What the label lists and what reports show
Ivabradine side effects
Ivabradine's FDA label: “Most common adverse reactions occurring in ≥ 1% of patients are bradycardia, hypertension, atrial fibrillation and luminous phenomena (phosphenes).” FAERS holds 6,817 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (471 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the ivabradine FDA label on DailyMed (effective November 10, 2025); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Corlanor?Corlanor may cause serious side effects. See “What is the most important information I should know about Corlanor?” The most common side effects of Corlanor are: increased blood pressure temporary brightness in part of your field of vision. This is usually caused by sudden changes in light (luminous phenomena). This brightness usually happens within the first 2 months of treatment with Corlanor and may go away during or after treatment with Corlanor. Be careful when driving or operating machinery where sudden changes in light can happen, especially when driving at night. These are not all the side effects of Corlanor. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Amgen Inc, effective November 10, 2025 (SPL set 92018a65-38f6-45f7-91d4-a34921b81d0d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions occurring in ≥ 1% of patients are bradycardia, hypertension, atrial fibrillation and luminous phenomena (phosphenes).
Table 2. Adverse Drug Reactions with Rates ≥ 1.0% Higher on Ivabradine than Placebo occurring in > 1% on Ivabradine in SHIFT
| Reaction | Ivabradine N = 3,260 | Placebo N = 3,278 |
|---|---|---|
| Bradycardia | 10% | 2.2% |
| Hypertension, blood pressure increased | 8.9% | 7.8% |
| Atrial fibrillation | 8.3% | 6.6% |
| Phosphenes, visual brightness | 2.8% | 0.5% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedADVERSE REACTIONS 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 Amgen Medical Information at 1-800-772-6436 (1-800-77-AMGEN) 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 Corlanor and 3,278 patients given placebo. The median duration of Corlanor 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.
Source: FDA drug label, Amgen Inc, effective November 10, 2025 (SPL set 92018a65-38f6-45f7-91d4-a34921b81d0d), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,817 reports list ivabradine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 523 are coded as a death and 2,464 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. Of the 21 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ivabradine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions