Drug Safety Information for CAVERJECT (Alprostadil)

Safety-related Labeling Changes for CAVERJECT (ALPROSTADIL) Rx Drug: FDA Link

Safety-related Labeling Changes for CAVERJECT IMPULSE (ALPROSTADIL) Rx Drug: FDA Link

Adverse Drug Reactions for CAVERJECT* (Alprostadil)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with CAVERJECT
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug ineffective	497
2	Erection increased	99
3	Erectile dysfunction	82
4	Product quality issue	78
5	Pyrexia	62
6	Penile pain	57
7	Condition aggravated	56
8	Cardiac failure	55
9	Pain*	54
10	Wrong technique in drug usage process	54
11	Drug effect decreased	54
12	Device malfunction	53
13	Priapism	42
14	Injection site pain	39
15	Myocardial infarction	39
16	Hypertension	35
17	Dyspnoea	34
18	Headache	34
19	Pleural effusion	33
20	Device failure	32

* This side effect also appears in "Top 10 Side Effects of CAVERJECT " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking CAVERJECT
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Erectile dysfunction	1704
2	Peripheral arterial occlusive disease	494
3	Heart disease congenital	279
4	Product used for unknown indication	258
5	Prophylaxis	160
6	Ill-defined disorder	114
7	Peripheral ischaemia	91
8	Intermittent claudication	80
9	Lumbar spinal stenosis	75
10	Arterial occlusive disease	69

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for CAVERJECT

Total Reports Filed with FDA: 6961

Number of FDA Adverse Event Reports by Patient Age for CAVERJECT

Total Reports Filed with FDA: 6961*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Alprostadil (Alprostadil, Prostin, Caverject, Prostavasin, Prostine vr, Prostin vr pediatric, Caverject impulse, Edex, Muse)

Charts are based on 6961 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.