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Rhinocort (Budesonide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Rhinocort (Budesonide) 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 (313)
Death (9)
Life Threatening Events (2)
Disability (2)

Reports by Reaction Type

Drug Dose Omission (66)Malaise (60)Dyspnoea (42)Intentional Drug Misuse (28)Sinusitis (28)Asthma (27)Gastrooesophageal Reflux Disease (27)Off Label Use (25)Drug Ineffective (22)Nasal Congestion (21)Headache (19)Insomnia (19)

Below are a few examples of reports where side effects / adverse reactions may be related to Rhinocort (Budesonide). For a complete list or a specific selection of reports, please use the links above.

Possible Rhinocort side effects in 57 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 57 year old female

Reactions: Migraine, Vomiting

Drug(s) suspected as cause:
Nexium
    Administration route: Oral

Rhinocort

Symbicort

Zomig
    Administration route: Oral



Possible Rhinocort side effects in 58 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-22

Patient: 58 year old male

Reactions: Drug Dose Omission, Dyspnoea, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Crestor
    Administration route: Oral

Mucinex

Rhinocort

Symbicort
    Dosage: 160/4.5 ug unknown frequency

Other drugs received by patient: Nexium



Possible Rhinocort side effects in

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient:

Reactions: Gastric Disorder

Drug(s) suspected as cause:
Nexium
    Administration route: Oral

Nexium
    Dosage: two times a day
    Administration route: Oral

Rhinocort

Symbicort
    Dosage: 160/4.5 mcg



Possible Rhinocort side effects in 60 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-22

Patient: 60 year old female

Reactions: Asthma, Malaise, Pulmonary Congestion, Incorrect Dose Administered, Epistaxis, Influenza

Drug(s) suspected as cause:
Nexium
    Administration route: Oral

Rhinocort

Symbicort
    Dosage: 160 / 4.5 mcg unknown frequency.



Possible Rhinocort side effects in 64 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 64 year old female

Reactions: Drug Dose Omission, Pneumonia, Dyspnoea, non-Cardiac Chest Pain, Malaise, Bronchitis, Nocturnal Dyspnoea, Arthritis, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Nexium
    Administration route: Oral

Pulmicort

Rhinocort

Symbicort
    Dosage: 160/4.5 mcg with unknown frequency
    Indication: Chronic Obstructive Pulmonary Disease

Other drugs received by patient: Prednisone TAB



Possible Rhinocort side effects in 4 year old male

Reported by a physician from Spain on 2012-08-16

Patient: 4 year old male, weighing 20.0 kg (44.0 pounds)

Reactions: Hepatitis Cholestatic

Drug(s) suspected as cause:
Acetaminophen
    Administration route: Oral
    Start date: 2011-01-01
    End date: 2012-03-01

Josamycin
    Administration route: Oral
    Start date: 2012-03-01
    End date: 2012-03-01

Rhinocort
    Start date: 2012-01-01



Possible Rhinocort side effects in 42 year old female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: 42 year old female

Reactions: Drug Dose Omission, Sinus Disorder, Insomnia, Pain, Headache

Drug(s) suspected as cause:
Atacand
    Administration route: Oral

Nexium
    Administration route: Oral

Rhinocort
    Dosage: 32 mcg, two sprays daily prn
    Indication: Sinusitis
    Start date: 2012-06-04



Possible Rhinocort side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: 62 year old female

Reactions: Headache, Sinusitis

Drug(s) suspected as cause:
Nexium
    Administration route: Oral

Rhinocort



Possible Rhinocort side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: female

Reactions: Nausea, Insomnia, Nasal Congestion, Intentional Drug Misuse, Cough, Epistaxis

Drug(s) suspected as cause:
Rhinocort



Possible Rhinocort side effects in 50 year old female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: 50 year old female

Reactions: Drug Dose Omission, Dyspepsia, Gastrooesophageal Reflux Disease, Eating Disorder

Drug(s) suspected as cause:
Nexium
    Administration route: Oral

Rhinocort



Possible Rhinocort side effects in 61 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-13

Patient: 61 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: Gingivitis, Eye Irritation, Gingival Disorder, Iron Deficiency, Intentional Drug Misuse, Headache, Nasal Congestion, Off Label Use, Visual Impairment, Vision Blurred, Sneezing, Sinusitis

Drug(s) suspected as cause:
Prilosec
    Administration route: Oral

Prilosec OTC
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Rhinocort
    Dosage: 2 sprays daily
    Start date: 2012-03-13
    End date: 2012-03-26

