Ivabradine Side Effects

Common Ivabradine Side Effects

The most commonly reported Ivabradine side effects (click to view or check a box to report):

Bradycardia (2)
Renal Failure Acute (2)
Hypotension (1)
Lung Disorder (1)
Dyspnoea (1)
Weight Decreased (1)
Musculoskeletal Chest Pain (1)
Haemorrhagic Erosive Gastritis (1)
Neutropenia (1)
Thrombocytopenia (1)
Pulmonary Oedema (1)
Pulmonary Fibrosis (1)
Oedema Peripheral (1)
Nausea (1)

If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Ivabradine Side Effects Reported to FDA

The following Ivabradine reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

The appearance of Ivabradine on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Musculoskeletal Chest Pain, Haemorrhagic Erosive Gastritis
This is a report of a 72-year-old male patient (weight: NA) from ES, suffering from the following symptoms/conditions: angina pectoris, who was treated with Ivabradine Hydrochloride (dosage: NA, start time: Dec 27, 2011), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Musculoskeletal Chest Pain
  • Haemorrhagic Erosive Gastritis
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ivabradine Hydrochloride treatment in male patients, resulting in musculoskeletal chest pain side effect. The patient was hospitalized.

Pulmonary Oedema, Oedema Peripheral, Bradycardia, Hypotension, Nausea, Renal Failure Acute
This report suggests a potential Ivabradine Pulmonary Oedema, Oedema Peripheral, Bradycardia, Hypotension, Nausea, Renal Failure Acute side effect(s) that can have serious consequences. A 81-year-old male patient (weight: NA) from FRANCE was diagnosed with the following symptoms/conditions: cardiac failure and used Ivabradine (dosage: 5 Mg, 1x/day) starting NS. Soon after starting Ivabradine the patient began experiencing various side effects, including:
  • Pulmonary Oedema
  • Oedema Peripheral
  • Bradycardia
  • Hypotension
  • Nausea
  • Renal Failure Acute
Drugs used concurrently:
  • Bronchodual (Unk)
  • Spiriva (Unk)
  • Allopurinol (Unk)
  • Noctran 10 (Unk)
  • Aspirin (Unk)
  • Fenofibrate (Unk)
  • Lasix
  • Digoxin (0.50 Mg, 1x/day)
The patient was hospitalized. Although Ivabradine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as pulmonary oedema, may still occur.

This Neutropenia problem was reported by a health professional from FRANCE. A 64-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Aug 07, 2011 this consumer started treatment with Ivabradine (dosage: NA). The following drugs were being taken at the same time:
  • Pantoprazole (40 Mg Daily)
  • Furosemide (Unk)
  • Spasfon
  • Perindopril Erbumine (2.5 Mg Daily)
  • Inspra (25 Mg Daily)
  • Crestor
  • Prozac (20 Mg Daily)
  • Calciparine (Unk)
When commencing Ivabradine, the patient experienced the following unwanted symptoms/side effects:
  • Neutropenia
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as neutropenia, may become evident only after a product is in use by the general population.

Dyspnoea, Pulmonary Fibrosis, Lung Disorder, Weight Decreased
This is a report of a 76-year-old male patient (weight: NA) from UNITED KINGDOM. The patient developed the following symptoms/conditions: angina pectoris and was treated with Ivabradine (dosage: 5 Mg, Qd) starting Aug 03, 2011. Concurrently used drugs:
  • Lansoprazole (Unk Ukn, Unk)
  • Atorvastatin (Unk Ukn, Unk)
  • Ezetimibe (Unk Ukn, Unk)
  • Felodipine (Unk Ukn, Unk)
  • Ramipril (2.5 Mg, Qd)
  • Furosemide (Unk Ukn, Unk)
  • Isosorbide Mononitrate (Unk Ukn, Unk)
  • Clopidogrel (Unk Ukn, Unk)
Soon after that, the consumer experienced the following side effects:
  • Dyspnoea
  • Pulmonary Fibrosis
  • Lung Disorder
  • Weight Decreased
The patient was hospitalized and became disabled. This opens a possibility that Ivabradine treatment could cause the above reactions, including dyspnoea, and some male subjects may be more susceptible.

Bradycardia, Thrombocytopenia, Renal Failure Acute
A 82-year-old male patient (weight: NA) from FRANCE with the following symptoms/conditions: cardiac failure started Ivabradine treatment (dosage: 5 Mg, 1x/day) on NS. Soon after starting Ivabradine treatment, the subject experienced various side effects, including:
  • Bradycardia
  • Thrombocytopenia
  • Renal Failure Acute
Concurrently used drugs:
  • Budesonide/formoterol Fumarate (Unk)
  • Spiriva (Unk)
  • Allopurinol (Unk)
  • Digoxin (0.50 Milligram(s), Daily)
  • Acetaminophen (Unk)
  • Xyzal (Unk)
  • Cordarone (200 Milligram(s);daily)
  • Noctran 10 (Unk)
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Ivabradine.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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    More About Ivabradine

    Side Effects reported to FDA: 5

    Ivabradine safety alerts: No

    Reported hospitalizations: 5

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