IMBRUVICA: 242 Adverse Event Reports & Safety Profile
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242
Total FAERS Reports
74 (30.6%)
Deaths Reported
125
Hospitalizations
242
As Primary/Secondary Suspect
3
Life-Threatening
1
Disabilities
First Report: 2013 · Latest Report: 20140627
What Are the Most Common IMBRUVICA Side Effects?
#1 Most Reported
Death
26 reports (10.7%)
#2 Most Reported
Disease progression
25 reports (10.3%)
#3 Most Reported
Diarrhoea
22 reports (9.1%)
All IMBRUVICA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 26 | 10.7% | 26 | 2 |
| Disease progression | 25 | 10.3% | 19 | 10 |
| Diarrhoea | 22 | 9.1% | 4 | 14 |
| Pneumonia | 15 | 6.2% | 8 | 12 |
| Asthenia | 14 | 5.8% | 4 | 7 |
| Atrial fibrillation | 13 | 5.4% | 2 | 4 |
| Fatigue | 13 | 5.4% | 4 | 5 |
| Dyspnoea | 11 | 4.6% | 2 | 5 |
| Rash | 10 | 4.1% | 2 | 4 |
| Anaemia | 9 | 3.7% | 4 | 8 |
| Investigation | 9 | 3.7% | 0 | 9 |
| Pyrexia | 9 | 3.7% | 3 | 9 |
| Unevaluable event | 9 | 3.7% | 8 | 0 |
| White blood cell count increased | 9 | 3.7% | 2 | 4 |
| Back pain | 8 | 3.3% | 2 | 6 |
| Dizziness | 8 | 3.3% | 3 | 3 |
| Dehydration | 7 | 2.9% | 5 | 5 |
| Epistaxis | 7 | 2.9% | 1 | 3 |
| Fall | 7 | 2.9% | 1 | 6 |
| Arthralgia | 6 | 2.5% | 2 | 3 |
Who Reports IMBRUVICA Side Effects? Age & Gender Data
Average age: 72.1 years. Most reports from: US. View detailed demographics →
Is IMBRUVICA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 10 | 3 | 7 |
| 2014 | 176 | 41 | 102 |
What Is IMBRUVICA Used For?
| Indication | Reports |
|---|---|
| Chronic lymphocytic leukaemia | 111 |
| Mantle cell lymphoma | 50 |
| Product used for unknown indication | 36 |
| Lymphoma | 6 |
IMBRUVICA vs Alternatives: Which Is Safer?
IMBRUVICA vs IMDEVIMAB
IMBRUVICA vs IMEGLIMIN
IMBRUVICA vs IMETELSTAT
IMBRUVICA vs IMIDAPRIL
IMBRUVICA vs IMIGLUCERASE
IMBRUVICA vs IMIPENEM
IMBRUVICA vs IMIPRAMINE
IMBRUVICA vs IMIQUIMOD
IMBRUVICA vs IMITREX
IMBRUVICA vs IMMUNE GLOBULIN NOS
Official FDA Label for IMBRUVICA
Official prescribing information from the FDA-approved drug label.