Prescription medicine
Ivacaftor Brand names: Kalydeco
Ivacaftor (Kalydeco) is a prescription medicine with an FDA approval on record since 2012. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ivacaftor FDA label on DailyMed (effective March 23, 2026, Vertex Pharmaceuticals Incorporated); the NDA 203188 record on Drugs@FDA; every ivacaftor label on DailyMed.
Highlights of the record
FDA label of March 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageKALYDECO is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 month and older who have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data [see Clinical Pharmacology (12.1) and Clinical Studies (14) ].
Forms and strengths
- 5.8 mg
- 13.4 mg
- 25 mg
- 50 mg
- 75 mg
- 150 mg
Granule; film-coated tablet.
On the market
- Earliest approval on file
- January 31, 2012 Kalydeco, Vertex Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 27, 2033 Kalydeco granule; not a generic launch date
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
- 7,897 through July 30, 2026
What is ivacaftor used for?
From the label: indications and usageKALYDECO is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 month and older who have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data [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. […]
FDA pharmacologic class: Cystic Fibrosis Transmembrane Conductance Regulator Potentiator.
Source: FDA drug label (Kalydeco), Vertex Pharmaceuticals Incorporated, effective March 23, 2026 (SPL set 0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25), via openFDA; the full label on DailyMed
What does the patient leaflet for ivacaftor 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 KALYDECO?KALYDECO can cause dizziness in some people who take it. If you experience dizziness, do not drive or operate machines until symptoms improve. You should avoid food or drink containing grapefruit while you are taking KALYDECO.
From the patient leaflet: How should I store KALYDECO?Store KALYDECO at room temperature between 68°F to 77°F (20°C to 25°C). Keep KALYDECO and all medicines out of the reach of children.
Source: FDA drug label (Kalydeco), Vertex Pharmaceuticals Incorporated, effective March 23, 2026 (SPL set 0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25), via openFDA; the full label on DailyMed
Is there a generic for ivacaftor (Kalydeco)?
No generic ivacaftor is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 14 patents for Kalydeco granule: the compound patent runs to May 20, 2027 (pediatric exclusivity to November 20, 2027), and the last listed entry to August 27, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ivacaftor label say about other medicines?
The ivacaftor label names 20 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name ivacaftor. 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 | Therefore, co-administration with strong CYP3A inducers, such as rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John's wort is not recommended [ see Warnings and Precautions (5.5) and Clinical Pharmacology (12.3) ]. |
| Ciprofloxacin | drug interactions | Ciprofloxacin Co-administration of KALYDECO with ciprofloxacin had no effect on the exposure of ivacaftor. |
| Clarithromycin | drug interactions | Based on simulations of these results, a reduction of the KALYDECO dosage is recommended for patients aged 6 months and older taking concomitant strong CYP3A inhibitors, such as ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, and clarithromycin. |
| Cyclosporine | drug interactions | Therefore, caution and appropriate monitoring are recommended when co-administering KALYDECO with sensitive CYP3A and/or P-gp substrates, such as digoxin, cyclosporine, and tacrolimus [ see Clinical Pharmacology (12.3) ]. |
| Digoxin | drug interactions | Co-administration 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 | Therefore, a reduction of the KALYDECO dosage is recommended for patients aged 6 months and older taking concomitant moderate CYP3A inhibitors, such as fluconazole and erythromycin. |
| Fluconazole | drug interactions | DRUG INTERACTIONS Potential for other drugs to affect ivacaftor CYP3A inhibitors: Reduce KALYDECO dosage in patients aged 6 months and older when co-administered with strong CYP3A inhibitors (e.g., ketoconazole) or moderate CYP3A inhibitors (e.g., fluconazole). |
| Glimepiride | drug interactions | Other therapeutic products for which exposure may be increased by KALYDECO include glimepiride and glipizide; these therapeutic products should be used with caution [see Clinical Pharmacology (12.3) ]. |
| Glipizide | drug interactions | Other therapeutic products for which exposure may be increased by KALYDECO include glimepiride and glipizide; these therapeutic products should be used with caution [see Clinical Pharmacology (12.3) ]. |
| Itraconazole | drug interactions | Based on simulations of these results, a reduction of the KALYDECO dosage is recommended for patients aged 6 months and older taking concomitant strong CYP3A inhibitors, such as ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, and clarithromycin. |
| Ketoconazole | drug interactions | DRUG INTERACTIONS Potential for other drugs to affect ivacaftor CYP3A inhibitors: Reduce KALYDECO dosage in patients aged 6 months and older when co-administered with strong CYP3A inhibitors (e.g., ketoconazole) or moderate CYP3A inhibitors (e.g., fluconazole). |
| Midazolam | drug interactions | Co-administration with oral midazolam, a sensitive CYP3A substrate, increased midazolam exposure 1.5-fold, consistent with weak inhibition of CYP3A by ivacaftor. |
| Phenobarbital | drug interactions | Therefore, co-administration with strong CYP3A inducers, such as rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John's wort is not recommended [ see Warnings and Precautions (5.5) and Clinical Pharmacology (12.3) ]. |
| Phenytoin | drug interactions | Therefore, co-administration with strong CYP3A inducers, such as rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John's wort is not recommended [ see Warnings and Precautions (5.5) and Clinical Pharmacology (12.3) ]. |
Every other medicine the ivacaftor label names
| Medicine named | Section | What the label says |
|---|---|---|
| Posaconazole | drug interactions | … concomitant strong CYP3A inhibitors, such as ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, and clarithromycin. |
| Rifabutin | drug interactions | Therefore, co-administration with strong CYP3A inducers, such as rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. … |
| Rifampin | drug interactions | Inducers of CYP3A Co-administration with rifampin, a strong CYP3A inducer, significantly decreased ivacaftor exposure (AUC) by approximately 9-fold. |
| Tacrolimus | drug interactions | … sensitive CYP3A and/or P-gp substrates, such as digoxin, cyclosporine, and tacrolimus [ see Clinical Pharmacology (12.3) ]. |
| Voriconazole | drug interactions | … CYP3A inhibitors, such as ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, and clarithromycin. |
| Warfarin | drug interactions | … international normalized ratio (INR) during co-administration of KALYDECO with warfarin is recommended. |
Other labels that name ivacaftor
Source: FDA drug label (Kalydeco), Vertex Pharmaceuticals Incorporated, effective March 23, 2026 (SPL set 0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25), via openFDA; the full label on DailyMed
What do FAERS reports show for ivacaftor?
The FDA Adverse Event Reporting System holds 7,897 reports that list ivacaftor among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 325 are coded as a death and 4,375 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 received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other cystic fibrosis transmembrane conductance regulator potentiators
- the pharmacologic class, with prices and generics
- Ivacaftor side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other