PCSK9 inhibitor adverse event reports that FDA received for the drugs of this class
- Kind of class
- Pharmacologic class (FDA Established Pharmacologic Class)
- Drug pages
- 4
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 . The data have the reports that FDA received through .
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 .
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 .
Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.
Reports on file
PCSK9 inhibitor is a pharmacologic class: an FDA Established Pharmacologic Class. The class has 4 drug pages on this site.
From August 2012 to June 2026, FDA received 180,025 adverse event reports that name a drug of the class. In these reports the drug is a suspect or interacting product. A report that names two drugs of the class counts one time for each.
FDA received 9,774 reports in the 12 months to June 2026 and 12,887 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, 9,774 (0.7%) name a drug of the class. Reports for patients aged 65 to 74 were 24.7% of the reports that name a drug of the class and 11.3% of all drug reports.
The number of people who use the product is not in the data. A count is not a rate.
Pharmacologic class
The Established Pharmacologic Class (EPC) of FDA is the class on the label of a drug. The site puts a drug in the class that its reports have most often.
Data version
openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.
Drugs of the class
The rows are in order of name. A brand name and its generic name are separate rows, because reporters name them separately.
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 .
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 . The site read the page on .
| Drug | Name type | Reports | Reports, 12 months to June 2026 |
|---|---|---|---|
| Alirocumab | Generic name | 934 | 39 |
| Evolocumab | Generic name | 961 | 121 |
| PraluentAlirocumab | Brand name | 22,476 | 1,068 |
| RepathaEvolocumab | Brand name | 155,654 | 8,546 |
Reaction lookup
These are the reaction terms that the reports of the class record. Type a term or a plain word to find its count.
What this list leaves out
The table lists the 1,513 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 180,002 of the 180,025 reports (99.9%).
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.
The table shows the first 50 of 1,513 terms.
| Reaction term (MedDRA) and plain meaning | Reports | Share of the 180,025 reports |
|---|---|---|
| Device difficult to usethe device was hard to use | 32,973 | 18.3% |
| Drug dose omission by device | 24,865 | 13.8% |
| Wrong technique in product usage processthe product was used in the wrong way | 22,371 | 12.4% |
| Accidental exposure to product | 16,804 | 9.3% |
| Injection site painpain where the injection was given | 12,002 | 6.7% |
| Product storage errorthe product was stored wrongly | 6,997 | 3.9% |
| Myalgiamuscle pain | 6,872 | 3.8% |
| Back pain | 5,909 | 3.3% |
| Injection site bruisingbruising where the injection was given | 5,559 | 3.1% |
| Drug dose omissiona dose was missed | 5,242 | 2.9% |
| Arthralgiajoint pain | 4,847 | 2.7% |
| Injection site haemorrhagebleeding where the injection was given | 4,672 | 2.6% |
| Fatiguetiredness | 4,603 | 2.6% |
| Muscle spasmsmuscle cramps | 4,309 | 2.4% |
| Device use errora mistake in using the device | 4,272 | 2.4% |
| Pain in extremitypain in an arm or leg | 4,251 | 2.4% |
| Rhinorrhoeaa runny nose | 4,098 | 2.3% |
| Influenza like illnessflu-like symptoms | 3,915 | 2.2% |
| Off label useused for a purpose or in a way not on the label | 3,890 | 2.2% |
| Painpain, site not specified | 3,782 | 2.1% |
| Headachehead pain | 3,538 | 2% |
| Product preparation error | 3,245 | 1.8% |
| Nasopharyngitisa cold | 3,099 | 1.7% |
| Incorrect dose administered by devicethe device gave the wrong dose | 3,093 | 1.7% |
| Diarrhoealoose or frequent stools | 3,042 | 1.7% |
