Pharmacologic class (EPC) · 3 drug pages

Cystic fibrosis transmembrane conductance regulator potentiator: adverse event reports filed with FDA

15,772 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.

15,772
reports across the class: 0.1% of all reports; 1,033
reports, 12 months to June 2026: 890 in the 12 months before; 66.8%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Cystic fibrosis transmembrane conductance regulator potentiator 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 15,772 adverse event reports received by FDA, 0.1% of the database, from May 2012 to June 2026.

1,033 reports arrived in the 12 months to June 2026, up 16% from 890 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 66.8% of the class's reports are marked serious, 2.9% record death among the outcomes and 52.3% record hospitalisation, as reported.

Across the class the reactions recorded most often are hospitalisation (14.2%), infective pulmonary exacerbation of cystic fibrosis (12.5%) and dyspnoea (4.3%). 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
OrkambiLumacaftor and ivacaftor	brand	8,112	50	61.8%	Infective pulmonary exacerbation of cystic fibrosis
KalydecoIvacaftor	brand	7,054	486	74.7%	Hospitalisation
AlyftrekVanzacaftor, tezacaftor, and deutivacaftor	brand	606	497	41.6%	Hospitalisation

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

Hospitalisationadmission to hospital14.2%2,234
Infective pulmonary exacerbation of cystic fibrosis12.5%1,966
Dyspnoeashortness of breath4.3%672
Infectionan infection, type not specified3.6%572
Coughcough3.6%571
Pulmonary function test decreased3.1%489
Malaisegeneral feeling of being unwell2.8%447
Pneumonialung infection2.8%439
Cystic fibrosis2.7%430
Chest discomfortchest discomfort2.6%413
Headachehead pain2.2%341
Nasopharyngitisa cold2.1%332
Influenzaflu2%318
Diarrhoealoose or frequent stools2%311
Fatiguetiredness2%309
Deaththe patient died; cause not stated by this term1.9%297
Nauseafeeling sick1.7%273
Lower respiratory tract infectiona chest infection1.7%270
Abdominal pain upperupper stomach pain1.6%254
Vomitingbeing sick1.5%244
Pyrexiafever1.4%225
Haemoptysiscoughing up blood1.4%220
Weight decreasedweight loss1.4%214
Sinusitissinus infection1.3%211
Cystic fibrosis respiratory infection suppression1.3%204

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

Death2.9%453

Life-threatening0.6%92

Hospitalisation (initial or prolonged)52.3%8,243

Disability0.3%43

Congenital anomaly0.4%56

Other serious16.3%2,569

Not serious33.2%5,240

Patient age

Under 20.7%114

2 to 1112.5%1,975

12 to 179.5%1,496

18 to 4423%3,634

45 to 643.9%615

65 to 740.7%106

75 and over0.1%19

Age not given49.5%7,813

Who reported

Physician12.3%1,933

Pharmacist16.3%2,568

Other health professional21.6%3,410

Lawyer0%0

Consumer or non-health professional49.7%7,833

Not given0.2%28

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 Cystic fibrosis transmembrane conductance regulator potentiator reports

Which drugs are in the Cystic fibrosis transmembrane conductance regulator potentiator class on this site?

Orkambi, Kalydeco and Alyftrek. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

15,772 reports through June 2026, 1,033 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?

hospitalisation (14.2%), infective pulmonary exacerbation of cystic fibrosis (12.5%), dyspnoea (4.3%), infection (3.6%) and cough (3.6%).

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.