Drug Safety Information for OCUCLEAR (Oxymetazoline hydrochloride)

Adverse Drug Reactions for OCUCLEAR* (Oxymetazoline 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 OCUCLEAR
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug ineffective	337
2	Headache	180
3	Dyspnoea	179
4	Nasal discomfort	139
5	Pain	125
6	Dizziness	123
7	Fatigue	120
8	Nausea	120
9	Anosmia	111
10	Product quality issue	107
11	Drug effect decreased	95
12	Epistaxis	95
13	Nasal congestion	91
14	Insomnia	91
15	Diarrhoea	89
16	Rhinorrhoea	88
17	Cough	87
18	Drug dependence	84
19	Ageusia	82
20	Incorrect drug administration duration	82

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	2136
2	Nasal congestion*	750
3	Hypersensitivity	327
4	Seasonal allergy	166
5	Respiratory tract congestion	143
6	Sinus disorder	127
7	Sinusitis	118
8	Epistaxis	106
9	Nasopharyngitis	98
10	Multiple allergies	93

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

Types of Adverse Events for OCUCLEAR

Total Reports Filed with FDA: 13235

Number of FDA Adverse Event Reports by Patient Age for OCUCLEAR

Total Reports Filed with FDA: 13235*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Oxymetazoline hydrochloride (Nasal spray, Nasal decongestant, Oxymetazoline hcl, Anefrin nasal, Being well nasal, Care one nasal, Dg health nasal, Extra moisturizing, Good sense nasal, Health mart nasal, Leader nasal, No drip, Rx act nasal, Smart sense nasal, Sunmark nasal, Sunmark nasal spray, Sunmark no drip, Topcare nasal spray, Topcare sinus relief, Up and up nasal, Vicks sinex, Dristan 12 hr, No drip nasal mist, Sinufrin plus, Assured nasal relief, Shoprite nasal, Vicks qlearquil, Nostrilla, Afrin, Afrin no drip, Nasal mist, 12 hour nasal, Nasal relief, Mucinex nasal spray, Sudafed om, Nasal, Equate nasal, Sinufrin, Visine l.r., Ocuclear)

Charts are based on 13235 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.