Drug Safety Information for OMNARIS (Ciclesonide)

Safety-related Labeling Changes for ALVESCO (CICLESONIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for OMNARIS (CICLESONIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for ZETONNA (CICLESONIDE) Rx Drug: FDA Link

Adverse Drug Reactions for OMNARIS* (Ciclesonide)

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 OMNARIS
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Asthma*	228
2	Dyspnoea	224
3	Headache	159
4	Cough	156
5	Fatigue*	154
6	Nausea*	111
7	Dizziness	101
8	Malaise	98
9	Pneumonia	97
10	Nasopharyngitis	94
11	Drug ineffective	85
12	Sinusitis	82
13	Wheezing	76
14	Blood pressure increased	75
15	Pain	71
16	Heart rate increased	69
17	Oropharyngeal pain	66
18	Hypersensitivity	66
19	Fall	62
20	Asthenia	61

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	1752
2	Asthma*	892
3	Chronic obstructive pulmonary disease*	159
4	Rhinitis perennial	144
5	Hypersensitivity	139
6	Multiple allergies	107
7	Rhinitis	104
8	Rhinitis allergic*	97
9	Rhinorrhoea	72
10	Sinusitis*	69

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

Types of Adverse Events for OMNARIS

Total Reports Filed with FDA: 9273

Number of FDA Adverse Event Reports by Patient Age for OMNARIS

Total Reports Filed with FDA: 9273*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ciclesonide (Zetonna, Omnaris, Alvesco)

Charts are based on 9273 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.