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Questran Adverse Events Reported to the FDA Over Time

How are Questran adverse event reports trending over time?

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

Most Common Questran Adverse Events Reported to the FDA

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

Diarrhoea
37 (4.37%)
Dehydration
25 (2.96%)
Alanine Aminotransferase Increased
19 (2.25%)
Aspartate Aminotransferase Increase...
19 (2.25%)
Renal Failure Acute
17 (2.01%)
Nausea
14 (1.65%)
Dysgeusia
13 (1.54%)
Gamma-glutamyltransferase Increased
12 (1.42%)
Blood Alkaline Phosphatase Increase...
11 (1.3%)
Constipation
11 (1.3%)
Drug Ineffective
11 (1.3%)
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Myalgia
11 (1.3%)
Renal Failure
10 (1.18%)
Vomiting
10 (1.18%)
Abdominal Pain
9 (1.06%)
Blood Creatine Phosphokinase Increa...
8 (.95%)
Blood Lactate Dehydrogenase Increas...
8 (.95%)
Organising Pneumonia
8 (.95%)
Pruritus
8 (.95%)
Arthralgia
7 (.83%)
Cough
7 (.83%)
Eosinophilia
7 (.83%)
Hepatic Enzyme Increased
7 (.83%)
Medication Error
7 (.83%)
Muscle Spasms
7 (.83%)
Renal Tubular Disorder
7 (.83%)
Abdominal Distension
6 (.71%)
Anxiety
6 (.71%)
Asthenia
6 (.71%)
Blood Cholesterol Increased
6 (.71%)
Dyspepsia
6 (.71%)
Fatigue
6 (.71%)
Histiocytosis Haematophagic
6 (.71%)
Rash
6 (.71%)
Weight Decreased
6 (.71%)
White Blood Cell Count Decreased
6 (.71%)
Abdominal Pain Upper
5 (.59%)
Aortic Aneurysm
5 (.59%)
Blood Sodium Decreased
5 (.59%)
Bursitis
5 (.59%)
Electrolyte Imbalance
5 (.59%)
Fall
5 (.59%)
Headache
5 (.59%)
Hepatitis Cholestatic
5 (.59%)
Liver Disorder
5 (.59%)
Lymphadenopathy
5 (.59%)
Muscular Weakness
5 (.59%)
Neoplasm Malignant
5 (.59%)
Neutropenia
5 (.59%)
Overdose
5 (.59%)
Pulmonary Embolism
5 (.59%)
Sarcoidosis
5 (.59%)
Acidosis Hyperchloraemic
4 (.47%)
Blood Triglycerides Increased
4 (.47%)
Cardio-respiratory Arrest
4 (.47%)
Deep Vein Thrombosis
4 (.47%)
Dry Mouth
4 (.47%)
Flatulence
4 (.47%)
General Physical Health Deteriorati...
4 (.47%)
Platelet Count Decreased
4 (.47%)
Pyrexia
4 (.47%)
Rectal Haemorrhage
4 (.47%)
Stevens-johnson Syndrome
4 (.47%)
Abdominal Discomfort
3 (.35%)
Aphonia
3 (.35%)
Breast Mass
3 (.35%)
C-reactive Protein Increased
3 (.35%)
Chest Pain
3 (.35%)
Coagulopathy
3 (.35%)
Decreased Appetite
3 (.35%)
Drug Intolerance
3 (.35%)
Drug Rash With Eosinophilia And Sys...
3 (.35%)
Dry Throat
3 (.35%)
Gastroenteritis
3 (.35%)
Hallucination
3 (.35%)
Hallucination, Auditory
3 (.35%)
Hyperhidrosis
3 (.35%)
Hypomagnesaemia
3 (.35%)
Hyponatraemia
3 (.35%)
Incorrect Dose Administered
3 (.35%)
Infusion Related Reaction
3 (.35%)
Iron Deficiency
3 (.35%)
Leukoencephalopathy
3 (.35%)
Malaise
3 (.35%)
Muscle Atrophy
3 (.35%)
Rhabdomyolysis
3 (.35%)
Sepsis
3 (.35%)
Skin Disorder
3 (.35%)
Stomatitis
3 (.35%)
Throat Irritation
3 (.35%)
Tumour Marker Increased
3 (.35%)
Adverse Event
2 (.24%)
Anaemia Macrocytic
2 (.24%)
Ascites
2 (.24%)
Blepharitis
2 (.24%)
Blood Bilirubin Increased
2 (.24%)
Blood Calcium Decreased
2 (.24%)
Blood Immunoglobulin M Increased
2 (.24%)
Blood Potassium Decreased
2 (.24%)
Blood Potassium Increased
2 (.24%)
Brain Oedema
2 (.24%)

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

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

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

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

Diarrhoea
112
Crohns Disease
50
Drug Use For Unknown Indication
44
Product Used For Unknown Indication
43
Hypercholesterolaemia
31
Drug Detoxification
26
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Blood Cholesterol Increased
20
Irritable Bowel Syndrome
12
Gastrointestinal Disorder
9
Liver Disorder
5
Blood Cholesterol Abnormal
5
Adverse Drug Reaction
5
Blood Cholesterol
4
Gallbladder Disorder
4
Pruritus
4
Hyperbilirubinaemia
3
Hyperlipidaemia
3
Cholecystectomy
3
Colon Operation
2
Short-bowel Syndrome
2
Overdose
2
Ill-defined Disorder
2
Pancreaticoduodenectomy
2
Colitis
2
Adverse Event
2
Intestinal Resection
2
Dyslipidaemia
2
Fatigue
2
Abdominal Pain
2
Post Gastric Surgery Syndrome
1
Hepatic Function Abnormal
1
Nephrolithiasis
1
Intestinal Functional Disorder
1
Rash
1
Prophylaxis Against Diarrhoea
1
Increased Appetite
1
Blood Triglycerides Increased
1
Polycystic Ovaries
1
Hyperhidrosis
1
Chelation Therapy
1
Prophylaxis
1
Therapeutic Procedure
1
Constipation
1
Dysentery
1
Colon Cancer
1
Total Bile Acids
1
Dyspepsia
1
Incontinence
1
Gastrointestinal Motility Disorder
1
Aspartate Aminotransferase Increase...
1
Bile Acid Malabsorption
1

Drug Labels

LabelLabelerEffective
Questran Par Pharmaceutical Inc. 17-AUG-12

Questran Case Reports

What Questran 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 Questran. 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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