SOMATREM: 163 Adverse Event Reports & Safety Profile
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163
Total FAERS Reports
5 (3.1%)
Deaths Reported
32
Hospitalizations
163
As Primary/Secondary Suspect
First Report: 19860131 · Latest Report: 20110208
What Are the Most Common SOMATREM Side Effects?
#1 Most Reported
Lymphoproliferative disorder
51 reports (31.3%)
#2 Most Reported
Clear cell renal cell carcinoma
51 reports (31.3%)
#3 Most Reported
Off label use
46 reports (28.2%)
All SOMATREM Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Clear cell renal cell carcinoma | 51 | 31.3% | 1 | 1 |
| Lymphoproliferative disorder | 51 | 31.3% | 1 | 1 |
| Off label use | 46 | 28.2% | 1 | 1 |
| Product use in unapproved indication | 32 | 19.6% | 1 | 1 |
| Renal cell carcinoma | 25 | 15.3% | 0 | 0 |
| Drug dose omission | 14 | 8.6% | 0 | 5 |
| Growth retardation | 14 | 8.6% | 0 | 2 |
| Malaise | 14 | 8.6% | 0 | 9 |
| Seizure | 11 | 6.8% | 1 | 3 |
| Hair follicle tumour benign | 10 | 6.1% | 1 | 1 |
| Pain | 10 | 6.1% | 0 | 2 |
| Off label use of device | 9 | 5.5% | 0 | 0 |
| Pyrexia | 9 | 5.5% | 1 | 5 |
| Weight increased | 9 | 5.5% | 0 | 2 |
| Headache | 8 | 4.9% | 0 | 5 |
| Intentional product use issue | 8 | 4.9% | 0 | 0 |
| Weight decreased | 8 | 4.9% | 0 | 2 |
| Acne | 7 | 4.3% | 0 | 1 |
| Arthralgia | 7 | 4.3% | 0 | 2 |
| Asthenia | 7 | 4.3% | 0 | 4 |
Who Reports SOMATREM Side Effects? Age & Gender Data
Gender: 38.2% female, 61.8% male. Average age: 12.8 years. Most reports from: US. View detailed demographics →
Is SOMATREM Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 5 | 0 | 1 |
| 2001 | 3 | 0 | 0 |
| 2011 | 1 | 0 | 0 |
What Is SOMATREM Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 58 |
| Growth hormone deficiency | 42 |
| Dwarfism | 35 |
| Hypopituitarism | 22 |
| Hypothalamo-pituitary disorder | 10 |
| Body height below normal | 7 |
| Turner's syndrome | 7 |
SOMATREM vs Alternatives: Which Is Safer?
SOMATREM vs SOMATROGON-GHLA
SOMATREM vs SOMATROPIN
SOMATREM vs SONIDEGIB
SOMATREM vs SORAFENIB
SOMATREM vs SORGHUM HALEPENSE POLLEN
SOMATREM vs SOTAGLIFLOZIN
SOMATREM vs SOTALOL
SOMATREM vs SOTATERCEPT
SOMATREM vs SOTATERCEPT-CSRK
SOMATREM vs SOTORASIB
Official FDA Label for SOMATREM
Official prescribing information from the FDA-approved drug label.