Prescription medicine
Tafenoquine Brand names: Arakoda, Krintafel
Tafenoquine (Arakoda) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the tafenoquine FDA label on DailyMed (effective January 10, 2025, 60 Degrees Pharmaceuticals, INC.); the NDA 210795 record on Drugs@FDA; every tafenoquine label on DailyMed.
Highlights of the record
FDA label of January 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageARAKODA is indicated for the prophylaxis of malaria in patients aged 18 years and older.
Forms and strengths
- 100 mg
- 150 mg
Film-coated tablet.
On the market
- Earliest approval on file
- July 20, 2018 Krintafel, Glaxosmithkline; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- December 2, 2035 Arakoda tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 72 through July 30, 2026
What is tafenoquine used for?
From the label: indications and usageARAKODA is indicated for the prophylaxis of malaria in patients aged 18 years and older. ARAKODA is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older.
Source: FDA drug label (Arakoda), 60 Degrees Pharmaceuticals, INC., effective January 10, 2025 (SPL set 299e49d8-470f-4779-a010-4a1ee0e0c6cd), via openFDA; the full label on DailyMed
What does the patient leaflet for tafenoquine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ARAKODA?ARAKODA can cause serious side effects including: • Breakdown of red blood cells (hemolytic anemia). See “ Do not take ARAKODA if you :” ARAKODA can cause a breakdown of red blood cells (hemolysis) in people with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Your healthcare provider will test you for G6PD deficiency before you start taking ARAKODA. Signs of hemolytic anemia may not happen right away (delayed reaction).Tell your healthcare provider or get emergency medical help right away if you develop signs of hemolytic anemia which include darkening of the urine, dizziness, confusion, feeling tired, light-headedness, or shortness of breath, pale skin or yellowing of the skin and whites of the eyes. • Decrease of oxygen in your blood caused by a certain type of abnormal red blood cell (methemoglobinemia). Signs and symptoms of methemoglobinemia may not happen right away (delayed reaction). Get medical help right away if you have bluish coloring of the lips or skin, headache, fatigue, shortness of breath, or lack of energy. • Mental health (psychiatric) symptoms. See “ Do not take ARAKODA if you :” Sleep problems, depression, anxiety and psychosis have happened while taking ARAKODA. Psychiatric symptoms may not happen right away (delayed reaction). Get emergency medical help right away if you develop hallucinations (seeing or hearing things that are really not there), delusions (false or strange thoughts or beliefs), or if you get confused or have problems thinking while taking ARAKODA. Call your healthcare provider if you develop changes in your mood, anxiety, trouble sleeping (insomnia), or nightmares for 3 days or longer while taking ARAKODA. • ARAKODA can have other serious side effects. See “ What are the possible side effects of ARAKODA? ”
From the patient leaflet: How should I store ARAKODA?Store ARAKODA at room temperature between 68°F to 77°F (20°C to 25°C). • Protect tablets from moisture. Keep ARAKODA and all medicines out of the reach of children.
Source: FDA drug label (Arakoda), 60 Degrees Pharmaceuticals, INC., effective January 10, 2025 (SPL set 299e49d8-470f-4779-a010-4a1ee0e0c6cd), via openFDA; the full label on DailyMed
Is there a generic for tafenoquine (Arakoda)?
No generic tafenoquine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Arakoda tablets, the last expiring on December 2, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the tafenoquine label say about other medicines?
The tafenoquine label names 5 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Chloroquine | warnings and precautions | Use with antimalarials other than chloroquine is not recommended. |
| Dofetilide | drug interactions | Avoid coadministration of ARAKODA with OCT2 and MATE substrates (e.g., dofetilide, metformin). |
| Mefloquine | warnings and precautions | Subjects with a history of psychiatric disorders were excluded from three of five ARAKODA trials in which mefloquine was included as a comparator. |
| Metformin | drug interactions | Avoid coadministration of ARAKODA with OCT2 and MATE substrates (e.g., dofetilide, metformin). |
| Primaquine | warnings and precautions | In this double-blind, randomized, placebo-controlled trial in which all patients with P. vivax malaria were treated with dihydroartemisinin/piperaquine (not approved artemisinin-containing antimalarial) and were coadministered KRINTAFEL, primaquine, or placebo, lack of efficacy (recurrence rates at 6 months following … |
Source: FDA drug label (Arakoda), 60 Degrees Pharmaceuticals, INC., effective January 10, 2025 (SPL set 299e49d8-470f-4779-a010-4a1ee0e0c6cd), via openFDA; the full label on DailyMed
What do FAERS reports show for tafenoquine?
The FDA Adverse Event Reporting System holds 72 reports that list tafenoquine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7 are coded as a death and 32 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Tafenoquine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other