MIPOMERSEN: 199 Adverse Event Reports & Safety Profile
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199
Total FAERS Reports
2 (1.0%)
Deaths Reported
25
Hospitalizations
199
As Primary/Secondary Suspect
Jan 29, 2013
FDA Approved
Discontinued
Status
Active Ingredient: MIPOMERSEN SODIUM · FDA Application: 203568 ·
Patent Expires: Jan 29, 2027 · First Report: 20130209 · Latest Report: 20180215
What Are the Most Common MIPOMERSEN Side Effects?
#1 Most Reported
Injection site pain
67 reports (33.7%)
#2 Most Reported
Injection site erythema
48 reports (24.1%)
#3 Most Reported
Hepatic enzyme increased
48 reports (24.1%)
All MIPOMERSEN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Injection site pain | 67 | 33.7% | 1 | 4 |
| Hepatic enzyme increased | 48 | 24.1% | 0 | 5 |
| Injection site erythema | 48 | 24.1% | 1 | 3 |
| Influenza like illness | 36 | 18.1% | 0 | 3 |
| Injection site bruising | 31 | 15.6% | 0 | 3 |
| Fatigue | 26 | 13.1% | 0 | 2 |
| Nausea | 24 | 12.1% | 0 | 4 |
| Injection site discolouration | 23 | 11.6% | 1 | 1 |
| Injection site swelling | 23 | 11.6% | 0 | 0 |
| Injection site rash | 18 | 9.1% | 0 | 0 |
| Injection site reaction | 17 | 8.5% | 1 | 1 |
| Myalgia | 17 | 8.5% | 0 | 3 |
| Headache | 16 | 8.0% | 0 | 0 |
| Injection site pruritus | 15 | 7.5% | 0 | 1 |
| Drug dose omission | 14 | 7.0% | 1 | 1 |
| Pyrexia | 14 | 7.0% | 0 | 4 |
| Injection site warmth | 12 | 6.0% | 0 | 1 |
| Pain | 12 | 6.0% | 0 | 2 |
| Alanine aminotransferase increased | 11 | 5.5% | 0 | 1 |
| Arthralgia | 11 | 5.5% | 0 | 1 |
Who Reports MIPOMERSEN Side Effects? Age & Gender Data
Gender: 59.6% female, 40.4% male. Average age: 55.1 years. Most reports from: US. View detailed demographics →
Is MIPOMERSEN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 6 | 0 | 3 |
| 2014 | 39 | 1 | 5 |
| 2015 | 41 | 0 | 5 |
| 2016 | 17 | 0 | 5 |
| 2017 | 45 | 0 | 1 |
| 2018 | 7 | 0 | 1 |
What Is MIPOMERSEN Used For?
| Indication | Reports |
|---|---|
| Type iia hyperlipidaemia | 138 |
| Hypercholesterolaemia | 23 |
| Product used for unknown indication | 13 |
| Blood cholesterol increased | 10 |
MIPOMERSEN vs Alternatives: Which Is Safer?
MIPOMERSEN vs MIRABEGRON
MIPOMERSEN vs MIRALAX
MIPOMERSEN vs MIRCERA
MIPOMERSEN vs MIRENA
MIPOMERSEN vs MIRIKIZUMAB-MRKZ
MIPOMERSEN vs MIRTAZAPINE
MIPOMERSEN vs MIRVETUXIMAB SORAVTANSINE-GYNX
MIPOMERSEN vs MISOPROSTOL
MIPOMERSEN vs MITAPIVAT
MIPOMERSEN vs MITOMYCIN
Official FDA Label for MIPOMERSEN
Official prescribing information from the FDA-approved drug label.