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REVATIO

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Revatio Adverse Events Reported to the FDA Over Time

How are Revatio adverse event reports trending over time?

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

Most Common Revatio Adverse Events Reported to the FDA

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

Death
1497 (10%)
Pulmonary Hypertension
383 (2.56%)
Dyspnoea
330 (2.2%)
Hypotension
260 (1.74%)
Headache
179 (1.2%)
Cardiac Failure
177 (1.18%)
Drug Ineffective
168 (1.12%)
Pneumonia
158 (1.06%)
Dizziness
154 (1.03%)
Right Ventricular Failure
141 (.94%)
Cardiac Failure Congestive
130 (.87%)
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Respiratory Failure
130 (.87%)
Fatigue
123 (.82%)
Malaise
119 (.8%)
Drug Interaction
111 (.74%)
Cardiac Arrest
109 (.73%)
Nausea
108 (.72%)
Oedema Peripheral
108 (.72%)
Disease Progression
95 (.63%)
Condition Aggravated
91 (.61%)
Vomiting
88 (.59%)
Fall
85 (.57%)
Blood Pressure Decreased
84 (.56%)
Diarrhoea
84 (.56%)
Hypoxia
84 (.56%)
Renal Failure
84 (.56%)
Vision Blurred
79 (.53%)
Asthenia
78 (.52%)
Syncope
71 (.47%)
Chest Pain
69 (.46%)
Flushing
69 (.46%)
Hypertension
67 (.45%)
Anaemia
64 (.43%)
Pulmonary Arterial Hypertension
64 (.43%)
Palpitations
63 (.42%)
Visual Acuity Reduced
63 (.42%)
Sepsis
62 (.41%)
Pyrexia
58 (.39%)
Epistaxis
57 (.38%)
Pleural Effusion
57 (.38%)
Interstitial Lung Disease
55 (.37%)
Chronic Obstructive Pulmonary Disea...
54 (.36%)
Liver Function Test Abnormal
54 (.36%)
Oxygen Saturation Decreased
53 (.35%)
General Physical Health Deteriorati...
52 (.35%)
Oedema
52 (.35%)
Tachycardia
52 (.35%)
Platelet Count Decreased
51 (.34%)
Thrombocytopenia
51 (.34%)
Cardiac Disorder
49 (.33%)
Insomnia
49 (.33%)
Respiratory Arrest
49 (.33%)
Haemoglobin Decreased
48 (.32%)
Multi-organ Failure
48 (.32%)
Myocardial Infarction
48 (.32%)
Abdominal Pain
47 (.31%)
Cough
47 (.31%)
Pulmonary Fibrosis
47 (.31%)
Pulmonary Oedema
47 (.31%)
Gait Disturbance
46 (.31%)
Lung Disorder
46 (.31%)
Visual Impairment
46 (.31%)
Convulsion
45 (.3%)
Rash
45 (.3%)
Deafness
44 (.29%)
Gastrointestinal Haemorrhage
44 (.29%)
Myalgia
44 (.29%)
Nasal Congestion
44 (.29%)
Weight Increased
44 (.29%)
Hepatic Function Abnormal
43 (.29%)
Pain
43 (.29%)
Renal Failure Acute
43 (.29%)
Loss Of Consciousness
42 (.28%)
Atrial Fibrillation
41 (.27%)
Sudden Death
40 (.27%)
Alanine Aminotransferase Increased
39 (.26%)
Weight Decreased
39 (.26%)
Abdominal Distension
38 (.25%)
Cardio-respiratory Arrest
38 (.25%)
Dyspepsia
38 (.25%)
Hepatic Failure
38 (.25%)
Arthralgia
37 (.25%)
Completed Suicide
37 (.25%)
International Normalised Ratio Incr...
37 (.25%)
Pain In Extremity
37 (.25%)
Ascites
36 (.24%)
Blood Pressure Increased
36 (.24%)
Bradycardia
36 (.24%)
Cerebrovascular Accident
35 (.23%)
Heart Rate Increased
35 (.23%)
Pneumothorax
35 (.23%)
Blindness
32 (.21%)
Circulatory Collapse
32 (.21%)
Feeling Abnormal
32 (.21%)
Cerebral Haemorrhage
31 (.21%)
Haemoptysis
31 (.21%)
Incorrect Dose Administered
31 (.21%)
Drug Exposure During Pregnancy
30 (.2%)
Pulmonary Arterial Pressure Increas...
30 (.2%)
Urinary Tract Infection
30 (.2%)
Aspartate Aminotransferase Increase...
29 (.19%)

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

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

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

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

Pulmonary Hypertension
2727
Pulmonary Arterial Hypertension
1008
Erectile Dysfunction
330
Drug Use For Unknown Indication
90
Product Used For Unknown Indication
81
Ill-defined Disorder
58
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Lung Disorder
53
Cardiac Failure Congestive
47
Hypertension
44
Pulmonary Fibrosis
38
Cardiac Disorder
36
Scleroderma
29
Chronic Obstructive Pulmonary Disea...
22
Dyspnoea
17
Idiopathic Pulmonary Fibrosis
16
Pulmonary Embolism
14
Raynauds Phenomenon
13
Interstitial Lung Disease
12
Cor Pulmonale Chronic
12
Emphysema
8
Right Ventricular Failure
7
Eisenmengers Syndrome
7
Cor Pulmonale
6
Scimitar Syndrome
6
Systemic Sclerosis
6
Essential Hypertension
6
Portopulmonary Hypertension
6
Sexual Dysfunction
6
Atrial Fibrillation
6
Mitral Valve Stenosis
5
Postoperative Care
5
Connective Tissue Disorder
5
Respiratory Disorder
5
Fallots Tetralogy
4
Vasodilation Procedure
4
Pulmonary Oedema
4
Pulmonary Arterial Pressure Increas...
4
Skin Ulcer
4
Cardiovascular Disorder
4
Disturbance In Sexual Arousal
4
Sarcoidosis
3
Cardiomyopathy
3
Gait Disturbance
3
Hypoventilation
3
Pulmonary Arterial Pressure
3
Pulmonary Veno-occlusive Disease
3
Pulmonary Valve Incompetence
3
Cardiac Failure
3
Lung Neoplasm Malignant
3
Persistent Foetal Circulation
3
Ph Body Fluid
3

Drug Labels

LabelLabelerEffective
RevatioCardinal Health27-JUN-12
RevatioPfizer Laboratories Div Pfizer Inc31-AUG-12
RevatioPfizer Laboratories Div Pfizer Inc31-AUG-12

Revatio Case Reports

What Revatio 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 Revatio. 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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