Tafenoquine Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 4, 2024.

Applies to tafenoquine: oral tablet.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Before taking this medicine, you and your child should be tested for G6PD deficiency or favism (blood disorder). Tafenoquine may cause hemolytic anemia in patients with these conditions. Talk to your doctor if you have concerns about this.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause a serious allergic reaction, including angioedema, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals.

Malaria is spread by the bites of certain kinds of infected female mosquitoes. If you are living in or will be traveling to an area where there is a chance of getting malaria, the following mosquito-control measures will help to prevent infection:

• If possible, avoid going out between dusk and dawn because it is at these times that mosquitoes most commonly bite.
• Remain in air-conditioned or well-screened rooms to reduce contact with mosquitoes.
• Wear long-sleeved shirts or blouses and long trousers to protect your arms and legs, especially from dusk through dawn when mosquitoes are out.
• Apply insect repellant, preferably one containing DEET, to uncovered areas of the skin from dusk through dawn when mosquitoes are out.
• If possible, sleep in a screened or air-conditioned room or under mosquito netting, preferably coated or soaked with pyrethrum, to avoid being bitten by malaria-carrying mosquitoes.
• Use mosquito coils or sprays to kill mosquitoes in living and sleeping quarters during evening and nighttime hours.

Do not use Krintafel™ with medicines to treat malaria other than chloroquine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of tafenoquine

Along with its needed effects, tafenoquine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tafenoquine:

Other side effects of tafenoquine

Some side effects of tafenoquine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to tafenoquine: oral tablet.

General adverse events

The recommended regimen for the prophylaxis of malaria was evaluated in 5 clinical trials. The duration of drug exposure in these 5 trials averaged 21 weeks (range: 10 to 29 weeks). Of the 5 trials, 3 were conducted in healthy semi-immune volunteers in Ghana or Kenya, 1 was in healthy soldiers in East Timor (Timor Leste), and 1 was in healthy volunteers in the US and UK.

In clinical trials in patients with Plasmodium vivax malaria, a single dose of this drug was used with chloroquine.^[Ref]

Ocular

For the prophylaxis of malaria:

• Very common (10% or more): Vortex keratopathy (up to 93%)
• Frequency not reported: Retinal abnormalities, retinal disorders, keratopathy, night blindness, photophobia, blurred vision, reduced visual acuity, visual impairment, vitreous floaters

For the radical cure of P vivax malaria:

• Uncommon (0.1% to 1%): Vortex keratopathy, photophobia^[Ref]

In the trials that included ophthalmic evaluations, vortex keratopathy was reported in 21% to 93% of subjects receiving this drug; the keratopathy did not cause any apparent functional visual changes and resolved within 1 year after stopping the drug in all patients.

For the prophylaxis of malaria: Keratopathy (5 reports) and retinal disorders (2 reports) were reported as serious ocular adverse reactions in trials that included ophthalmic evaluations.^[Ref]

Nervous system

For the prophylaxis of malaria:

• Very common (10% or more): Headache (included headache, sinus headache, migraine, tension headache; up to 32%)
• Common (1% to 10%): Dizziness (included dizziness, postural dizziness), motion sickness (included motion sickness, vertigo, positional vertigo)
• Frequency not reported: Hyperacusis, Meniere's disease, amnesia, abnormal coordination, hyperesthesia, hypoesthesia, somnolence, syncope, tremor, visual field defect

For the radical cure of P vivax malaria:

• Common (1% to 10%): Headache, dizziness
• Uncommon (0.1% to 1%): Somnolence^[Ref]

Gastrointestinal

For the prophylaxis of malaria:

• Very common (10% or more): Diarrhea (up to 18%)
• Common (1% to 10%): Nausea, vomiting

For the radical cure of P vivax malaria:

• Common (1% to 10%): Nausea, vomiting^[Ref]

Musculoskeletal

For the prophylaxis of malaria:

• Very common (10% or more): Back pain (14%)^[Ref]

Hematologic

For the prophylaxis of malaria:

• Very common (10% or more): Asymptomatic methemoglobin elevations (13%)
• Common (1% to 10%): Decreased hemoglobin
• Frequency not reported: Hemolytic anemia, anemia, thrombocytopenia

For the radical cure of P vivax malaria:

• Common (1% to 10%): Decreased hemoglobin levels, elevated methemoglobin
• Frequency not reported: Asymptomatic methemoglobin elevations^[Ref]

For the prophylaxis of malaria: Decreased hemoglobin (at least 3 g/dL) was reported in 2.3% of subjects.^[Ref]

Psychiatric

For the prophylaxis of malaria:

• Common (1% to 10%): Any sleep symptom (included abnormal dreams, insomnia, nightmares, sleep disorder, somnambulism), insomnia, abnormal dreams (included abnormal dreams, nightmares), depression/depressed mood, anxiety (included anxiety disorder, panic attack, stress)
• Frequency not reported: Agitation, neurosis

For the radical cure of P vivax malaria:

• Common (1% to 10%): Insomnia
• Uncommon (0.1% to 1%): Anxiety
• Rare (less than 0.1%): Abnormal dreams
• Frequency not reported: Depression, psychosis^[Ref]

For the radical cure of P vivax malaria: Cases of depression and psychosis (2 each) have been reported primarily in patients with history of psychiatric disorders after receiving single doses that were higher than the approved 300 mg dose (350 to 600 mg).^[Ref]

Renal

For the prophylaxis of malaria:

• Frequency not reported: Increased blood creatinine, decreased glomerular filtration rate

For the radical cure of P vivax malaria:

• Common (1% to 10%): Increased blood creatinine^[Ref]

Hepatic

For the prophylaxis of malaria:

• Common (1% to 10%): Increased/abnormal ALT
• Frequency not reported: Hyperbilirubinemia, cholestatic jaundice, increased blood bilirubin

For the radical cure of P vivax malaria:

• Uncommon (0.1% to 1%): Increased ALT^[Ref]

Hypersensitivity

For the prophylaxis of malaria:

• Frequency not reported: Hypersensitivity

For the radical cure of P vivax malaria:

• Rare (less than 0.1%): Hypersensitivity reactions (e.g., angioedema, urticaria)^[Ref]

Dermatologic

For the prophylaxis of malaria:

• Frequency not reported: Urticaria^[Ref]

See also:

Frequently asked questions

• What is the difference between Arakoda and Krintafel?
• How do you take Arakoda for the prevention of malaria?
• How do you take Krintafel?

Further information

Tafenoquine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer