Tafenoquine Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 30, 2022.

Applies to tafenoquine: oral tablet.

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:

More common

• Bluish-colored lips, fingernails, or palms
• dark urine
• difficulty breathing
• dizziness or lightheadedness
• fever
• headache
• pale skin
• rapid heartbeat
• sore throat
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Abnormal dreams
• anxiety
• discouragement
• feeling sad or empty
• hives or welts, itching, skin rash
• irritability
• lack of appetite
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• loss of interest or pleasure
• redness of the skin
• sleepiness or unusual drowsiness
• trouble concentrating
• trouble sleeping

Rare

• Agitation
• back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• clay-colored stools
• diarrhea
• fainting
• fast heartbeat
• general body swelling
• hoarseness
• increased sensitivity to pain
• increased sensitivity to touch
• irritation
• joint pain, stiffness, or swelling
• nausea
• nosebleed
• pinpoint red spots on the skin
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• tremor
• trouble with swallowing
• trouble breathing
• unpleasant breath odor
• vomiting
• vomiting of blood
• yellow eyes or skin

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:

More common

• Blurred vision or any other change in vision
• eye redness, irritation, or pain

Less common

• Motion sickness

Rare

• Change in color vision
• decreased vision
• difficulty seeing at night
• increased sense of hearing
• increased sensitivity of the eyes to sunlight
• loss of memory
• night blindness
• poor coordination
• problems with memory
• seeing floating dark spots or material before the eyes

For Healthcare Professionals

Applies to tafenoquine: oral tablet.

General

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

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]

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]

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 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]

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]

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]

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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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