Drug Safety Information for PROLIA (Denosumab)
REMS for Prolia (DENOSUMAB) Biological Drug: Safety Information Link
FDA Risk Evaluation and Mitigation Strategy REMS
FDA Safety-related Labeling Changes for PROLIA (DENOSUMAB) Biological Drug: Safety Information Link
hypocalcemia leading to increased bone fractures, hospitalization, life-threatening events, and death Black box warning was added to Amgen’s osteoporosis drug Prolia (denosumab) because of the risk of severe hypocalcemia, (low calcium levels), in patients with advanced chronic kidney disease.
Required post-approval safety study:
A long-term observational study in administrative databases to prospectively evaluate the incidence of serious infection including skin infection, dermatologic adverse events, and over-suppression of bone turnover in postmenopausal women administered Prolia (denosumab). Due Date: 2023-06-30
Required post-approval safety study:
Inclusion of a new target population, adults with glucocorticoid-induced osteoporosis, in the required postmarketing study entitled, ""The Prolia Postmarketing Active Safety Surveillance Program"" (Study 20090601), designated above as PMR 2399-#3 (or PMR #3). Due Date: 2022-06-30
Required post-approval safety study:
Inclusion of a new target population, men with osteoporosis, in the required postmarketing study entitled, ""The Denosumab Global Postmarketing Safety Observational Study Due Date: 2023-06-30
Required post-approval safety study:
Inclusion of a new target population, men with osteoporosis, in the required postmarketing study entitled, ""The Prolia Postmarketing Active Safety Surveillance Program Due Date: 2022-06-30
Required post-approval safety study:
A long-term surveillance study in postmenopausal women administered Prolia (denosumab) to prospectively evaluate the incidence of serious infection including skin infections, dermatologic adverse events, and over-suppression of bone turnover. Due Date: 2022-06-30
Original FDA Drug Approval Date for PROLIA: 2010-06-01
Adverse Drug Reactions for PROLIA* (Denosumab)
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 PROLIA
(reported in FDA Medwatch/FAERS Reports)
| Side Effect | # of FDA Reports | |
|---|---|---|
| 1 | Death | 4667 |
| 2 | Osteonecrosis of jaw | 1971 |
| 3 | Back pain | 1900 |
| 4 | Pain in extremity | 1770 |
| 5 | Arthralgia | 1727 |
| 6 | Pain | 1555 |
| 7 | Hypocalcaemia | 1213 |
| 8 | Rash | 1034 |
| 9 | Fatigue | 1016 |
| 10 | Bone pain | 961 |
| 11 | Myalgia | 937 |
| 12 | Asthenia | 929 |
| 13 | Nausea | 875 |
| 14 | Malaise | 819 |
| 15 | Fall | 818 |
| 16 | Tooth disorder | 759 |
| 17 | Pain in jaw | 717 |
| 18 | Dyspnoea | 701 |
| 19 | Pruritus | 690 |
| 20 | Muscle spasms | 665 |
* This side effect also appears in "Top 10 Side Effects of PROLIA " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking PROLIA
(associated with FDA Medwatch/FAERS Reports)
| Reason | # of FDA Reports | |
|---|---|---|
| 1 | Osteoporosis postmenopausal | 35505 |
| 2 | Product used for unknown indication | 18578 |
| 3 | Osteoporosis | 15450 |
| 4 | Metastases to bone | 4152 |
| 5 | Prophylaxis | 1997 |
| 6 | Prostate cancer | 1042 |
| 7 | Osteopenia | 895 |
| 8 | Breast cancer metastatic | 733 |
| 9 | Breast cancer | 674 |
| 10 | Bone disorder | 665 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for PROLIA
Total Reports Filed with FDA: 90233
Number of FDA Adverse Event Reports by Patient Age for PROLIA
Total Reports Filed with FDA: 90233*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Denosumab (Xgeva, Amg 162, Prolia)
Charts are based on 90233 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 PROLIA 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.