Prescription medicine
Elexacaftor and ivacaftor and tezacaftor Brand names: Trikafta
Elexacaftor and ivacaftor and tezacaftor (Trikafta) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the elexacaftor and ivacaftor and tezacaftor FDA label on DailyMed (effective June 22, 2026); every elexacaftor and ivacaftor and tezacaftor label on DailyMed.
Highlights of the record
FDA label of June 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
DRUG-INDUCED LIVER INJURY AND LIVER FAILURE.
TRIKAFTA can cause serious and potentially fatal drug-induced liver injury. Cases of liver failure leading to transplantation and death have been reported in patients with and without a history of liver disease taking TRIKAFTA, in both clinical trials and the postmarketing setting [see Adverse Reactions (6) ]. Liver injury has been reported within the first month of therapy and up to 15 months following initiation of TRIKAFTA . Assess liver function tests (ALT, AST, alkaline phosphatase, and bilirubin) in all patients prior to initiating TRIKAFTA. Assess liver function tests every month during the first 6 months of treatment, then every 3 months for the next 12 months, then at least annually thereafter. Consider more frequent monitoring for patients with a history of liver disease or liver function test elevations at baseline [see Dosage and Administration (2.1), Warnings and Precautions (5.1), Adverse Reactions (6) and Use in Specific Populations (8.7) ]. Interrupt TRIKAFTA for significant elevations in liver function tests or in the event of signs or symptoms of liver injury. Consider referral to a hepatologist. Follow patients closely with clinical and laboratory monitoring until abnormalities resolve. If abnormalities resolve, resume treatment only if the benefit is expected to outweigh the risk. […]
Used for
From the label: indications and usageTRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients aged 2 years and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene that is either responsive based on clinical and/or in vitro data (see Table 6 ) or results in production of CFTR protein [see Clinical Pharmacology (12.1) ].
Forms and strengths
Kit.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 12,399 through July 30, 2026
What is elexacaftor and ivacaftor and tezacaftor used for?
From the label: indications and usageTRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients aged 2 years and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene that is either responsive based on clinical and/or in vitro data (see Table 6 ) or results in production of CFTR protein [see Clinical Pharmacology (12.1) ]. If the patient's genotype is unknown, an FDA-cleared CF genetic test should be used to confirm the presence of at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. […]
Source: FDA drug label (Trikafta), Vertex Pharmaceuticals Incorporated, effective June 22, 2026 (SPL set f354423a-85c2-41c3-a9db-0f3aee135d8d), via openFDA; the full label on DailyMed
What does the patient leaflet for elexacaftor and ivacaftor and tezacaftor say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TRIKAFTA?TRIKAFTA can cause serious liver damage and liver failure. Liver failure leading to transplantation and death have been seen in some people with or without a history of liver problems taking TRIKAFTA. Your healthcare provider will do blood tests to check your liver: before you start TRIKAFTA then every month during your first 6 months of taking TRIKAFTA then every 3 months during the next 12 months of taking TRIKAFTA then at least every year while you are taking TRIKAFTA Your healthcare provider may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past or are experiencing signs or symptoms of liver injury. Stop taking TRIKAFTA and call your healthcare provider right away if you have any of the following symptoms of liver problems: pain, swelling, or discomfort in the upper right stomach (abdominal) area yellowing of your skin or the white part of your eyes mental changes nausea or vomiting dark, amber-colored urine loss of appetite have fluid in your stomach area (ascites)
From the patient leaflet: What should I avoid while taking TRIKAFTA?Avoid food or drink that contains grapefruit while you are taking TRIKAFTA.
From the patient leaflet: How should I store TRIKAFTA?Store TRIKAFTA at room temperature between 68ºF to 77ºF (20ºC to 25ºC). Keep TRIKAFTA and all medicines out of the reach of children.
Source: FDA drug label (Trikafta), Vertex Pharmaceuticals Incorporated, effective June 22, 2026 (SPL set f354423a-85c2-41c3-a9db-0f3aee135d8d), via openFDA; the full label on DailyMed
Is there a generic for elexacaftor and ivacaftor and tezacaftor (Trikafta)?
No generic elexacaftor and ivacaftor and tezacaftor is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the elexacaftor and ivacaftor and tezacaftor label say about other medicines?
