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Orlistat Adverse Events Reported to the FDA Over Time

How are Orlistat adverse event reports trending over time?

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

Most Common Orlistat Adverse Events Reported to the FDA

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

Diarrhoea
54 (2.01%)
Drug Interaction
47 (1.75%)
Abdominal Pain
46 (1.72%)
Death
41 (1.53%)
Myocardial Infarction
41 (1.53%)
Fall
38 (1.42%)
Abortion Spontaneous
37 (1.38%)
Chest Pain
34 (1.27%)
Cerebrovascular Accident
32 (1.19%)
Drug Exposure During Pregnancy
30 (1.12%)
Lower Respiratory Tract Infection
30 (1.12%)
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Breast Cancer
29 (1.08%)
Angina Pectoris
28 (1.04%)
Renal Failure Acute
26 (.97%)
Asthma
25 (.93%)
Dizziness
25 (.93%)
Cellulitis
24 (.9%)
Dyspnoea
24 (.9%)
Vision Blurred
23 (.86%)
Diverticulitis
22 (.82%)
Malaise
22 (.82%)
Nausea
22 (.82%)
Nephrolithiasis
21 (.78%)
Cholelithiasis
20 (.75%)
Vomiting
20 (.75%)
Headache
19 (.71%)
Renal Failure
19 (.71%)
Pulmonary Oedema
18 (.67%)
Hypertension
17 (.63%)
Hypothyroidism
17 (.63%)
Lactic Acidosis
17 (.63%)
Depressed Level Of Consciousness
16 (.6%)
Dysarthria
16 (.6%)
Ill-defined Disorder
16 (.6%)
Pneumonia
16 (.6%)
Asthenia
15 (.56%)
Atrial Fibrillation
15 (.56%)
Chest Discomfort
15 (.56%)
Diabetes Mellitus
15 (.56%)
Pancreatitis Acute
15 (.56%)
Dehydration
14 (.52%)
Infection
14 (.52%)
Suicidal Ideation
14 (.52%)
Transient Ischaemic Attack
14 (.52%)
Deep Vein Thrombosis
13 (.48%)
Rectal Haemorrhage
13 (.48%)
Abdominal Pain Upper
12 (.45%)
Circulatory Collapse
12 (.45%)
Contusion
12 (.45%)
Maternal Drugs Affecting Foetus
12 (.45%)
Type 2 Diabetes Mellitus
12 (.45%)
Acute Prerenal Failure
11 (.41%)
Blood Glucose Increased
11 (.41%)
Hypotension
11 (.41%)
Palpitations
11 (.41%)
Thrombosis
11 (.41%)
Transposition Of The Great Vessels
11 (.41%)
Agitation
10 (.37%)
Cardiac Failure
10 (.37%)
Fatigue
10 (.37%)
Nephropathy
10 (.37%)
Oedema Peripheral
10 (.37%)
Constipation
9 (.34%)
Depression
9 (.34%)
Hernia
9 (.34%)
Neoplasm Malignant
9 (.34%)
Pain
9 (.34%)
Psychotic Disorder
9 (.34%)
Abdominal Distension
8 (.3%)
Alanine Aminotransferase Increased
8 (.3%)
Back Pain
8 (.3%)
Blood Alkaline Phosphatase Increase...
8 (.3%)
Breast Mass
8 (.3%)
Cardiac Disorder
8 (.3%)
Convulsion
8 (.3%)
Cough
8 (.3%)
Heat Stroke
8 (.3%)
Liver Function Test Abnormal
8 (.3%)
Pregnancy
8 (.3%)
Pruritus
8 (.3%)
Pyrexia
8 (.3%)
Renal Impairment
8 (.3%)
Skin Cancer
8 (.3%)
Aspartate Aminotransferase Increase...
7 (.26%)
Caesarean Section
7 (.26%)
Confusional State
7 (.26%)
Gallbladder Cancer
7 (.26%)
Haematochezia
7 (.26%)
Head Injury
7 (.26%)
Jaundice
7 (.26%)
Nasopharyngitis
7 (.26%)
Pancreatitis
7 (.26%)
Upper Limb Fracture
7 (.26%)
Urinary Tract Infection
7 (.26%)
Abdominal Tenderness
6 (.22%)
Acute Hepatic Failure
6 (.22%)
Asthenopia
6 (.22%)
Basal Cell Carcinoma
6 (.22%)
Blood Pressure Increased
6 (.22%)
Gastroenteritis
6 (.22%)
Hysterectomy
6 (.22%)

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

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

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

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

Obesity
915
Drug Use For Unknown Indication
106
Weight Control
50
Weight Decreased
45
Product Used For Unknown Indication
26
Overweight
25
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Investigation
6
Weight Loss Diet
4
Drug Exposure During Pregnancy
3
Cognitive Disorder
2
Hyperlipidaemia
2
Central Obesity
2
Type 2 Diabetes Mellitus
1
Hepatic Steatosis
1
Blood Cholesterol Increased
1
Weight Abnormal
1
Weight Increased
1
Body Mass Index Increased
1
Weight
1

Drug Labels

LabelLabelerEffective
XenicalGenentech, Inc.31-JAN-12

Orlistat Case Reports

What Orlistat 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 Orlistat. 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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