Prescription medicine
Alprostadil Brand names: Caverject, Edex, Prostin; first approved as Prostin Vr Pediatric
Alprostadil (Edex) is a prescription medicine with an FDA approval on record since 1981. A generic is approved and listed by 1 labeler, but in the October 7, 2026 NADAC survey pharmacies bought only the brand, at $106.24 per kit (Caverject impulse 20 mcg kit).
- Generic approved
Check it at the source: the alprostadil FDA label on DailyMed (effective March 27, 2024, Endo USA, Inc.); the NDA 18484 record on Drugs@FDA; every alprostadil label on DailyMed.
Highlights of the record
FDA label of March 27, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageedex ® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.
Forms and strengths
- 0.5ml
Injection (powder) (lyophilized) for solution; injection (solution); injection (solution) (concentrate).
On the market
- Earliest approval on file
- October 16, 1981 Prostin Vr Pediatric, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first January 20, 1998; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 1 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $106.24 per kit Caverject impulse 20 mcg kit
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2012 0 Class I among all firms' recalls; latest February 22, 2017; 36 more by firms not listed as its makers
- FAERS reports
- 3,591 through July 30, 2026
What is alprostadil used for?
From the label: indications and usageedex ® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.
Conditions named in the indications of alprostadil's FDA labels, with every medicine labeled for each:
From other alprostadil labelsErectile dysfunction: INDICATIONS AND USAGE edex ® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.
FDA pharmacologic class: Prostaglandin Analog and Prostaglandin E1 Agonist.
Source: FDA drug label (Edex), Endo USA, Inc., effective March 27, 2024 (SPL set e8b8ec8d-1318-43e4-a182-446e9f9579de), via openFDA; the full label on DailyMed
Is there a generic for alprostadil (Edex)?
The FDA approved the first generic alprostadil on January 20, 1998. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists alprostadil from 1 labeler under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it. In the latest NADAC survey pharmacies bought only the brand, so a generic may not be on sale yet.
- 1981 earliest approval on file
- 1998 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for alprostadil (Edex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $106.24 per kit (Caverject impulse 20 mcg kit), up 5% from $101.01 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Caverject impulse 10 mcg kit (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Caverject impulse 10 mcg kit | Brand | $82.49 per kit | n/a | +5% |
| Caverject impulse 20 mcg kit | Brand | $106.24 per kit | n/a | +5% |
| Edex 10 mcg cartridge 2-pk kit | Brand | $182.92 per kit | n/a | n/a |
| Edex 20 mcg cartridge 2-pk kit | Brand | $237.37 per kit | n/a | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has alprostadil been recalled?
The FDA's Enforcement Report lists 37 recalls naming alprostadil since 2012: 0 Class I (the most serious), 36 Class II, 1 Class III; 1 still ongoing. 36 of them are by firms that FDA's NDC Directory does not list as a maker of alprostadil and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 18, 2022 | Class III | Teva Pharmaceuticals USA Inc not a listed maker | Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing |
| October 12, 2021 | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy not a listed maker | Lack of assurance of sterility |
| July 29, 2021 | Class II | Teva Pharmaceuticals USA not a listed maker | Lack of Assurance of Sterility |
| March 26, 2020 | Class II | Innovative Intrathecal Solutions, Inc. … not a listed maker | Lack of Assurance of Sterility |
| January 15, 2020 | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical not a listed maker | Lack of Assurance of Sterility |
| December 20, 2019 | Class II | Assurance Infusion not a listed maker | Lack of sterility assurance. |
| July 22, 2019 | Class II | Wise Pharmacy not a listed maker | Lack of Processing Controls |
| August 10, 2018 | Class II | Westlab Pharmacy, Inc. dba Westlab Pharmacy not a listed maker | Incorrect Product Formulation |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the alprostadil label say about other medicines?
The alprostadil label names 5 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Furosemide | drug interactions | Standard therapy includes antibiotics, such as penicillin and gentamicin; vasopressors, such as dopamine and isoproterenol; cardiac glycosides; and diuretics, such as furosemide. |
| Gentamicin | drug interactions | Standard therapy includes antibiotics, such as penicillin and gentamicin; vasopressors, such as dopamine and isoproterenol; cardiac glycosides; and diuretics, such as furosemide. |
| Heparin | drug interactions | Therefore, caution should be exercised with concomitant administration of heparin and edex ® . (Also, see Drug-Drug Interactions in CLINICAL PHARMACOLOGY, Pharmacokinetics .) |
| Isoproterenol | drug interactions | Standard therapy includes antibiotics, such as penicillin and gentamicin; vasopressors, such as dopamine and isoproterenol; cardiac glycosides; and diuretics, such as furosemide. |
| Warfarin | warnings and precautions | Injection site bleeding may occur in patients taking anticoagulants, such as warfarin or heparin. |
Source: FDA drug label (Edex), Endo USA, Inc., effective March 27, 2024 (SPL set e8b8ec8d-1318-43e4-a182-446e9f9579de), via openFDA; the full label on DailyMed
What do FAERS reports show for alprostadil?
The FDA Adverse Event Reporting System holds 3,591 reports that list alprostadil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 272 are coded as a death and 726 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other prostaglandin analogs
- the pharmacologic class, with prices and generics
- Alprostadil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other