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QUININE SULFATE

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Quinine Sulfate Adverse Events Reported to the FDA Over Time

How are Quinine Sulfate adverse event reports trending over time?

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

Most Common Quinine Sulfate Adverse Events Reported to the FDA

What are the most common Quinine Sulfate adverse events reported to the FDA?

Unevaluable Event
194 (4.61%)
Thrombocytopenia
163 (3.88%)
Renal Failure
103 (2.45%)
Blood Disorder
62 (1.47%)
Pain
62 (1.47%)
Vomiting
56 (1.33%)
Drug Hypersensitivity
53 (1.26%)
Thrombotic Thrombocytopenic Purpura
51 (1.21%)
Abdominal Pain
49 (1.17%)
Nausea
49 (1.17%)
Malaise
46 (1.09%)
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Renal Failure Acute
45 (1.07%)
Back Pain
39 (.93%)
Idiopathic Thrombocytopenic Purpura
39 (.93%)
Death
38 (.9%)
Haemorrhage
36 (.86%)
Completed Suicide
35 (.83%)
Diarrhoea
35 (.83%)
Chills
34 (.81%)
Pyrexia
32 (.76%)
Anaemia
30 (.71%)
Off Label Use
30 (.71%)
Coagulopathy
29 (.69%)
Dizziness
29 (.69%)
Jaundice
28 (.67%)
Anxiety
26 (.62%)
Gastrointestinal Disorder
26 (.62%)
Drug Interaction
24 (.57%)
Muscle Spasms
22 (.52%)
Musculoskeletal Stiffness
22 (.52%)
Pancreatic Carcinoma
22 (.52%)
Chest Pain
21 (.5%)
Haemolytic Uraemic Syndrome
21 (.5%)
Deafness
20 (.48%)
Haemodialysis
20 (.48%)
Headache
20 (.48%)
Hepatic Failure
20 (.48%)
Intentional Overdose
20 (.48%)
Nervousness
20 (.48%)
Platelet Count Decreased
20 (.48%)
Cardiac Arrest
19 (.45%)
Fear
19 (.45%)
Syncope
19 (.45%)
Blindness
18 (.43%)
Alanine Aminotransferase Increased
17 (.4%)
Arthritis
17 (.4%)
Asthenia
17 (.4%)
Hypoglycaemia
17 (.4%)
Pain In Extremity
17 (.4%)
Cardio-respiratory Arrest
16 (.38%)
Gastrointestinal Haemorrhage
16 (.38%)
Hypotension
16 (.38%)
Purpura
16 (.38%)
Renal Disorder
16 (.38%)
Blood Alkaline Phosphatase Increase...
15 (.36%)
Chronic Obstructive Pulmonary Disea...
15 (.36%)
Hypertension
15 (.36%)
Thrombocytopenic Purpura
15 (.36%)
Tinnitus
15 (.36%)
Atrial Fibrillation
14 (.33%)
Body Mass Index Decreased
14 (.33%)
Contusion
14 (.33%)
Haemoglobin Decreased
14 (.33%)
Liver Function Test Abnormal
14 (.33%)
Blood Bilirubin Increased
13 (.31%)
Condition Aggravated
13 (.31%)
Confusional State
13 (.31%)
Depression
13 (.31%)
Dyspnoea
13 (.31%)
Fatigue
13 (.31%)
Rash Erythematous
13 (.31%)
Autoimmune Thrombocytopenia
12 (.29%)
Emotional Distress
12 (.29%)
Medication Error
12 (.29%)
Pleural Effusion
12 (.29%)
Cough
11 (.26%)
Depressed Level Of Consciousness
11 (.26%)
Respiratory Arrest
11 (.26%)
Urinary Tract Infection
11 (.26%)
Abdominal Pain Upper
10 (.24%)
Adverse Event
10 (.24%)
Cardiac Failure Congestive
10 (.24%)
Epistaxis
10 (.24%)
Haematemesis
10 (.24%)
Neutropenia
10 (.24%)
Pancytopenia
10 (.24%)
Therapeutic Response Decreased
10 (.24%)
Aplastic Anaemia
9 (.21%)
Arrhythmia
9 (.21%)
Blood Cholesterol Increased
9 (.21%)
Blood Magnesium Decreased
9 (.21%)
Blood Potassium Decreased
9 (.21%)
Convulsion
9 (.21%)
Cytolytic Hepatitis
9 (.21%)
Dialysis
9 (.21%)
Ecchymosis
9 (.21%)
Fibrin D Dimer Increased
9 (.21%)
Haematoma
9 (.21%)
Hyponatraemia
9 (.21%)
Impaired Healing
9 (.21%)
Lipase Increased
9 (.21%)

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

What are the most common Quinine Sulfate adverse events reported to the FDA?

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

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

Muscle Spasms
1029
Drug Use For Unknown Indication
232
Product Used For Unknown Indication
195
Muscle Cramp
49
Malaria
28
Restless Legs Syndrome
24
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Plasmodium Falciparum Infection
24
Pain In Extremity
15
Ill-defined Disorder
13
Night Cramps
6
Suicide Attempt
6
Drug Exposure During Pregnancy
5
Systemic Lupus Erythematosus
5
Intentional Overdose
4
Pain
4
Antibiotic Prophylaxis
3
Infection Parasitic
3
Epilepsy
3
Arthritis
3
Babesiosis
3
Cerebral Malaria
3
Malaria Prophylaxis
3
Rocky Mountain Spotted Fever
3
Typhoid Fever
2
Homeopathy
2
Rheumatoid Arthritis
2
Muscle Relaxant Therapy
2
Drug Level
2
Gout
2
Pneumonia
2
Psoriatic Arthropathy
2
Myalgia
2
Respiratory Tract Infection
2
Influenza Like Illness
1
Peripheral Vascular Disorder
1
Stem Cell Transplant
1
Jaundice
1
Neuropathy
1
Dyskinesia
1
Abortion Induced
1
Paraesthesia
1
Conjunctivitis Infective
1
Blood Cholesterol Increased
1
Abdominal Pain Upper
1
Completed Suicide
1
Diarrhoea
1
Analgesic Therapy
1
Fibromyalgia
1
Back Pain
1
Immunosuppression
1
Lice Infestation
1

Drug Labels

LabelLabelerEffective
QualaquinSTAT RX USA LLC18-MAR-10
Quinine SulfateMutual Pharmaceutical Company, Inc.29-JUN-12
QualaquinAR Scientific Inc.28-FEB-13
Quinine SulfateMylan Pharmaceuticals Inc.07-MAR-13
Quinine SulfateTeva Pharmaceuticals USA Inc25-MAR-13
Quinine SulfateMylan Pharmaceuticals Inc.15-APR-13
QualaquinAR Scientific Inc.23-APR-13

Quinine Sulfate Case Reports

What Quinine Sulfate 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 Quinine Sulfate. 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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