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Caverject Powder Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Caverject (alprostadil) Powder is used to treat erectile dysfunction (impotence) and to help diagnose certain causes of this disorder. Alprostadil is also used to improve blood flow in newborn babies with a certain genetic heart condition. This medication guide addresses only the adult male use of this medication in erectile disorders. It is a prostaglandin that relaxes blood vessels and muscles in the penis, increasing blood flow into the penis, causing an erection. This medication may be available in generic form. Common side effects include pain in the penis, urethra, or testicles, headache, dizziness, back pain, a rash on the skin of the penis, warmth or numbness of the penis, or cough, stuffy nose, cold symptoms.
The dose of Caverject is individualized for each patient under supervision by a physician. Doses of greater than 60 micrograms are not recommended. Caverject may interact with nitroglycerin, hydralazine, or blood thinners. Women should not use Caverject, therefore, it is unlikely to be prescribed during pregnancy or breast-feeding. Consult your doctor if you have questions. Men should use a condom to prevent transfer of this medication to a sexual partner if she is pregnant or could become pregnant.
Our Caverject (alprostadil) Powder 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.
Caverject Powder 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 Caverject Powder (Alprostadil Sterile Powder for Injection) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Caverject Powder FDA Prescribing Information: Side Effects
Local Adverse Reactions: The following local adverse reaction information was derived from con- trolled and uncontrolled studies, including an uncontrolled 18-month safety study.
Local Adverse Reactions Reported by ≥ 1% of Patients
Treated with CAVERJECT for up to 18 Months*
N = 1861
N = 1861
|Penile pain||37%||Penis disorder***||3%|
|Prolonged erection||4%||Injection site ecchymosis||2%|
|Penile fibrosis**||3%||Penile rash||1%|
|Injection site hematoma||3%||Penile edema||1%|
| * Except for penile pain (2%), no significant local adverse
reactions were reported by 294 patientswho received 1 to 3 injections of placebo.
** See General Precautions.
*** Includes numbness, yeast infection, irritation, sensitivity, phimosis, pruritus, erythema, venous leak, penile skin tear, strange feeling of penis, discoloration of penile head, itch at tip of penis.
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%. In the majority of cases, spontaneous detumescence occurred. To minimize the chances of prolonged erection or priapism, CAVERJECT should be titrated slowly to the lowest effective dose (see DOSAGE AND ADMINISTRATION section). The patient must be instructed to immediately report to his physician or, if unavailable, to seek immediate medical assistance for any erection that persists for longer than 4 hours. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
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 (see DOSAGE AND ADMINISTRATION).
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, irri tation, sensit ivity, phimosis, pruritus, erythema, venous leak, painful erect ion, and abnormal ejaculat ion.
Systemic Adverse Events: The following systemic adverse event information was derived from controlled and uncontrolled studies, including an uncontrolled 18-month safety study.
Systemic Adverse Events Reported by ≥ 1% of Patients Treated
with CAVERJECT for up to 18 Months*
|Body System/Reaction|| CAVERJECT
N = 1861
|Body System/Reaction (continued)|| CAVERJECT
N = 1861
|Cardiovascular System||Urogenital System|
|Central Nervous System||Miscellaneous|
|Upper respiratory infection||4%|
| * No significant adverse events were reported
by 294 patients who received 1 to 3 injections ofplacebo.
** prostatitis, pain, hypertrophy, enlargement
*** pain in various anatomical structures other than injection site
**** injuries, fractures, abrasions, lacerations, dislocat ions
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 micrograms and above 30 micrograms of alprostadil, respectively, and appeared to be dose-dependent. However, these changes were usually clinically unimportant; only three patients discont inued the treatment because of symptomatic hypotension.
CAVERJECT had no clinically important effect on serum or urine laboratory tests.
Read the entire FDA prescribing information for Caverject Powder (Alprostadil Sterile Powder for Injection) »
Additional Caverject Powder Information
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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