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SIBUTRAMINE

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Sibutramine Adverse Events Reported to the FDA Over Time

How are Sibutramine adverse event reports trending over time?

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

Most Common Sibutramine Adverse Events Reported to the FDA

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

Drug Ineffective
164 (4.44%)
Headache
87 (2.35%)
Palpitations
72 (1.95%)
Insomnia
66 (1.79%)
Dizziness
62 (1.68%)
Dyspnoea
56 (1.52%)
Blood Pressure Increased
49 (1.33%)
Fatigue
46 (1.24%)
Heart Rate Increased
42 (1.14%)
Weight Increased
42 (1.14%)
Weight Loss Poor
42 (1.14%)
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Chest Pain
40 (1.08%)
Feeling Abnormal
36 (.97%)
Chest Discomfort
34 (.92%)
Increased Appetite
33 (.89%)
Nausea
33 (.89%)
Dry Mouth
32 (.87%)
Constipation
29 (.78%)
Asthenia
27 (.73%)
Hypertension
26 (.7%)
Drug Exposure During Pregnancy
25 (.68%)
Anxiety
24 (.65%)
Malaise
24 (.65%)
Depression
23 (.62%)
Pulmonary Hypertension
23 (.62%)
Cardiomegaly
21 (.57%)
Cough
21 (.57%)
Hyperhidrosis
21 (.57%)
Tremor
21 (.57%)
Abortion Induced
20 (.54%)
Cardiac Failure Congestive
20 (.54%)
Hunger
20 (.54%)
Psychotic Disorder
20 (.54%)
Tricuspid Valve Incompetence
20 (.54%)
Abdominal Pain
19 (.51%)
Arrhythmia
19 (.51%)
Diarrhoea
19 (.51%)
Nervousness
19 (.51%)
Irritability
18 (.49%)
Pain
18 (.49%)
Pain In Extremity
18 (.49%)
Pyrexia
18 (.49%)
Drug Interaction
17 (.46%)
Dyspnoea Exertional
17 (.46%)
Hypoaesthesia
17 (.46%)
Vomiting
17 (.46%)
Dilatation Ventricular
16 (.43%)
Hypotension
16 (.43%)
Abdominal Pain Upper
15 (.41%)
Confusional State
15 (.41%)
Paraesthesia
15 (.41%)
Respiratory Distress
15 (.41%)
Syncope
15 (.41%)
Agitation
14 (.38%)
Cerebrovascular Accident
14 (.38%)
Drug Effect Decreased
14 (.38%)
Loss Of Consciousness
14 (.38%)
Aggression
13 (.35%)
Mitral Valve Incompetence
13 (.35%)
Pericardial Effusion
13 (.35%)
Appetite Disorder
12 (.32%)
Back Pain
12 (.32%)
Cardiac Failure
12 (.32%)
Hallucination, Auditory
12 (.32%)
Pulmonary Embolism
12 (.32%)
Abdominal Distension
11 (.3%)
Cardiac Arrest
11 (.3%)
Cardiovascular Disorder
11 (.3%)
Myocardial Infarction
11 (.3%)
Pruritus
11 (.3%)
Renal Failure Acute
11 (.3%)
Tachycardia
11 (.3%)
Abnormal Behaviour
10 (.27%)
Abortion Spontaneous
10 (.27%)
Convulsion
10 (.27%)
Disturbance In Attention
10 (.27%)
Feeling Jittery
10 (.27%)
Hypersensitivity
10 (.27%)
Medication Error
10 (.27%)
Paranoia
10 (.27%)
Sinus Tachycardia
10 (.27%)
Thirst
10 (.27%)
Vaginal Haemorrhage
10 (.27%)
Ventricular Fibrillation
10 (.27%)
Electrocardiogram Qt Prolonged
9 (.24%)
Migraine
9 (.24%)
Overdose
9 (.24%)
Rash
9 (.24%)
Vision Blurred
9 (.24%)
Anaemia
8 (.22%)
Cardiac Disorder
8 (.22%)
Delusion
8 (.22%)
Dysphonia
8 (.22%)
Flushing
8 (.22%)
Hallucination, Visual
8 (.22%)
Oedema Peripheral
8 (.22%)
Somnolence
8 (.22%)
Acute Myocardial Infarction
7 (.19%)
Alopecia
7 (.19%)
Anorexia
7 (.19%)
Arthralgia
7 (.19%)

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

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

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

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

Obesity
337
Weight Control
331
Drug Use For Unknown Indication
280
Weight Decreased
224
Product Used For Unknown Indication
82
Overweight
30
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Depression
16
Decreased Appetite
11
Drug Exposure During Pregnancy
9
Medical Diet
7
Weight
6
Eating Disorder
3
Increased Appetite
3
Maternal Exposure Timing Unspecifie...
3
Diabetes Mellitus
2
Body Mass Index Increased
2
Maternal Exposure During Pregnancy
2
Blood Cholesterol Decreased
2
Polycystic Ovaries
2
Headache
2
Hypertension
2
Suicide Attempt
2
Weight Increased
2
Fibromyalgia
1
Premenstrual Syndrome
1
Antidepressant Therapy
1
Body Mass Index
1
Attention Deficit/hyperactivity Dis...
1
Insulin Resistance
1
Hypothalamo-pituitary Disorder
1
Body Dysmorphic Disorder
1
Brain Neoplasm
1
Self Esteem Decreased
1
Central Obesity
1
Prophylaxis
1
Self-medication
1
Blood Cholesterol
1
Gastric Disorder
1
Appetite Disorder
1
Ill-defined Disorder
1
Anxiety
1
Binge Eating
1
Weight Abnormal
1
Weight Loss Poor
1
Weight Loss Diet
1
Migraine
1
Serotonin Syndrome
1

Drug Labels

LabelLabelerEffective
MeridiaAbbott Laboratories12-AUG-10

Sibutramine Case Reports

What Sibutramine 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 Sibutramine. 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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