| Circumstance or information capable of leading to medication errora situation that could lead to a medication error | 2,870 | 1.6% |
| Cough | 2,832 | 1.6% |
| Dizzinesslight-headedness or unsteadiness | 2,819 | 1.6% |
| Nauseafeeling sick | 2,778 | 1.5% |
| Dyspnoeashortness of breath | 2,726 | 1.5% |
| Product communication issue | 2,718 | 1.5% |
| Injection site erythemaredness where the injection was given | 2,556 | 1.4% |
| Intercepted product administration error | 2,519 | 1.4% |
| Injection site swellingswelling where the injection was given | 2,476 | 1.4% |
| Rashskin rash | 2,450 | 1.4% |
| Device issuea problem with the device | 2,445 | 1.4% |
| Malaisegeneral feeling of being unwell | 2,401 | 1.3% |
| Pruritusitching | 2,157 | 1.2% |
| Product dose omission issuea dose was missed | 2,082 | 1.2% |
| Astheniaweakness or lack of energy | 2,060 | 1.1% |
| Feeling abnormalfeeling odd or not right | 2,017 | 1.1% |
| Product dose omissiona dose was missed | 1,991 | 1.1% |
| Blood glucose increasedraised blood sugar reading | 1,875 | 1% |
| Injury associated with device | 1,792 | 1% |
| Oropharyngeal painsore throat | 1,742 | 1% |
| Incorrect disposal of product | 1,683 | 0.9% |
| Deaththe patient died; cause not stated by this term | 1,651 | 0.9% |
| Injection site mass | 1,615 | 0.9% |
| Underdoseless than the intended dose | 1,612 | 0.9% |
| Drug ineffectivethe medicine did not work as expected | 1,568 | 0.9% |
The counts add to more than 180,025 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 .
Reports by month
FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.
Outcomes, patients and reporters
| Outcome | Reports | Share | Share as a bar |
|---|---|---|---|
| Death | 2,378 | 1.3% | |
| Life-threatening | 672 | 0.4% | |
| Hospitalization (initial or prolonged) | 9,902 | 5.5% | |
| Disability or Permanent Damage | 1,066 | 0.6% | |
| Congenital Anomaly/Birth Defect | 42 | under 0.1% | |
| Other Serious (Important Medical Events) | 23,216 | 12.9% | |
| Not serious | 149,354 | 83% |
An outcome in a report is not proof that a drug was the cause. The reporter gives the outcome, and FDA does not verify it. A report can have more than one outcome. 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 .
| Age | Reports | Share | Share as a bar |
|---|---|---|---|
| Under 2 | 16 | under 0.1% | |
| 2 to 11 | 38 | under 0.1% | |
| 12 to 17 | 52 | under 0.1% | |
| 18 to 44 | 2,722 | 1.5% | |
| 45 to 64 | 39,871 | 22.1% | |
| 65 to 74 | 44,551 | 24.7% | |
| 75 and over | 33,933 | 18.8% | |
| Age not given | 58,842 | 32.7% |
| Reporter | Reports | Share | Share as a bar |
|---|---|---|---|
| Physician | 52,610 | 29.2% | |
| Pharmacist | 9,561 | 5.3% | |
| Other health professional | 20,060 | 11.1% | |
| Lawyer | 7 | under 0.1% | |
| Consumer or non-health professional | 96,649 | 53.7% | |
| Not given | 1,138 | 0.6% |
Official pages
- 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 . The links open in a new tab.
Cite this page
Reported Reactions. PCSK9 inhibitor: adverse event reports that FDA received. https://reportedreactions.com/class/pcsk9-inhibitor/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .
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.
The class of a drug is the Established Pharmacologic Class that openFDA attaches to its reports most often. When the reports have none, it is the class in the NDC Directory. 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
Which drugs are in the PCSK9 inhibitor class on this site?
Alirocumab, Evolocumab, Praluent and Repatha, in order of name. The class of a drug comes from the pharmacologic class (EPC) on its FDA label.
Can the table of drugs rank the drugs?
No. FDA says:
Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
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 .
Drugs also differ in the conditions that they treat and in their time on the market.
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.