Teriparatide: adverse event reports filed with FDA

5,975

reports as suspect product

0% of all reports · about 269 a year

1,358

reports, 12 months to June 2026

911 in the 12 months before

68.7%

marked serious by the reporter

36.5% across the class

5.4%

record death among outcomes, as reported

322 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Teriparatide reports recording the termmedian drug in parathyroid hormone analog

1. Dizzinesslight-headedness or unsteadiness7.9%471
2. Nauseafeeling sick7.7%460
3. Back painback pain7.4%444
4. Device malfunctionthe device did not work properly7.4%444
5. Falla fall7.3%435
6. Fatiguetiredness7%416
7. Product dose omission issuea dose was missed6.8%409
8. Pain in extremitypain in an arm or leg6.5%386
9. Arthralgiajoint pain6.4%380
10. Device operational issue6%360
11. Painpain, site not specified5.7%338
12. Headachehead pain5.5%331
13. Malaisegeneral feeling of being unwell4.5%270
14. Astheniaweakness or lack of energy4.1%247
15. Dyspnoeashortness of breath3.2%191
16. Gait disturbancedifficulty walking3%182
17. Wrong technique in product usage processthe product was used in the wrong way3%179
18. Muscle spasmsmuscle cramps3%177
19. Injection site bruisingbruising where the injection was given2.9%176
20. Deaththe patient died; cause not stated by this term2.9%171
21. Bone painbone pain2.8%168
22. Vomitingbeing sick2.8%165
23. Off label useused for a purpose or in a way not on the label2.6%154
24. Injection site painpain where the injection was given2.4%146
25. Myalgiamuscle pain2.3%139
26. Diarrhoealoose or frequent stools2.3%138
27. Decreased appetitereduced appetite2.2%133
28. Feeling abnormalfeeling odd or not right2.2%131
29. Pneumonialung infection2.2%131
30. Spinal fracturea broken bone in the spine2.2%130

Top 30 of 883 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the parathyroid hormone analog class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 106,260 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 49.8% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 5,975 reports.

Drugs most often listed in the same reports

Other products listed in reports where Teriparatide is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the parathyroid hormone analog class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Teriparatide as a suspect or interacting product; reports listing it only as a concomitant medication (936) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.