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Caverject

Last reviewed on RxList: 6/7/2018
Caverject Side Effects Center

Last reviewed on RxList 6/07/2018

Caverject (alprostadil) is a naturally occurring form of prostaglandin used to treat erectile dysfunction (impotence) and to help diagnose certain causes of this disorder. Caverject is also used to improve blood flow in newborn babies with a certain genetic heart condition. Caverject is available in generic form. Common side effects of Caverject include:

  • injection site reactions (mild/moderate pain, irritation, or slight bleeding),
  • unusual discharge from your penis,
  • pain in your penis/urethra/testicles,
  • headache,
  • dizziness,
  • back pain,
  • a rash on the skin of your penis,
  • itching/warmth/numbness of your penis,
  • cough,
  • stuffy nose,
  • cold symptoms, and
  • flu symptoms.

Tell your doctor if you have unlikely but serious side effects of Caverject including:

  • redness/tenderness/swelling of the penis, or
  • lumps or unusual curving of the penis.

The dose of Caverject is individualized for each patient under supervision of a physician. Doses of greater than 60 mcg are not recommended. Caverject may interact with nitroglycerin, hydralazine, or blood thinners. Tell your doctor all medications you use. This medication is not for use by women; therefore it is unlikely to be used during pregnancy or breast-feeding. It is recommended men use a condom to prevent transfer of this medication to a sexual partner if she is pregnant or could become pregnant.

Our Caverject (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.

QUESTION

Erectile dysfunction (ED) is… See Answer
Caverject Consumer Information

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

Stop using alprostadil and call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • bleeding after an injection;
  • a painful erection that lasts 4 hours or longer;
  • new or worsening pain in your penis; or
  • redness, swelling, tenderness, lumps, unusual shape or curving of the erect penis.

Common side effects may include:

  • mild pain in your penis, urethra, or testicles;
  • redness of the penis; or
  • warmth or burning in your urethra.

Your sex partner may have side effects such as burning, itching, or irritation of body areas that come into contact with your penis.

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.

Read the entire detailed patient monograph for Caverject (Alprostadil Injection)

SLIDESHOW

Erectile Dysfunction (ED) Causes and Treatment See Slideshow
Caverject Professional Information

SIDE EFFECTS

The following are described elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Local Adverse Reactions

Local adverse reactions derived from 1861 patients in clinical studies of CAVERJECT, including an 18-month, open-label study, are shown in Table 2.

Table 2. Local Adverse Reactions Reported by ≥ 1% of Patients Treated with CAVERJECT for up to 18 Months

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%
* Penis disorder includes: numbness, irritation, sensitivity, pruritus, erythema, skin tear, discoloration, itching.

The following local adverse reactions were reported in < 1% of patients: injection site hemorrhage, injection site inflammation, injection site itching, injection site swelling, injection site edema, urethral bleeding, penile warmth, numbness, irritation, sensitivity, pruritus, erythema, painful erection, and abnormal ejaculation.

In these studies, no local adverse reactions were reported in the 294 patients who received placebo, except for penile pain (2%).

Penile Pain

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

Prolonged Erection/Priapism

Prolonged erection was defined as an erection that lasted for 4 to 6 hours; priapism was defined as an erection that lasted 6 hours or longer. In clinical studies the frequency of prolonged erection after intracavernosal administration of CAVERJECT was 4%, while the frequency of priapism was 0.4% [see WARNINGS AND PRECAUTIONS].

Penile Hematoma/Ecchymosis

In clinical studies the frequency of penile hematoma and ecchymosis was 3% and 2%, respectively.

Systemic Adverse Reactions

Systemic adverse reactions reported by ≥ 1% of subjects in clinical studies of CAVERJECT included: dizziness (1%).

The following systemic adverse reactions were reported in < 1% of patients: testicular pain, scrotal edema, hematuria, pelvic pain, hypotension, vasodilation, vasovagal reaction, diaphoresis, rash, and non-application site pruritus. Three patients (0.2%) discontinued due to symptomatic hypotension.

No systemic adverse reactions were reported in the 294 patients who received placebo.

In addition to the adverse reactions observed for CAVERJECT, the following adverse reactions have been reported in clinical studies of CAVERJECT IMPULSE:

CAVERJECT IMPULSE was evaluated in 87 patients in an open-label crossover study of 6 weeks treatment duration that compared the formulation of alprostadil for injection contained in CAVERJECT IMPULSE with the formulation contained in CAVERJECT. Doses used in this study ranged from 2.5 mcg to 20 mcg. Adverse reactions reported for the CAVERJECT IMPULSE formulation included: penis disorder (4.6%), prolonged erection (1.1%), injection site erythema (1.1%), rash (1.1%), dizziness (1.1%), and hematospermia (1.1%). Penis disorder included penile pain, post-injection pain, and pain with erection.

CAVERJECT IMPULSE was also evaluated in 63 patients in a single-dose, double-blind, crossover study that compared CAVERJECT IMPULSE with CAVERJECT. Doses used in this study ranged from 2.5 mcg to 20 mcg. Adverse reactions reported for the CAVERJECT IMPULSE formulation included: penile pain (1.6%) and pruritis (1.6%).

Postmarketing Experience

The following adverse reaction has been identified during post-approval use of CAVERJECT:

There have been reports of needle breakage during administration of CAVERJECT. In some instances surgical removal of the needle was required.

Read the entire FDA prescribing information for Caverject (Alprostadil Injection)

Related Resources for Caverject

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Read the Caverject User Reviews »

© Caverject Patient Information is supplied by Cerner Multum, Inc. and Caverject Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

Erectile dysfunction (ED) is… See Answer

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