Caverject Side Effects
Please note - some side effects for Caverject may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Caverject - for the Consumer
Caverject Impulse
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Caverject Impulse:
Seek medical attention right away if any of these SEVERE side effects occur when using Caverject Impulse:Mild bleeding at the injection site; mild to moderate genital pain.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal ejaculation; bleeding from the tip of the penis; bloody urine or change in the amount of urine; chest pain; curving of the erect penis; dizziness; fainting; fast or irregular heartbeat; new or worsening genital pain; painful or prolonged erection; redness, lumps, swelling, tenderness, inflammation, numbness, strange sensation, or discoloration of the penis; severe or persistent bleeding or bruising at the injection site; severe or persistent pain, swelling, or redness at the injection site; swelling of the leg veins; white patches or discharge from the penis.
Caverject
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Caverject:
Seek medical attention right away if any of these SEVERE side effects occur when using Caverject:Mild bleeding at the injection site; mild genital pain.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal ejaculation; bleeding from the tip of the penis; bloody urine or change in the amount of urine; chest pain; curving of the erect penis; dizziness; fainting; fast or irregular heartbeat; new or worsening genital pain; painful or prolonged erection; redness, lumps, swelling, tenderness, inflammation, numbness, strange sensation, or discoloration of the penis; severe or persistent bleeding or bruising at the injection site; severe or persistent pain, swelling, or redness at the injection site; swelling of the leg veins; white patches or discharge from the penis.
Caverject Side Effects - for the Professional
Caverject
Local Adverse Reactions
The following local adverse reaction information was derived from controlled and uncontrolled studies of Caverject Sterile Powder, including an uncontrolled 18-month safety study.
| Event | Caverject N = 1861 |
|---|---|
|
|
| Penile pain | 37% |
| Prolonged erection | 4% |
| Penile fibrosis† | 3% |
| Injection site hematoma | 3% |
| Penis disorder‡ | 3% |
| Injection site ecchymosis | 2% |
| Penile rash | 1% |
| Penile edema | 1% |
Penile Pain
Penile pain after intracavernosal administration of Caverject was reported at least once by 37% of patients in clinical studies of up to 18 months in duration. In the majority of the cases, penile pain was rated mild or moderate in intensity. Three percent of patients discontinued treatment because of penile pain. The frequency of penile pain was 2% in 294 patients who received 1 to 3 injections of placebo.
Prolonged Erection/Priapism
In clinical trials, prolonged erection was defined as an erection that lasted for 4 to 6 hours; priapism was defined as erection that lasted 6 hours or longer. The frequency of prolonged erection after intracavernosal administration of Caverject was 4%, while the frequency of priapism was 0.4%.
Hematoma/Ecchymosis
The frequency of hematoma and ecchymosis was 3% and 2%, respectively. In most cases, hematoma/ecchymosis was judged to be a complication of a faulty injection technique. Accordingly, proper instruction of the patient in self-injection is of importance to minimize the potential of hematoma/ecchymosis.
The following local adverse reactions were reported by fewer than 1% of patients after injection of Caverject: balanitis, injection site hemorrhage, injection site inflammation, injection site itching, injection site swelling, injection site edema, urethral bleeding, penile warmth, numbness, yeast infection, irritation, sensitivity, phimosis, pruritus, erythema, venous leak, painful erection, and abnormal ejaculation.
Systemic Adverse Events
The following systemic adverse event information was derived from controlled and uncontrolled studies of Caverject Sterile Powder, including an uncontrolled 18-month safety study.
| Body System/Reaction | Caverject N = 1861 |
|---|---|
| Cardiovascular System | |
| Hypertension | 2% |
| Central Nervous System | |
| Headache | 2% |
| Dizziness | 1% |
| Musculoskeletal System | |
| Back pain | 1% |
| Respiratory System | |
| Upper respiratory infection | 4% |
| Flu syndrome | 2% |
| Sinusitis | 2% |
| Nasal congestion | 1% |
| Cough | 1% |
| Urogenital System | |
| Prostatic Disorder† | 2% |
| Miscellaneous | |
| Localized pain‡ | 2% |
| Trauma§ | 2% |
The following systemic events, which were reported for < 1% of patients in clinical studies, were judged by investigators to be possibly related to use of Caverject: testicular pain, scrotal disorder, scrotal edema, hematuria, testicular disorder, impaired urination, urinary frequency, urinary urgency, pelvic pain, hypotension, vasodilation, peripheral vascular disorder, supraventricular extrasystoles, vasovagal reactions, hypesthesia, non-generalized weakness, diaphoresis, rash, non-application site pruritus, skin neoplasm, nausea, dry mouth, increased serum creatinine, leg cramps, and mydriasis.
Hemodynamic changes, manifested as decreases in blood pressure and increases in pulse rate, were observed during clinical studies, principally at doses above 20 mcg and above 30 mcg of alprostadil, respectively, and appeared to be dose-dependent. However, these changes were usually clinically unimportant; only three patients discontinued the treatment because of symptomatic hypotension.
Caverject had no clinically important effect on serum or urine laboratory tests.
The safety of Caverject IMPULSE was evaluated in a study that compared the formulation of alprostadil for injection contained in Caverject IMPULSE with the formulation contained in Caverject Sterile Powder. The doses used by the 87 patients in this crossover study were the same for both formulations. The number and type of events reported for Caverject IMPULSE were consistent between formulations in this study and in other controlled and uncontrolled studies with Caverject Sterile Powder.
TopSide Effects by Body System
Local
Local side effects have included penile pain (37%), prolonged erection (4%), penile fibrosis (3%), injection site hematoma (3%), penis disorder (3%), injection site ecchymosis (2%), penile rash (1%), penile edema (1%), balanitis, injection site hemorrhage, injection site inflammation, injection site itching, injection site swelling and edema, urethral bleeding, penile warmth, numbness, yeast infection, irritation, sensitivity, phimosis, pruritus, erythema, venous leak, painful erection, and abnormal ejaculation. Postmarketing experience has included reports of needle breakage.
Cardiovascular
Hemodynamic changes manifested as hypotension and increases in pulse rate were generally observed at doses above 20 mcg and 30 mcg respectively, and appeared to be dose-dependent. These changes were usually reported as clinically unimportant, and only three patients discontinued treatment because of symptomatic hypotension.
Cardiovascular side effects have included hypertension (2%), hypotension, vasodilation, peripheral vascular disorder, supraventricular extrasystoles, vasovagal reactions, and increases in pulse rate.
Nervous system
Nervous system side effects have included headache (2%), dizziness (1%), hypesthesia, and non-generalized weakness.
Musculoskeletal
Musculoskeletal side effects have included back pain (1%) and leg cramps.
Respiratory
Respiratory side effects have included upper respiratory infection (4%), flu syndrome (2%), sinusitis (2%), nasal congestion (1%), and cough (1%).
Genitourinary
Genitourinary side effects have included prostatic disorder (2%), testicular pain, scrotal disorder, scrotal edema, hematuria, testicular disorder, impaired urination, urinary frequency, urinary urgency, and pelvic pain.
Ocular
Ocular side effects have included mydriasis.
Gastrointestinal
Gastrointestinal side effects have rarely included nausea and dry mouth.
Other
Other side effects have included localized pain (2%), trauma (2%), diaphoresis, rash, non-application site pruritus, skin neoplasm, and increased serum creatinine.
TopMore resources:
Caverject injectable and transurethral
Caverject Local - Includes detailed dosage instructions.
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