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Adcirca Adverse Events Reported to the FDA Over Time

How are Adcirca adverse event reports trending over time?

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

Most Common Adcirca Adverse Events Reported to the FDA

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

Death
85 (5.47%)
Dyspnoea
57 (3.67%)
Headache
43 (2.77%)
Pneumonia
35 (2.25%)
Hospitalisation
34 (2.19%)
Hypotension
33 (2.12%)
Vision Blurred
26 (1.67%)
Visual Impairment
23 (1.48%)
Back Pain
22 (1.41%)
Atrial Fibrillation
20 (1.29%)
Diarrhoea
20 (1.29%)
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Fatigue
20 (1.29%)
Epistaxis
19 (1.22%)
Pain
19 (1.22%)
Cardiac Failure Congestive
18 (1.16%)
Chest Pain
18 (1.16%)
Off Label Use
17 (1.09%)
Oedema Peripheral
16 (1.03%)
Cardiac Failure
15 (.96%)
Fluid Retention
15 (.96%)
Pulmonary Hypertension
15 (.96%)
Syncope
15 (.96%)
Heart Rate Increased
14 (.9%)
Dizziness
13 (.84%)
Fall
13 (.84%)
Loss Of Consciousness
13 (.84%)
Palpitations
13 (.84%)
Right Ventricular Failure
13 (.84%)
Arthralgia
12 (.77%)
Nausea
12 (.77%)
Pain In Extremity
12 (.77%)
Cough
11 (.71%)
Flushing
10 (.64%)
Insomnia
10 (.64%)
Myocardial Infarction
10 (.64%)
Vomiting
10 (.64%)
Abdominal Discomfort
9 (.58%)
Blood Pressure Increased
9 (.58%)
Gastrooesophageal Reflux Disease
9 (.58%)
Laceration
9 (.58%)
Malaise
9 (.58%)
Myalgia
9 (.58%)
Pleural Effusion
9 (.58%)
Renal Failure
9 (.58%)
Asthenia
8 (.51%)
Blindness
8 (.51%)
Chest Discomfort
8 (.51%)
Decreased Appetite
8 (.51%)
Rash
8 (.51%)
Anaemia
7 (.45%)
Blood Pressure Decreased
7 (.45%)
Disease Progression
7 (.45%)
Drug Ineffective
7 (.45%)
Drug Interaction
7 (.45%)
Muscle Spasms
7 (.45%)
Oedema
7 (.45%)
Pyrexia
7 (.45%)
Bradycardia
6 (.39%)
Diplopia
6 (.39%)
Hyperhidrosis
6 (.39%)
Nasal Congestion
6 (.39%)
Presyncope
6 (.39%)
Pulmonary Arterial Hypertension
6 (.39%)
Renal Failure Acute
6 (.39%)
Respiratory Failure
6 (.39%)
Ascites
5 (.32%)
Blood Glucose Increased
5 (.32%)
Cardiac Arrest
5 (.32%)
Deafness
5 (.32%)
Gait Disturbance
5 (.32%)
Gastrointestinal Haemorrhage
5 (.32%)
Hyperthyroidism
5 (.32%)
Lung Neoplasm Malignant
5 (.32%)
Sepsis
5 (.32%)
Tremor
5 (.32%)
Visual Acuity Reduced
5 (.32%)
Abdominal Pain
4 (.26%)
Arthritis
4 (.26%)
Atrial Tachycardia
4 (.26%)
Bone Pain
4 (.26%)
Circulatory Failure Neonatal
4 (.26%)
Cold Sweat
4 (.26%)
Colour Blindness Acquired
4 (.26%)
Dyspepsia
4 (.26%)
Fibromyalgia
4 (.26%)
Haemorrhage
4 (.26%)
Hypertension
4 (.26%)
Hypoaesthesia
4 (.26%)
Intentional Drug Misuse
4 (.26%)
International Normalised Ratio Abno...
4 (.26%)
Left Ventricular Failure
4 (.26%)
Macular Degeneration
4 (.26%)
Overdose
4 (.26%)
Paraesthesia
4 (.26%)
Pelvic Fracture
4 (.26%)
Pruritus
4 (.26%)
Renal Failure Chronic
4 (.26%)
Sudden Hearing Loss
4 (.26%)
Systemic Lupus Erythematosus
4 (.26%)
Unresponsive To Stimuli
4 (.26%)
Wheelchair User
4 (.26%)

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

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

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

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

Pulmonary Arterial Hypertension
185
Pulmonary Hypertension
137
Cor Pulmonale Chronic
7
Product Used For Unknown Indication
4
Scleroderma
3
Essential Hypertension
1
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Cardiac Failure Congestive
1
Lung Disorder
1
Cardiac Disorder
1
Pulmonary Embolism
1
Chronic Obstructive Pulmonary Disea...
1
Bowel Preparation
1

Drug Labels

LabelLabelerEffective
AdcircaUnited Therapeutics Corporation27-JUN-12

Adcirca Case Reports

What Adcirca 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 Adcirca. 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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