The elexacaftor and ivacaftor and tezacaftor label names 25 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name elexacaftor and ivacaftor and tezacaftor. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | Elexacaftor and tezacaftor exposures are expected to decrease during concomitant use with strong CYP3A inducers [see Clinical Pharmacology (12.3) ]. Examples of strong CYP3A inducers include: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin and St. … |
| Ciprofloxacin | drug interactions | Interactions with TRIKAFTA Ciprofloxacin Ciprofloxacin had no clinically relevant effect on the exposure of tezacaftor or ivacaftor and is not expected to affect the exposure of elexacaftor. |
| Clarithromycin | drug interactions | … strong CYP3A inhibitors include: ketoconazole, itraconazole, posaconazole and voriconazole telithromycin and clarithromycin The dosage of TRIKAFTA should be reduced when used concomitantly with moderate CYP3A inhibitors [see Dosage and Administration (2.4) and Warnings and Precautions (5.6) ]. |
| Cyclosporine | drug interactions | When used concomitantly with digoxin or other substrates of P-gp with a narrow therapeutic index such as cyclosporine, everolimus, sirolimus and tacrolimus, caution and appropriate monitoring should be used [see Clinical Pharmacology (12.3) ]. |
| Digoxin | drug interactions | Transporters Concomitant use of ivacaftor or tezacaftor/ivacaftor with digoxin, a sensitive P-gp substrate, increased digoxin AUC by 1.3-fold, consistent with weak inhibition of P-gp by ivacaftor. |
| Erythromycin | drug interactions | Concomitant use of fluconazole increased ivacaftor AUC by 2.9-fold [see Clinical Pharmacology (12.3) ]. Examples of moderate CYP3A inhibitors include: fluconazole erythromycin Grapefruit Concomitant use of TRIKAFTA with grapefruit juice, which contains one or more components that moderately inhibit CYP3A, may increase … |
| Estradiol and levonorgestrel | drug interactions | Hormonal Contraceptives TRIKAFTA has been studied with ethinyl estradiol/levonorgestrel and was found to have no clinically relevant effect on the exposures of the oral contraceptive. |
| Everolimus | drug interactions | When used concomitantly with digoxin or other substrates of P-gp with a narrow therapeutic index such as cyclosporine, everolimus, sirolimus and tacrolimus, caution and appropriate monitoring should be used [see Clinical Pharmacology (12.3) ]. |
| Fluconazole | drug interactions | Concomitant use of fluconazole increased ivacaftor AUC by 2.9-fold [see Clinical Pharmacology (12.3) ]. Examples of moderate CYP3A inhibitors include: fluconazole erythromycin Grapefruit Concomitant use of TRIKAFTA with grapefruit juice, which contains one or more components that moderately inhibit CYP3A, may increase … |
| Glimepiride | drug interactions | Other medicinal products for which exposure may be increased by TRIKAFTA include glimepiride and glipizide; these medicinal products should be used with caution [see Clinical Pharmacology (12.3) ]. |
| Glipizide | drug interactions | Other medicinal products for which exposure may be increased by TRIKAFTA include glimepiride and glipizide; these medicinal products should be used with caution [see Clinical Pharmacology (12.3) ]. |
| Glyburide | drug interactions | Concomitant use of TRIKAFTA may increase exposures of medicinal products that are substrates of these transporters, such as statins, glyburide, nateglinide and repaglinide. |
| Itraconazole | drug interactions | Concomitant use with itraconazole, a strong CYP3A inhibitor, increased elexacaftor AUC by 2.8-fold and tezacaftor AUC by 4.0- to 4.5-fold. |
| Ketoconazole | drug interactions | When used concomitantly with itraconazole and ketoconazole, ivacaftor AUC increased by 15.6-fold and 8.5-fold, respectively [see Clinical Pharmacology (12.3) ]. Examples of strong CYP3A inhibitors include: ketoconazole, itraconazole, posaconazole and voriconazole telithromycin and clarithromycin The dosage of TRIKAFTA … |
Every other medicine the elexacaftor and ivacaftor and tezacaftor label names
| Medicine named | Section | What the label says |
|---|---|---|
| Nateglinide | drug interactions | Concomitant use of TRIKAFTA may increase exposures of medicinal products that are substrates of these transporters, such as statins, glyburide, nateglinide and repaglinide. |
| Phenobarbital | drug interactions | … ]. Examples of strong CYP3A inducers include: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin and St. John's wort ( Hypericum perforatum ) Strong or Moderate CYP3A Inhibitors The dosage … |
| Phenytoin | drug interactions | … inducers include: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin and St. John's wort ( Hypericum perforatum ) Strong or Moderate CYP3A Inhibitors The dosage of TRIKAFTA should be … |
| Posaconazole | drug interactions | … Examples of strong CYP3A inhibitors include: ketoconazole, itraconazole, posaconazole and voriconazole telithromycin and clarithromycin The dosage of TRIKAFTA should be reduced when used … |
| Repaglinide | drug interactions | Concomitant use of TRIKAFTA may increase exposures of medicinal products that are substrates of these transporters, such as statins, glyburide, nateglinide and repaglinide. |
| Rifabutin | drug interactions | … Pharmacology (12.3) ]. Examples of strong CYP3A inducers include: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin and St. … |
| Rifampin | drug interactions | Concomitant use of ivacaftor with rifampin, a strong CYP3A inducer, significantly decreased ivacaftor area under the curve (AUC) by 89%. |
| Sirolimus | drug interactions | When used concomitantly with digoxin or other substrates of P-gp with a narrow therapeutic index such as cyclosporine, everolimus, sirolimus and tacrolimus, caution and appropriate monitoring should … |
| Tacrolimus | drug interactions | When used concomitantly with digoxin or other substrates of P-gp with a narrow therapeutic index such as cyclosporine, everolimus, sirolimus and tacrolimus, caution and appropriate monitoring should … |
| Voriconazole | drug interactions | … CYP3A inhibitors include: ketoconazole, itraconazole, posaconazole and voriconazole telithromycin and clarithromycin The dosage of TRIKAFTA should be reduced when used concomitantly with moderate … |
| Warfarin | drug interactions | Ivacaftor may inhibit CYP2C9; therefore, monitoring of the international normalized ratio (INR) during concomitant use of TRIKAFTA with warfarin is recommended. |
Other labels that name elexacaftor and ivacaftor and tezacaftor
Check elexacaftor and ivacaftor and tezacaftor against other medicines
Source: FDA drug label (Trikafta), Vertex Pharmaceuticals Incorporated, effective June 22, 2026 (SPL set f354423a-85c2-41c3-a9db-0f3aee135d8d), via openFDA; the full label on DailyMed
What do FAERS reports show for elexacaftor and ivacaftor and tezacaftor?
The FDA Adverse Event Reporting System holds 12,399 reports that list elexacaftor and ivacaftor and tezacaftor among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 241 are coded as a death and 3,411 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2020 (5,170, against a median of 1,050 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Elexacaftor and ivacaftor and tezacaftor side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other