Omnitrope: adverse event reports filed with FDA

11,243

reports as suspect product

0.1% of all reports · about 668 a year

2,264

reports, 12 months to June 2026

2,045 in the 12 months before

26.8%

marked serious by the reporter

42.8% across the class

1.6%

record death among outcomes, as reported

182 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 Omnitrope reports recording the termmedian drug in recombinant human growth hormone

1. Device breakagethe device broke14%1,577
2. Injection site painpain where the injection was given13.5%1,521
3. Device leakagethe device leaked10.9%1,230
4. Incorrect dose administered by devicethe device gave the wrong dose9.4%1,057
5. Incorrect dose administeredthe wrong dose was given9.2%1,034
6. Circumstance or information capable of leading to medication errora situation that could lead to a medication error7.9%883
7. Device issuea problem with the device7.1%795
8. Product dose omission issuea dose was missed6.4%718
9. Circumstance or information capable of leading to device use error5.9%663
10. Drug dose omission by device5.2%582
11. Headachehead pain4.8%540
12. Injection site haemorrhagebleeding where the injection was given4.7%530
13. Injection site bruisingbruising where the injection was given4.4%490
14. Device mechanical issue3.9%437
15. Wrong technique in product usage processthe product was used in the wrong way3.6%404
16. Product storage errorthe product was stored wrongly3.2%360
17. Wrong technique in device usage process3.1%350
18. Device difficult to usethe device was hard to use3%341
19. Needle issuea problem with the needle2.9%329
20. Device malfunctionthe device did not work properly2.9%322
21. Drug ineffectivethe medicine did not work as expected2.3%262
22. Fatiguetiredness2%222
23. Product availability issuethe product was not available1.9%217
24. Malaisegeneral feeling of being unwell1.9%212
25. Accidental exposure to product1.9%211
26. Arthralgiajoint pain1.8%202
27. Off label useused for a purpose or in a way not on the label1.7%195
28. Injection site discharge1.7%192
29. Device defective1.6%184
30. Device use issue1.6%181

Top 30 of 715 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 5 drugs in the recombinant human growth hormone 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 21,450 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. 71% 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 11,243 reports.

Drugs most often listed in the same reports

Other products listed in reports where Omnitrope 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 recombinant human growth hormone 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 Omnitrope as a suspect or interacting product; reports listing it only as a concomitant medication (212) 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.