Rhinocort
    Dosage: 32 mcg 120 meter spray/unit
    Indication: Seasonal Allergy

Rhinocort
    Dosage: 32 mcg 120 meter spray/unit
    Indication: Sinus Disorder

Rhinocort
    Dosage: 2 puffs, prn

Rhinocort
    Dosage: 2 puffs, prn

Rhinocort
    Dosage: 2 sprays daily
    Start date: 2012-03-13
    End date: 2012-03-26

Rhinocort
    Dosage: 32 mcg 120 meter spray/unit
    Indication: Rhinitis Seasonal

Rhinocort
    Dosage: 2 puffs, prn

Rhinocort
    Dosage: 2 sprays daily
    Start date: 2012-03-13
    End date: 2012-03-26

Other drugs received by patient: Rolaids; Anacin; Antibiotics



Possible Rhinocort side effects in 57 year old female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 57 year old female

Reactions: Asthma

Drug(s) suspected as cause:
Rhinocort



Possible Rhinocort side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-12

Patient:

Reactions: Oral Candidiasis, Diarrhoea, Sleep Disorder, Pain, Oropharyngeal Pain, Cough

Drug(s) suspected as cause:
Metoprolol Tartrate
    Administration route: Oral

Prinivil
    Administration route: Oral

Rhinocort
    Dosage: 4 df, qd

Symbicort
    Dosage: 2 df, bid

Symbicort
    Dosage: 320 microgram, bid

Toprol-XL
    Administration route: Oral

Other drugs received by patient: Zantac; Diltiazem HCL; Aristocort (Triamcinolone); Ativan; Mobic; Nasacort AQ; Coreg; Proair HFA; Zyrtec; Procardia XL; Potassium (Unspecified); Aciphex; Cozaar; Lasix



Possible Rhinocort side effects in 65 year old female

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

Patient: 65 year old female

Reactions: Malaise, Dyspnoea, Bronchitis, Bronchial Hyperreactivity

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral

Rhinocort

Other drugs received by patient: Steroids



Possible Rhinocort side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient:

Reactions: Bone Fragmentation, Tinnitus, Osteoporosis, Drug Ineffective, Pain, Weight Increased, Abdominal Discomfort, Malaise, Intervertebral Disc Disorder, Hearing Impaired, Back Pain, Intervertebral Disc Protrusion, Mastoid Disorder, Drug Intolerance, Multiple Fractures, Nerve Compression, Paraesthesia, Dysstasia, Activities of Daily Living Impaired, Gait Disturbance

Drug(s) suspected as cause:
Celexa
    Dosage: unk

Hydrocodone Bitartrate
    Dosage: 5 mg/ 325mgunk

Hydrocodone Bitartrate
    Dosage: 10mg / 325mg

Nexium
    Administration route: Oral

Prinivil
    Administration route: Oral

Prolia
    Dosage: 7 mon

Rhinocort

Symbicort

Other drugs received by patient: Depakote; Calcium (Unspecified) (+) Vitamin D (Unspecified); Lamictal; Requip; Lipitor



Possible Rhinocort side effects in 88 year old female

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

Patient: 88 year old female

Reactions: Hearing Impaired

Drug(s) suspected as cause:
Nexium
    Administration route: Oral

Rhinocort



Possible Rhinocort side effects in 65 year old female

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

Patient: 65 year old female

Reactions: Regurgitation, Drug Dose Omission, Diabetic Foot, Pain, Diabetic Vascular Disorder, Hypokalaemia, Malaise, Insomnia

Drug(s) suspected as cause:
Nexium
    Administration route: Oral

Rhinocort

Other drugs received by patient: Plavix; Levothyroxine Sodium; Furosemide; Potassium Chloride Crys; Morphine Sulfate; Neurontin; Ferrous Sulfate TAB; Aspirin; Estradiol; Glyburide; Asmanex Twisthaler; Oxycontin; Mycelex; Lipitor; Zoloft; Vitamin D; Percocet; Premarin; Glimepiride; Ondansetron Hydrochloride; Alprazolam



Possible Rhinocort side effects in 50 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-09

Patient: 50 year old female, weighing 78.0 kg (171.6 pounds)

Reactions: Breast Cancer, Off Label Use

Drug(s) suspected as cause:
Crestor
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2005-01-01

Rhinocort
    Dosage: 2 spray each as required
    Indication: Rhinitis Allergic
    Start date: 2007-01-01

