Brand name · Evolocumab
Repatha: adverse event reports filed with FDA
155,654 reports list it as a suspect or interacting product, 2012–2026. Class: PCSK9 inhibitor.
- 155,654
- reports as suspect product
- 0.8% of all reports · about 11,189 a year
- 8,546
- reports, 12 months to June 2026
- 11,622 in the 12 months before
- 15.2%
- marked serious by the reporter
- 17% across the class
- 1.1%
- record death among outcomes, as reported
- 1,789 reports · not verified by FDA
155,654 adverse event reports received by FDA list the brand name Repatha (evolocumab) as a suspect or interacting product, from August 2012 to June 2026. A further 4,280 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 8,546 reports listed it, down 26% from 11,622 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 11,189 reports a year and 0.8% of the 20,646,523 reports in the database, and 86.5% of the reports for the PCSK9 inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded device difficult to use (21.1%), drug dose omission by device (15.8%) and wrong technique in product usage process (14.3%). A report can list several reactions, so shares add to more than 100%; 2,177 different terms appear across these reports. Device difficult to use is recorded in 21.1% of these reports, a larger share than in the median PCSK9 inhibitor drug (0.4%).
15.2% of the reports are marked serious by the reporter (17% across the class); 1.1% record death among the outcomes and 4.7% record hospitalisation, as reported. 51.8% of the reports came from consumers, and the largest patient age group is 65 to 74 (25.3%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Repatha reports recording the termmedian drug in pcsk9 inhibitor
- Device difficult to usethe device was hard to use21.1%32,918
- Drug dose omission by device15.8%24,623
- Wrong technique in product usage processthe product was used in the wrong way14.3%22,313
- Accidental exposure to product10.8%16,755
- Injection site painpain where the injection was given6.9%10,741
- Product storage errorthe product was stored wrongly4.3%6,651
- Back painback pain3.5%5,435
- Myalgiamuscle pain3.4%5,216
- Drug dose omissiona dose was missed3.2%4,913
- Injection site bruisingbruising where the injection was given3%4,724
- Device use errora mistake in using the device2.7%4,246
- Injection site haemorrhagebleeding where the injection was given2.6%3,990
- Arthralgiajoint pain2.5%3,814
- Fatiguetiredness2.4%3,659
- Off label useused for a purpose or in a way not on the label2.3%3,629
- Rhinorrhoeaa runny nose2.3%3,584
- Pain in extremitypain in an arm or leg2.1%3,343
- Influenza like illnessflu-like symptoms2%3,122
- Muscle spasmsmuscle cramps2%3,094
- Incorrect dose administered by devicethe device gave the wrong dose1.9%3,010
- Painpain, site not specified1.8%2,872
- Circumstance or information capable of leading to medication errora situation that could lead to a medication error1.8%2,870
- Product preparation error1.8%2,831
- Headachehead pain1.8%2,801
- Product communication issue1.7%2,718
- Nasopharyngitisa cold1.6%2,457
- Diarrhoealoose or frequent stools1.5%2,272
- Dizzinesslight-headedness or unsteadiness1.4%2,238
- Nauseafeeling sick1.4%2,190
Top 30 of 2,177 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 4 drugs in the pcsk9 inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 180,025 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 96.2% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Blood cholesterol increased | 27,480 | 17.7% |
| Hypercholesterolaemia | 20,516 | 13.2% |
| Blood cholesterol abnormal | 12,757 | 8.2% |
| Hyperlipidaemia | 8,325 | 5.3% |
| Type iia hyperlipidaemia | 4,811 | 3.1% |
| Low density lipoprotein increased | 2,410 | 1.5% |
The indication field is filled in by the reporter and is often blank; shares are of all 155,654 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Repatha reports |
|---|---|---|
| Aspirin | 2,173 | 1.4% |
| Zetia | 1,311 | 0.8% |
| Crestor | 1,091 | 0.7% |
| Ezetimibe | 1,008 | 0.6% |
| Plavix | 979 | 0.6% |
| Metoprolol | 925 | 0.6% |
| Insulin | 840 | 0.5% |
| Lisinopril | 833 | 0.5% |
| Atorvastatin | 792 | 0.5% |
| Clopidogrel | 790 | 0.5% |
Other products listed in reports where Repatha is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Repatha | PCSK9 inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 155,654 | 180,025 | 20,646,523 |
| Share of that pool | — | 86.5% | 0.8% |
| Reports, latest 12 months | 8,546 | — | 1,332,454 |
| Marked serious | 15.2% | 17% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 11 | 13 | 91 |
| Hospitalisation recorded, per 1,000 reports | 47 | 55 | 213 |
| Consumer-filed share | 51.8% | 53.7% | 45.8% |
| Top term, share of reports | Device difficult to use 21.1% | median 0.4% | 0.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the pcsk9 inhibitor class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Praluent | brand | 22,476 | 1,068 | 24.9% |
| Evolocumab | generic | 961 | 121 | 91.5% |
| Alirocumab | generic | 934 | 39 | 51.3% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Repatha reports
How many adverse event reports has FDA received for Repatha?
155,654 reports list Repatha as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 8,546 of them arrived in the latest 12 months. Another 4,280 list it only as a concomitant medication.
What reactions are recorded in Repatha reports?
device difficult to use (21.1%), drug dose omission by device (15.8%), wrong technique in product usage process (14.3%), accidental exposure to product (10.8%) and injection site pain (6.9%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Repatha was responsible.
How serious are the reports?
15.2% are marked serious by the reporter. Among the outcomes recorded, 1.1% of reports include death and 4.7% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (51.8%), physician (31.8%) and other health professional (10.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Repatha rising?
8,546 reports in the 12 months to June 2026, down 26% from 11,622 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Repatha was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Repatha?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Repatha as a suspect or interacting product; reports listing it only as a concomitant medication (4,280) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.