Alprostadil adverse event reports that FDA received

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

Name type: Generic name
Class: Prostaglandin analog

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 March 2004 to June 2026, FDA received 681 adverse event reports that name Alprostadil. In these reports the drug is a suspect or interacting product.

In the same period, 845 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 24 reports in the 12 months to June 2026 and 31 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, 24 (under 0.1%) name Alprostadil. Reports from consumers or other non-health professionals were 13.1% of the reports that name Alprostadil and 45.8% 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 Alprostadil 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 3 reports that name Alprostadil.
In January to March 2026, FDA received 11.
In April to June 2025, FDA received 8.

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 61 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 677 of the 681 reports (99.4%).

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 61 terms.

Reaction terms in the reports that name Alprostadil, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 681 reports
Off label useused for a purpose or in a way not on the label	75	11%
Drug ineffectivethe medicine did not work as expected	67	9.8%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	28	4.1%
Priapism	25	3.7%
Gastrointestinal infection	22	3.2%
Hypotensionlow blood pressure	22	3.2%
Cardiac failureheart failure	20	2.9%
Cytomegalovirus viraemia	20	2.9%
Pyrexiafever	18	2.6%
Product use in unapproved indicationused for a purpose not on the label	17	2.5%
Condition aggravatedthe condition being treated got worse	16	2.3%
Infantile apnoeic attack	15	2.2%
Apnoeapauses in breathing	14	2.1%
Hepatic enzyme increasedraised liver enzymes	14	2.1%
Hypokalaemialow blood potassium	14	2.1%
Infantile apnoea	14	2.1%
Apnoeic attack	12	1.8%
Cystitis haemorrhagic	12	1.8%
Pulmonary oedemafluid in the lungs	12	1.8%
Myocardial infarctionheart attack	11	1.6%
Diarrhoealoose or frequent stools	10	1.5%
Painpain, site not specified	10	1.5%
Blood alkaline phosphatase increased	9	1.3%
Bradycardiaslow heart rate	9	1.3%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	9	1.3%
Infantile cortical hyperostosis	9	1.3%
Chillschills or shivering	8	1.2%
Dyspnoeashortness of breath	8	1.2%
Oxygen saturation decreased	8	1.2%
Pneumonialung infection	8	1.2%
Drug ineffective for unapproved indication	7	1%
Drug interactionan interaction between medicines	7	1%
Hepatic fibrosis	7	1%
Loss of consciousnesspassing out	7	1%
Pain in extremitypain in an arm or leg	7	1%
Pleural effusionfluid around the lung	7	1%
Product use issuea problem in how the product was used	7	1%
Shockshock, a collapse of the circulation	7	1%
Stomatitissore mouth	7	1%
Body temperature increasedraised temperature	6	0.9%
Cerebral infarction	6	0.9%
Drug effect decreasedthe medicine had less effect	6	0.9%
Generalised oedema	6	0.9%
Neonatal apnoeic attack	6	0.9%
Neonatal hypoxia	6	0.9%
PO2 decreased	6	0.9%
Patent ductus arteriosus	6	0.9%
Pathogen resistance	6	0.9%
Pulmonary congestion	6	0.9%
Syncopefainting	6	0.9%

Download all 61 terms of Alprostadil (CSV)

The counts add to more than 681 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 Alprostadil with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Alprostadil (this page)	Generic name	681
Caverject	Brand name	1,198
Caverject Impulse	Brand name	231
Edex	Brand name	402

Sum of the separately reported names: 2,512. 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 Alprostadil, 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
2004	33	31	2	7	10	5	0	13	2
2005	47	42	7	13	8	2	0	23	5
2006	50	48	4	9	16	1	0	30	2
2007	28	27	1	2	9	1	0	14	1
2008	30	27	8	1	7	3	0	9	3
2009	18	12	2	5	4	1	0	4	6
2010	29	28	3	1	9	1	0	17	1
2011	29	29	2	4	11	3	0	18	0
2012	28	27	9	4	10	1	0	17	1
2013	12	9	1	1	2	0	0	7	3
2014	4	3	0	1	1	1	0	3	1
2015	13	11	1	0	2	0	0	9	2
2016	30	29	0	0	4	1	0	26	1
2017	43	33	5	0	2	0	0	28	10
2018	21	15	2	1	7	1	0	9	6
2019	59	55	7	4	12	3	0	47	4
2020	42	39	6	6	9	1	1	30	3
2021	36	27	1	2	10	1	0	21	9
2022	29	25	5	3	11	0	0	17	4
2023	28	26	1	3	19	1	1	19	2
2024	26	25	1	2	12	0	0	18	1
2025	28	25	1	1	8	7	0	15	3
2026	18	17	1	3	7	0	0	11	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 Alprostadil, 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 Alprostadil, by the year in which FDA received them
Year	Reports
2004	25
2005	46
2006	52
2007	29
2008	33
2009	15
2010	35
2011	31
2012	27
2013	12
2014	4
2015	12
2016	33
2017	42
2018	22
2019	61
2020	42
2021	45
2022	32
2023	17
2024	26
2025	26
2026	14

Reports that name Alprostadil, 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 Alprostadil
Age	Reports	Share
Under 2	98	14.4%
2 to 11	35	5.1%
12 to 17	1	0.1%
18 to 44	43	6.3%
45 to 64	98	14.4%
65 to 74	90	13.2%
75 and over	93	13.7%
Age not given	223	32.7%

Sex of the patient in the reports that name Alprostadil
Sex	Reports	Share
Female	180	26.4%
Male	391	57.4%
Unknown or not given	110	16.2%

Type of reporter in the reports that name Alprostadil
Reporter	Reports	Share
Physician	176	25.8%
Pharmacist	59	8.7%
Other health professional	197	28.9%
Lawyer	1	0.1%
Consumer or non-health professional	89	13.1%
Not given	159	23.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 18.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Alprostadil record
Indication as recorded (MedDRA)	Reports	Share
Erectile dysfunction	84	12.3%
Heart disease congenital	63	9.3%
Prophylaxis	35	5.1%
Peripheral arterial occlusive disease	21	3.1%
Patent ductus arteriosus	20	2.9%
Arteriosclerosis obliterans	17	2.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 681 reports.

Pages near this one

Caverject same ingredient
Caverject Impulse same ingredient
Edex same ingredient
Bimatoprost same class
Carboprost tromethamine same class
Alprolix next in the A to Z list
Alrex next in the A to Z list
Alprazolam next in the A to Z list
Altabax next in the A to Z list
Alphagan P next in the A to Z list
Altace next in the A to Z list
Alphagan 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 AlprostadilThe 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. Alprostadil: adverse event reports that FDA received. https://reportedreactions.com/drug/alprostadil/ 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 Alprostadil as a suspect or interacting product. The 845 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 Alprostadil 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 Alprostadil?

No. It is a count of what people reported to FDA: 681 reports from March 2004 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?

Other health professional (28.9%), physician (25.8%) and consumer or non-health professional (13.1%). 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.

To the top of the page