Seroquel
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2008-01-01

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2008-01-01



Possible Rhinocort side effects in 48 year old female

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

Patient: 48 year old female

Reactions: Blood Glucose Decreased, Throat Irritation, Intentional Drug Misuse, Laryngitis, Pharyngitis

Drug(s) suspected as cause:
Prednisone TAB

Rhinocort



Possible Rhinocort side effects in 66 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-08

Patient: 66 year old female

Reactions: Drug Dose Omission, Dyspnoea, Sleep Disorder DUE To General Medical Condition, Insomnia Type, Abnormal Behaviour, Nasal Congestion, Sinusitis, Breathing-Related Sleep Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nexium
    Administration route: Oral

Rhinocort

Seroquel XR
    Administration route: Oral



Possible Rhinocort side effects in 59 year old male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 59 year old male

Reactions: Myalgia, Drug Dose Omission, Dyspnoea, Adverse Reaction, Muscle Enzyme Increased

Drug(s) suspected as cause:
Crestor
    Administration route: Oral

Rhinocort



Possible Rhinocort side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: 64 year old male

Reactions: Memory Impairment

Drug(s) suspected as cause:
Atacand
    Administration route: Oral

Nexium
    Administration route: Oral

Rhinocort



Possible Rhinocort side effects in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: 61 year old female

Reactions: Drug Dose Omission, Intervertebral Disc Protrusion, Type 2 Diabetes Mellitus, Dyspepsia, Palpitations, Pain

Drug(s) suspected as cause:
Crestor
    Administration route: Oral

Nexium
    Administration route: Oral

Rhinocort

Toprol-XL
    Administration route: Oral



Possible Rhinocort side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: 64 year old male

Reactions: Brain Neoplasm, Lung Carcinoma Cell Type Unspecified Stage IV

Drug(s) suspected as cause:
Rhinocort



Possible Rhinocort side effects in 54 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-03

Patient: 54 year old female

Reactions: Asthma, Foot Fracture, Drug Dose Omission, Malaise, Gastric Disorder, Fall, Ligament Sprain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nexium
    Administration route: Oral

Rhinocort

Symbicort



Possible Rhinocort side effects in 53 year old female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 53 year old female, weighing 74.8 kg (164.6 pounds)

Reactions: Dyspnoea, Circumstance or Information Capable of Leading To Medication Error, Headache, Intentional Drug Misuse, Nasal Congestion, Facial Pain, Eye Pain, Rhinalgia, Medication Error, Sinus Headache, DRY Mouth, Dizziness, Adverse Event, Sinusitis, Epistaxis

Drug(s) suspected as cause:
Rhinocort

Rhinocort
    Dosage: 64 mcg 1 spray daily
    Indication: Rhinitis Allergic

Other drugs received by patient: Tegretol



Possible Rhinocort side effects in 50 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-02

Patient: 50 year old female, weighing 78.0 kg (171.6 pounds)

Reactions: Off Label Use, Breast Cancer

Drug(s) suspected as cause:
Crestor
    Administration route: Oral
    Indication: Blood Cholesterol

Rhinocort
    Dosage: 2 spray each as required
    Indication: Rhinitis Allergic
    Start date: 2007-01-01

Seroquel
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2008-01-01



Possible Rhinocort side effects in 55 year old male

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 55 year old male

Reactions: Drug Dose Omission, Seasonal Allergy, Malaise

Drug(s) suspected as cause:
Rhinocort



Possible Rhinocort side effects in 42 year old female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 42 year old female

Reactions: Drug Dose Omission, Insomnia, Pain, Headache

Drug(s) suspected as cause:
Atacand
    Administration route: Oral

Nexium
    Administration route: Oral

Rhinocort
    Dosage: 32 mcg, two sprays daily prn
    Indication: Sinusitis
    Start date: 2012-06-04



Possible Rhinocort side effects in 59 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-01

Patient: 59 year old female, weighing 50.8 kg (111.8 pounds)

Reactions: Activities of Daily Living Impaired, Pain in Extremity, Dizziness, Intentional Drug Misuse, Arthritis

Drug(s) suspected as cause:
Budesonide
    Dosage: 1 spray daily
    Indication: Rhinitis
    Start date: 2011-01-01
    End date: 2012-01-01

Rhinocort
    Dosage: 1 spray daily
    Start date: 2012-01-01

Rhinocort
    Indication: Rhinitis
    Start date: 2000-01-01
    End date: 2011-01-01

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