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BROMOCRIPTINE MESYLATE

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Bromocriptine Mesylate Adverse Events Reported to the FDA Over Time

How are Bromocriptine Mesylate adverse event reports trending over time?

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

Most Common Bromocriptine Mesylate Adverse Events Reported to the FDA

What are the most common Bromocriptine Mesylate adverse events reported to the FDA?

Drug Exposure During Pregnancy
30 (2.58%)
Hallucination, Visual
21 (1.81%)
Vomiting
18 (1.55%)
Muscle Rigidity
17 (1.46%)
Nausea
17 (1.46%)
Impulse-control Disorder
15 (1.29%)
Headache
14 (1.2%)
Dyspnoea
13 (1.12%)
Persecutory Delusion
13 (1.12%)
Pyrexia
13 (1.12%)
Hypersexuality
12 (1.03%)
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Blood Prolactin Increased
11 (.95%)
Apathy
10 (.86%)
Heart Rate Increased
10 (.86%)
Condition Aggravated
9 (.77%)
Drug Ineffective
9 (.77%)
Drug Interaction
9 (.77%)
Neuroleptic Malignant Syndrome
9 (.77%)
Premature Baby
9 (.77%)
Abdominal Pain
8 (.69%)
Blood Creatine Phosphokinase Increa...
8 (.69%)
Foetal Heart Rate Abnormal
8 (.69%)
Premature Labour
8 (.69%)
Abdominal Tenderness
7 (.6%)
Abnormal Behaviour
7 (.6%)
Akinesia
7 (.6%)
Caesarean Section
7 (.6%)
Dyskinesia
7 (.6%)
Ectopic Pregnancy
7 (.6%)
Laparotomy
7 (.6%)
Peritoneal Haemorrhage
7 (.6%)
Psychotic Disorder
7 (.6%)
Salpingectomy
7 (.6%)
Visual Field Defect
7 (.6%)
Abdominal Distension
6 (.52%)
Abdominal Rigidity
6 (.52%)
Affect Lability
6 (.52%)
Autonomic Nervous System Imbalance
6 (.52%)
Blood Pressure Systolic Decreased
6 (.52%)
Breast Engorgement
6 (.52%)
Cardiac Failure
6 (.52%)
Chest Discomfort
6 (.52%)
Communication Disorder
6 (.52%)
Dehydration
6 (.52%)
Fallopian Tube Perforation
6 (.52%)
Heterotopic Pregnancy
6 (.52%)
Hypertension
6 (.52%)
Loss Of Consciousness
6 (.52%)
Normal Newborn
6 (.52%)
Pathological Gambling
6 (.52%)
Shock
6 (.52%)
Somnolence
6 (.52%)
Stress Cardiomyopathy
6 (.52%)
Suicide Attempt
6 (.52%)
Trigeminal Neuralgia
6 (.52%)
Urinary Tract Infection
6 (.52%)
Uterine Cervical Pain
6 (.52%)
Aggression
5 (.43%)
Agitation
5 (.43%)
Arteriospasm Coronary
5 (.43%)
Blood Lactate Dehydrogenase Increas...
5 (.43%)
Blood Pressure Increased
5 (.43%)
Constipation
5 (.43%)
Death
5 (.43%)
Depression
5 (.43%)
Fall
5 (.43%)
Hyperhidrosis
5 (.43%)
Hyperthermia
5 (.43%)
Malaise
5 (.43%)
Muscle Atrophy
5 (.43%)
Obsessive-compulsive Disorder
5 (.43%)
Oedema Peripheral
5 (.43%)
Peripartum Cardiomyopathy
5 (.43%)
Pituitary Tumour
5 (.43%)
Activities Of Daily Living Impaired
4 (.34%)
Alanine Aminotransferase Increased
4 (.34%)
Angiopathy
4 (.34%)
Aspartate Aminotransferase Increase...
4 (.34%)
Breast Pain
4 (.34%)
Consciousness Fluctuating
4 (.34%)
Dizziness
4 (.34%)
Drug Level Increased
4 (.34%)
Dyspnoea Paroxysmal Nocturnal
4 (.34%)
Ejection Fraction Decreased
4 (.34%)
General Physical Health Deteriorati...
4 (.34%)
Hemianopia
4 (.34%)
Hyperprolactinaemia
4 (.34%)
Lactation Disorder
4 (.34%)
Leukocytosis
4 (.34%)
Mastitis
4 (.34%)
Metabolic Acidosis
4 (.34%)
Mucosal Dryness
4 (.34%)
Orthopnoea
4 (.34%)
Orthostatic Hypotension
4 (.34%)
Pituitary Haemorrhage
4 (.34%)
Psychomotor Hyperactivity
4 (.34%)
Renal Failure Acute
4 (.34%)
Sinus Tachycardia
4 (.34%)
Surgery
4 (.34%)
Ventricular Fibrillation
4 (.34%)
Weight Decreased
4 (.34%)

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

What are the most common Bromocriptine Mesylate adverse events reported to the FDA?

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

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

Prolactinoma
43
Parkinsons Disease
36
Hyperprolactinaemia
23
Pituitary Tumour Benign
19
Lactation Inhibition Therapy
8
Pituitary Tumour
6
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Drug Use For Unknown Indication
6
Product Used For Unknown Indication
6
Aphasia
5
Hypothalamo-pituitary Disorder
4
Neuroleptic Malignant Syndrome
4
Amenorrhoea
3
Prolactin-producing Pituitary Tumou...
3
Parkinsonism
3
Blood Prolactin
2
Pituitary Enlargement
2
Autonomic Nervous System Imbalance
2
Suppressed Lactation
2
Hypothalamo-pituitary Disorders
2
Blood Prolactin Abnormal
1
Drug Therapy
1
Hyperpituitarism
1
Psychiatric Symptom
1
Pituitary-dependent Cushings Syndro...
1
Lactation Puerperal Increased
1
Visual Field Defect
1
Panic Disorder
1
Infertility
1
Blood Prolactin Increased
1
Sunct Syndrome
1
Acromegaly
1
Neoplasm Malignant
1
Multiple System Atrophy
1
Adenoma Benign
1
Infertility Female
1

Drug Labels

LabelLabelerEffective
Bromocriptine MesylateMylan Pharmaceuticals Inc.28-NOV-06
Bromocriptine MesylatePaddock Laboratories, Inc.17-JUN-09
Bromocriptine MesylateAmerican Health Packaging13-JAN-10
Bromocriptine MesylateSandoz Inc01-APR-10
CyclosetSantarus, Inc.15-SEP-10
Bromocriptine MesylatePhysicians Total Care, Inc.01-MAY-12
Bromocriptine MesylateSandoz Inc20-SEP-12
ParlodelValidus Pharmaceuticals LLC17-OCT-12
Bromocriptine MesylateZydus Pharmaceuticals (USA) Inc.22-OCT-12
Bromocriptine MesylateCadila Healthcare Limited04-DEC-12

Bromocriptine Mesylate Case Reports

What Bromocriptine Mesylate 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 Bromocriptine Mesylate. 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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