Prescription medicine
Mavacamten Brand names: Camzyos
Mavacamten (Camzyos) is a prescription medicine with an FDA approval on record since 2022. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the mavacamten FDA label on DailyMed (effective April 17, 2025, Myokardia, Inc.); the NDA 214998 record on Drugs@FDA; every mavacamten label on DailyMed.
Highlights of the record
FDA label of April 17, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
RISK OF HEART FAILURE.
CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction [see Warnings and Precautions (5.1) ]. Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Interrupt CAMZYOS if LVEF is <50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status [see Dosage and Administration (2.1) and Warnings and Precautions (5.1) ]. Concomitant use of CAMZYOS with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of CAMZYOS is contraindicated with the following [see Contraindications (4) and Warnings and Precautions (5.2) ]:
Strong CYP2C19 inhibitors
Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers Because of the risk of heart failure due to systolic dysfunction, CAMZYOS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called CAMZYOS REMS PROGRAM [see Warnings and Precautions (5.3) ]. WARNING: RISK OF HEART FAILURE See full prescribing information for complete boxed warning.
CAMZYOS can cause heart failure due to systolic dysfunction. […]
Used for
From the label: indications and usageCAMZYOS ® is indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.
Forms and strengths
- 2.5 mg
- 5 mg
- 10 mg
- 15 mg
Gelatin-coated capsule.
On the market
- Earliest approval on file
- April 28, 2022 Camzyos, Bristol; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- April 28, 2036 Camzyos capsules; 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
- 5,081 through July 30, 2026
What is mavacamten used for?
From the label: indications and usageCAMZYOS ® is indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms. CAMZYOS is a cardiac myosin inhibitor indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.
FDA pharmacologic class: Cardiac Myosin Inhibitor.
Source: FDA drug label (CAMZYOS), NDA214998 (Bristol), as published by Myokardia, Inc., effective April 17, 2025 (SPL set 669c936b-3ee6-4e36-8a22-79dd11b1255b), via openFDA; the full label on DailyMed
What does the patient leaflet for mavacamten 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 CAMZYOS?CAMZYOS may 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 you take your first dose and during your treatment with CAMZYOS to help your healthcare provider understand how your heart is responding to CAMZYOS. People who develop a serious infection or irregular heartbeat have a greater risk of heart failure during treatment with CAMZYOS. Tell your healthcare provider or get medical help right away if you develop new or worsening: o shortness of breath o swelling in your legs o chest pain o a racing sensation in your heart (palpitations) o fatigue o rapid weight gain • The risk of heart failure is also increased when CAMZYOS 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 treatment with CAMZYOS. • Because of the serious risk of heart failure, CAMZYOS is only available through a restricted program called the CAMZYOS Risk Evaluation and Mitigation Strategy (REMS) Program. o Your healthcare provider must be enrolled in the CAMZYOS REMS Program in order for you to be prescribed CAMZYOS. o Before you take CAMZYOS, you must enroll in the CAMZYOS REMS Program. Talk to your healthcare provider about how to enroll in the CAMZYOS REMS Program. You will be given information about the program when you enroll. o Before you take CAMZYOS, your healthcare provider and pharmacist will make sure you understand how to take CAMZYOS safely, which will include returning for echocardiograms when advised by your healthcare provider. […]
From the patient leaflet: How should I store CAMZYOS?Store CAMZYOS at room temperature between 68°F to 77°F (20°C to 25°C). Keep CAMZYOS and all medicines out of the reach of children.
Source: FDA drug label (CAMZYOS), NDA214998 (Bristol), as published by Myokardia, Inc., effective April 17, 2025 (SPL set 669c936b-3ee6-4e36-8a22-79dd11b1255b), via openFDA; the full label on DailyMed
Is there a generic for mavacamten (Camzyos)?
No generic mavacamten is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Camzyos capsules: the compound patent runs to April 28, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2022 earliest approval on file
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the mavacamten label say about other medicines?
The mavacamten label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name mavacamten. 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 |
|---|---|---|
| Cimetidine | warnings and precautions | Advise patients of the potential for drug interactions, including with over-the-counter medications (such as omeprazole, esomeprazole, or cimetidine). |
| Diltiazem | drug interactions | Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited [see Warnings and … |
| Disopyramide | drug interactions | Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited [see Warnings and … |
| Esomeprazole | warnings and precautions | Advise patients of the potential for drug interactions, including with over-the-counter medications (such as omeprazole, esomeprazole, or cimetidine). |
| Norethindrone | drug interactions | Combined hormonal contraceptives (CHCs) containing a combination of ethinyl estradiol and norethindrone may be used with mavacamten, but if other CHCs are used, advise patients to add nonhormonal contraception (such as condoms) or use an alternative contraceptive method that is not affected by CYP450 enzyme induction … |
| Omeprazole | warnings and precautions | Advise patients of the potential for drug interactions, including with over-the-counter medications (such as omeprazole, esomeprazole, or cimetidine). |
| Ranolazine | drug interactions | Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited [see Warnings and … |
| Verapamil | drug interactions | Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited [see Warnings and … |
Other labels that name mavacamten
Source: FDA drug label (CAMZYOS), NDA214998 (Bristol), as published by Myokardia, Inc., effective April 17, 2025 (SPL set 669c936b-3ee6-4e36-8a22-79dd11b1255b), via openFDA; the full label on DailyMed
What do FAERS reports show for mavacamten?
The FDA Adverse Event Reporting System holds 5,081 reports that list mavacamten among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 127 are coded as a death and 891 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 2025 (1,458, against a median of 0 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?
- Mavacamten side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other