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Edex

Edex

Edex Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Edex (alprostadil) is a vasodilator prescribed for the treatment of certain types of erectile dysfunction in men. Side effects of Edex may include but are not limited to bleeding or bruising at the site of medication administration, pain in the groing, penis, testicles or legs, redness of the penis, headache, back pain, skin problems, and vision problesm. Serious side effects may occur. Side effects and drug interactions should be reviewed prior to receiving this medication.

When reconstituted in a single dose cartridge, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 micrograms, respectively. The dosage range of Edex for the treatment of erectile dysfunction is 1 to 40 mcg and is first determined by the doctor. The intracavernous injection should be given over a 5 to 10 second interval. At home treatments require specific instructions given to the patient by the prescribing doctor. Caution should be exercised with concomitant administration of heparin and Edex. Edex is not indicated for use in women or pediatric patients.

Our Edex (alprostadil) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Edex in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using alprostadil and call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting;
  • bleeding from your urethra;
  • bleeding, bruising, or swelling where you injected the medication;
  • a painful erection that lasts 4 hours or longer;
  • severe pain or irritation of your penis or urethra; or
  • redness, lumps, tenderness, unusual shape or curving of the erect penis.

Less serious side effects may include:

  • pain in your penis, urethra, or testicles;
  • headache, dizziness;
  • back pain;
  • a rash on the skin of your penis;
  • warmth or numbness of your penis; or
  • cough, stuffy nose, cold symptoms.

Your sexual partner may also experience side effects such as burning, itching, or irritation of the body areas that come into contact with your penis.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Edex (Alprostadil for Injection) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Edex FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

edex® (alprostadil for injection) , 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® (alprostadil for injection) 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® (alprostadil for injection) 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. Penile pain was judged by patients to be mild in intensity for 80% of painful injections, moderate in intensity for 16% of painful injections, and severe in intensity for 4% of painful injections. The frequency of penile pain reports decreased over time; forty-one percent of the patients experienced pain during the first 2 months and 3% of the patients experienced pain during months 21-24. In placebo-controlled studies, penile pain was reported by 31% of patients after edex® (alprostadil for injection) and by 9% of patients after placebo injection.

Prolonged Erection/Priapism: Prolonged erections greater than four hours in duration occurred in 4% of all patients treated up to 24 months. In placebo-controlled studies, 3% of patients treated with edex® (alprostadil for injection) and < 1% of patients treated with placebo reported prolonged erections greater than four hours. The incidence of priapism (erections greater than 6 hours in duration) was < 1% with long-term use for up to 24 months. In the majority of cases, spontaneous detumescence occurred. A higher incidence of prolonged erections was found in younger patients ( < 40 years), non-diabetic patients, and patients with psychogenic etiology of erectile dysfunction. (See WARNINGS.)

Hematoma/Ecchymosis: In patients treated with edex® (alprostadil for injection) for up to 24 months, local bleeding, hematoma and ecchymosis were observed in 15%, 5% and 4% of patients, respectively. In placebo-controlled studies, the frequency of local bleeding was 6% with injection of edex® (alprostadil for injection) and 3% with injection of placebo. In most cases, these reactions were attributed to faulty injection technique.

Local Adverse Reactions Reported by ≥ 1% of Patients All Study Periods*

Local Reaction edex® (alprostadil for injection)
N = 1065
n (%)
Local Reaction edex® (alprostadil for injection)
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)** 116 (11) Cavernous body fibrosis 20 (2)
Prolonged erection   Peyronie's disease 11 (1)
   > 4 ≤ 6 Hours 44 (4) Faulty injection technique*** 59 (6)
   > 6 Hours 6 ( < 1) Penis disorder 28 (3)
Bleeding 158 (15) Erythema 17 (2)
Hematoma 56 (5)    
* Protocol Numbers KU-620-001, KU-620-002, KU-620-003, F-8653.
** Penile pain reported without an association to injection site or erection, such as pain in penis and scrotum, pain in glans penis, and burning penile pain.
*** Examples include injection into glans penis, urethra or subcutaneously.

Systemic Adverse Experiences

The following systemic adverse experiences were reported in controlled and uncontrolled studies in ≥ 1% of patients treated for up to 24 months with edex® (alprostadil for injection) .

Systemic Adverse Experiences Reported by ≥ 1% of Patients*

BODY SYSTEM
Adverse Experience
edex® (alprostadil for injection)
N = 1065
n (%)
BODY SYSTEM
Adverse Experience
edex® (alprostadil for injection)
N = 1065
n (%)
BODY SYSTEM
Adverse Experience
edex® (alprostadil for injection)
N = 1065
n (%)
RESPIRATORY CARDIOVASCULAR UROGENITAL
Upper respiratory tract   Hypertension 17 (2) Prostate disorder 15 (1)
infection 58 (5) Myocardial infarction 13 (1) Testicular pain 13 (1)
Sinusitis 14 (1) Abnormal ECG 12 (1) Inguinal hernia 11 (1)
BODY AS A WHOLE METABOLIC/NURITIONAL DERMATOLOGIC
Influenza-like symptoms 35 (3) Hypertriglyceridemia 17 (2) Skin disorder 14 (1)
Headache 20 (2) Hypercholesterolemia 12 (1) SPECIAL SENSES
Infection 18 (2) Hyperglycemia 12 (1) Abnormal vision 11 (1)
Pain 16 (2)        
MUSCULOSKELETAL        
Back pain 23 (2)        
Leg pain 13 (1)        
* Protocol Numbers KU-620-001, KU-620-002, KU-620-003, F-8653.

Hemodynamic changes, manifested as increases or decreases in blood pressure and pulse rate, were observed during clinical studies but did not appear to be dose-dependent. Four patients ( < 1%) reported clinical symptoms of hypotension such as dizziness or syncope.

edex® (alprostadil for injection) had no clinically important effect on serum or urine laboratory tests.

Post-Marketing Adverse Experiences

Needle breakage.

Read the entire FDA prescribing information for Edex (Alprostadil for Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.



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