Revatio (sildenafil citrate) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Revatio
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Sildenafil citrate
Class: Phosphodiesterase 5 inhibitor

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From October 2005 to June 2026, FDA received 9,801 adverse event reports that name Revatio. In these reports the drug is a suspect or interacting product.

In the same period, 23,520 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 77 reports in the 12 months to June 2026 and 161 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 77 (under 0.1%) name Revatio. Reports for patients 75 and over were 22.3% of the reports that name Revatio and 9.5% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Revatio is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 18 reports that name Revatio.
In January to March 2026, FDA received 18.
In April to June 2025, FDA received 29.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 541 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 9,799 of the 9,801 reports (99.9%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 541 terms.

Reaction terms in the reports that name Revatio, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 9,801 reports
Deaththe patient died; cause not stated by this term	2,254	23%
Dyspnoeashortness of breath	989	10.1%
Pulmonary hypertensionhigh pressure in the lung arteries	635	6.5%
Malaisegeneral feeling of being unwell	570	5.8%
Product use issuea problem in how the product was used	548	5.6%
Off label useused for a purpose or in a way not on the label	540	5.5%
Headachehead pain	472	4.8%
Pneumonialung infection	463	4.7%
Falla fall	346	3.5%
Condition aggravatedthe condition being treated got worse	335	3.4%
Dizzinesslight-headedness or unsteadiness	320	3.3%
Fatiguetiredness	317	3.2%
Hypotensionlow blood pressure	317	3.2%
Diarrhoealoose or frequent stools	311	3.2%
Cardiac failureheart failure	289	2.9%
Cardiac failure congestivecongestive heart failure	286	2.9%
Fluid retentionthe body holding extra fluid	283	2.9%
Nauseafeeling sick	264	2.7%
Drug ineffectivethe medicine did not work as expected	244	2.5%
Weight decreasedweight loss	204	2.1%
Astheniaweakness or lack of energy	203	2.1%
Cardiac disorder	203	2.1%
Cough	202	2.1%
Oedema peripheralswelling of the legs, ankles or hands	199	2%
Painpain, site not specified	191	1.9%
Vomitingbeing sick	178	1.8%
Pulmonary arterial hypertension	172	1.8%
Renal failurekidney failure	171	1.7%
Oxygen saturation decreased	168	1.7%
Epistaxisnosebleed	166	1.7%
Chest pain	165	1.7%
Nasopharyngitisa cold	164	1.7%
Disease progressionthe disease advanced	160	1.6%
Anaemialow red blood cells	155	1.6%
Respiratory failurethe lungs could not supply enough oxygen	150	1.5%
Pain in extremitypain in an arm or leg	146	1.5%
Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease	141	1.4%
Peripheral swellingswelling of the arms or legs	133	1.4%
Right ventricular failure	133	1.4%
Product use in unapproved indicationused for a purpose not on the label	128	1.3%
Weight increasedweight gain	126	1.3%
Syncopefainting	122	1.2%
Feeling abnormalfeeling odd or not right	120	1.2%
Myocardial infarctionheart attack	119	1.2%
Hospitalisationadmission to hospital	118	1.2%
Insomniadifficulty sleeping	115	1.2%
Oedemaswelling from fluid	114	1.2%
Gait disturbancedifficulty walking	113	1.2%
Flushingsudden reddening or warmth of the skin	110	1.1%
Lung disordera lung problem, type not specified	110	1.1%

Download all 541 terms of Revatio (CSV)

The counts add to more than 9,801 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Sildenafil with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Sildenafil	Generic name	10,726
Sildenafil citrate	Generic name	5,933
Revatio (this page)	Brand name	9,801
Viagra	Brand name	28,349

Sum of the separately reported names: 54,809. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Revatio, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2005	2	2	0	0	0	0	0	2	0
2006	41	40	3	2	13	0	0	32	1
2007	79	72	12	5	15	5	0	55	7
2008	140	118	43	2	26	2	2	77	22
2009	250	199	141	4	27	2	1	65	51
2010	409	392	270	10	63	3	0	163	17
2011	475	423	267	10	81	4	0	166	52
2012	998	898	503	8	260	2	0	443	100
2013	1,052	962	539	19	315	8	0	560	90
2014	903	706	354	23	231	10	0	460	197
2015	1,065	811	335	9	376	4	1	510	254
2016	1,008	797	294	11	418	7	0	545	211
2017	692	550	270	4	251	5	0	347	142
2018	532	414	177	9	204	7	0	230	118
2019	558	391	145	9	194	2	1	213	167
2020	546	400	134	13	205	4	0	220	146
2021	425	392	206	5	179	2	0	187	33
2022	149	136	69	3	52	0	0	56	13
2023	134	120	57	5	60	0	1	46	14
2024	114	105	45	2	47	0	0	45	9
2025	149	129	56	2	55	0	0	76	20
2026	80	79	23	0	45	1	0	45	1

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Revatio, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Revatio, by the year in which FDA received them
Year	Reports
2005	2
2006	38
2007	72
2008	123
2009	192
2010	507
2011	497
2012	1,149
2013	1,043
2014	1,097
2015	1,184
2016	1,006
2017	714
2018	546
2019	525
2020	339
2021	190
2022	144
2023	131
2024	149
2025	117
2026	36

Reports that name Revatio, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Revatio
Age	Reports	Share
Under 2	143	1.5%
2 to 11	137	1.4%
12 to 17	42	0.4%
18 to 44	558	5.7%
45 to 64	2,067	21.1%
65 to 74	1,824	18.6%
75 and over	2,188	22.3%
Age not given	2,842	29%

Sex of the patient in the reports that name Revatio
Sex	Reports	Share
Female	6,302	64.3%
Male	3,069	31.3%
Unknown or not given	430	4.4%

Type of reporter in the reports that name Revatio
Reporter	Reports	Share
Physician	1,970	20.1%
Pharmacist	478	4.9%
Other health professional	2,232	22.8%
Lawyer	13	0.1%
Consumer or non-health professional	4,981	50.8%
Not given	127	1.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 74.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Revatio record
Indication as recorded (MedDRA)	Reports	Share
Pulmonary hypertension	3,316	33.8%
Pulmonary arterial hypertension	2,061	21%
Cardiac disorder	122	1.2%
Lung disorder	95	1%
Dyspnoea	68	0.7%
Hypertension	60	0.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 9,801 reports.

Drugs in the same reports

Other drugs that the reports of Revatio name, in any role, in order of name
Drug	Reports that name the two
Ambrisentan	450
Aspirin	386
Coumadin	395
Furosemide	828
Lasix	746
Letairis	549
Opsumit	506
Spironolactone	465
Tracleer	581
Warfarin	510

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Sildenafil same ingredient
Sildenafil citrate same ingredient
Viagra same ingredient
Cialis same class
Adcirca same class
Tadalafil same class
Retrovir next in the A to Z list
Revcovi next in the A to Z list
Retinol next in the A to Z list
Revellex next in the A to Z list
Retin-A next in the A to Z list
Revestive next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for RevatioThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Revatio: adverse event reports that FDA received. https://reportedreactions.com/drug/revatio/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Revatio as a suspect or interacting product. The 23,520 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Revatio was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Revatio?

No. It is a count of what people reported to FDA: 9,801 reports from October 2005 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (50.8%), other health professional (22.8%) and physician (20.1%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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