Prescription medicine
Ivacaftor and tezacaftor Brand names: Symdeko
Ivacaftor and tezacaftor (Symdeko) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ivacaftor and tezacaftor FDA label on DailyMed (effective August 21, 2026); every ivacaftor and tezacaftor label on DailyMed.
Highlights of the record
FDA label of August 21, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSYMDEKO is indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence [see Clinical Pharmacology (12.1) and Clinical Studies (14) ].
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
- 5,286 through July 30, 2026
What is ivacaftor and tezacaftor used for?
From the label: indications and usageSYMDEKO is indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence [see Clinical Pharmacology (12.1) and Clinical Studies (14) ]. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use. […]
Source: FDA drug label (SYMDEKO), Vertex Pharmaceuticals Incorporated, effective August 21, 2026 (SPL set 302ae804-37db-44fd-ac2f-3dbdeda9aa4b), via openFDA; the full label on DailyMed
What does the patient leaflet for 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 should I avoid while taking SYMDEKO?SYMDEKO can cause dizziness in some people who take it. If you experience dizziness, do not drive or operate machines until symptoms improve. Avoid food or drink that contains grapefruit while you are taking SYMDEKO.
From the patient leaflet: How should I store SYMDEKO?Store SYMDEKO at room temperature between 68°F to 77°F (20°C to 25°C). Keep SYMDEKO and all medicines out of the reach of children.
Source: FDA drug label (SYMDEKO), Vertex Pharmaceuticals Incorporated, effective August 21, 2026 (SPL set 302ae804-37db-44fd-ac2f-3dbdeda9aa4b), via openFDA; the full label on DailyMed
Is there a generic for ivacaftor and tezacaftor (Symdeko)?
No generic 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 ivacaftor and tezacaftor label say about other medicines?
The ivacaftor and tezacaftor label names 23 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name 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 | … Counseling Information (17) ]. Examples of strong CYP3A inducers include: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John's wort (Hypericum perforatum) |
| Ciprofloxacin | drug interactions | Ciprofloxacin Co-administration of SYMDEKO with ciprofloxacin had no significant effect on the exposure of tezacaftor or ivacaftor. |
| Clarithromycin | drug interactions | … strong CYP3A inhibitors include: ketoconazole, itraconazole, posaconazole, and voriconazole telithromycin and clarithromycin Co-administration of fluconazole increased ivacaftor exposure (AUC) by 3.0-fold. |
| 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 | Digoxin and Other P-gp Substrates Co-administration of SYMDEKO with digoxin, a sensitive P-gp substrate, increased digoxin exposure by 1.3-fold consistent with weak inhibition of P-gp by ivacaftor. |
| Erythromycin | drug interactions | … (12.3), and Patient Counseling Information (17) ]. Examples of moderate CYP3A inhibitors include: fluconazole erythromycin Co-administration of SYMDEKO with grapefruit juice, which contains one or more components that moderately inhibit CYP3A, may increase exposure of tezacaftor and ivacaftor; … |
| Estradiol and norethindrone | drug interactions | Hormonal Contraceptives SYMDEKO has been studied with an ethinyl estradiol/norethindrone oral contraceptive and was found to have no significant effect on the exposures of the hormonal 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 | Reduce SYMDEKO dosage when co-administered with strong (e.g., ketoconazole) or moderate (e.g., fluconazole) CYP3A inhibitors. |
| Glimepiride | drug interactions | Other medicinal products for which exposure may be increased by SYMDEKO 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 SYMDEKO include glimepiride and glipizide; these medicinal products should be used with caution [see Clinical Pharmacology (12.3) ]. |
| Itraconazole | drug interactions | Inhibitors of CYP3A Co-administration with itraconazole, a strong CYP3A inhibitor, increased tezacaftor exposure (AUC) by 4.0-fold and ivacaftor by 15.6-fold. |
| Ketoconazole | drug interactions | Reduce SYMDEKO dosage when co-administered with strong (e.g., ketoconazole) or moderate (e.g., fluconazole) CYP3A inhibitors. |
| Midazolam | drug interactions | Potential for tezacaftor/ivacaftor to affect other drugs 7.4 CYP3A Substrates Co-administration of SYMDEKO with midazolam (oral), a sensitive CYP3A substrate, did not affect midazolam exposure. |
Every other medicine the ivacaftor and tezacaftor label names
| Medicine named | Section | What the label says |
|---|---|---|
| Phenobarbital | drug interactions | … ]. Examples of strong CYP3A inducers include: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John's wort (Hypericum perforatum) |
| Phenytoin | drug interactions | … inducers include: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John's wort (Hypericum perforatum) |
| Posaconazole | drug interactions | … Examples of strong CYP3A inhibitors include: ketoconazole, itraconazole, posaconazole, and voriconazole telithromycin and clarithromycin Co-administration of fluconazole increased ivacaftor exposure … |
| Rifabutin | drug interactions | … Information (17) ]. Examples of strong CYP3A inducers include: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John's wort (Hypericum perforatum) |
| Rifampin | drug interactions | Co-administration of ivacaftor with rifampin, a strong CYP3A inducer, significantly decreased ivacaftor exposure (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 | … inhibitors include: ketoconazole, itraconazole, posaconazole, and voriconazole telithromycin and clarithromycin Co-administration of fluconazole increased ivacaftor exposure (AUC) by 3.0-fold. |
| Warfarin | drug interactions | Ivacaftor may inhibit CYP2C9; therefore, monitoring of the international normalized ratio (INR) during co-administration of SYMDEKO with warfarin is recommended. |
Other labels that name ivacaftor and tezacaftor
Source: FDA drug label (SYMDEKO), Vertex Pharmaceuticals Incorporated, effective August 21, 2026 (SPL set 302ae804-37db-44fd-ac2f-3dbdeda9aa4b), via openFDA; the full label on DailyMed
What do FAERS reports show for ivacaftor and tezacaftor?
The FDA Adverse Event Reporting System holds 5,286 reports that list ivacaftor and tezacaftor among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 74 are coded as a death and 2,899 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 2019 (3,045, against a median of 39 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?
- Ivacaftor and tezacaftor side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other