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]
