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Malarone

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Malarone

Malarone

Malarone Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Malarone (atovaquone and proguanil hcl) is used to treat or prevent malaria, a disease caused by parasites. Parasites that cause malaria typically enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia. Atovaquone and proguanil are antimalarial medications. This medication is available in generic form. Common side effects include nausea, vomiting, abdominal pain, headache, diarrhea, weakness, loss of appetite, and dizziness.

Dose is one Malarone Tablet (adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day. The dosage for prevention of malaria in pediatric patients is based upon body weight. For malaria prevention, take 1 or 2 days before entering an area where malaria is common. Take it every day during your stay and for at least 7 days after you leave. To treat malaria, take Malarone 3 days in a row. Malarone may interact with blood thinners, rifabutin, rifampin, tetracycline, or metoclopramide. Tell your doctor all medications you are taking. During pregnancy, Malarone should be used only when prescribed. While you are pregnant, traveling to an area with malaria places you and your infant at a much higher risk of contracting the parasite. It is not known if atovaquone passes into breast milk and may have undesirable effects on a nursing infant. The proguanil in this medication passes into breast milk and the effects of this medication on a nursing infant are not known. The CDC recommends against using this product for malaria prevention if you are breastfeeding an infant weighing less than 11 pounds (5 kilograms). Consult your doctor before breast-feeding.

Our Malarone (atovaquone and proguanil hcl) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Malarone in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Malarone (Atovaquone and Proguanil Hcl) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Malarone Overview - Patient Information: Side Effects

SIDE EFFECTS: See also How to Use section.

Side effects may include nausea, vomiting, abdominal pain, headache, diarrhea, weakness, loss of appetite, and dizziness. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of serious liver problems (such as persistent/severe nausea and vomiting, abdominal pain, unexplained tiredness, dark urine, yellowing eyes/skin), signs of anemia (such as worsening tiredness, rapid breathing, pale skin/lips/nails, fast heartbeat while resting), signs of severe infection (such as high fever, severe chills, body aches, sore throat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Malarone (Atovaquone and Proguanil Hcl)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Malarone FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Because MALARONE contains atovaquone and proguanil hydrochloride, the type and severity of adverse reactions associated with each of the compounds may be expected. The lower prophylactic doses of MALARONE were better tolerated than the higher treatment doses.

Prophylaxis of P. falciparum Malaria

In 3 clinical trials (2 of which were placebo-controlled) 381 adults (mean age 31 years) received MALARONE for the prophylaxis of malaria; the majority of adults were black (90%) and 79% were male. In a clinical trial for the prophylaxis of malaria, 125 pediatric patients (mean age 9 years) received MALARONE; all subjects were black and 52% were male. Adverse experiences reported in adults and pediatric patients, considered attributable to therapy, occurred in similar proportions of subjects receiving MALARONE or placebo in all studies. Prophylaxis with MALARONE was discontinued prematurely due to a treatment-related adverse experience in 3 of 381 (0.8%) adults and 0 of 125 pediatric patients.

In a placebo-controlled study of malaria prophylaxis with MALARONE involving 330 pediatric patients (aged 4 to 14 years) in Gabon, a malaria-endemic area, the safety profile of MALARONE was consistent with that observed in the earlier prophylactic studies in adults and pediatric patients. The most common treatment-emergent adverse events with MALARONE were abdominal pain (13%), headache (13%), and cough (10%). Abdominal pain (13% vs. 8%) and vomiting (5% vs. 3%) were reported more often with MALARONE than with placebo. No patient withdrew from the study due to an adverse experience with MALARONE. No routine laboratory data were obtained during this study.

Non-immune travelers visiting a malaria-endemic area received MALARONE (n = 1,004) for prophylaxis of malaria in 2 active-controlled clinical trials. In one study (n = 493), the mean age of subjects was 33 years and 53% were male; 90% of subjects were white, 6% of subjects were black and the remaining were of other racial/ethnic groups. In the other study (n = 511), the mean age of subjects was 36 years and 51% were female; the majority of subjects (97%) were white. Adverse experiences occurred in a similar or lower proportion of subjects receiving MALARONE than an active comparator (Table 3). Fewer neuropsychiatric adverse experiences occurred in subjects who received MALARONE than mefloquine. Fewer gastrointestinal adverse experiences occurred in subjects receiving MALARONE than chloroquine/proguanil. Compared with active comparator drugs, subjects receiving MALARONE had fewer adverse experiences overall that were attributed to prophylactic therapy (Table 3). Prophylaxis with MALARONE was discontinued prematurely due to a treatment-related adverse experience in 7 of 1,004 travelers.

Table 3: Adverse Experiences in Active-Controlled Clinical Trials of MALARONE for Prophylaxis of P. falciparum Malaria

