Drug Safety Information for NORPACE (Disopyramide phosphate)

Adverse Drug Reactions for NORPACE* (Disopyramide phosphate)

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 NORPACE
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug ineffective*	72
2	Atrial fibrillation	61
3	Drug interaction	46
4	Electrocardiogram qt prolonged	44
5	Dyspnoea	40
6	Malaise	40
7	Dizziness	38
8	Loss of consciousness	36
9	Torsade de pointes	34
10	Asthenia	33
11	Palpitations	31
12	Hypoglycaemia	31
13	Decreased appetite	31
14	Ventricular tachycardia	30
15	Constipation*	27
16	Nausea	26
17	Bradycardia	25
18	Fatigue	24
19	Arrhythmia	22
20	Headache	22

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

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

	Reason	# of FDA Reports
1	Atrial fibrillation	504
2	Arrhythmia	317
3	Product used for unknown indication	236
4	Ill-defined disorder	63
5	Cardiac disorder	58
6	Heart rate irregular	54
7	Hypertension	48
8	Ventricular extrasystoles	47
9	Supraventricular tachycardia	36
10	Syncope	33

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

Types of Adverse Events for NORPACE

Total Reports Filed with FDA: 3674

Number of FDA Adverse Event Reports by Patient Age for NORPACE

Total Reports Filed with FDA: 3674*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Disopyramide phosphate (Rhythmodan, Disopyramide, Norpace, Norpace cr)

Charts are based on 3674 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.