ivacaftor
Pharmaranks rates Ivacaftor 3.1/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Ivacaftor is a cystic fibrosis transmembrane conductance regulator potentiator used to treat Cystic Fibrosis.
Cystic Fibrosis Transmembrane Conductance Regulator Potentiator · by Lupin
Generic of Kalydeco
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Ivacaftor
- Form
- Powder
- Strength
- Ivacaftor 150MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- cystic fibrosis
- Manufacturer
- Lupin
- FDA application
- ANDA216074
- Availability
- Discontinued (per FDA)
Drug class
May treat (source: NIH RxClass)
Dosage forms
Powder
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Ivacaftor treat?
- Ivacaftor (Ivacaftor) may be used to treat cystic fibrosis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Ivacaftor rated?
- pharmaranks gives Ivacaftor a composite score of 3.1 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Ivacaftor?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ivacaftor. To pay less, Ivacaftor is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Ivacaftor?
- Ivacaftor is marketed by Lupin. You can see Lupin's full profile, rating, and other products on pharmaranks.
- Is Ivacaftor a brand-name or generic drug?
- Ivacaftor is a generic medication; its active ingredient is Ivacaftor. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Ivacaftor available over the counter?
- No. Ivacaftor is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Ivacaftor come in?
- Ivacaftor is currently marketed as powder, per the FDA's National Drug Code Directory.
- What class of drug is Ivacaftor?
- Ivacaftor is classified as cystic fibrosis transmembrane conductance regulator potentiator, per the FDA's Established Pharmacologic Class.
- Is Ivacaftor FDA-registered?
- Ivacaftor is on record with the U.S. FDA under application number ANDA216074. You can verify this on its official FDA label.
- Has Ivacaftor been recalled by the FDA?
- Ivacaftor has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Ivacaftor safe?
- There's no single safe-or-not verdict. pharmaranks gives Ivacaftor a recall-safety score of 62/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
Information is sourced from public FDA regulatory data. Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
What people report to the FDA about Ivacaftor
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 4,478 reports naming Ivacaftor, and the FDA flagged 92% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- hospitalisation984 reports
- lower respiratory tract infection206 reports
- infective pulmonary exacerbation of cystic fibrosis182 reports
- anxiety121 reports
- malaise119 reports
- exposure during pregnancy102 reports
- depression101 reports
- cystic fibrosis96 reports
Read these as a signal, not a rate. A report does not mean Ivacaftor caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
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ivacaftor
62/100