Skip to main content

What the FDA labels say about taking them together

Fulvestrant and ribociclib

Ribociclib's FDA label of July 1, 2026 names fulvestrant in its warnings and precautions section; the fulvestrant labels PlainMeds reads (3) do not name ribociclib. The ribociclib label: “In patients with advanced or metastatic breast cancer who received 600 mg KISQALI plus NSAI or fulvestrant, 15 out of 1054 patients (1.4%) had a > 500 ms post-baseline QTcF value and 61 out of 1054 patients (6%) had a > …”

Check it at the source: the fulvestrant FDA label on DailyMed (effective September 25, 2020, AstraZeneca Pharmaceuticals LP); the ribociclib FDA label on DailyMed (effective July 1, 2026, Novartis Pharmaceuticals Corporation).

What does the fulvestrant label say about ribociclib?

Fulvestrant's label (effective September 25, 2020) and its 2 other brand-application labels do not name ribociclib in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (FASLODEX), AstraZeneca Pharmaceuticals LP, effective September 25, 2020 (SPL set 83d7a440-e904-4e36-afb5-cb02b1c919f7), via openFDA; the full label on DailyMed

What does the ribociclib label say about fulvestrant?

Ribociclib label, warnings and precautions

In patients with advanced or metastatic breast cancer (MONALEESA-2, MONALEESA-3, and MONALEESA-7) who received 600 mg KISQALI plus NSAI or fulvestrant, 15 out of 1054 patients (1.4%) had a > 500 ms post-baseline QTcF value and 61 out of 1054 patients (6%) had a > 60 ms QTcF increase from baseline.

Source: FDA drug label (KISQALI), Novartis Pharmaceuticals Corporation, effective July 1, 2026 (SPL set aaeaef94-f3f5-4367-8ea2-b181d7be2da8), via openFDA; the full label on DailyMed

These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.

Both medicines on the record

19Fulvestrant generic labelers
0Ribociclib generic labelers
FulvestrantRibociclib
Labeled forBreast cancerBreast cancer
Boxed warningNoNo
Pharmacy cost (NADAC)n/a$289.72 per unit 600 mg daily dose
Shortage nowA presentation being discontinuedNo current entry

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

What next?