Malarone Side Effects

Generic name: atovaquone / proguanil

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

Some side effects of Malarone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to atovaquone / proguanil: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking atovaquone / proguanil: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• severe or uncontrolled vomiting or diarrhea;

• fever, mouth sores;

• problems with speech, balance, or walking;

• severe skin rash;

• nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); o

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.

Less serious side effects of atovaquone / proguanil may include:

• mild stomach pain or upset stomach;

• mild diarrhea;

• headache;

• mild itching;

• weakness; or

• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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.

Dermatologic

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

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.

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.

Musculoskeletal

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

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.

Respiratory

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

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.

Psychiatric

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

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%).

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.