Applies to alprostadil: intracavernosal powder for solution. Other dosage forms:

• intravenous solution
• urethral suppository

Serious side effects of Alprostadil

Along with its needed effects, alprostadil may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking alprostadil:

Rare

• Curving of penis with pain during erection
• erection continuing for 4 to 6 hours
• erection continuing longer than 6 hours with severe and continuing pain of the penis
• swelling in or pain of the testes

Other side effects of Alprostadil

Some side effects of alprostadil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bleeding and pain at the injection site (short-term)
• painful erection

Rare

• Bruising or clotted blood in the penis at the injection site, usually caused by an incorrect injection

For Healthcare Professionals

Applies to alprostadil: compounding powder, injectable kit, injectable powder for injection, injectable solution, transurethral suppository.

General

The most common side effects were penile pain, local bleeding, fever, urethral pain, urethral burning, apnea, and flushing.^[Ref]

Genitourinary

Very common (10% or more): Penile pain (up to 36%), urethral pain (13%), urethral burning (12%)

Common (1% to 10%): Prolonged erection greater than 4 hours, penile angulation, penile fibrosis, cavernous body fibrosis, Peyronie's disease, penis disorder, prostate disorder, testicular pain, urethral bleeding/spotting and other minor urethral abrasions, vaginal burning/itching

Uncommon (0.1% to 1%): Priapism, scrotal erythema, dysuria, hematuria, pollakiuria, micturition urgency, urethral hemorrhage, balanitis, phimosis, ejaculation disorder, scrotal disorder, scrotal pain, testicular swelling, testicular edema, scrotal edema, spermatocele, testicular disorder, testicular mass, penile hemosiderin deposits, swelling of the preputium or the glans, perineal pain, painful erection

Rare (less than 0.1%): Urinary tract infection

Frequency not reported: Anuria, abnormal ejaculation, penile deviations, penile warmth, urinary frequency/urinary urgency/impaired urination^[Ref]

Cardiovascular

Very common (10% or more): Flushing (10.1%)

Common (1% to 10%): Bradycardia, hypotension, tachycardia, cardiac arrest, edema, hematoma, hypertension, myocardial infarction, abnormal ECG

Uncommon (0.1% to 1%): Vascular fragility, supraventricular extrasystoles, vein disorder, vasodilatation, peripheral vascular disorder, peripheral edema, swelling of the leg veins

Frequency not reported: Congestive heart failure, hyperemia, second degree heart block, shock, spasm of the right ventricle infundibulum, supraventricular tachycardia, ventricular fibrillation, rapid pulse, pneumopericardium, ventricular hypertrophy, tachyphylaxis, ductus arteriosus histological changes, venous leak, cardiac arrhythmias, postural hypotension, changes in blood pressure, vagal shock, vasovagal reactions, myocardial ischemia^[Ref]

Local

Very common (10% or more): Local bleeding (15%)

Common (1% to 10%): Injection site hematoma, injection site burning, sensation of tension in the penis, injection site pain

Uncommon (0.1% to 1%): Injection site hemorrhage, injection site edema, injection site inflammation, injection site mass, injection site pruritus, injection site swelling and reddening, injection site irritation, injection site anesthesia, injection site warmth

Frequency not reported: Localized pain^[Ref]

Respiratory

Very common (10% or more): Apnea (12%)

Common (1% to 10%): Upper respiratory tract infection, sinusitis, rhinitis

Frequency not reported: Bradypnea, bronchial wheezing, hypercapnia, respiratory depression, respiratory distress, tachypnea, hypoplastic lungs, pneumothorax^[Ref]

Other

Very common (10% or more): Fever (14%)

Common (1% to 10%): Sepsis, influenza-like symptoms, pain, accidental injury

Uncommon (0.1% to 1%): Asthenia

Rare (less than 0.1%): Vertigo

Frequency not reported: Hypothermia, jitteriness, non-generalized weakness^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, leg pain, pelvic pain, muscle spasms

Uncommon (0.1% to 1%): Exostosis

Frequency not reported: Hyperextension of the neck, stiffness, cortical proliferation of the long bones, microcephaly, leg cramps^[Ref]

Metabolic

Common (1% to 10%): Hypokalemia, hypertriglyceridemia, hypercholesterolemia, hyperglycemia

Frequency not reported: Hypoglycemia, hyperkalemia^[Ref]

Nervous system

Common (1% to 10%): Seizures, headache, dizziness

Uncommon (0.1% to 1%): Syncope, hypoesthesia, hyperesthesia, presyncope

Frequency not reported: Cerebral bleeding, lethargy, numbness, collapse, amnesia, cerebrovascular accident^[Ref]

Dermatologic

Common (1% to 10%): Ecchymosis, erythema, skin disorder

Uncommon (0.1% to 1%): Rash, pruritus, hyperhidrosis

Rare (less than 0.1%): Urticaria

Frequency not reported: Diaphoresis, sensitivity, irritation, non-application site pruritus^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, inguinal hernia

Uncommon (0.1% to 1%): Obstruction gastric, gastric mucosal hypertrophy, nausea, dry mouth

Frequency not reported: Gastric regurgitation, peritonitis^[Ref]

Immunologic

Common (1% to 10%): Infection

Uncommon (0.1% to 1%): Fungal infection, common cold

Rare (less than 0.1%): Anaphylactic/anaphylactoid reactions^[Ref]

Hematologic

Common (1% to 10%): Disseminated intravascular coagulation

Uncommon (0.1% to 1%): Blood creatinine increased

Very rare (less than 0.01%): Thrombocytopenia

Frequency not reported: Anemia, bleeding, hypochromic anemia^[Ref]

Ocular

Common (1% to 10%): Abnormal vision

Uncommon (0.1% to 1%): Mydriasis^[Ref]

Hepatic

Frequency not reported: Hyperbilirubinemia, biliary atresia^[Ref]

Renal

Frequency not reported: Polycystic kidneys, renal failure^[Ref]

Psychiatric

Frequency not reported: Hyperirritability^[Ref]