What the label lists and what reports show
Alprostadil side effects
Alprostadil's FDA label lists its adverse reactions in its own words. FAERS holds 3,591 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is erection increased (136 reports).
- Generic approved
Check it at the source: the alprostadil FDA label on DailyMed (effective March 27, 2024, Endo USA, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsedex ® , administered by intracavernous injection in doses ranging from 1 to 40 mcg per injection for periods up to 24 months, has been evaluated in clinical trials for safety in over 1,065 patients with erectile dysfunction. Discontinuation of therapy due to a side effect in clinical trials was required in approximately 9% of patients treated with edex ® and in <1% of patients treated with placebo. Local Adverse Reactions The following local adverse reactions were reported in studies including 1,065 patients treated with edex ® for up to two years. Penile Pain With use of up to 24 months, penile pain was reported at least once by 29% of patients during injection, 35% of patients during erection, and by 30% of patients after erection. On a per injection basis, 15% of injections were associated with penile pain. …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Local Reaction | edex® N = 1065 n (%) | Local Reaction | edex® N = 1065 n (%) |
|---|---|---|---|
| Penile pain during injection | 305 (29) | Ecchymosis | 44 (4) |
| Penile pain during erection | 368 (35) | Penile angulation | 72 (7) |
| Penile pain after erection | 317 (30) | Penile fibrosis | 52 (5) |
| Penile pain (other) 2 | 116 (11) | Cavernous body fibrosis | 20 (2) |
| > 4 ≤ 6 Hours | 44 (4) | Faulty injection technique 3 | 59 (6) |
| > 6 Hours | 6 (<1) | Penis disorder | 28 (3) |
| Bleeding | 158 (15) | Erythema | 17 (2) |
| Hematoma | 56 (5) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, 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?
3,591 reports list alprostadil among the medicines taken, 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. Of the 18 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Alprostadil: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions