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Mefloquine Adverse Events Reported to the FDA Over Time

How are Mefloquine adverse event reports trending over time?

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

Most Common Mefloquine Adverse Events Reported to the FDA

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

Anxiety
173 (3.22%)
Depression
131 (2.44%)
Dizziness
99 (1.84%)
Insomnia
96 (1.79%)
Fatigue
89 (1.66%)
Headache
86 (1.6%)
Suicidal Ideation
80 (1.49%)
Panic Attack
73 (1.36%)
Psychotic Disorder
72 (1.34%)
Disturbance In Attention
71 (1.32%)
Nausea
69 (1.28%)
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Vertigo
66 (1.23%)
Hallucination
65 (1.21%)
Paranoia
59 (1.1%)
Tinnitus
57 (1.06%)
Confusional State
56 (1.04%)
Diarrhoea
54 (1.01%)
Asthenia
53 (.99%)
Paraesthesia
53 (.99%)
Feeling Abnormal
50 (.93%)
Nightmare
50 (.93%)
Pyrexia
50 (.93%)
Abnormal Dreams
48 (.89%)
Balance Disorder
47 (.88%)
Amnesia
43 (.8%)
Mental Disorder
42 (.78%)
Sleep Disorder
42 (.78%)
Vomiting
42 (.78%)
Dyspnoea
41 (.76%)
Convulsion
40 (.74%)
Palpitations
39 (.73%)
Aggression
35 (.65%)
Agitation
35 (.65%)
Mood Swings
35 (.65%)
Tremor
34 (.63%)
Memory Impairment
32 (.6%)
Malaise
30 (.56%)
Weight Decreased
29 (.54%)
Cognitive Disorder
28 (.52%)
Tachycardia
28 (.52%)
Hyperhidrosis
27 (.5%)
Hypoaesthesia
27 (.5%)
Dehydration
26 (.48%)
Disorientation
26 (.48%)
Myalgia
26 (.48%)
Coordination Abnormal
25 (.47%)
Fear
25 (.47%)
Abnormal Behaviour
24 (.45%)
Anger
24 (.45%)
Thinking Abnormal
24 (.45%)
Completed Suicide
23 (.43%)
Grand Mal Convulsion
22 (.41%)
Drug Exposure During Pregnancy
21 (.39%)
Loss Of Consciousness
21 (.39%)
Rash
21 (.39%)
Deafness
20 (.37%)
Speech Disorder
20 (.37%)
Chest Pain
19 (.35%)
Delirium
19 (.35%)
Drug Toxicity
19 (.35%)
Vision Blurred
18 (.34%)
Chills
17 (.32%)
Delusion
17 (.32%)
Abdominal Pain Upper
16 (.3%)
Contusion
16 (.3%)
Emotional Disorder
16 (.3%)
Hypertension
16 (.3%)
Malaria
16 (.3%)
Heart Rate Increased
15 (.28%)
Muscle Twitching
15 (.28%)
Oedema Peripheral
15 (.28%)
Hallucination, Auditory
14 (.26%)
Hallucination, Visual
14 (.26%)
Impaired Work Ability
14 (.26%)
Muscle Spasms
14 (.26%)
Road Traffic Accident
14 (.26%)
Decreased Appetite
13 (.24%)
Mania
13 (.24%)
Night Sweats
13 (.24%)
Vestibular Disorder
13 (.24%)
Abdominal Pain
12 (.22%)
Arthralgia
12 (.22%)
Blood Lactate Dehydrogenase Increas...
12 (.22%)
Chest Discomfort
12 (.22%)
Cough
12 (.22%)
Drug Ineffective
12 (.22%)
Dyspepsia
12 (.22%)
Fall
12 (.22%)
Gastrointestinal Bacterial Infectio...
12 (.22%)
Mood Altered
12 (.22%)
Overdose
12 (.22%)
Persecutory Delusion
12 (.22%)
Stress
12 (.22%)
Upper Respiratory Tract Infection
12 (.22%)
Homicidal Ideation
11 (.2%)
Liver Function Test Abnormal
11 (.2%)
Medication Error
11 (.2%)
Nervous System Disorder
11 (.2%)
Nystagmus
11 (.2%)
Physical Assault
11 (.2%)
Restlessness
11 (.2%)

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This graph shows the top adverse events submitted to the FDA for Mefloquine, 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 Mefloquine 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 Mefloquine

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

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This graph shows the top categories of adverse events submitted to the FDA for Mefloquine, 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 Mefloquine 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 Mefloquine According to Those Reporting Adverse Events

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

Malaria Prophylaxis
720
Drug Use For Unknown Indication
134
Malaria
94
Prophylaxis
85
Product Used For Unknown Indication
21
Leukoencephalopathy
14
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Plasmodium Falciparum Infection
9
Foreign Travel
9
Progressive Multifocal Leukoencepha...
6
Suicidal Ideation
4
Prophylactic Chemotherapy
2
Type 1 Diabetes Mellitus
1
Adverse Event
1
Yellow Fever
1
Cerebral Disorder
1
Atrioventricular Block Complete
1
Anti-infective Therapy
1
Occupational Problem Environmental
1
Pyrexia
1
Depression
1
Babesiosis
1
Bradycardia
1
Unevaluable Event
1

Drug Labels

LabelLabelerEffective
Mefloquine HydrochloridePhysicians Total Care, Inc.12-JAN-10
Mefloquine HydrochlorideRebel Distributors Corp28-DEC-10
Mefloquine HydrochlorideWest-ward Pharmaceutical Corp05-AUG-11
Mefloquine HydrochlorideRoxane Laboratories, Inc.05-SEP-11
Mefloquine HydrochlorideRebel Distributors Corp09-FEB-12
Mefloquine HydrochlorideH.J. Harkins Company, Inc.16-FEB-12
Mefloquine HydrochlorideSandoz Inc11-JUL-12
Mefloquine HydrochlorideBarr Laboratories Inc.16-AUG-12

Mefloquine Case Reports

What Mefloquine 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 Mefloquine. 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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