Drug Safety Information for FORTEO (Teriparatide recombinant human)
Safety-related Labeling Changes for FORTEO (TERIPARATIDE RECOMBINANT HUMAN) Rx Drug: FDA Link
Safety-related Labeling Changes for BONSITY (TERIPARATIDE RECOMBINANT HUMAN) Rx Drug: FDA Link
Required post-approval safety study:
Forteo User Registry Study (B3D-MC-GHBX[2]) Study B3D-MC-GHBX(2) is a prospective cohort study that will allow voluntary registration of adult Forteo (teriparatide, rPTH[1-34]) users in the United States during a 5 year enrollment period that will be initiated on approval of this supplement. On an annual basis, data collected from the registered patients will be linked with participating cancer registries to ascertain any new cases of osteosarcoma in Forteo-exposed patients. Outcomes will be ascertained through athologically confirmed cases of osteosarcoma newly reported at any time after the registered patient began Forteo (teriparatide, rPTH[1-34]) treatment. Due Date: 2022-09-01
Original FDA Drug Approval Date for FORTEO: 2002-11-26
Adverse Drug Reactions for FORTEO* (Teriparatide recombinant human)
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 FORTEO
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Fall | 4637 |
2 | Nausea* | 2794 |
3 | Dizziness* | 2770 |
4 | Pain* | 2511 |
5 | Pain in extremity | 2402 |
6 | Asthenia | 2388 |
7 | Injection site haemorrhage | 2178 |
8 | Arthralgia* | 2154 |
9 | Fatigue* | 2083 |
10 | Death | 2080 |
11 | Back pain* | 2071 |
12 | Muscle spasms | 2013 |
13 | Product quality issue | 1968 |
14 | Headache* | 1721 |
15 | Malaise | 1688 |
16 | Feeling abnormal | 1664 |
17 | Injection site erythema | 1608 |
18 | Hospitalisation | 1546 |
19 | Dyspnoea | 1455 |
20 | Injection site pain | 1391 |
* This side effect also appears in "Top 10 Side Effects of FORTEO " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking FORTEO
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Osteoporosis* | 124133 |
2 | Product used for unknown indication | 1761 |
3 | Bone disorder | 1360 |
4 | Bone density decreased | 1133 |
5 | Osteopenia | 896 |
6 | Fracture | 752 |
7 | Spinal fracture | 580 |
8 | Osteoporosis postmenopausal | 541 |
9 | Senile osteoporosis | 358 |
10 | Osteoporotic fracture | 322 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for FORTEO
Total Reports Filed with FDA: 166123
Number of FDA Adverse Event Reports by Patient Age for FORTEO
Total Reports Filed with FDA: 166123*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Teriparatide recombinant human (Forteo)
Charts are based on 166123 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 FORTEO 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.