Eflornithine: uses, dosing, side effects & brands
Eflornithine is an antiprotozoal sold in the U.S. under 3 brand and generic names, for hypertrichosis and african trypanosomiasis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Antiprotozoal
- Treats (across its forms)
- Hypertrichosis and African Trypanosomiasis
- Available as
- Topical · Injectable · Tablet
- Sold as
- 3 products — Vaniqa, Ornidyl and Iwilfin
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How Iwilfin is dosed
From the FDA label for Iwilfin (application NDA215500). Other eflornithine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Prior to initiation of IWILFIN, perform baseline audiogram, complete blood count, and liver function tests. ( 2.1 , 5.3 ) Recommended dosage of IWILFIN is based on body surface area (see Table 1 ). ( 2.2 ) IWILFIN is taken orally twice daily with or without food until disease progression, unacceptable toxicity, or for a maximum of two years. ( 2.2 ) IWILFIN tablets may be swallowed whole, chewed, or crushed and mixed with soft food or liquid. ( 2.5 ) 2.1 Recommended Testing Before Initiating IWILFIN Prior to initiating IWILFIN, perform complete blood count, liver function tests, and baseline audiogram [see Warnings and Precautions (5.1 - 5.3) ]. 2.2 Recommended Dosage of IWILFIN The recommended IWILFIN dosage, based on body surface area (BSA), is provided in Table 1. Administer IWILFIN orally twice daily for two years or until recurrence of disease or unacceptable toxicity. Recalculate the BSA dosage every 3 months during treatment with IWILFIN. Table 1: Recommended Dose Body Surface Area (m 2 ) Dosage >1.5 768 mg (four tablets) orally twice a day 0.75 to 1.5 576 mg (three tablets) orally twice a day 0.5 to < 0.75 384 mg (two tablets) orally twice a day 0.25 to < 0.5 192 mg (one tablet) orally twice a day 2.3 Dosage Recommendations for Renal Impairment For the treatment of patients with severe renal impairment (eGFR <30 mL/min), reduce the recommended dose of IWILFIN by 50% as…
Everything below is the FDA label for Iwilfin (tablet). Eflornithine is also sold as topical and injectable, and those are different medicines to take — follow the label for the one you were prescribed.
Iwilfin side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.1) ] Hepatotoxicity [see Warnings and Precautions (5.2) ] Hearing Loss [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence ≥5%) are hearing loss, otitis media, pyrexia, pneumonia, and diarrhea. ( 6.1 ) Most common Grade 3 or 4 laboratory abnormalities (incidence ≥2%) are increased ALT, increased AST, decreased neutrophil count, and decreased hemoglobin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact US WorldMeds at 1-877-IWILFIN 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 rates observed in clinical practice. The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to IWILFIN as a single agent, taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface area (BSA), until disease progression, unacceptable toxicity, or for a maximum of 2 years in patients who demonstrated at least a partial response to prior multiagent, multimodality therapy for newly diagnosed or relapsed/refractory…
Who shouldn’t take Iwilfin
None. None ( 4 )
Every eflornithine product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Topical | No data | — | View → | |
| 2 | 70/100 | Prescription | Injectable | No data | — | View → | |
| 3 | Not yet rated | Prescription | Tablet | No data | — | View → |
What eflornithine pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| EFL;192 | 250 mg | white | round | — |
Eflornithine and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for eflornithine: levels in milk, effects in breastfed infants, and the drugs it would consider insteadMaternal intravenous eflornithine 400 mg/kg daily for 7 days did not cause any adverse serious effects in breastfed infants. After topical application, eflornithine is poorly absorbed so it is not likely to reach the bloodstream of the infant or cause any adverse effects in breastfed infants.
National Institute of Child Health and Human Development, record revised December 20, 2021. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about eflornithine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 38 reports naming eflornithine, and the FDA flagged 63% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- alopecia2 reports
- atrial fibrillation2 reports
- blood creatinine increased2 reports
- constipation2 reports
- disease recurrence2 reports
- dizziness2 reports
- fatigue2 reports
- headache2 reports
Read these as a signal, not a rate. A report does not mean eflornithine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is Iwilfin?
Iwilfin (Eflornithine Hydrochloride) is an antiprotozoal used to treat Hypertrichosis, African Trypanosomiasis.
What kind of drug is eflornithine?
The FDA classifies eflornithine as an antiprotozoal. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take eflornithine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run eflornithine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is eflornithine sold under?
We track 3 eflornithine-containing products in the U.S.: Vaniqa, Ornidyl and Iwilfin. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does eflornithine come in?
Across the brands we track, eflornithine is currently marketed as topical, injectable and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic eflornithine?
We do not currently list a generic-labelled eflornithine product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Eflornithine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/eflornithine
- MLA
- “Eflornithine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/eflornithine.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for eflornithine on DailyMed (NIH) ↗.