Drug Safety Information for CORLANOR (Ivabradine hydrochloride)

FDA Safety-related Labeling Changes for CORLANOR (IVABRADINE HYDROCHLORIDE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for CORLANOR (IVABRADINE) Rx Drug: Safety Information Link

Adverse Drug Reactions for CORLANOR* (Ivabradine hydrochloride)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with CORLANOR
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug interaction	42
2	Renal failure acute	41
3	Dyspnoea	40
4	Malaise	24
5	Dizziness	21
6	Dehydration	21
7	Arthralgia	18
8	Multi-organ failure	16
9	Hypoglycaemia	16
10	Death	15
11	Erythema	14
12	Hypotension	14
13	Pruritus	14
14	Headache	14
15	Vomiting	13
16	Fatigue	13
17	Cardiac failure	13
18	Lung disorder	13
19	Shock	12
20	Feeling abnormal	12

* This side effect also appears in "Top 10 Side Effects of CORLANOR " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking CORLANOR
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Product used for unknown indication	297
2	Angina pectoris	114
3	Cardiac failure	75
4	Heart rate increased	39
5	Myocardial infarction	32
6	Tachycardia	26
7	Angina unstable	25
8	Myocardial ischaemia	24
9	Coronary artery disease	20
10	Prophylaxis	11

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for CORLANOR

Total Reports Filed with FDA: 1412

Number of FDA Adverse Event Reports by Patient Age for CORLANOR

Total Reports Filed with FDA: 1412*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ivabradine hydrochloride (Corlanor)

Charts are based on 1412 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.