Drug Safety Information for LUPRON DEPOT-3 (Leuprolide acetate)

FDA Safety-related Labeling Changes for LUPRON (LEUPROLIDE ACETATE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for LUPRON DEPOT (LEUPROLIDE ACETATE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for LUPRON DEPOT-PED (LEUPROLIDE ACETATE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for LUPRON DEPOT (LEUPROLIDE ACETATE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for LUPRON DEPOT (LEUPROLIDE ACETATE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for ELIGARD (LEUPROLIDE ACETATE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for LUPANETA PACK (LEUPROLIDE ACETATE; NORETHINDRONE ACETATE) Rx Drug: Safety Information Link

Adverse Drug Reactions for LUPRON DEPOT-3* (Leuprolide acetate)

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 LUPRON DEPOT-3
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Hot flush*2418
2Headache*1377
3Fatigue1254
4Pain*1036
5Nausea1012
6Arthralgia*830
7Dizziness746
8Death744
9Drug ineffective730
10Abdominal pain706
11Asthenia703
12Vaginal haemorrhage699
13Weight increased*615
14Insomnia*612
15Back pain598
16Dyspnoea598
17Depression*582
18Mood swings*527
19Vomiting525
20Pain in extremity495

* This side effect also appears in "Top 10 Side Effects of LUPRON DEPOT-3 " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking LUPRON DEPOT-3
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Endometriosis*17218
2Prostate cancer*15817
3Product used for unknown indication9554
4Uterine leiomyoma*3789
5Precocious puberty*1714
6Prostate cancer metastatic885
7Prostate cancer stage iv553
8Prostate cancer stage ii423
9Breast cancer376
10In vitro fertilisation311

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


Types of Adverse Events for LUPRON DEPOT-3

Total Reports Filed with FDA: 74688


Number of FDA Adverse Event Reports by Patient Age for LUPRON DEPOT-3

Total Reports Filed with FDA: 74688*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Leuprolide acetate (Leuprolide, Lupron depot-4, Lupron, Lupron depot-3, Leuprorelin, Lupron depot-ped, Viadur, Enantone, Leuprorelin acetate, Enanton, Leuprolide acetate, Lupron depot, Eligard)

Charts are based on 74688 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.

Click to go back to search results and LUPRON DEPOT-3 Reviews and Review Summary .

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.