Evolocumab adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Evolocumab
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: PCSK9 inhibitor

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From June 2014 to June 2026, FDA received 961 adverse event reports that name Evolocumab. In these reports the drug is a suspect or interacting product.

In the same period, 448 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 121 reports in the 12 months to June 2026 and 152 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 121 (under 0.1%) name Evolocumab. Reports from consumers or other non-health professionals were 5.9% of the reports that name Evolocumab and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Evolocumab is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 32 reports that name Evolocumab.
In January to March 2026, FDA received 27.
In April to June 2025, FDA received 39.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 100 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 949 of the 961 reports (98.8%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 100 terms.

Reaction terms in the reports that name Evolocumab, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 961 reports
Drug ineffectivethe medicine did not work as expected	75	7.8%
Deaththe patient died; cause not stated by this term	63	6.6%
Coronary artery disease	53	5.5%
Myocardial infarctionheart attack	52	5.4%
Dyspnoeashortness of breath	48	5%
Cough	43	4.5%
Myalgiamuscle pain	43	4.5%
Atrial fibrillationan irregular heart rhythm	42	4.4%
Cardiac disorder	42	4.4%
Dysphoniaa hoarse voice	42	4.4%
Nasopharyngitisa cold	42	4.4%
Muscle spasmsmuscle cramps	40	4.2%
Off label useused for a purpose or in a way not on the label	40	4.2%
Angina pectoris	38	4%
Dyspnoea exertional	38	4%
Chest discomfort	37	3.9%
Myoglobin blood increased	36	3.7%
Obstructive sleep apnoea syndrome	36	3.7%
Wheezing	36	3.7%
Brain natriuretic peptide increased	35	3.6%
Eosinophilia	35	3.6%
Fractional exhaled nitric oxide increased	35	3.6%
Obstructive airways disorder	35	3.6%
Secretion discharge	35	3.6%
Drug intolerancethe medicine was not tolerated	34	3.5%
Exostosis	34	3.5%
Plantar fasciitis	34	3.5%
Cardiovascular disorder	33	3.4%
Sensation of foreign body	33	3.4%
Pneumothoraxa collapsed lung	31	3.2%
Cerebrovascular accidentstroke	25	2.6%
Disease progressionthe disease advanced	25	2.6%
Angina unstable	24	2.5%
Increased upper airway secretion	24	2.5%
Arteriosclerosis	22	2.3%
Peripheral swellingswelling of the arms or legs	21	2.2%
Vascular stent stenosis	20	2.1%
Arthralgiajoint pain	19	2%
Acute myocardial infarction	18	1.9%
Bronchospasmtightening of the airways	18	1.9%
Nauseafeeling sick	18	1.9%
Type IIa hyperlipidaemia	17	1.8%
Adverse eventan unwanted medical event, type not specified	16	1.7%
Rashskin rash	16	1.7%
Aortic stenosis	15	1.6%
Cardiac failureheart failure	15	1.6%
Embolism venous	15	1.6%
Renal impairmentreduced kidney function	15	1.6%
Diarrhoealoose or frequent stools	14	1.5%
Pruritusitching	14	1.5%

Download all 100 terms of Evolocumab (CSV)

The counts add to more than 961 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Evolocumab with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Evolocumab (this page)	Generic name	961
Repatha	Brand name	155,654

Sum of the separately reported names: 156,615. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Evolocumab, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2014	10	10	0	0	0	0	0	10	0
2015	16	12	6	2	3	0	0	3	4
2016	2	2	0	1	1	0	0	0	0
2017	33	32	5	0	23	0	0	11	1
2018	61	53	9	6	33	1	0	23	8
2019	51	47	2	3	24	0	0	27	4
2020	109	94	7	27	45	2	0	67	15
2021	127	121	22	8	46	9	1	83	6
2022	99	85	20	10	43	3	0	59	14
2023	108	102	10	3	43	1	0	73	6
2024	135	126	26	4	31	2	5	85	9
2025	136	127	29	4	31	6	0	101	9
2026	74	68	11	4	21	1	1	55	6

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Evolocumab, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Evolocumab, by the year in which FDA received them
Year	Reports
2014	10
2015	16
2016	8
2017	49
2018	73
2019	58
2020	118
2021	114
2022	98
2023	98
2024	135
2025	125
2026	59

Reports that name Evolocumab, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Evolocumab
Age	Reports	Share
Under 2	0	0%
2 to 11	3	0.3%
12 to 17	9	0.9%
18 to 44	78	8.1%
45 to 64	244	25.4%
65 to 74	186	19.4%
75 and over	120	12.5%
Age not given	321	33.4%

Sex of the patient in the reports that name Evolocumab
Sex	Reports	Share
Female	289	30.1%
Male	423	44%
Unknown or not given	249	25.9%

Type of reporter in the reports that name Evolocumab
Reporter	Reports	Share
Physician	437	45.5%
Pharmacist	50	5.2%
Other health professional	415	43.2%
Lawyer	0	0%
Consumer or non-health professional	57	5.9%
Not given	2	0.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 26.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Evolocumab record
Indication as recorded (MedDRA)	Reports	Share
Type iia hyperlipidaemia	181	18.8%
Dyslipidaemia	155	16.1%
Hypercholesterolaemia	129	13.4%
Hyperlipidaemia	98	10.2%
Low density lipoprotein increased	25	2.6%
Acute coronary syndrome	17	1.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 961 reports.

Drugs in the same reports

Other drugs that the reports of Evolocumab name, in any role, in order of name
Drug	Reports that name the two
Aspirin	189
Atorvastatin	184
Bisoprolol	52
Clopidogrel	112
Crestor	71
Ezetimibe	256
Metoprolol	68
Prednisolone	57
Rosuvastatin	173
Simvastatin	68

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Repatha same ingredient
Alirocumab same class
Praluent same class
Evista next in the A to Z list
Evoltra next in the A to Z list
Eviplera next in the A to Z list
Evoxac next in the A to Z list
Evicel next in the A to Z list
Evrysdi next in the A to Z list
Everolimus next in the A to Z list
Evusheld next in the A to Z list
Evenity next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for EvolocumabThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Evolocumab: adverse event reports that FDA received. https://reportedreactions.com/drug/evolocumab/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Evolocumab as a suspect or interacting product. The 448 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Evolocumab was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Evolocumab?

No. It is a count of what people reported to FDA: 961 reports from June 2014 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (45.5%), other health professional (43.2%) and consumer or non-health professional (5.9%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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