298]
Additionally, polyamines are also involved in keratin synthesis, and inhibition of polyamines can decrease the proliferation of hair matrix cells and thus inhibit the anagen phase of hair production.[A4113]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L49288]
The mean percutaneous absorption of eflornithine in women with unwanted facial hair, from a 13.9% w/w cream formulation, is < 1% of the radioactive dose, following either single or multiple doses under conditions of clinical use, that included shaving within 2 hours before radiolabeled dose application in addition to other forms of cutting or plucking and tweezing to remove facial hair.
Steady state was reached within four days of twice-daily application. Following twice-daily application of 0.5 g of the cream (total dose 1.0 g/day; 139 mg as anhydrous eflornithine hydrochloride), under conditions of clinical use in women with unwanted facial hair (n=10), the steady-state Cmax, Ctrough and AUC12hr were approximately 10 ng/mL, 5 ng/mL, and 92 ng hr/mL, respectively, expressed in terms of the anhydrous free base of eflornithine hydrochloride. At steady state, the dose-normalized peak concentrations (Cmax) and the extent of daily systemic exposure (AUC) of eflornithine following twice-daily application of 0.5 g of the cream (total dose 1.0 g/day) is estimated to be approximately 100- and 60-fold lower, respectively, when compared to 370 mg/day once-daily oral doses.
[L49298]
[L49298][L49298]
[L49288]
[L49288]
[L49298]
[L49298]
[L49298]
Proteins and enzymes this drug interacts with in the body
ATC P01CX03
ATC L01XX79
ATC D11AX16
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Show
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Eflornithine
Additional database identifiers
Drugs Product Database (DPD)
12187
ChemSpider
2902
BindingDB
50028197
HUGO Gene Nomenclature Committee (HGNC)
HGNC:8109
GenAtlas
ODC1
GeneCards
ODC1
GenBank Gene Database
M16650
GenBank Protein Database
29893806
Guide to Pharmacology
1276
UniProt Accession
DCOR_HUMAN
DrugBank citations
If you use DrugBank data in your research, please cite:
- DrugBank 6.02024Recommended citationKnox C., Wilson M., Klinger C.M., et alDrugBank 6.0: the DrugBank Knowledgebase for 2024Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
- DrugBank 5.02018Wishart D.S., Feunang Y.D., Guo A.C., et alDrugBank 5.0: a major update to the DrugBank database for 2018Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
- DrugBank 4.02014Law V., Knox C., Djoumbou Y., et alDrugBank 4.0: shedding new light on drug metabolismNucleic Acids Res. 2014 Jan 142(1):D1091-7
- DrugBank 3.02011Knox C., Law V., Jewison T., et alDrugBank 3.0: a comprehensive resource for 'omics' research on drugsNucleic Acids Res. 2011 Jan39(Database issue):D1035-41
- DrugBank 2.02008Wishart D.S., Knox C., Guo A.C., et alDrugBank: a knowledgebase for drugs, drug actions and drug targets.Nucleic Acids Research2008 Jan36(Database issue):D901-6
- DrugBank 1.02006Wishart D.S., Knox C., Guo A.C., et alDrugBank: a comprehensive resource for in silico drug discovery and exploration.Nucleic Acids Research2006 Jan 134(Database issue):D668-72