DrugLib.com — Drug Information Portal

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

Albuterol HFA (Albuterol Sulfate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

A total of 973 subjects were treated with Albuterol Sulfate HFA Inhalation Aerosol during the worldwide clinical development program.

The adverse reaction information presented in the table below concerning Albuterol Sulfate HFA Inhalation Aerosol is derived from a 6-week, evaluator-blind study which compared Albuterol Sulfate HFA Inhalation Aerosol (180 mcg four times daily) with an HFA-134a placebo inhaler and an active comparator HFA-134a albuterol inhaler in 172 asthmatic patients 12 to 76 years of age. The table lists the incidence of all adverse events (whether considered by the investigator drug related or unrelated to drug) from this study which occurred at a rate of 3% or greater in the Albuterol Sulfate HFA Inhalation Aerosol treatment group and more frequently in the Albuterol Sulfate HFA Inhalation Aerosol treatment group than in the placebo group. Overall, the incidence and nature of the adverse events reported for Albuterol Sulfate HFA Inhalation Aerosol and the active comparator HFA-134a albuterol inhaler were comparable.

Adverse Experience Incidences (% of Patients) in a Six-Week Clinical Trial*
Body System/
Adverse Event (as Preferred Term)
Albuterol Sulfate Inhalation Aerosol
Active comparator HFA-134a Albuterol Inhaler HFA-134a Placebo Inhaler
(N = 58) (N = 56) (N = 58)
* This table includes all adverse events (whether considered by the investigator drug related or unrelated to drug) which occurred at an incidence rate of at least 3.0% in the Albuterol Sulfate HFA Inhalation Aerosol group and more frequently in the Albuterol Sulfate HFA Inhalation Aerosol group than in the HFA-134a placebo inhaler group.
Body as a WholeHeadache752
CardiovascularTachycardia320
MusculoskeletalPain300
Nervous SystemDizziness300
Respiratory Pharyngitis1479
SystemRhinitis542

Adverse events reported by less than 3% of the patients receiving Albuterol Sulfate HFA Inhalation Aerosol but by a greater proportion of Albuterol Sulfate HFA Inhalation Aerosol patients than placebo patients, which have the potential to be related to Albuterol Sulfate HFA Inhalation Aerosol, included chest pain, infection, diarrhea, glossitis, accidental injury (nervous system), anxiety, dyspnea, ear disorder, ear pain, and urinary tract infection. Adverse events reported by 3% or more patients receiving Albuterol Sulfate and by an equal or lesser proportion of Albuterol Sulfate HFA Inhalation Aerosol patients than placebo patients included asthma, back pain, increased cough and infection (respiratory).

The most frequent adverse events occurring in three studies conducted in 32 volunteers or 25 asthmatics in which Albuterol Sulfate HFA Inhalation Aerosol was administered as single cumulative albuterol doses of up to 1080 mcg over an hour (volunteers) or 1350 mcg over 1½ hours (asthmatics) were consistent with those associated with high-dose inhaled albuterol and included tremor, nervousness, and headache.

Rare cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles) have been reported after the use of inhaled albuterol. In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, insomnia, headache, and drying or irritation of the oropharynx.

Drug label data at the top of this Page last updated: 2006-10-09

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

All Rights reserved - Copyright DrugLib.com, 2006-2012