  Percent of Subjects With Adverse Experiencesa (Percent of Subjects With Adverse Experiences Attributable to Therapy)
Study 1 Study 2
MALARONE
n = 493
(28 days)b
Mefloquine
n = 483
(53 days)b
MALARONE
n = 511
(26 days)b
Chloroquine plus Proguanil
n = 511
(49 days)b
Diarrhea 38 (8) 36 (7) 34 (5) 39 (7)
Nausea 14 (3) 20 (8) 11 (2) 18 (7)
Abdominal pain 17 (5) 16 (5) 14 (3) 22 (6)
Headache 12 (4) 17 (7) 12 (4) 14 (4)
Dreams 7 (7) 16 (14) 6 (4) 7 (3)
Insomnia 5 (3) 16 (13) 4 (2) 5 (2)
Fever 9 ( < 1) 11 (1) 8 ( < 1) 8 ( < 1)
Dizziness 5 (2) 14 (9) 7 (3) 8 (4)
Vomiting 8 (1) 10 (2) 8 (0) 14 (2)
Oral ulcers 9 (6) 6 (4) 5 (4) 7 (5)
Pruritus 4 (2) 5 (2) 3 (1) 2 ( < 1)
Visual difficulties 2 (2) 5 (3) 3 (2) 3 (2)
Depression < 1 ( < 1) 5 (4) < 1 ( < 1) 1 ( < 1)
Anxiety 1 ( < 1) 5 (4) < 1 ( < 1) 1 ( < 1)
Any adverse experience 64 (30) 69 (42) 58 (22) 66 (28)
Any neuropsychiatric event 20 (14) 37 (29) 16 (10) 20 (10)
Any GI event 49 (16) 50 (19) 43 (12) 54 (20)
aAdverse experiences that started while receiving active study drug.
bMean duration of dosing based on recommended dosing regimens.

In a third active-controlled study, MALARONE (n = 110) was compared with chloroquine/proguanil (n = 111) for the prophylaxis of malaria in 221 non-immune pediatric patients (2 to 17 years of age). The mean duration of exposure was 23 days for MALARONE, 46 days for chloroquine, and 43 days for proguanil, reflecting the different recommended dosage regimens for these products. Fewer patients treated with MALARONE reported abdominal pain (2% vs. 7%) or nausea ( < 1% vs. 7%) than children who received chloroquine/proguanil. Oral ulceration (2% vs. 2%), vivid dreams (2% vs. < 1%), and blurred vision (0% vs. 2%) occurred in similar proportions of patients receiving either MALARONE or chloroquine/proguanil, respectively. Two patients discontinued prophylaxis with chloroquine/proguanil due to adverse events, while none of those receiving MALARONE discontinued due to adverse events.

Treatment of Acute, Uncomplicated P. falciparum Malaria

In 7 controlled trials, 436 adolescents and adults received MALARONE for treatment of acute, uncomplicated P. falciparum malaria. The range of mean ages of subjects was 26 to 29 years; 79% of subjects were male. In these studies, 48% of subjects were classified as other racial/ethnic groups, primarily Asian; 42% of subjects were black and the remaining subjects were white. Attributable adverse experiences that occurred in ≥ 5% of patients were abdominal pain (17%), nausea (12%), vomiting (12%), headache (10%), diarrhea (8%), asthenia (8%), anorexia (5%), and dizziness (5%). Treatment was discontinued prematurely due to an adverse experience in 4 of 436 (0.9%) adolescents and adults treated with MALARONE.

In 2 controlled trials, 116 pediatric patients (weighing 11 to 40 kg) (mean age 7 years) received MALARONE for the treatment of malaria. The majority of subjects were black (72%); 28% were of other racial/ethnic groups, primarily Asian. Attributable adverse experiences that occurred in ≥ 5% of patients were vomiting (10%) and pruritus (6%). Vomiting occurred in 43 of 319 (13%) pediatric patients who did not have symptomatic malaria but were given treatment doses of MALARONE for 3 days in a clinical trial. The design of this clinical trial required that any patient who vomited be withdrawn from the trial. Among pediatric patients with symptomatic malaria treated with MALARONE, treatment was discontinued prematurely due to an adverse experience in 1 of 116 (0.9%).

In a study of 100 pediatric patients (5 to < 11 kg body weight) who received MALARONE for the treatment of uncomplicated P. falciparum malaria, only diarrhea (6%) occurred in ≥ 5% of patients as an adverse experience attributable to MALARONE. In 3 patients (3%), treatment was discontinued prematurely due to an adverse experience.

Abnormalities in laboratory tests reported in clinical trials were limited to elevations of transaminases in malaria patients being treated with MALARONE. The frequency of these abnormalities varied substantially across trials of treatment and were not observed in the randomized portions of the prophylaxis trials.

One active-controlled trial evaluated the treatment of malaria in Thai adults (n = 182); the mean age of subjects was 26 years (range 15 to 63 years); 80% of subjects were male. Early elevations of ALT and AST occurred more frequently in patients treated with MALARONE (n = 91) compared to patients treated with an active control, mefloquine (n = 91). On Day 7, rates of elevated ALT and AST with MALARONE and mefloquine (for patients who had normal baseline levels of these clinical laboratory parameters) were ALT 26.7% vs. 15.6%; AST 16.9% vs. 8.6%, respectively. By Day 14 of this 28-day study, the frequency of transaminase elevations equalized across the 2 groups.

Postmarketing Experience

In addition to adverse events reported from clinical trials, the following events have been identified during postmarketing use of MALARONE. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to MALARONE.

Blood and Lymphatic System Disorders: Neutropenia and anemia. Pancytopenia in patients with severe renal impairment treated with proguanil [see CONTRAINDICATIONS].

Immune System Disorders: Allergic reactions including anaphylaxis, angioedema, and urticaria, and vasculitis.

Nervous System Disorders: Seizures and psychotic events (such as hallucinations); however, a causal relationship has not been established.

Gastrointestinal Disorders: Stomatitis.

Hepatobiliary Disorders: Elevated liver laboratory tests, hepatitis, cholestasis; hepatic failure requiring transplant has been reported.

Skin and Subcutaneous Tissue Disorders: Photosensitivity, rash, erythema multiforme, and Stevens-Johnson syndrome.

Read the entire FDA prescribing information for Malarone (Atovaquone and Proguanil Hcl) »

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Malarone - User Reviews

Malarone User Reviews

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Here is a collection of user reviews for the medication Malarone sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

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