OCELLA: 836 Adverse Event Reports & Safety Profile
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836
Total FAERS Reports
6 (0.7%)
Deaths Reported
276
Hospitalizations
836
As Primary/Secondary Suspect
35
Life-Threatening
40
Disabilities
First Report: 20010521 · Latest Report: 20140421
What Are the Most Common OCELLA Side Effects?
#1 Most Reported
Injury
643 reports (76.9%)
#2 Most Reported
Pain
628 reports (75.1%)
#3 Most Reported
Emotional distress
443 reports (53.0%)
All OCELLA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Injury | 643 | 76.9% | 5 | 173 |
| Pain | 628 | 75.1% | 4 | 174 |
| Emotional distress | 443 | 53.0% | 5 | 110 |
| Deep vein thrombosis | 346 | 41.4% | 1 | 65 |
| Pulmonary embolism | 301 | 36.0% | 5 | 86 |
| Thrombosis | 225 | 26.9% | 1 | 12 |
| Anxiety | 214 | 25.6% | 2 | 92 |
| Cerebrovascular accident | 193 | 23.1% | 0 | 13 |
| Cholecystitis chronic | 161 | 19.3% | 0 | 78 |
| General physical health deterioration | 148 | 17.7% | 2 | 70 |
| Anhedonia | 95 | 11.4% | 1 | 59 |
| Cholelithiasis | 88 | 10.5% | 0 | 41 |
| Cholecystectomy | 84 | 10.1% | 0 | 48 |
| Gallbladder disorder | 72 | 8.6% | 0 | 38 |
| Biliary dyskinesia | 67 | 8.0% | 0 | 23 |
| Gallbladder injury | 62 | 7.4% | 0 | 23 |
| Abdominal pain | 59 | 7.1% | 2 | 24 |
| Cholecystitis acute | 47 | 5.6% | 0 | 34 |
| Cholecystitis | 44 | 5.3% | 0 | 16 |
| Fear of disease | 30 | 3.6% | 0 | 6 |
Who Reports OCELLA Side Effects? Age & Gender Data
Average age: 29.2 years. Most reports from: US. View detailed demographics →
Is OCELLA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 0 | 0 |
| 2002 | 6 | 0 | 2 |
| 2003 | 6 | 1 | 3 |
| 2004 | 12 | 0 | 4 |
| 2005 | 17 | 0 | 7 |
| 2006 | 30 | 0 | 18 |
| 2007 | 34 | 0 | 14 |
| 2008 | 47 | 0 | 22 |
| 2009 | 101 | 0 | 48 |
| 2010 | 78 | 1 | 47 |
| 2011 | 64 | 1 | 35 |
| 2012 | 47 | 1 | 30 |
| 2013 | 6 | 0 | 3 |
| 2014 | 1 | 0 | 0 |
What Is OCELLA Used For?
| Indication | Reports |
|---|---|
| Contraception | 69 |
| Acne | 44 |
| Premenstrual syndrome | 23 |
| Product used for unknown indication | 18 |
| Premenstrual dysphoric disorder | 10 |
| Oral contraception | 8 |
| Menstrual cycle management | 5 |
| Menstruation irregular | 5 |
| Polycystic ovaries | 5 |
OCELLA vs Alternatives: Which Is Safer?
OCELLA vs OCRELIZUMAB
OCELLA vs OCRIPLASMIN
OCELLA vs OCTINOXATE\OCTISALATE\ZINC
OCELLA vs OCTINOXATE\OCTOCRYLENE
OCELLA vs OCTREOTIDE
OCELLA vs OCTREOTIDE\OCTREOTIDE
OCELLA vs ODEVIXIBAT
OCELLA vs OFATUMUMAB
OCELLA vs OFLOXACIN
OCELLA vs OLANZAPINE
Official FDA Label for OCELLA
Official prescribing information from the FDA-approved drug label.