PROMACTA: 297 Adverse Event Reports & Safety Profile
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297
Total FAERS Reports
44 (14.8%)
Deaths Reported
54
Hospitalizations
297
As Primary/Secondary Suspect
4
Life-Threatening
4
Disabilities
First Report: 2009 · Latest Report: 20140615
What Are the Most Common PROMACTA Side Effects?
#1 Most Reported
Platelet count decreased
34 reports (11.4%)
#2 Most Reported
Death
29 reports (9.8%)
#3 Most Reported
Drug ineffective
26 reports (8.8%)
All PROMACTA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Platelet count decreased | 34 | 11.5% | 0 | 9 |
| Death | 29 | 9.8% | 29 | 5 |
| Drug ineffective | 26 | 8.8% | 1 | 4 |
| Investigation | 17 | 5.7% | 1 | 17 |
| Nausea | 16 | 5.4% | 0 | 0 |
| Diarrhoea | 13 | 4.4% | 0 | 2 |
| Headache | 12 | 4.0% | 0 | 1 |
| Platelet count increased | 12 | 4.0% | 0 | 3 |
| Treatment noncompliance | 12 | 4.0% | 0 | 2 |
| Fatigue | 11 | 3.7% | 0 | 2 |
| Abdominal pain upper | 9 | 3.0% | 1 | 1 |
| Pain in extremity | 8 | 2.7% | 0 | 1 |
| Rash | 8 | 2.7% | 0 | 0 |
| Asthenia | 7 | 2.4% | 0 | 1 |
| Dizziness | 7 | 2.4% | 0 | 1 |
| Drug administration error | 7 | 2.4% | 0 | 2 |
| Pneumonia | 7 | 2.4% | 3 | 6 |
| Pruritus | 7 | 2.4% | 0 | 0 |
| Arthralgia | 6 | 2.0% | 0 | 1 |
| Chills | 5 | 1.7% | 1 | 0 |
Who Reports PROMACTA Side Effects? Age & Gender Data
Average age: 61.9 years. Most reports from: US. View detailed demographics →
Is PROMACTA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 1 | 0 | 0 |
| 2010 | 1 | 0 | 0 |
| 2011 | 1 | 0 | 0 |
| 2012 | 16 | 0 | 1 |
| 2013 | 70 | 4 | 9 |
| 2014 | 14 | 6 | 7 |
What Is PROMACTA Used For?
| Indication | Reports |
|---|---|
| Immune thrombocytopenic purpura | 102 |
| Product used for unknown indication | 88 |
| Thrombocytopenia | 29 |
| Platelet count decreased | 15 |
| Hepatitis c | 10 |
| Chronic hepatitis c | 5 |
PROMACTA vs Alternatives: Which Is Safer?
PROMACTA vs PROMAZINE
PROMACTA vs PROMETHAZINE
PROMACTA vs PROMETHAZINE\PROMETHAZINE
PROMACTA vs PROMETHAZINE\THIOUREA
PROMACTA vs PROPAFENONE
PROMACTA vs PROPARACAINE
PROMACTA vs PROPECIA
PROMACTA vs PROPIOMAZINE
PROMACTA vs PROPOFOL
PROMACTA vs PROPOXYPHENE
Official FDA Label for PROMACTA
Official prescribing information from the FDA-approved drug label.