Pharmacologic class (EPC) · 4 drug pages

PCSK9 inhibitor: adverse event reports filed with FDA

180,025 reports list a drug in this class as a suspect or interacting product, 2012–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

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

180,025
reports across the class: 0.9% of all reports; 9,774
reports, 12 months to June 2026: 12,887 in the 12 months before; 17%
marked serious by the reporter: 57.4% across all reports; 4
drugs with a page: brand and generic names counted separately

PCSK9 inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 4 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 180,025 adverse event reports received by FDA, 0.9% of the database, from August 2012 to June 2026.

9,774 reports arrived in the 12 months to June 2026, down 24% from 12,887 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 17% of the class's reports are marked serious, 1.3% record death among the outcomes and 5.5% record hospitalisation, as reported.

Across the class the reactions recorded most often are device difficult to use (18.3%), drug dose omission by device (13.8%) and wrong technique in product usage process (12.4%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
RepathaEvolocumab	brand	155,654	8,546	15.2%	Device difficult to use
PraluentAlirocumab	brand	22,476	1,068	24.9%	Myalgia
Evolocumab	generic	961	121	91.5%	Drug ineffective
Alirocumab	generic	934	39	51.3%	Myalgia

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Device difficult to usethe device was hard to use18.3%32,973
Drug dose omission by device13.8%24,865
Wrong technique in product usage processthe product was used in the wrong way12.4%22,371
Accidental exposure to product9.3%16,804
Injection site painpain where the injection was given6.7%12,002
Product storage errorthe product was stored wrongly3.9%6,997
Myalgiamuscle pain3.8%6,872
Back painback pain3.3%5,909
Injection site bruisingbruising where the injection was given3.1%5,559
Drug dose omissiona dose was missed2.9%5,242
Arthralgiajoint pain2.7%4,847
Injection site haemorrhagebleeding where the injection was given2.6%4,672
Fatiguetiredness2.6%4,603
Muscle spasmsmuscle cramps2.4%4,309
Device use errora mistake in using the device2.4%4,272
Pain in extremitypain in an arm or leg2.4%4,251
Rhinorrhoeaa runny nose2.3%4,098
Influenza like illnessflu-like symptoms2.2%3,915
Off label useused for a purpose or in a way not on the label2.2%3,890
Painpain, site not specified2.1%3,782
Headachehead pain2%3,538
Product preparation error1.8%3,245
Nasopharyngitisa cold1.7%3,099
Incorrect dose administered by devicethe device gave the wrong dose1.7%3,093
Diarrhoealoose or frequent stools1.7%3,042

Solid bar: share of all class reports. Hollow bar: the median share across the 4 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death1.3%2,378

Life-threatening0.4%672

Hospitalisation (initial or prolonged)5.5%9,902

Disability0.6%1,066

Congenital anomaly0%42

Other serious12.9%23,216

Not serious83%149,354

Patient age

Under 20%16

2 to 110%38

12 to 170%52

18 to 441.5%2,722

45 to 6422.1%39,871

65 to 7424.7%44,551

75 and over18.8%33,933

Age not given32.7%58,842

Who reported

Physician29.2%52,610

Pharmacist5.3%9,561

Other health professional11.1%20,060

Lawyer0%7

Consumer or non-health professional53.7%96,649

Not given0.6%1,138

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about PCSK9 inhibitor reports

Which drugs are in the PCSK9 inhibitor class on this site?

Repatha, Praluent, Evolocumab and Alirocumab. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

180,025 reports through June 2026, 9,774 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

device difficult to use (18.3%), drug dose omission by device (13.8%), wrong technique in product usage process (12.4%), accidental exposure to product (9.3%) and injection site pain (6.7%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.