AERS = FDA AERS (Adverse Event Reporting System) FOI Reports

This page will provide information on the adverse events reported to the FDA for lupron/leuprolide in men, women, children, fetuses, and babies for the time period of January 2005 through December 2006 only (23 months worth of AERS). These AERS reports, at left, obtained under FOI (Freedom of Information) Act, are divided as follows:

(1) Most reports found for the period of January 2005 through December 2006 related to 'Drug Exposure Before Pregnancy', 'Transplacental Exposure' and 'Congenital Anomalies', including death; (for a listing of fetal deaths for period of 11/97 - 12/04, see 'Deaths' page, at bottom)

(2) All reports found for the period of January 2005 through December 2006 related to Ovarian Hyperstimulation Syndrome (OHSS); and

(3) Selective reports (and *not* a comprehensive list) of 'Life-Threatening' and 'Disabling' illnesses, 'Hospitalizations' and 'Other' adverse events for the period of January 2005 through December 2006.

The AERS FOI Reports reproduced at left contain all information as found in the FDA AERS FOI Reports. Additional information beyond that listed in the AERS FOI Reports can be obtained from the FDA by requesting individual ISR# (Individual Safety Numbers) reports.

It should be noted that only 1% to 10% of all adverse events are reported to the FDA, therefore 90% to 99% of adverse events remain unreported to the FDA AERS.

The FDA, in it's AERS FOI Reports, defines "Preferred Term" as "The reported reaction, in medical terminology [coded by MedDRA], describing the event." "Suspect Drug" is defined as "The drug that the initial reporter deemed most likely to be associated with the reactions." And "Concomitant Drug" is defined as "A list of drugs taken at the same time as the suspect medication, but not suspected of causing the adverse event."

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Definitions for medical terms can be found at the following links:

www.medterms.com

http://www.nlm.nih.gov/medlineplus/mplusdictionary.html

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The following are links to reports of adverse events to lupron/leuprolide found on the eHealthMe website: (recall that approximately only 1% to 10% of all adverse events ever wind up being "reported") -

See Top Ten Overall Lupron Side effects

20 Reports of Rash

87 Reports of Pulmonary Embolism

10 Reports of Malignant Hepatic Neoplasm

15 Reports of Malignant Neoplasm

27 Reports of Jaundice

45 Reports of Metastases to Liver

15 Reports of Abscess

32 Reports of Erythema

25 Reports of Cholelithiasis

33 Reports of Diabetes

31 Reports of Constipation

84 Reports of Pyrexia

18 Reports of Cardiac Failure Congestive

13 Reports of Pain in Extremety

13 Reports of Pollakiuria

20 Reports of Myalgia

11 Reports of Bedridden

290 Reports of Fatigue

270 Reports of Asthenia

260 Reports of Nausea

259 Reports of Arthralgia

235 Reports of Hot Flush

224 Reports of Pain

194 Reports of Pyrexia

191 Reports of Osteonecrosis

182 Reports of Headache

168 Reports of Dyspnea

3 Reports of Hemolysis

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This page is under construction.