Pharmacologic class (EPC) · 3 drug pages

Plasma kallikrein inhibitor: adverse event reports filed with FDA

3,769 reports list a drug in this class as a suspect or interacting product, 2010–2026.

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.

3,769
reports across the class: 0% of all reports; 465
reports, 12 months to June 2026: 380 in the 12 months before; 54.6%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Plasma kallikrein inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 3,769 adverse event reports received by FDA, 0% of the database, from August 2010 to June 2026.

465 reports arrived in the 12 months to June 2026, up 22% from 380 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 54.6% of the class's reports are marked serious, 2.5% record death among the outcomes and 33.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are hereditary angioedema (42.2%), drug ineffective (7.8%) and product dose omission issue (7.3%). 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
TakhzyroLanadelumab-flyo	brand	1,706	243	53.3%	Hereditary angioedema
KalbitorEcallantide	brand	1,390	12	60.4%	Hereditary angioedema
OrladeyoBerotralstat hydrochloride	brand	673	210	45.5%	Hereditary angioedema

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

Hereditary angioedema42.2%1,591
Drug ineffectivethe medicine did not work as expected7.8%293
Product dose omission issuea dose was missed7.3%277
Headachehead pain6%227
Off label useused for a purpose or in a way not on the label5.9%224
Inappropriate schedule of product administrationthe product was taken at the wrong times5.5%208
Weight decreasedweight loss5.1%191
Nauseafeeling sick4.9%183
Malaisegeneral feeling of being unwell4.8%182
Weight increasedweight gain4.8%181
Product use issuea problem in how the product was used4.5%168
Injection site painpain where the injection was given4.4%164
Painpain, site not specified3.8%142
Diarrhoealoose or frequent stools3.7%140
Dizzinesslight-headedness or unsteadiness3.6%137
Fatiguetiredness3.5%132
Vomitingbeing sick3.2%121
Stressstress3.2%120
Covid-19COVID-19 infection3.1%118
Abdominal painstomach or belly pain3%114
Dyspnoeashortness of breath2.9%111
Falla fall2.7%103
Insurance issue2.5%96
No adverse eventno adverse event was reported2.5%96
Urticariahives2.5%96

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death2.5%94

Life-threatening2.1%80

Hospitalisation (initial or prolonged)33.1%1,249

Disability0.3%13

Congenital anomaly0.1%4

Other serious31.9%1,203

Not serious45.4%1,713

Patient age

Under 20.1%3

2 to 111%36

12 to 172.8%106

18 to 4422.7%855

45 to 6419.6%738

65 to 744.7%179

75 and over2.3%85

Age not given46.9%1,767

Who reported

Physician14.6%552

Pharmacist5.9%223

Other health professional17.2%649

Lawyer0%0

Consumer or non-health professional61.7%2,325

Not given0.5%20

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 Plasma kallikrein inhibitor reports

Which drugs are in the Plasma kallikrein inhibitor class on this site?

Takhzyro, Kalbitor and Orladeyo. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

3,769 reports through June 2026, 465 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?

hereditary angioedema (42.2%), drug ineffective (7.8%), product dose omission issue (7.3%), headache (6%) and off label use (5.9%).

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.