Genotropinsomatropin

Name: GENOTROPIN (somatropin) — FDA Adverse Event Reports
Creator: PillSignal
License: https://open.fda.gov/license/

According to the FDA label: GENOTROPIN is a recombinant human growth hormone indicated for: • Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature ( 1.1 ) • Adult: Treatment of adults with either adult onset or childhood onset GHD ( 1.2 ) 1.1 Pediatric Patients GENOTROPIN is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of…

49,481 adverse event reports submitted to the FDA (2004–2026)

This data reflects voluntary reports submitted to the FDA's Adverse Event Monitoring System (AEMS), formerly the FDA Adverse Event Reporting System (FAERS). A report does not mean the medication caused the event. Data may be incomplete or contain errors. Learn more about AEMS. New to this data? Read our guide on how to interpret FDA adverse event reports →

New to FDA adverse event data? Here's how to read these reports →

Top Reported Adverse Events

The most frequently reported events in association with Genotropin in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.

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Drug Dose Omission by Device 16,870 reports
A report that a dose was missed because a device, such as a pump or injector, did not deliver it. This is a usage and device category.
Full definition in the glossary →
Device Leakage 8,923 reports
Device Breakage 7,530 reports
Device Mechanical Issue 6,814 reports
Device Information Output Issue 6,040 reports
Device Issue 4,605 reports
A general report of a problem with a medical device, used when no more specific issue is named.
Full definition in the glossary →
Wrong Technique in Device Usage Process 4,510 reports
A report that a device was used with the wrong technique. This is a usage category, the same idea as wrong technique in product usage process.
Full definition in the glossary →
Poor Quality Device Used 3,099 reports
Device Use Error 2,967 reports
Device Physical Property Issue 2,692 reports
Device Use Issue 2,536 reports
Device Delivery System Issue 2,000 reports
Device Malfunction 1,949 reports
A report that a medical device did not work as intended.
Full definition in the glossary →
Device Defective 1,825 reports
Incorrect Dose Administered By Device 1,622 reports

Browse the full glossary →

Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.

Who Is Reporting

Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.

By Sex

View reporter sex data as a table

Genotropin adverse event reports by reporter sex
Sex	Reports
Male	27,389
Female	17,845
Unknown	53

By Age Group

View age group data as a table

Genotropin adverse event reports by reporter age group
Age group	Reports
0-17	31,555
18-34	2,079
35-49	1,603
50-64	2,206
65-74	1,352
75+	707

This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.

Reported Outcomes

Outcomes recorded in FAERS reports that included Genotropin. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.

View outcome data as a table

Genotropin adverse event reports by reported outcome
Outcome	Reports
Non-Serious	38,570
Other Serious	7,117
Hospitalization	4,197
Death	892
Life-Threatening	405
Disability	268

Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.

Report Volume Over Time

Number of FAERS reports received per quarter for Genotropin. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.

View report trend as a table

Genotropin adverse event reports by year
Year	Reports
2004	220
2005	196
2006	224
2007	246
2008	187
2009	317
2010	563
2011	493
2012	1,581
2013	489
2014	557
2015	733
2016	921
2017	1,186
2018	1,911
2019	1,657
2020	1,896
2021	3,374
2022	5,194
2023	8,591
2024	9,365
2025	8,366
2026 (partial)	1,214

The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.

Medications commonly reported with Genotropin

In FDA adverse event reports that mention Genotropin, these medications appeared most often in the same report.

Hydrocortisone (1,591 reports)
Levothyroxine (1,443 reports)
Hydrocortisone % (1,319 reports)
Anti Itch (1,318 reports)
Anti-itch (1,318 reports)

This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.

Other medications with similar adverse event profiles in FDA FAERS reports.

Data Source

This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.

View this data on the FDA website →

Data last updated: June 2026