ZOFRAN: 113 Adverse Event Reports & Safety Profile
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113
Total FAERS Reports
9 (8.0%)
Deaths Reported
39
Hospitalizations
113
As Primary/Secondary Suspect
9
Life-Threatening
2
Disabilities
First Report: 2006 · Latest Report: 20140531
What Are the Most Common ZOFRAN Side Effects?
#1 Most Reported
Nausea
14 reports (12.4%)
#2 Most Reported
Drug hypersensitivity
14 reports (12.4%)
#3 Most Reported
Vomiting
12 reports (10.6%)
All ZOFRAN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug hypersensitivity | 14 | 12.4% | 0 | 4 |
| Nausea | 14 | 12.4% | 1 | 4 |
| Vomiting | 12 | 10.6% | 0 | 2 |
| Drug ineffective | 11 | 9.7% | 0 | 0 |
| Foetal exposure during pregnancy | 11 | 9.7% | 1 | 5 |
| Headache | 8 | 7.1% | 2 | 3 |
| Malaise | 8 | 7.1% | 0 | 2 |
| Convulsion | 7 | 6.2% | 1 | 5 |
| Dehydration | 7 | 6.2% | 2 | 5 |
| Dyspnoea | 7 | 6.2% | 1 | 5 |
| Hyperhidrosis | 7 | 6.2% | 1 | 3 |
| Serotonin syndrome | 7 | 6.2% | 1 | 7 |
| Anxiety | 6 | 5.3% | 1 | 4 |
| Exposure during pregnancy | 6 | 5.3% | 0 | 1 |
| Pyrexia | 6 | 5.3% | 0 | 4 |
| Premature baby | 5 | 4.4% | 0 | 2 |
| Tremor | 5 | 4.4% | 0 | 1 |
Who Reports ZOFRAN Side Effects? Age & Gender Data
Average age: 44.6 years. Most reports from: US. View detailed demographics →
Is ZOFRAN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2006 | 1 | 0 | 1 |
| 2009 | 1 | 0 | 1 |
| 2010 | 1 | 0 | 1 |
| 2011 | 3 | 0 | 1 |
| 2012 | 6 | 0 | 5 |
| 2013 | 22 | 5 | 11 |
| 2014 | 17 | 0 | 5 |
What Is ZOFRAN Used For?
| Indication | Reports |
|---|---|
| Nausea | 36 |
| Product used for unknown indication | 26 |
| Prophylaxis of nausea and vomiting | 5 |
| Vomiting | 5 |
ZOFRAN vs Alternatives: Which Is Safer?
ZOFRAN vs ZOLADEX
ZOFRAN vs ZOLBETUXIMAB
ZOFRAN vs ZOLBETUXIMAB-CLZB
ZOFRAN vs ZOLEDRONIC ACID
ZOFRAN vs ZOLMITRIPTAN
ZOFRAN vs ZOLOFT
ZOFRAN vs ZOLPIDEM
ZOFRAN vs ZOLPIDEM\ZOLPIDEM
ZOFRAN vs ZOMETA
ZOFRAN vs ZONISAMIDE
Official FDA Label for ZOFRAN
Official prescribing information from the FDA-approved drug label.