DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Nasacort AQ (Triamcinolone Acetonide) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Systemic and local corticosteroid use may result in the following:

  • Epistaxis, Candida albicans infection, nasal septal perforation, impaired wound healing [see Warnings and Precautions]
  • Glaucoma and Cataracts [see Warnings and Precautions]
  • Immunosuppression [see Warnings and Precautions]
  • Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction [see Warnings and Precautions (5.4, 5.5), Use in Specific Populations and Clinical Pharmacology]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In placebo-controlled, double-blind, and open-label clinical studies, 1483 adults and children 12 years and older received treatment with NASACORT AQ Nasal Spray. These patients were treated for an average duration of 51 days. In the controlled trials (2–5 weeks duration) from which the following adverse reaction data are derived, 1394 patients were treated with NASACORT AQ Nasal Spray for an average of 19 days. In a long-term, open-label study, 172 patients received treatment for an average duration of 286 days. Adverse reactions from 12 studies in adults and adolescent patients 12 to 17 years of age receiving NASACORT AQ Nasal Spray 27.5 mcg to 440 mcg once daily are summarized in Table 1.

In clinical trials, nasal septum perforation was reported in one adult patient who received NASACORT AQ Nasal Spray.

Table 1 - Adverse drug reactions > 2% and greater than placebo with NASACORT AQ Nasal Spray 220 mcg treatment in studies in adults and adolescents 12 years and older
Placebo
(N=962)
NASACORT AQ 220 mcg
(N=857)
Adverse reaction % %
Coding dictionary for adverse events is Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART).
Pharyngitis 3.6 5.1
Epistaxis 0.8 2.7
Cough increased 1.5 2.1

A total of 602 children 6 to 12 years of age were studied in 3 double-blind, placebo-controlled clinical trials. Of these, 172 received 110 mcg/day and 207 received 220 mcg/day of NASACORT AQ Nasal Spray for two, six, or twelve weeks. The longest average durations of treatment for patients receiving 110 mcg/day and 220 mcg/day were 76 days and 80 days, respectively. One percent of patients treated with NASACORT AQ were discontinued due to adverse experiences. No patient receiving 110 mcg/day and one patient receiving 220mcg/day discontinued due to a serious adverse event. A similar adverse reaction profile was observed in pediatric patients 6–12 years of age as compared to adolescents and adults with the exception of epistaxis which occurred in less than 2% of the children studied. Adverse reactions from 2 studies in children 4 to 12 years of age receiving NASACORT AQ Nasal Spray 110 mcg once daily are summarized in Table 2.

Table 2 - Adverse drug reactions > 2% and greater than placebo with NASACORT AQ Nasal Spray 110 mcg treatment in US studies in patients 4 to 12 years of age
Placebo
(N=202)
NASACORT AQ 110 mcg
(N=179)
Adverse reaction % %
Coding dictionary for adverse events is Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART).
Flu syndrome 7.4 8.9
Cough increased 6.4 8.4
Pharyngitis 6.4 7.8
Bronchitis 1.0 3.4
Dyspepsia 1.0 3.4
Tooth disorder 1.0 3.4

A total of 474 children 2 to 5 years of age were studied in a 4-week double-blind, placebo-controlled clinical trial. Of these, 236 received 110 mcg/day of NASACORT AQ Nasal Spray for a mean duration of 28 days. No patient discontinued due to a serious adverse event. Adverse reactions from the single placebo-controlled study in children 2 to 5 years of age receiving NASACORT AQ Nasal Spray 110 mcg once daily are summarized in Table 3.

Table 3 - Adverse drug reactions > 2% and greater than placebo with NASACORT AQ Nasal Spray 110 mcg treatment in children 2 to 5 years of age
Placebo
(N=238)
NASACORT AQ 110 mcg
(N=236)
Adverse reactions % %
Coding dictionary for adverse events is Medical Dictionary for Regulatory Activities terminology (MedDRA) Version 8.1
Headache 4.2 5.5
Pharyngolaryngeal pain 4.2 5.5
Epistaxis 5.0 5.1
Nasopharyngitis 3.8 5.1
Abdominal upper pain 0.8 4.7
Diarrhea 1.3 3.0
Asthma 2.1 2.5
Rash 1.7 2.5
Excoriation 0.0 2.5
Rhinorrhea 1.7 2.1

In the event of accidental overdose, an increased potential for these adverse experiences may be expected, but acute systemic adverse experiences are unlikely [see Overdosage].

Post-Marketing Experience

In addition to the adverse drug reactions reported during clinical studies and listed above, the following adverse reactions have been identified during post-approval use of NASACORT AQ Nasal Spray. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Reactions that have been reported during post-marketing experience include: nasal discomfort and congestion, sneezing, alterations of taste and smell, nausea, insomnia, dizziness, fatigue, dyspnea, decreased blood cortisol, cataract, glaucoma, increased ocular pressure, pruritus, rash, and hypersensitivity.



REPORTS OF SUSPECTED NASACORT AQ SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Nasacort AQ. The information is not vetted and should not be considered as verified clinical evidence.

Possible Nasacort AQ side effects / adverse reactions in 64 year old male

Reported by a consumer/non-health professional from United States on 2011-10-28

Patient: 64 year old male

Reactions: Tooth Loss, Gingival Recession, Dental Caries, Toothache, Gingival Infection

Suspect drug(s):
Advair Diskus 100/50
    Dosage: 1puff twice per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-01-01

Nasacort AQ
    Dosage: 2spr per day
    Indication: Multiple Allergies
    Start date: 2009-01-01

Other drugs received by patient: Calcium Carbonate; Atrovent; Vitamin D; Probiotics; Ativan; Avapro; Ascorbic Acid; Multi-Vitamin



Possible Nasacort AQ side effects / adverse reactions in 62 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-08

Patient: 62 year old female weighing 65.3 kg (143.7 pounds)

Reactions: Nasal Septum Perforation

Suspect drug(s):
Nasacort AQ



See index of all Nasacort AQ side effect reports >>

Drug label data at the top of this Page last updated: 2013-07-11

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017