PROZAC: 219 Adverse Event Reports & Safety Profile
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219
Total FAERS Reports
12 (5.5%)
Deaths Reported
57
Hospitalizations
219
As Primary/Secondary Suspect
10
Life-Threatening
13
Disabilities
First Report: 1993 · Latest Report: 20140614
What Are the Most Common PROZAC Side Effects?
#1 Most Reported
Foetal exposure during pregnancy
42 reports (19.2%)
#2 Most Reported
Drug hypersensitivity
31 reports (14.2%)
#3 Most Reported
Suicidal ideation
17 reports (7.8%)
All PROZAC Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Foetal exposure during pregnancy | 42 | 19.2% | 3 | 3 |
| Drug hypersensitivity | 31 | 14.2% | 0 | 0 |
| Suicidal ideation | 17 | 7.8% | 0 | 3 |
| Depression | 16 | 7.3% | 0 | 2 |
| Drug ineffective | 16 | 7.3% | 0 | 1 |
| Anxiety | 15 | 6.9% | 1 | 2 |
| Insomnia | 15 | 6.9% | 1 | 2 |
| Drug interaction | 14 | 6.4% | 1 | 9 |
| Dizziness | 12 | 5.5% | 0 | 2 |
| Fatigue | 12 | 5.5% | 1 | 3 |
| Aggression | 8 | 3.7% | 0 | 2 |
| Arthralgia | 8 | 3.7% | 0 | 0 |
| Attention deficit/hyperactivity disorder | 8 | 3.7% | 0 | 2 |
| Malaise | 8 | 3.7% | 1 | 4 |
| Nausea | 8 | 3.7% | 0 | 2 |
| Asthenia | 7 | 3.2% | 0 | 2 |
| Decreased appetite | 7 | 3.2% | 1 | 3 |
| Diarrhoea | 7 | 3.2% | 0 | 1 |
| Drug withdrawal syndrome | 7 | 3.2% | 0 | 3 |
| Electrocardiogram qt prolonged | 7 | 3.2% | 0 | 6 |
Who Reports PROZAC Side Effects? Age & Gender Data
Average age: 47.2 years. Most reports from: US. View detailed demographics →
Is PROZAC Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 0 | 0 |
| 2002 | 4 | 0 | 0 |
| 2003 | 1 | 0 | 0 |
| 2004 | 3 | 0 | 1 |
| 2005 | 1 | 0 | 1 |
| 2006 | 2 | 0 | 1 |
| 2008 | 2 | 0 | 0 |
| 2009 | 1 | 0 | 0 |
| 2010 | 2 | 0 | 0 |
| 2011 | 3 | 1 | 2 |
| 2012 | 9 | 1 | 6 |
| 2013 | 29 | 2 | 19 |
| 2014 | 35 | 3 | 13 |
What Is PROZAC Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 87 |
| Depression | 47 |
| Anxiety | 8 |
PROZAC vs Alternatives: Which Is Safer?
PROZAC vs PRUCALOPRIDE
PROZAC vs PSEUDOEPHEDRINE
PROZAC vs PSEUDOEPHEDRINE\TRIPROLIDINE
PROZAC vs PSYLLIUM HUSK
PROZAC vs PULMICORT FLEXHALER
PROZAC vs PYRAZINAMIDE
PROZAC vs PYRIDOSTIGMINE
PROZAC vs PYRIDOXINE
PROZAC vs PYRIDOXINE\THIAMINE
PROZAC vs PYRIMETHAMINE
Official FDA Label for PROZAC
Official prescribing information from the FDA-approved drug label.