Drug Safety Information for ZEMPLAR (Paricalcitol)

Adverse Drug Reactions for ZEMPLAR* (Paricalcitol)

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 ZEMPLAR
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Death	2874
2	Cardiac disorder	323
3	Dyspnoea	269
4	Nausea	252
5	Sepsis	232
6	Myocardial infarction	215
7	Vomiting	205
8	Adverse event	203
9	Fatigue	179
10	Cardiac failure	178
11	Diarrhoea	166
12	Asthenia	165
13	Dizziness	163
14	Fall	159
15	Oedema peripheral	148
16	Pain	144
17	Hypotension	144
18	Pruritus*	138
19	Cardiac arrest	138
20	Cerebrovascular accident	134

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

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

	Reason	# of FDA Reports
1	Hyperparathyroidism secondary	3308
2	Product used for unknown indication	2874
3	Renal failure	2674
4	Hyperparathyroidism	1538
5	Nephropathy	1461
6	Renal failure chronic	1352
7	Renal disorder	218
8	Dialysis	90
9	Hypoparathyroidism secondary	79
10	Renal transplant	66

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

Types of Adverse Events for ZEMPLAR

Total Reports Filed with FDA: 21569

Number of FDA Adverse Event Reports by Patient Age for ZEMPLAR

Total Reports Filed with FDA: 21569*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Paricalcitol (Paricalcitol, Paricalcitol abbvie, Zemplar)

Charts are based on 21569 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.