pharmacopeia
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/api/v1/drug/ivabradine

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Cytochrome P450 3A4 Inhibitors; Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists.

Cytochrome P450 3A4Hyperpolarization-activated Cyclic Nucleotide-gated Channel

Indications

Sourced from openFDA
  • Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. ( 1.1 ) 1.1 Heart Failure in Adult Patients Ivabradine tablets are indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction ≤ 35%, who are in sinus rhythm with resting heart rate ≥ 70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use.ICD-10: I50.9

Contraindications

Sourced from openFDA
  • Ivabradine tablets are contraindicated in patients with: Acute decompensated heart failure Clinically significant hypotension Sick sinus syndrome, sinoatrial block or 3 rd degree AV block, unless a functioning demand pacemaker is present Clinically significant bradycardia [see Warnings and Precautions (5.3) ] Severe hepatic impairment [see Use in Specific Populations (8.6) ] Pacemaker dependence (heart rate maintained exclusively by the pacemaker) [see Drug Interactions (7.3) ] Concomitant use of strong cytochrome P450 3A4 (CYP3A4) inhibitors [see Drug Interactions (7.1) ] Acute decompensated heart failure ( 4 ) Clinically significant hypotension ( 4 ) Sick sinus syndrome, sinoatrial block or 3 rd degree AV block, unless a functioning demand pacemaker is present ( 4 ) Clinically significant bradycardia ( 4 ) Severe hepatic impairment ( 4 ) Heart rate maintained exclusively by the pacemaker ( 4 ) In combination with strong cytochrome CYP3A4 inhibitors ( 4 )contraindicated

Dosage & administration

Sourced from openFDA

Adult patients ● Starting dose is 2.5 (vulnerable adults) or 5 mg twice daily with food. After 2 weeks of treatment, adjust dose based on heart rate. The maximum dose is 7.5 mg twice daily. ( 2.1 ) 2.1 Adults The recommended starting dose of ivabradine tablets is 5 mg twice daily with food. Assess patient after two weeks and adjust dose to achieve a resting heart rate between 50 and 60 beats per minute (bpm) as shown in Table 1. Thereafter, adjust dose as needed based on resting heart rate and tolerability. The maximum dose is 7.5 mg twice daily. In adult patients unable to swallow tablets, Corlanor oral solution can be used [see Clinical Pharmacology (12.3) ] . In patients with a history of conduction defects or other patients in whom bradycardia could lead to hemodynamic compromise, initiate therapy at 2.5 mg twice daily before increasing the dose based on heart rate [see Warnings and Precautions (5.3) ] . Table 1. Dose Adjustment for Adults * [see Warnings and Precautions (5.3) ] Heart Rate Dose Adjustment > 60 bpm Increase dose by 2.5 mg (given twice daily) up to a maximum dose of 7.5 mg twice daily 50-60 bpm Maintain dose < 50 bpm or signs and symptoms of bradycardia Decrease dose by 2.5 mg (given twice daily); if current dose is 2.5 mg twice daily, discontinue therapy*

Warnings & precautions

Sourced from openFDA

Fetal toxicity: Females should use effective contraception. ( 5.1 ) Monitor patients for atrial fibrillation. ( 5.2 ) Monitor heart rate decreases and bradycardia symptoms during treatment. ( 5.3 ) Not recommended in patients with 2 nd degree AV block. ( 5.3 ) 5.1 Fetal Toxicity Ivabradine tablets may cause fetal toxicity when administered to a pregnant woman based on findings in animal studies. Embryo-fetal toxicity and cardiac teratogenic effects were observed in fetuses of pregnant rats treated during organogenesis at exposures 1 to 3 times the human exposures (AUC 0 - 24hr ) at the maximum recommended human dose (MRHD) [see Use in Specific Populations (8.1) ]. Advise females of reproductive potential to use effective contraception when taking ivabradine tablets [see Use in Specific Populations (8.3) ] . 5.2 Atrial Fibrillation Ivabradine tablets increases the risk of atrial fibrillation. In the Systolic Heart Failure Treatment with the I f Inhibitor Ivabradine Trial (SHIFT), the rate of atrial fibrillation was 5.0% per patient-year in patients treated with ivabradine tablets and 3.9% per patient-year in patients treated with placebo [see Clinical Studies (14) ] . Regularly monitor cardiac rhythm. Discontinue ivabradine tablets if atrial fibrillation develops. 5.3 Bradycardia and Conduction Disturbances Adult Patients Bradycardia, sinus arrest, and heart block have occurred with ivabradine tablets.

Adverse reactions

Sourced from openFDA

Clinically significant adverse reactions that appear in other sections of the labeling include: Atrial Fibrillation [see Warnings and Precautions (5.2) ] Bradycardia and Conduction Disturbances [see Warnings and Precautions (5.3) ] Most common adverse reactions occurring in ≥ 1% of patients are bradycardia, hypertension, atrial fibrillation and luminous phenomena (phosphenes). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals, LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Patients with Heart Failure In SHIFT, safety was evaluated in 3,260 patients treated with ivabradine tablets and 3,278 patients given placebo. The median duration of ivabradine tablets exposure was 21.5 months. The most common adverse drug reactions in the SHIFT trial are shown in Table 2 [see Warnings and Precautions (5.2) , ( 5.3 )]. Table 2.

