CLOFIBRATE: 81 Adverse Event Reports & Safety Profile
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81
Total FAERS Reports
0
Deaths Reported
68
Hospitalizations
81
As Primary/Secondary Suspect
9
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Yes
Generic Available
FDA Application: 016099 ·
First Report: 20141031 · Latest Report: 20230810
What Are the Most Common CLOFIBRATE Side Effects?
#1 Most Reported
Pain
73 reports (90.1%)
#2 Most Reported
Therapeutic product effect incomplete
64 reports (79.0%)
#3 Most Reported
Procedural pain
64 reports (79.0%)
All CLOFIBRATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Pain | 73 | 90.1% | 0 | 64 |
| Chronic sinusitis | 64 | 79.0% | 0 | 64 |
| Dyspepsia | 64 | 79.0% | 0 | 64 |
| Infusion related reaction | 64 | 79.0% | 0 | 64 |
| Malaise | 64 | 79.0% | 0 | 64 |
| Procedural pain | 64 | 79.0% | 0 | 64 |
| Therapeutic product effect incomplete | 64 | 79.0% | 0 | 64 |
| Female genital tract fistula | 63 | 77.8% | 0 | 63 |
| Nausea | 63 | 77.8% | 0 | 63 |
| Off label use | 63 | 77.8% | 0 | 63 |
| Paraesthesia oral | 63 | 77.8% | 0 | 63 |
| Pyrexia | 63 | 77.8% | 0 | 63 |
| Weight decreased | 63 | 77.8% | 0 | 63 |
| Abdominal pain | 62 | 76.5% | 0 | 62 |
| Anaemia | 62 | 76.5% | 0 | 62 |
| Colitis | 62 | 76.5% | 0 | 62 |
| Constipation | 62 | 76.5% | 0 | 62 |
| Erythema | 62 | 76.5% | 0 | 62 |
| Frequent bowel movements | 62 | 76.5% | 0 | 62 |
| Rectal haemorrhage | 62 | 76.5% | 0 | 62 |
Who Reports CLOFIBRATE Side Effects? Age & Gender Data
Gender: 97.3% female, 2.7% male. Average age: 69.7 years. Most reports from: CA. View detailed demographics →
Is CLOFIBRATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 10 | 0 | 1 |
| 2016 | 1 | 0 | 1 |
| 2018 | 8 | 0 | 8 |
| 2023 | 1 | 0 | 0 |
What Is CLOFIBRATE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 65 |
| Blood cholesterol increased | 9 |
Official FDA Label for CLOFIBRATE
Official prescribing information from the FDA-approved drug label.