PROAIR RESPICLICK SIDE EFFECTS
- Generic Name: albuterol sulfate inhalation powder
- Brand Name: ProAir Respiclick
- Drug Class: Beta2 Agonists
SIDE EFFECTS
Use of PROAIR RESPICLICK may be associated with the following:
- Paradoxical bronchospasm
- Cardiovascular Effects
- Immediate hypersensitivity reactions
- Hypokalemia
Clinical Trials Experience
A total of 1289 subjects were treated with PROAIR RESPICLICK during the clinical development program. The most common adverse reactions (≥1% and > placebo) were back pain, pain, gastroenteritis viral, sinus headache, and urinary tract infection. 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 practice.
Adults And Adolescents 12 Years Of Age And Older
The adverse reaction information presented in Table 1 below concerning PROAIR RESPICLICK is derived from the 12-week blinded treatment period of three studies which compared PROAIR RESPICLICK 180 mcg four times daily with a double-blinded matched placebo in 653 asthmatic patients 12 to 76 years of age.
Table 1: Adverse Reactions Experienced by Greater Than or Equal to 1.0% of Adult and Adolescent Patients in the PROAIR RESPICLICK Group and Greater Than Placebo in three 12-Week Clinical Trials1
| Preferred Term | Number (%) of patients | |
| PROAIR RESPICLICK 180 mcg QID N=321 |
Placebo N=333 |
|
| Back pain | 6 (2%) | 4 (1%) |
| Pain | 5 (2%) | 2 (<1%) |
| Gastroenteritis viral | 4 (1%) | 3 (<1%) |
| Sinus headache | 4 (1%) | 3 (<1%) |
| Urinary tract infection | 4 (1%) | 3 (<1%) |
| 1 This table includes all adverse events (whether considered by the investigator drug related or unrelated to drug) which occurred at an incidence rate of greater than or equal to 1.0% in the PROAIR RESPICLICK group and greater than placebo. | ||
In a long-term study of 168 patients treated with PROAIR RESPICLICK for up to 52 weeks (including a 12-week double-blind period), the most commonly reported adverse events greater than or equal to 5% were upper respiratory infection, nasopharyngitis, sinusitis, bronchitis, cough, oropharyngeal pain, headache, and pyrexia.
In a small cumulative dose study, tremor, palpitations, and headache were the most frequently occurring (≥5%) adverse events.
Pediatric Patients 4 To 11 Years Of Age
The adverse reaction information presented in Table 2 below concerning PROAIR RESPICLICK is derived from a 3-week pediatric clinical trial which compared PROAIR RESPICLICK 180 mcg albuterol 4 times daily with a double-blinded matched placebo in 185 asthmatic patients 4 to 11 years of age.
Table 2: Adverse Reactions Experienced by Greater Than or Equal to 2.0% of Patients 4 to 11 Years of Age in the PROAIR RESPICLICK Group and Greater Than Placebo in the 3 Week Trial
| Preferred Term | Number (%) of patients | |
| PROAIR RESPICLICK 180 mcg QID N=93 |
Placebo N=92 |
|
| Nasopharyngitis | 2 (2%) | 1 (1%) |
| Oropharyngeal pain | 2 (2%) | 1 (1%) |
| Vomiting | 3 (3%) | 1 (1%) |
Postmarketing Experience
In addition to the adverse reactions reported from clinical trials with PROAIR RESPICLICK, the following adverse events have been reported during use of other inhaled albuterol sulfate products: Urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles), rare cases of aggravated bronchospasm, lack of efficacy, asthma exacerbation (potentially fatal), muscle cramps, and various oropharyngeal side-effects such as throat irritation, altered taste, glossitis, tongue ulceration, and gagging. 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.
In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as: angina, hypertension or hypotension, palpitations, central nervous system stimulation, insomnia, headache, nervousness, tremor, muscle cramps, drying or irritation of the oropharynx, hypokalemia, hyperglycemia, and metabolic acidosis.
SRC: NLM .