Zicam Side Effects
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Active Ingredient: ACETAMINO DEXTROMET ECHINACEA GALPHIMIA MENTHA PI OXYMETAZO ZINC ACET ZINC GLUC
Side Effects reported to FDA: 2405. View Zicam Adverse Reports
Reported hospitalizations: 6
Zicam Extreme Congestion Relief Nasal Gel: Recall - Contamination With Burkholderia Cepacia
ISSUE: Matrixx Initiatives notified the public of a recall of one lot of Zicam Extreme Congestion Relief nasal gel. Burkholderia cepacia was found in a single sample of the product taken from the affected lot. The problem was detected during a routine review at the manufacturing facility. Tests on additional samples from the same lot have shown no evidence of the organism.
Burkholderia cepacia poses little medical risk to healthy individuals. However, Burkholderia cepacia in a nasal spray could cause upper airway colonization and secondarily lead to respiratory infections in individuals with a compromised immune system or those with chronic lung conditions, such as cystic fibrosis. The organism is resistant to many antibiotics and may be difficult to eradicate in this sensitive population if an infection occurs.
The affected lot is 2J23, Expiration 09/15.
BACKGROUND: The product is a non-drip liquid nasal gel used as a nasal decongestant and is packaged in a 0.5 oz. spray bottle contained in an outer carton, bearing NDC number 62750-005-10. The product was distributed to retailers nationwide throughout the United States.
RECOMMENDATION: Matrixx is notifying its distributors and retail customers by FEDEX letter and by phone and is arranging for return of all recalled products. Consumers that have the affected lot of Zicam Extreme Congestion Relief nasal gel should stop using the product and contact Matrixx. See the Press Release for additional information.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
[12/18/2012 - Press Release - Matrixx Initiatives]
Zicam Adverse Reactions
Anosmia ( 1843 Reports)|Ageusia ( 1140 Reports)|Nasal Discomfort ( 270 Reports)|Hyposmia ( 236 Reports)|Burning Sensation ( 160 Reports)|Hypogeusia ( 151 Reports)|Dysgeusia ( 137 Reports)|Parosmia ( 132 Reports)|Rhinalgia ( 53 Reports)|Product Quality Issue ( 45 Reports)|Pain ( 44 Reports)|Headache ( 40 Reports)|Lacrimation Increased ( 33 Reports)|Nasal Congestion ( 33 Reports)|Sinus Disorder ( 31 Reports)|Epistaxis ( 29 Reports)|Rhinorrhoea ( 23 Reports)|Sinusitis ( 19 Reports)|Dyspnoea ( 18 Reports)|Weight Decreased ( 17 Reports)|Nausea ( 16 Reports)|Anxiety ( 15 Reports)|Depression ( 15 Reports)|Nasopharyngitis ( 15 Reports)|Throat Irritation ( 15 Reports)|Feeling Abnormal ( 14 Reports)|Eye Irritation ( 13 Reports)|No Therapeutic Response ( 13 Reports)|Sinus Headache ( 13 Reports)|Condition Aggravated ( 11 Reports)|