Atovaquone / proguanil Side Effects

Not all side effects for atovaquone / proguanil may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to atovaquone / proguanil: oral tablet

In addition to its needed effects, some unwanted effects may be caused by atovaquone / proguanil. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking atovaquone / proguanil, check with your doctor or nurse as soon as possible:

Incidence not known
  • Blistering, peeling, loosening of skin
  • chills
  • convulsions
  • difficulty swallowing
  • fast heartbeat
  • hives or welts
  • increased sensitivity of skin to sunlight
  • itching, redness or other discoloration of skin
  • joint or muscle pain
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
  • loss of bladder control
  • muscle spasm or jerking of all extremities
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rash
  • red, irritated eyes
  • red skin lesions, often with a purple center
  • seeing, hearing, or feeling things that are not there
  • severe mental changes
  • severe sunburn
  • shortness of breath
  • skin rash
  • sores, ulcers or white spots in mouth or on lips
  • sudden loss of consciousness
  • tightness in chest
  • unusual tiredness or weakness
  • wheezing

Some of the side effects that can occur with atovaquone / proguanil may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Abdominal pain
  • back pain
  • coughing
  • diarrhea
  • dreams
  • fever
  • headache
  • itching skin
  • lack of or loss of strength
  • nausea
  • muscle pain
  • sore throat
  • sores in mouth
  • sneezing
  • vomiting
Less common
  • Acid or sour stomach
  • belching
  • blurred or loss of vision
  • disturbed color perception
  • dizziness
  • double vision
  • flu like symptoms
  • halos around lights
  • heartburn
  • indigestion
  • loss of appetite
  • night blindness
  • overbright appearance of lights
  • sleeplessness
  • stomach discomfort, upset or pain
  • trouble sleeping
  • tunnel vision
  • unable to sleep
  • weight loss
Rare
  • Discouragement
  • fear
  • feeling sad or empty
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • nervousness
  • trouble concentrating

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 material does not endorse drugs, diagnose patients, or recommend therapy. This 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 combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials 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 substances you are taking, check with your doctor, nurse, or pharmacist.

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