Prescription medicine
Aficamten Brand names: Myqorzo
Aficamten (Myqorzo) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the aficamten FDA label on DailyMed (effective December 16, 2025, Cytokinetics Inc.); the NDA 219083 record on Drugs@FDA; every aficamten label on DailyMed.
Highlights of the record
FDA label of December 16, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
RISK OF HEART FAILURE.
MYQORZO reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction [see Warnings and Precautions (5.1) ]. Echocardiogram assessments are required prior to and during treatment with MYQORZO to monitor for systolic dysfunction. Initiation of MYQORZO in patients with LVEF <55% is not recommended. Decrease the dose of MYQORZO if LVEF is <50% and ≥40% [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ]. Interrupt the dose of MYQORZO if LVEF <40% or if the patient experiences heart failure symptoms or worsening clinical status due to systolic dysfunction [see Dosage and Administration (2.2) ]. Because of the risk of heart failure due to systolic dysfunction, MYQORZO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYQORZO REMS Program [see Warnings and Precautions (5.2) ]. WARNING: RISK OF HEART FAILURE See full prescribing information for complete boxed warning. MYQORZO can cause heart failure due to systolic dysfunction. ( 5.1 ) Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during MYQORZO use. ( 2.1 ) Initiation in patients with left ventricular ejection fraction (LVEF) <55% is not recommended. ( 2.1 ) Decrease dose if LVEF <50% and ≥40%. […]
Used for
From the label: indications and usageMYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.
Forms and strengths
- 5 mg
- 10 mg
- 15 mg
- 20 mg
Film-coated tablet.
On the market
- Earliest approval on file
- December 19, 2025 Myqorzo, Cytokinetics; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- July 15, 2042 Myqorzo tablets; 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
- 67 through July 30, 2026
What is aficamten used for?
From the label: indications and usageMYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. MYQORZO is a cardiac myosin inhibitor indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.
Source: FDA drug label (MYQORZO), Cytokinetics Inc., effective December 16, 2025 (SPL set fd778507-1274-4d1a-a659-5431d55c543a), via openFDA; the full label on DailyMed
What does the patient leaflet for aficamten 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 MYQORZO?MYQORZO can cause serious side effects, including: Heart failure, a condition where the heart cannot pump with enough force. Heart failure is a serious condition that can lead to death. You must have echocardiograms before and during treatment with MYQORZO and monitor for signs and symptoms of heart failure. People who develop a serious illness such as a serious infection or who develop a new or worsening irregular heartbeat have a greater risk of heart failure during treatment with MYQORZO. Tell your healthcare provider or get medical help right away if you develop new or worsening: shortness of breath swelling in your legs a racing sensation in your heart (palpitations) fatigue chest pain rapid weight gain The risk of heart failure is also increased when MYQORZO is taken with certain other medicines. Tell your healthcare provider about the medicines you take, both prescribed and obtained over-the-counter, before and during your treatment with MYQORZO. Because of the risk of heart failure, MYQORZO is only available through a restricted distribution program called the MYQORZO Risk Evaluation and Mitigation Strategy (REMS) Program. Your healthcare provider must be enrolled in the MYQORZO REMS Program for you to be prescribed MYQORZO. Before you start treatment with MYQORZO, you must enroll in the MYQORZO REMS Program. Talk to your healthcare provider about how to enroll in the program. You will be given information about the program when you enroll. Before you take MYQORZO, your healthcare provider and pharmacist will make sure you understand how to take MYQORZO safely, which will include returning for echocardiograms when advised by your healthcare provider. MYQORZO can only be dispensed by a certified pharmacy that participates in the MYQORZO REMS Program. […]
From the patient leaflet: How should I store MYQORZO?Store MYQORZO at room temperature between 68°F to 77°F (20°C to 25°C). MYQORZO comes in a bottle with a child-resistant closure. Keep MYQORZO and all medicines out of the reach of children.
Source: FDA drug label (MYQORZO), Cytokinetics Inc., effective December 16, 2025 (SPL set fd778507-1274-4d1a-a659-5431d55c543a), via openFDA; the full label on DailyMed
Is there a generic for aficamten (Myqorzo)?
No generic aficamten is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Myqorzo tablets: the compound patent runs to January 18, 2039, and the last listed entry to July 15, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2042 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the aficamten label say about other medicines?
The aficamten label names 4 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Fluconazole | drug interactions | Fluconazole or Voriconazole Clinical Impact Fluconazole is a moderate CYP2C9 inhibitor, moderate CYP3A inhibitor, and strong CYP2C19 inhibitor. Voriconazole is a strong CYP3A inhibitor, moderate CYP2C19 inhibitor, and weak CYP2C9 inhibitor. … |
| Fluvoxamine | drug interactions | Fluvoxamine; Clinical Impact; Fluvoxamine is a strong CYP2C19 inhibitor, weak to moderate CYP3A inhibitor, weak CYP2C9 inhibitor, and weak CYP2D6 inhibitor. Coadministration of fluvoxamine is predicted to increase aficamten exposure, which may increase the risk of developing heart failure due to systolic dysfunction. |
| Rifampin | contraindications | CONTRAINDICATIONS MYQORZO is contraindicated with concomitant use of rifampin [see Warnings and Precautions (5.3) and Drug Interactions (7.1) ]. |
| Voriconazole | drug interactions | Fluconazole or Voriconazole Clinical Impact Fluconazole is a moderate CYP2C9 inhibitor, moderate CYP3A inhibitor, and strong CYP2C19 inhibitor. Voriconazole is a strong CYP3A inhibitor, moderate CYP2C19 inhibitor, and weak CYP2C9 inhibitor. … |
Source: FDA drug label (MYQORZO), Cytokinetics Inc., effective December 16, 2025 (SPL set fd778507-1274-4d1a-a659-5431d55c543a), via openFDA; the full label on DailyMed
What do FAERS reports show for aficamten?
The FDA Adverse Event Reporting System holds 67 reports that list aficamten among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 36 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Aficamten side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other