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Malarone Side Effects

Generic name: atovaquone / proguanil

Medically reviewed by Drugs.com. Last updated on Jan 29, 2024.

Note: This document contains side effect information about atovaquone / proguanil. Some dosage forms listed on this page may not apply to the brand name Malarone.

Applies to atovaquone / proguanil: oral tablet.

Serious side effects of Malarone

Along with its needed effects, atovaquone/proguanil 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 as soon as possible if any of the following side effects occur while taking atovaquone / proguanil:

Incidence not known

Other side effects of Malarone

Some side effects of atovaquone / proguanil 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

Less common

Rare

For Healthcare Professionals

Applies to atovaquone / proguanil: oral tablet.

General

In general, side effects associated with the use of atovaquone-proguanil have been mild. Side effects are more pronounced and occur more frequently when higher doses are used in the treatment of malaria than with lower prophylactic doses.[Ref]

Dermatologic

Dermatologic side effects have included pruritus (2%). Cutaneous reactions ranging from rash, photosensitivity, and urticaria have been reported during postmarketing experience.[Ref]

Gastrointestinal

Gastrointestinal side effects have included abdominal pain (5% to 17%), nausea (3% to 12%), vomiting (1% to 12%), diarrhea (4% to 8%), mouth ulcers (6%), anorexia (5%), dyspepsia (2%), and gastritis (2%). GI upset has also been reported. Stomatitis has been reported during postmarketing experience.[Ref]

Hepatic

Hepatic side effects have included transient increases in liver function tests. These increases have not required discontinuation of therapy. Rare cases of hepatitis, cholestasis, and a single case of hepatic failure have been reported during postmarketing experience.[Ref]

Musculoskeletal

Musculoskeletal side effects have included asthenia (8%), myalgia (7%), and back pain (4%).[Ref]

Nervous system

Nervous system side effects have included headache (4% to 17%), dizziness (2% to 5%), vertigo (2%), and visual disturbances (2%). Rare cases of seizures and psychotic events (such as hallucinations) have been reported during postmarketing experience. However, a causal relationship has not been established.[Ref]

Respiratory

Respiratory side effects have rarely included cough (4%).[Ref]

Hypersensitivity

Hypersensitivity side effects have included rare cases of anaphylaxis. Rare cases of erythema multiforme, Stevens-Johnson syndrome, vasculitis, and angioedema have been reported during postmarketing experience.[Ref]

Psychiatric

Psychiatric side effects including strange or vivid dreams (7%), insomnia (3%), anxiety (less than 1%), and depression (less than 1%) have been reported.[Ref]

Hematologic

Hematologic side effects including neutropenia, anemia (rarely), and pancytopenia in patients with severe renal impairment treated with proguanil have been reported during the postmarketing experience.

Other

Other side effects have included flu-like symptoms (4%) and fever (3%).[Ref]

References

1. Product Information. Malarone (atovaquone-proguanil). Glaxo Wellcome. 2001;PROD.

2. Overbosch D, Schilthuis H, Bienzle U, et al. Atovaquone-Proguanil versus Mefloquine for Malaria Prophylaxis in Nonimmune Travelers: Results from a Randomized, Double-Blind Study. Clin Infect Dis. 2001;33:1015-21.

3. Winstanley P. Malaria: treatment. J R Coll Physicians Lond. 1998;32:203-7.

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.