Tafenoquine
Tafenoquine is an antimalarial drug used to prevent malaria (Arakoda, Kodatef) and to prevent the relapse of Plasmodium vivax malaria (Krintafel).
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 3 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Tafenoquine: Patient Information Guide
A plain-language walkthrough of Tafenoquine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Tafenoquine is an antimalarial used across two distinct treatment goals, depending on the specific product prescribed.
- Arakoda (tablets, oral): Prevention (prophylaxis) of malaria in adults 18 years and older who are traveling to or living in malaria-endemic areas.
- Kodatef (tablets, oral): Malaria prophylaxis, consistent with the approved use of Arakoda.
- Krintafel (tablets, oral): Radical cure — meaning prevention of relapse — of Plasmodium vivax malaria in patients 16 years and older who are receiving chloroquine for an active P. vivax infection. Krintafel must be used alongside chloroquine; it is not for treating an active malaria episode on its own, and it is not recommended with antimalarials other than chloroquine.
⚙️How it works▾
Tafenoquine is an 8-aminoquinoline antimalarial — a class of drugs designed to attack the malaria parasite at multiple points in its life cycle. Importantly, it works against the dormant liver stage of the parasite (called hypnozoites), which is what allows Plasmodium vivax malaria to come back weeks or months after the original infection. It also acts against the parasite forms circulating in red blood cells. Laboratory studies suggest tafenoquine may block a process the parasite uses to neutralize a toxic byproduct (hematin polymerization) and may trigger a cell-death process in the parasite. Its ability to hit both liver and blood stages makes it uniquely useful for preventing malaria relapse.
Tafenoquine is also active against gametocytes — the form of the parasite that mosquitoes pick up — and against pre-erythrocytic (pre-blood-stage) liver forms, which helps prevent the infection from establishing itself in the first place.
💊How it's taken▾
All tafenoquine products are taken by mouth as tablets with food, and tablets must be swallowed whole (not broken, crushed, or chewed). The dosing schedule varies significantly by product and must not be mixed up.
- Arakoda / Kodatef: Uses a three-phase approach — a daily loading phase for 3 days before entering a malaria zone, a once-weekly maintenance dose while in the area, and a single terminal dose in the week after leaving. Arakoda can be used for up to 6 months of continuous dosing. Instructions for making up missed doses are detailed in the prescribing information — follow those carefully.
- Krintafel: A single dose taken with food on the first or second day of chloroquine treatment for active P. vivax malaria. If vomiting occurs within one hour of taking the dose, a repeat dose may be given once.
🤒Side effects — in detail▾
The most commonly reported side effects with tafenoquine include:
- Headache
- Dizziness
- Nausea, vomiting, or diarrhea
- Back pain
- Sleep disturbances — insomnia, abnormal dreams
- Elevated liver enzymes (ALT) detected on blood tests
- Motion sickness
- Depression or anxious mood
More serious reactions to watch for include signs of red blood cell breakdown (hemolytic anemia) such as fatigue, pale or yellow skin, or dark urine; bluish skin from methemoglobinemia (low blood oxygen); psychiatric symptoms like hallucinations, delusions, or severe mood changes; and allergic reactions including swelling or hives. Because tafenoquine stays in the body for a long time, these serious effects can be delayed — seek medical attention promptly if any of them appear, even after finishing the medication.
⚠️Warnings & precautions▾
- Hemolytic anemia (red blood cell destruction): The biggest risk. Tafenoquine can cause serious or life-threatening breakdown of red blood cells in people with G6PD deficiency. G6PD testing is required before prescribing. People with deficiency or unknown status must not take it. Even patients with normal G6PD can experience hemoglobin drops.
- Risk to G6PD-deficient fetuses and infants: Tafenoquine is not recommended during pregnancy because the fetus could be G6PD-deficient even if the mother is not. If the infant being breastfed is G6PD-deficient or has unknown status, breastfeeding is contraindicated during treatment and for 3 months after the last dose.
- Methemoglobinemia: Asymptomatic (no noticeable symptoms) rises in methemoglobin were seen in about 13% of patients in trials. Watch for bluish or grey-tinged skin or lips, which signal low blood oxygen.
- Psychiatric effects: Sleep problems, depression, anxiety, and in rare cases psychosis have been reported. Tafenoquine is contraindicated in anyone with a history of psychotic disorders. Seek prompt evaluation for moderate or severe mood changes, insomnia, nightmares, or disorganized thinking.
- Hypersensitivity (allergic) reactions: Serious reactions including angioedema (swelling under the skin) and urticaria (hives) have occurred. Stop tafenoquine and seek care immediately if these develop.
- Delayed reactions: Tafenoquine's half-life of roughly 16–17 days means side effects can start — or keep going — weeks after the last dose. Stay alert even after finishing the medication.
- Eye changes: A condition called vortex keratopathy (a pattern of deposits on the cornea of the eye) was seen in up to 93% of patients in some trials, but it resolved within a year of stopping the drug and did not appear to affect vision. Rare retinal (back-of-eye) abnormalities were also reported.
🔀What it interacts with▾
Tafenoquine has a few key drug interactions to be aware of:
- OCT2 and MATE transporter substrates (e.g., metformin, dofetilide): Tafenoquine inhibits transporters that help the body process certain drugs. This could raise blood levels of those drugs and increase their side effects. Avoid combining if possible; if you must, watch closely for toxicity from the other drug.
- Other antimalarials (for Krintafel): Krintafel should only be used with chloroquine. Using it alongside other antimalarials is not recommended because it may increase the risk of P. vivax malaria returning.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- G6PD testing required: Every patient must be tested for G6PD deficiency before starting tafenoquine. People with deficiency or unknown status must not take it.
