Short answer: In the label's studies of 1,065 men treated for up to 24 months, the most common Edex side effect was penile pain: 29% during injection, 35% during erection and 30% after. Local bleeding occurred in 15%, penile angulation in 7%, hematoma and penile fibrosis in 5% each, and erections over 4 hours in 4%. About 9% stopped because of side effects. Edex has no boxed warning.
What Edex is approved for: Edex is approved to treat erectile dysfunction caused by nerve, blood vessel, psychological or mixed causes (Indications and Usage). It is injected into the side of the penis (intracavernous use).
Source
EDEX (alprostadil for injection), prescribing information and patient information. Endo USA. DailyMed, version published July 13, 2026. DailyMed setid e8b8ec8d-1318-43e4-a182-446e9f9579de
No. The current Edex label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Edex.
| Local reaction | edex N = 1065, n (%) |
|---|---|
| Penile pain during injection | 305 (29) |
| Penile pain during erection | 368 (35) |
| Penile pain after erection | 317 (30) |
| Penile pain (other) | 116 (11) |
| Prolonged erection > 4 ≤ 6 hours | 44 (4) |
| Prolonged erection > 6 hours | 6 (<1) |
| Bleeding | 158 (15) |
| Hematoma | 56 (5) |
| Ecchymosis | 44 (4) |
| Penile angulation | 72 (7) |
| Penile fibrosis | 52 (5) |
| Cavernous body fibrosis | 20 (2) |
| Peyronie's disease | 11 (1) |
| Faulty injection technique | 59 (6) |
| Penis disorder | 28 (3) |
| Erythema | 17 (2) |
Up to 24 months of use. Values are n (%). Faulty injection technique means, for example, injecting into the glans, urethra or under the skin. Penile pain (other) is pain not linked to the injection site or erection.
| Adverse experience | edex N = 1065, n (%) |
|---|---|
| Upper respiratory tract infection | 58 (5) |
| Influenza-like symptoms | 35 (3) |
| Back pain | 23 (2) |
| Headache | 20 (2) |
| Infection | 18 (2) |
| Hypertension | 17 (2) |
| Hypertriglyceridemia | 17 (2) |
| Pain | 16 (2) |
| Myocardial infarction | 13 (1) |
Controlled and uncontrolled studies, up to 24 months. Values are n (%). The full table also lists sinusitis, abnormal ECG, high cholesterol, high blood sugar, prostate disorder, testicular pain, inguinal hernia, skin disorder, abnormal vision and leg pain at 1% each.
About 9% of patients stopped Edex because of a side effect, vs under 1% on placebo.
Penile pain in placebo-controlled studies: 31% after Edex vs 9% after placebo. Per injection, 15% of injections were painful; 80% of painful injections were mild, 16% moderate and 4% severe. Pain fell over time, from 41% of patients in the first 2 months to 3% in months 21 to 24.
Erections over 4 hours in placebo-controlled studies: 3% on Edex vs under 1% on placebo. They were more frequent in men under 40, men without diabetes and men with psychological causes of ED.
Medicine or drawing blood from the penis was needed in 1.6% of 311 patients with prolonged erection or priapism; most erections went down on their own.
Local bleeding in placebo-controlled studies was 6% with Edex vs 3% with placebo, mostly from faulty injection technique. Four patients (under 1%) had symptoms of low blood pressure such as dizziness or fainting. Needle breakage has been reported after approval.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Who should not use it. Edex is not used by men with conditions that make priapism more likely (sickle cell anemia or trait, multiple myeloma, leukemia), men with penile fibrosis such as cavernosal fibrosis or Peyronie's disease, or men with penile implants.
Prolonged erection and priapism. Erections over 4 hours occurred in 4% and priapism (over 6 hours) in under 1% over up to 24 months. Slow titration to the lowest effective dose lowers the risk. Untreated priapism can cause penile tissue damage and permanent loss of potency.
Penile fibrosis and curvature. Penile fibrosis, including Peyronie's disease, was 7.8% overall in studies up to 24 months. The penis is examined at the start and at regular intervals, such as every 3 months; Edex is stopped if angulation, fibrosis or Peyronie's develops and can be restarted if it subsides.
Low blood pressure and dizziness. Injection can raise alprostadil levels in the blood, especially with significant venous leakage, which may cause low blood pressure or dizziness.
Bleeding and blood thinners. The injection site is pressed for five minutes or until bleeding stops. People on warfarin or heparin may bleed more; with heparin, the label urges caution.
Other cautions. Combining Edex with other vasoactive drugs is not recommended. ED treatments are generally not used when sexual activity is inadvisable because of heart disease. The superfine needle can break, and needles and cartridges are never reused or shared.
From the Information for Patients (Precautions) that comes with Edex:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.