Krintafel Side Effects
Generic name: tafenoquine
Medically reviewed by Drugs.com. Last updated on Aug 4, 2024.
Note: This document provides detailed information about Krintafel.
Applies to tafenoquine: oral tablet Side Effects associated with tafenoquine. Some dosage forms listed on this page may not apply specifically to the brand name Krintafel.
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 Krintafel
Along with its needed effects, tafenoquine (the active ingredient contained in Krintafel) 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 side effects
- 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 side effects
- 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 side effects
- 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 Krintafel
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 side effects
- blurred vision or any other change in vision
- eye redness, irritation, or pain
Less common side effects
Rare side effects
- 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 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:
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:
Dermatologic
For the prophylaxis of malaria:
- Frequency not reported: Urticaria[Ref]
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References
1. Cerner Multum, Inc. "Australian Product Information."
2. (2018) "Product Information. Krintafel (tafenoquine)." GlaxoSmithKline
3. (2018) "Product Information. Arakoda (tafenoquine)." 60 Degrees Pharmaceuticals LLC
Frequently asked questions
- What is the difference between Arakoda and Krintafel?
- How do you take Krintafel?
- How do you take Arakoda for the prevention of malaria?
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Further information
Krintafel 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.