Repathaevolocumab
According to the FDA label: REPATHA is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia. adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
157,026 adverse event reports submitted to the FDA (2008–2026)
Top Reported Adverse Events
The most frequently reported events in association with Repatha in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
- Device Difficult To Use 32,601 reports
Drug Dose Omission by Device 24,421 reports
A report that a dose was missed because a device, such as a pump or injector, did not deliver it. This is a usage and device category.
Full definition in the glossary →Wrong Technique in Product Usage Process 22,053 reports
A report that the medication was used or administered with the wrong technique, such as an incorrect injection or inhaler method. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →Accidental Exposure to Product 16,450 reports
A report that someone was unintentionally exposed to a medication, for example a child or another person who was not the patient. This is a safety-tracking category.
Full definition in the glossary →Injection Site Pain 10,546 reports
Pain at the spot on the body where a medication was injected.
Full definition in the glossary →Product Storage Error 6,647 reports
A report that a medication was stored incorrectly, for example at the wrong temperature. This is a handling category, not a sign of a problem with the drug.
Full definition in the glossary →Back Pain 5,497 reports
Myalgia 5,332 reports
Drug Dose Omission 4,929 reports
A report that a dose of medication was missed or skipped.
Full definition in the glossary →Injection Site Bruising 4,632 reports
Bruising at the spot where a medication was injected.
Full definition in the glossary →- Device Use Error 4,119 reports
Arthralgia 3,979 reports
Fatigue 3,927 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Injection Site Haemorrhage 3,893 reports
Bleeding at the spot where a medication was injected. Also spelled hemorrhage in American English.
Full definition in the glossary →Off Label Use 3,865 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 84,636 |
| Male | 60,610 |
| Unknown | 65 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 143 |
| 18-34 | 576 |
| 35-49 | 4,588 |
| 50-64 | 33,232 |
| 65-74 | 39,844 |
| 75+ | 30,517 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Repatha. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 132,472 |
| Other Serious | 18,698 |
| Hospitalization | 7,881 |
| Death | 1,902 |
| Disability | 802 |
| Life-Threatening | 571 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Repatha. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2008 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2014 | 13 |
| 2015 | 801 |
| 2016 | 6,377 |
| 2017 | 20,201 |
| 2018 | 28,249 |
| 2019 | 9,722 |
| 2020 | 8,997 |
| 2021 | 10,475 |
| 2022 | 12,352 |
| 2023 | 24,559 |
| 2024 | 25,529 |
| 2025 | 7,890 |
| 2026 (partial) | 1,858 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Repatha
In FDA adverse event reports that mention Repatha, these medications appeared most often in the same report.
- Aspirin (3,508 reports)
- Ezetimibe (3,152 reports)
- Rosuvastatin (2,370 reports)
- Clopidogrel (2,367 reports)
- Ergocalciferol (1,911 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026