Use in specific populations

Sourced from openFDA

Lactation: Breastfeeding not recommended. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on findings in animals, ivabradine tablets may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies of ivabradine tablets in pregnant women to inform any drug-associated risks. In animal reproduction studies, oral administration of ivabradine to pregnant rats during organogenesis at a dosage providing 1 to 3 times the human exposure (AUC 0-24hr ) at the MRHD resulted in embryo-fetal toxicity and teratogenicity manifested as abnormal shape of the heart, interventricular septal defect, and complex anomalies of primary arteries. Increased post-natal mortality was associated with these teratogenic effects in rats. In pregnant rabbits, increased post-implantation loss was noted at an exposure (AUC 0-24hr ) 5 times the human exposure at the MRHD. Lower doses were not tested in rabbits. The background risk of major birth defects for the indicated population is unknown. The estimated background risk of major birth defects in the U.S. general population is 2 to 4%, however, and the estimated risk of miscarriage is 15 to 20% in clinically recognized pregnancies. Advise a pregnant woman of the potential risk to the fetus.

Pharmacokinetics

Sourced from openFDA
Metabolism
The peak concentration (C max ) and area under the plasma concentration time curve (AUC) are similar for ivabradine and S 18982 between oral solution and tablets for the same dose. Absorption and Bioavailability Following oral administration, peak plasma ivabradine concentrations are reached in approximately1 hour under fasting conditions.

Overdosage

Sourced from openFDA

Overdose may lead to severe and prolonged bradycardia. In the event of bradycardia with poor hemodynamic tolerance, temporary cardiac pacing may be required. Supportive treatment, including intravenous (IV) fluids, atropine, and intravenous beta-stimulating agents such as isoproterenol, may be considered.

Approval history

Sourced from openFDA
  • Apr 15, 2015NDANDA206143Amgen Inc
  • Apr 22, 2019NDANDA209964Amgen Inc
  • Dec 30, 2021ANDAANDA214051Ingenus Pharms Llc
  • Oct 5, 2022ANDAANDA213366Annora Pharma
  • Nov 29, 2023ANDAANDA213442Zydus Pharms
  • Sep 5, 2024ANDAANDA213276Bionpharma
  • Nov 8, 2024ANDAANDA215238Alembic
  • Apr 28, 2025ANDAANDA213483Msn

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Corlanor, Solution, 5 mg/5 mL (NDC 55513-813-28)To be discontinued
    Sponsor: Amgen Inc.
    Updated
  • Corlanor, Tablet, eq. 5 mg base (NDC 55513-800-60)To be discontinued
    Sponsor: Amgen Inc.
    Updated
  • Corlanor, Tablet, eq. 7.5 mg base (NDC 55513-810-60)To be discontinued
    Sponsor: Amgen Inc.
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
6,654 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use1,30920%
  2. 2Dyspnoea4626.9%
  3. 3Hypotension4206.3%
  4. 4Dizziness3545.3%
  5. 5Cardiac Failure3294.9%
  6. 6Fatigue3214.8%
  7. 7Drug Interaction3144.7%
  8. 8Drug Ineffective2824.2%
  9. 9Nausea2593.9%
  10. 10Bradycardia2523.8%
  11. 11Headache2363.5%
  12. 12Chest Pain1962.9%
  13. 13Malaise1872.8%
  14. 14Palpitations1772.7%
  15. 15Asthenia1622.4%

Literature

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Recent PubMed references pinned to Ivabradine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 100 ClinicalTrials.gov registrations naming Ivabradine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Ivabradine work?
Mechanism-of-action classes: Cytochrome P450 3A4 Inhibitors; Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists.
What is Ivabradine used for?
According to FDA labeling, Ivabradine carries indications including: Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. ( 1.1 ) 1.1 Heart Failure in Adult Patients Ivabradine tablets are indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction ≤ 35%, who are in sinus rhythm with resting heart rate ≥ 70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Ivabradine?
Ivabradine is classified as Other cardiac preparations, Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker, Cytochrome P450 3A4 Inhibitors, Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists, Negative Chronotropy.
What are the brand names for Ivabradine?
Ivabradine is marketed under brand names including Corlanor.
What are the contraindications for Ivabradine?
Ivabradine labeling lists contraindications including: Ivabradine tablets are contraindicated in patients with: Acute decompensated heart failure Clinically significant hypotension Sick sinus syndrome, sinoatrial block or 3 rd degree AV block, unless a functioning demand pacemaker is present Clinically significant bradycardia [see Warnings and Precautions (5.3) ] Severe hepatic impairment [see Use in Specific Populations (8.6) ] Pacemaker dependence (heart rate maintained exclusively by the pacemaker) [see Drug Interactions (7.3) ] Concomitant use of strong cytochrome P450 3A4 (CYP3A4) inhibitors [see Drug Interactions (7.1) ] Acute decompensated heart failure ( 4 ) Clinically significant hypotension ( 4 ) Sick sinus syndrome, sinoatrial block or 3 rd degree AV block, unless a functioning demand pacemaker is present ( 4 ) Clinically significant bradycardia ( 4 ) Severe hepatic impairment ( 4 ) Heart rate maintained exclusively by the pacemaker ( 4 ) In combination with strong cytochrome CYP3A4 inhibitors ( 4 ). Always consult the full prescribing information and a clinician.
Note. Data for ivabradine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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