Does Nasacort AQ (triamcinolone acetonide) cause side effects?
Nasacort AQ (triamcinolone acetonide) is a corticosteroid nasal inhaler-spray used to relieve the symptoms of runny nose. Corticosteroids are naturally occurring hormones produced by the adrenal glands that prevent or suppress inflammation and immune responses.
When given by intranasal spray, Nasacort AQ provides relief from allergy symptoms such as
- allergy-induced watery nasal discharge (rhinorrhea),
- nasal congestion,
- postnasal drip,
- sneezing, and
- itching of the back of the throat.
Approximately 50% of the Nasacort AQ is absorbed into the blood. A beneficial response usually is noted within a few days but can take as long as 4 weeks.
Common side effects of Nasacort AQ include:
- nasal irritation and itching,
- increased cough,
- nausea or vomiting,
- sore throat,
- nasal congestion,
- sneezing,
- nasal burning,
- bloody nasal discharge,
- nasal dryness,
- dizziness, and
- watery eyes.
Serious side effects of Nasacort AQ include:
- nasal septal perforation,
- oral or nasal fungal infections,
- growth suppression in children,
- glaucoma,
- cataracts, and
- decreased production of cortisol by the adrenal glands.
No drug interactions have been described with Nasacort AQ.
Serious complications (including cleft palate and stillbirths) have been reported when oral corticosteroids were administered during pregnancy.
- It is unknown if the small amounts of corticosteroids that appear in the blood following intranasal use of Nasacort AQ carry the same risk.
- Nasacort AQ use during pregnancy should be avoided unless the physician feels that the potential therapeutic benefit justifies the potential risk to the fetus.
It is unknown if Nasacort AQ accumulates in breast milk. Other corticosteroids are excreted in breast milk.
- The effects on the child, if any, are unknown.
- Consult your doctor before breastfeeding.
What are the important side effects of Nasacort AQ (triamcinolone acetonide)?
The most common side effects following nasal inhalation of triamcinolone acetonide are
- nasal irritation and itching,
- increased cough,
- nausea or vomiting,
- sore throat,
- nasal congestion,
- sneezing,
- nasal burning,
- bloody nasal discharge, and
- nasal dryness.
Other adverse effects reported with intranasal triamcinolone acetonide include headache, dizziness, and watery eyes. All of these are either mild or uncommon.
Nasal septal perforation, oral or nasal fungal infections, growth suppression in children, glaucoma, cataracts, and decreased production of cortisol by the adrenal glands also may occur.
Nasacort AQ (triamcinolone acetonide) side effects list for healthcare professionals
Systemic and local corticosteroid use may result in the following:
- Epistaxis, Candida albicans infection, nasal septal perforation, impaired wound healing
- Glaucoma and Cataracts
- Immunosuppression
- Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction
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
Adverse reaction | Placebo (N=962) % | Nasacort AQ 220 mcg (N=857) % |
Pharyngitis | 3.6 | 5.1 |
Epistaxis | 0.8 | 2.7 |
Cough increased | 1.5 | 2.1 |
Coding dictionary for adverse events is Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART). |
- 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
Adverse reaction | Placebo (N=202) % | Nasacort AQ 110 mcg (N=179) % |
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 |
Coding dictionary for adverse events is Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART). |
- 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
Adverse reactions | Placebo (N=238) % | Nasacort AQ 110 mcg (N=236) % |
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 |
Coding dictionary for adverse events is Medical Dictionary for Regulatory Activities terminology (MedDRA) Version 8.1 |
- In the event of accidental overdose, an increased potential for these adverse experiences may be expected, but acute systemic adverse experiences are unlikely.
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:
Summary
Nasacort AQ (triamcinolone acetonide) is a corticosteroid nasal inhaler-spray used to relieve the symptoms of runny nose. Common side effects of Nasacort AQ include nasal irritation and itching, increased cough, nausea or vomiting, sore throat, nasal congestion, sneezing, nasal burning, bloody nasal discharge, nasal dryness, dizziness, and watery eyes. Nasacort AQ use during pregnancy should be avoided unless the physician feels that the potential therapeutic benefit justifies the potential risk to the fetus. It is unknown if Nasacort AQ accumulates in breast milk.
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Treatment & Diagnosis
Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.