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MALARONE

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Malarone Adverse Events Reported to the FDA Over Time

How are Malarone adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Malarone, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Malarone is flagged as the suspect drug causing the adverse event.

Most Common Malarone Adverse Events Reported to the FDA

What are the most common Malarone adverse events reported to the FDA?

Diarrhoea
167 (2.87%)
Pyrexia
142 (2.44%)
Nausea
127 (2.18%)
Vomiting
127 (2.18%)
Malaria
98 (1.68%)
Headache
95 (1.63%)
Dizziness
90 (1.55%)
Fatigue
87 (1.49%)
Drug Ineffective
84 (1.44%)
Hallucination
84 (1.44%)
Malaise
83 (1.43%)
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Rash
74 (1.27%)
Abdominal Pain
66 (1.13%)
Drug Exposure During Pregnancy
59 (1.01%)
Asthenia
58 (1%)
Insomnia
52 (.89%)
Pruritus
51 (.88%)
Urticaria
50 (.86%)
Anxiety
43 (.74%)
Dyspnoea
43 (.74%)
Abnormal Dreams
42 (.72%)
Mouth Ulceration
40 (.69%)
Drug Interaction
39 (.67%)
Abdominal Pain Upper
37 (.64%)
Weight Decreased
36 (.62%)
Oedema Peripheral
34 (.58%)
Nightmare
32 (.55%)
Depression
31 (.53%)
Hypersensitivity
31 (.53%)
Pain
31 (.53%)
Thrombocytopenia
31 (.53%)
Alopecia
30 (.52%)
Confusional State
30 (.52%)
Alanine Aminotransferase Increased
29 (.5%)
Transaminases Increased
29 (.5%)
Anaemia
28 (.48%)
Anorexia
28 (.48%)
Chills
28 (.48%)
Myalgia
28 (.48%)
Swelling Face
28 (.48%)
Decreased Appetite
27 (.46%)
Gamma-glutamyltransferase Increased
27 (.46%)
Syncope
27 (.46%)
Blister
26 (.45%)
Vision Blurred
26 (.45%)
Jaundice
25 (.43%)
Loss Of Consciousness
25 (.43%)
Paraesthesia
25 (.43%)
Aspartate Aminotransferase Increase...
24 (.41%)
Plasmodium Falciparum Infection
24 (.41%)
Rash Generalised
24 (.41%)
Cough
22 (.38%)
Dehydration
22 (.38%)
Psychotic Disorder
22 (.38%)
Aphthous Stomatitis
21 (.36%)
Gastrointestinal Disorder
21 (.36%)
Abortion Spontaneous
20 (.34%)
Feeling Abnormal
20 (.34%)
Panic Attack
20 (.34%)
Hepatic Enzyme Increased
19 (.33%)
Rash Macular
19 (.33%)
Arthralgia
18 (.31%)
Back Pain
18 (.31%)
Chest Pain
18 (.31%)
Influenza Like Illness
18 (.31%)
Tachycardia
18 (.31%)
Convulsion
17 (.29%)
Pancreatitis
17 (.29%)
Tremor
17 (.29%)
Visual Acuity Reduced
17 (.29%)
Abortion Induced
16 (.27%)
Angioedema
16 (.27%)
Epistaxis
16 (.27%)
Muscular Weakness
16 (.27%)
Palpitations
16 (.27%)
Psoriasis
16 (.27%)
Rash Pruritic
16 (.27%)
Abdominal Discomfort
15 (.26%)
Erythema
15 (.26%)
Hyperhidrosis
15 (.26%)
Pancytopenia
15 (.26%)
Aggression
14 (.24%)
Chromaturia
14 (.24%)
Haematuria
14 (.24%)
Treatment Noncompliance
14 (.24%)
Amnesia
13 (.22%)
Atrial Fibrillation
13 (.22%)
Eye Swelling
13 (.22%)
International Normalised Ratio Incr...
13 (.22%)
Overdose
13 (.22%)
Paranoia
13 (.22%)
Poor Quality Sleep
13 (.22%)
Sleep Disorder
13 (.22%)
Somnolence
13 (.22%)
Crying
12 (.21%)
Depressed Mood
12 (.21%)
Disorientation
12 (.21%)
Epilepsy
12 (.21%)
Face Oedema
12 (.21%)
Hypoaesthesia
12 (.21%)
Hypotension
12 (.21%)

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This graph shows the top adverse events submitted to the FDA for Malarone, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Malarone is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Malarone

What are the most common Malarone adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Malarone, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Malarone is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Malarone According to Those Reporting Adverse Events

Why are people taking Malarone, according to those reporting adverse events to the FDA?

Malaria Prophylaxis
967
Malaria
173
Prophylaxis
144
Drug Use For Unknown Indication
122
Product Used For Unknown Indication
27
Plasmodium Falciparum Infection
12
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Ill-defined Disorder
11
Foreign Travel
7
Lyme Disease
5
Prophylactic Chemotherapy
3
Drug Exposure During Pregnancy
3
Babesiosis
2
Intentional Overdose
2
Immunisation
2
Drug Hypersensitivity
1

Drug Labels

LabelLabelerEffective
MalaronePD-Rx Pharmaceuticals, Inc.15-DEC-11
MalaroneGlaxoSmithKline LLC27-FEB-13

Malarone Case Reports

What Malarone safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Malarone. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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