- Pregnancy: Tafenoquine is not recommended during pregnancy. Females of reproductive potential should take a pregnancy test before starting and use effective contraception during treatment and for 3 months after the last dose.
- Breastfeeding: Do not breastfeed if the infant has G6PD deficiency or unknown G6PD status, during treatment and for 3 months after the last dose. Check the infant's G6PD status before breastfeeding begins.
- History of psychotic disorders: Tafenoquine is contraindicated in patients with a history of psychotic disorders or who currently have psychotic symptoms (hallucinations, delusions, disorganized behavior).
- Children: Krintafel is approved for patients 16 and older; Arakoda and Kodatef are approved for patients 18 and older. Safety in younger children has not been established.
- Older adults: Clinical trials did not include enough patients over 65 to draw firm conclusions, though no specific differences in response have been identified.
- Kidney or liver disease: The effect of tafenoquine in people with impaired kidney or liver function has not been studied. Extra monitoring for side effects is recommended if tafenoquine must be used.
- NADH-methemoglobin reductase deficiency: This rare enzyme deficiency requires careful monitoring during tafenoquine treatment due to methemoglobinemia risk.
- Allergy to tafenoquine or 8-aminoquinolines: Do not take tafenoquine if you have had a serious allergic reaction to this drug, related drugs in this class, or any ingredient in the product.
🚑If you take too much▾
There were no reported overdose cases with Arakoda in clinical trials. Based on its known side effects, an overdose would most likely cause a drop in hemoglobin (red blood cell levels) and a rise in methemoglobin (reduced oxygen-carrying capacity of the blood). Treatment is supportive — meaning managing symptoms as they arise — and you should seek emergency medical care right away if an overdose is suspected.
📡Pharmacodynamics — effects in the body▾
At doses used in clinical studies, tafenoquine did not cause a clinically meaningful prolongation of the QTc interval — the part of the heart's electrical cycle measured on an ECG (electrocardiogram). This was evaluated at doses higher than those approved for use, providing reassurance about heart rhythm safety at recommended doses. A saturable relationship was identified between how much tafenoquine is in the body and how well it prevents P. vivax malaria from recurring — meaning that beyond a certain exposure level, higher doses don't add meaningful benefit, which is why specific approved doses are used.
🔬Pharmacokinetics — how your body processes it▾
Tafenoquine is taken by mouth and is best absorbed when taken with food — a high-fat meal increased drug exposure by about 41% in studies using an investigational capsule form. It binds very tightly to proteins in the blood (over 99.5%) and distributes widely throughout the body. The drug is barely broken down by the liver — most of it circulates unchanged. Its most notable feature is its very long half-life of approximately 16–17 days, meaning it takes weeks for the body to clear it; this supports once-weekly dosing for prevention but also means side effects can linger well after the last dose. The full picture of how tafenoquine is excreted from the body is not yet fully known.
📦How to store it▾
Store at less than 30°C (86°F). Protect from moisture.
📄 Written from Tafenoquine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Tafenoquine
17 supplements and herbal products have documented interactions with Tafenoquine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Tafenoquine — the kind of thing our pharmacy team would talk through with you at the counter.
What's the difference between Krintafel and Arakoda — they both seem to be the same drug? ▾
Why do I have to get a blood test before taking this medication? ▾
I'm on metformin for diabetes. Is that going to be a problem? ▾
What side effects should I actually expect, versus what should send me to the doctor? ▾
Can I take tafenoquine if I'm pregnant or trying to get pregnant? ▾
I'm taking Arakoda for a long trip — do I really need to take the dose after I leave the malaria area too? ▾
Is Tafenoquine available over the counter? ▾
When was Tafenoquine first available? ▾
Who makes Tafenoquine? ▾
💬 Answers drafted from Tafenoquine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Tafenoquine comes
Tafenoquine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Arakoda is used for malaria prophylaxis (prevention) in adults 18 years and older
- Kodatef is used for malaria prophylaxis, consistent with the approved use of Arakoda
- Krintafel is used to prevent relapse of Plasmodium vivax malaria in patients 16 years and older who are receiving chloroquine therapy for an active P. vivax infection
- Krintafel is NOT used to treat an active malaria episode on its own
- Arakoda is taken with food using a three-phase schedule: a loading phase daily for 3 days before travel, a weekly maintenance dose while in the malaria zone, and a single terminal dose in the week after leaving the area
- Kodatef follows the same loading and maintenance dosing schedule as Arakoda
- Krintafel is taken as a single dose with food on the first or second day of chloroquine therapy; if vomiting occurs within one hour, a repeat dose may be given once
- All brands: swallow tablets whole — do not break, crush, or chew them
📊 Tafenoquine across the U.S. market
How Tafenoquine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Tafenoquine products
A representative set of FDA-listed product records for Tafenoquine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 100 mg | Oral | 60 Degrees Pharmaceuticals, INC | UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE | View NDC → |
| 100 mg | Oral | 60 Degrees Pharmaceuticals, INC. | NDA | View NDC → |
| 100 mg | Oral | 60 Degrees Pharmaceuticals, LLC × 2 listings | NDA | View NDC → |
| 150 mg | Oral | GlaxoSmithKline LLC × 4 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | MSN Life Sciences Private Limited | BULK INGREDIENT | View NDC → |
| 25 kg/25 kg | — | Piramal Pharma Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 10 of 10 products — FDA National Drug Code Directory. See every product, package size and price: browse all 10 Tafenoquine NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Tafenoquine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Tafenoquine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Tafenoquine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2054023 1 dose form · 2 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 2054095In current FDA listings
Look up RxCUI 2054023 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Tafenoquine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Tafenoquine belongs to the Aminoquinolines class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 3 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. 60 Degrees Pharmaceuticals, INC. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.