INLYTA: 506 Adverse Event Reports & Safety Profile
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506
Total FAERS Reports
113 (22.3%)
Deaths Reported
75
Hospitalizations
506
As Primary/Secondary Suspect
4
Life-Threatening
First Report: 2012 · Latest Report: 20140622
What Are the Most Common INLYTA Side Effects?
#1 Most Reported
Disease progression
97 reports (19.2%)
#2 Most Reported
Diarrhoea
96 reports (19.0%)
#3 Most Reported
Death
75 reports (14.8%)
All INLYTA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Disease progression | 97 | 19.2% | 30 | 10 |
| Diarrhoea | 96 | 19.0% | 7 | 11 |
| Death | 75 | 14.8% | 75 | 4 |
| Fatigue | 68 | 13.4% | 3 | 8 |
| Nausea | 45 | 8.9% | 3 | 5 |
| Renal cancer | 45 | 8.9% | 6 | 4 |
| Dysphonia | 40 | 7.9% | 0 | 5 |
| Decreased appetite | 33 | 6.5% | 3 | 5 |
| Asthenia | 29 | 5.7% | 4 | 8 |
| Hypertension | 26 | 5.1% | 1 | 7 |
| Vomiting | 26 | 5.1% | 4 | 4 |
| Weight decreased | 26 | 5.1% | 3 | 2 |
| Blood pressure increased | 22 | 4.4% | 0 | 3 |
| Constipation | 22 | 4.4% | 0 | 0 |
| Pain in extremity | 21 | 4.2% | 1 | 3 |
| Metastatic renal cell carcinoma | 17 | 3.4% | 10 | 4 |
| Dyspnoea | 16 | 3.2% | 2 | 5 |
| Headache | 16 | 3.2% | 1 | 3 |
| Renal cell carcinoma | 14 | 2.8% | 5 | 1 |
| Blister | 13 | 2.6% | 2 | 1 |
Who Reports INLYTA Side Effects? Age & Gender Data
Average age: 65.1 years. Most reports from: US. View detailed demographics →
Is INLYTA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 2 | 0 | 1 |
| 2013 | 62 | 15 | 20 |
| 2014 | 128 | 37 | 33 |
What Is INLYTA Used For?
| Indication | Reports |
|---|---|
| Renal cancer | 236 |
| Renal cell carcinoma | 71 |
| Metastatic renal cell carcinoma | 46 |
| Renal cancer metastatic | 22 |
| Neoplasm malignant | 15 |
| Malignant urinary tract neoplasm | 7 |
INLYTA vs Alternatives: Which Is Safer?
INLYTA vs INOTERSEN
INLYTA vs INOTUZUMAB OZOGAMICIN
INLYTA vs INSULIN
INLYTA vs INSULIN ASPART
INLYTA vs INSULIN ASPART\INSULIN DEGLUDEC
INLYTA vs INSULIN BEEF
INLYTA vs INSULIN DEGLUDEC
INLYTA vs INSULIN DEGLUDEC\LIRAGLUTIDE
INLYTA vs INSULIN DETEMIR
INLYTA vs INSULIN GLARGINE
Official FDA Label for INLYTA
Official prescribing information from the FDA-approved drug label.