AFATINIB DIMALEATE: 48 Adverse Event Reports & Safety Profile
Boost Your Natural Energy & Metabolism
Mitolyn — 6 exotic plants to unlock your body's fat-burning power. 90-day guarantee.
48
Total FAERS Reports
16 (33.3%)
Deaths Reported
21
Hospitalizations
48
As Primary/Secondary Suspect
7
Life-Threatening
1
Disabilities
Jul 12, 2013
FDA Approved
Prescription
Status
FDA Application: 201292 ·
Patent Expires: Oct 10, 2029 · First Report: 201603 · Latest Report: 20250811
What Are the Most Common AFATINIB DIMALEATE Side Effects?
#1 Most Reported
Diarrhoea
10 reports (20.8%)
#2 Most Reported
Rash
5 reports (10.4%)
#3 Most Reported
Malignant neoplasm progression
5 reports (10.4%)
All AFATINIB DIMALEATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Diarrhoea | 10 | 20.8% | 3 | 6 |
| Malignant neoplasm progression | 5 | 10.4% | 2 | 3 |
| Rash | 5 | 10.4% | 2 | 1 |
Who Reports AFATINIB DIMALEATE Side Effects? Age & Gender Data
Gender: 68.4% female, 31.6% male. Average age: 63.3 years. Most reports from: JP. View detailed demographics →
Is AFATINIB DIMALEATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2016 | 5 | 2 | 4 |
| 2019 | 4 | 2 | 2 |
| 2020 | 4 | 2 | 2 |
| 2021 | 6 | 4 | 4 |
| 2022 | 6 | 1 | 3 |
| 2023 | 2 | 0 | 1 |
| 2024 | 3 | 0 | 2 |
| 2025 | 2 | 0 | 1 |
What Is AFATINIB DIMALEATE Used For?
| Indication | Reports |
|---|---|
| K-ras gene mutation | 7 |
| Product used for unknown indication | 7 |
| Non-small cell lung cancer | 6 |
| Non-small cell lung cancer stage iv | 5 |
Official FDA Label for AFATINIB DIMALEATE
Official prescribing information from the FDA-approved drug label.