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Xenical Adverse Events Reported to the FDA Over Time

How are Xenical adverse event reports trending over time?

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

Most Common Xenical Adverse Events Reported to the FDA

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

Diarrhoea
91 (2.29%)
Abdominal Pain
61 (1.53%)
Constipation
61 (1.53%)
Chest Pain
59 (1.48%)
Cholelithiasis
56 (1.41%)
Drug Interaction
56 (1.41%)
Dyspnoea
54 (1.36%)
Nausea
54 (1.36%)
Dizziness
50 (1.26%)
Abdominal Pain Upper
44 (1.11%)
Haematochezia
41 (1.03%)
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Drug Ineffective
40 (1.01%)
Rectal Haemorrhage
39 (.98%)
Vomiting
36 (.91%)
Epilepsy
34 (.86%)
Pancreatitis
33 (.83%)
Headache
32 (.8%)
Steatorrhoea
32 (.8%)
Weight Increased
30 (.75%)
Diverticulitis
29 (.73%)
Fatigue
28 (.7%)
Cerebrovascular Accident
27 (.68%)
Hypertension
27 (.68%)
Convulsion
26 (.65%)
Malaise
26 (.65%)
Myocardial Infarction
26 (.65%)
Blood Pressure Increased
25 (.63%)
Palpitations
25 (.63%)
Liver Disorder
23 (.58%)
Nephrolithiasis
23 (.58%)
Fall
21 (.53%)
Gallbladder Disorder
21 (.53%)
Hypoglycaemia
21 (.53%)
Ill-defined Disorder
20 (.5%)
Vaginal Haemorrhage
20 (.5%)
Angina Pectoris
19 (.48%)
Anxiety
19 (.48%)
Atrial Fibrillation
19 (.48%)
Hyperhidrosis
19 (.48%)
Hypotension
19 (.48%)
Pain
19 (.48%)
Asthenia
18 (.45%)
Asthma
18 (.45%)
Drug Exposure During Pregnancy
18 (.45%)
Thrombosis
18 (.45%)
Cholecystectomy
17 (.43%)
Weight Decreased
17 (.43%)
Abdominal Distension
16 (.4%)
Chest Discomfort
16 (.4%)
Death
16 (.4%)
Diabetes Mellitus
16 (.4%)
Cholecystitis Acute
15 (.38%)
Dyspepsia
15 (.38%)
Faeces Discoloured
15 (.38%)
Flatulence
15 (.38%)
Gastrointestinal Haemorrhage
15 (.38%)
Hepatic Steatosis
15 (.38%)
Intestinal Obstruction
15 (.38%)
Liver Function Test Abnormal
15 (.38%)
Loss Of Consciousness
15 (.38%)
Paraesthesia
15 (.38%)
Syncope
15 (.38%)
Abortion Spontaneous
14 (.35%)
Alanine Aminotransferase Increased
14 (.35%)
Blood Glucose Increased
14 (.35%)
Breast Cancer
14 (.35%)
Condition Aggravated
14 (.35%)
Hepatic Enzyme Increased
14 (.35%)
Renal Failure
14 (.35%)
Arthralgia
13 (.33%)
Colitis
13 (.33%)
Depression
13 (.33%)
Gastrointestinal Disorder
13 (.33%)
Anaemia
12 (.3%)
Cardiac Disorder
12 (.3%)
Dehydration
12 (.3%)
Frequent Bowel Movements
12 (.3%)
Gastric Ulcer
12 (.3%)
Hepatitis
12 (.3%)
International Normalised Ratio Incr...
12 (.3%)
Malabsorption
12 (.3%)
Pruritus
12 (.3%)
Pyrexia
12 (.3%)
Rash
12 (.3%)
Transaminases Increased
12 (.3%)
Back Pain
11 (.28%)
Blood Triglycerides Increased
11 (.28%)
Confusional State
11 (.28%)
Hypothyroidism
11 (.28%)
Oedema
11 (.28%)
Tachycardia
11 (.28%)
Arrhythmia
10 (.25%)
Blood Cholesterol Increased
10 (.25%)
Hypokalaemia
10 (.25%)
Jaundice
10 (.25%)
Muscle Spasms
10 (.25%)
Pain In Extremity
10 (.25%)
Pancreatitis Acute
10 (.25%)
Pulmonary Embolism
10 (.25%)
Renal Failure Acute
10 (.25%)
Suicidal Ideation
10 (.25%)

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

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

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

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

Obesity
883
Drug Use For Unknown Indication
363
Weight Control
177
Overweight
97
Product Used For Unknown Indication
40
Weight Decreased
23
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Constipation
9
Hepatic Steatosis
6
Blood Cholesterol Increased
5
Hyperlipidaemia
4
Weight Loss Diet
4
Lipomatosis
3
Fat Intolerance
3
Ill-defined Disorder
3
Gastrooesophageal Reflux Disease
3
Blood Cholesterol Decreased
3
Weight
2
Weight Increased
2
Hypertriglyceridaemia
2
Weight Fluctuation
2
Acne
2
Gastric Disorder
2
Pancreatitis
2
Unevaluable Event
2
Fat Tissue Increased
2
Foetal Exposure During Pregnancy
1
Hypercholesterolaemia
1
Type V Hyperlipidaemia
1
Lipids Increased
1
Laxative Supportive Care
1
Pancreatitis Chronic
1
Metabolic Syndrome
1
Diabetes Mellitus
1
Body Fat Disorder
1
Oral Contraception
1
Gastrointestinal Disorder
1
Breast Cancer
1
Blood Cholesterol Abnormal
1
Lipid Metabolism Disorder
1
Gastrointestinal Mucosal Disorder
1
Back Pain
1

Drug Labels

LabelLabelerEffective
XenicalGenentech, Inc.31-JAN-12

Xenical Case Reports

What Xenical 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 Xenical. 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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