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Omnaris (Ciclesonide Nasal) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Omnaris (Ciclesonide Nasal) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (15)
Death (4)
Disability (1)

Reports by Reaction Type

Death (3)Dizziness (2)Vomiting (2)Confusional State (1)Drug Ineffective (1)Nasal Discomfort (1)Intraocular Pressure Increased (1)Upper-Airway Cough Syndrome (1)Road Traffic Accident (1)Face Oedema (1)Oedema Peripheral (1)Sinusitis (1)

Possible Omnaris side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Vision Blurred

Drug(s) suspected as cause:
Omnaris
    Dosage: unk
    Indication: Hypersensitivity
    Start date: 2012-07-20

Singulair
    Dosage: unk
    Administration route: Oral
    Start date: 2012-07-20

Other drugs received by patient: Nadolol; Nasonex; Synthroid



Possible Omnaris side effects in 19 year old male

Reported by a physician from Mexico on 2012-08-15

Patient: 19 year old male, weighing 80.0 kg (176.0 pounds)

Reactions: Road Traffic Accident

Adverse event resulted in: death

Drug(s) suspected as cause:
Omnaris



Possible Omnaris side effects in 51 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-13

Patient: 51 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Menstrual Disorder, Face Oedema, Oedema Peripheral, Deformity

Drug(s) suspected as cause:
Omnaris
    Indication: Rhinitis
    Start date: 2012-07-04
    End date: 2012-07-29

Omnaris
    Indication: Sinusitis
    Start date: 2012-07-04
    End date: 2012-07-29



Possible Omnaris side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Omnaris



Possible Omnaris side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Omnaris



Possible Omnaris side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: female

Reactions: Macular Degeneration

Drug(s) suspected as cause:
Omnaris



Possible Omnaris side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Omnaris



Possible Omnaris side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: female

Reactions: Sinusitis

Drug(s) suspected as cause:
Omnaris
    Start date: 2011-06-01
    End date: 2012-01-01

Triamcinolone
    Start date: 2012-01-01



Possible Omnaris side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-07-16

Patient: female, weighing 61.0 kg (134.2 pounds)

Reactions: Confusional State, Dyspnoea, Gastrointestinal Disorder, Cough

Drug(s) suspected as cause:
Formoterol Fumarate
    Dosage: 1 df, bid
    Indication: Hypersensitivity

Omnaris

Other drugs received by patient: Clonazepam; Dramin B-6; Tibolone; Citalopram Hydrobromide; Donarem Retard



Possible Omnaris side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-06-19

Patient: 65 year old female

Reactions: Borderline Glaucoma, Intraocular Pressure Increased

Drug(s) suspected as cause:
Omnaris

Other drugs received by patient: Zetia; Lisinopril; ALL Other Therapeutic Products



Possible Omnaris side effects in 32 year old male

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: 32 year old male, weighing 104.3 kg (229.5 pounds)

Reactions: Seasonal Allergy, Upper-Airway Cough Syndrome, Epistaxis

Drug(s) suspected as cause:
Omnaris
    Indication: Seasonal Allergy
    Start date: 2011-01-05

Rhinocort
    Start date: 2011-01-05



Possible Omnaris side effects in 64 year old male

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-06-12

Patient: 64 year old male

Reactions: Vomiting, Dizziness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Omnaris



Possible Omnaris side effects in 64 year old male

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-06-01

Patient: 64 year old male

Reactions: Vomiting, Dizziness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Omnaris



Possible Omnaris side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-22

Patient: male

Reactions: Nasal Discomfort, Drug Ineffective, Condition Aggravated

Drug(s) suspected as cause:
Flonase
    Indication: Product Used FOR Unknown Indication

Omnaris
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01



Possible Omnaris side effects in 56 year old female

Reported by a consumer/non-health professional from Germany on 2011-10-03

Patient: 56 year old female, weighing 79.0 kg (173.8 pounds)

Reactions: Off Label Use, Anosmia, Olfactory Nerve Disorder

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Omnaris

Other drugs received by patient: Antibiotics

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