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

 
 



ADVERSE REACTIONS

Use of PROAIR HFA may be associated with the following:

  • Paradoxical bronchospasm [see Warnings and Precautions ( 5.1 )]
  • Cardiovascular Effects [see Warnings and Precautions ( 5.4 )]
  • Immediate hypersensitivity reactions [see Warnings and Precautions ( 5.6 )]
  • Hypokalemia [see Warnings and Precautions ( 5.8 )]

Clinical Trials Experience

A total of 1090 subjects were treated with PROAIR HFA Inhalation Aerosol, or with the same formulation of albuterol as in PROAIR HFA Inhalation Aerosol, during the worldwide clinical development program.

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.

Adult and Adolescents 12 Years of Age and Older: The adverse reaction information presented in the table below concerning PROAIR HFA Inhalation Aerosol is derived from a 6-week, blinded study which compared PROAIR HFA Inhalation Aerosol (180 mcg four times daily) with a double-blinded matched placebo HFA-Inhalation Aerosol and an evaluator-blinded marketed 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 PROAIR HFA Inhalation Aerosol treatment group and more frequently in the PROAIR HFA Inhalation Aerosol treatment group than in the matched placebo group. Overall, the incidence and nature of the adverse events reported for PROAIR HFA Inhalation Aerosol and the marketed active comparator HFA-134a albuterol inhaler were comparable.

Adverse Experience Incidences (% of Patients) in a Six-Week Clinical TrialThis 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 PROAIR HFA Inhalation Aerosol group and more frequently in the PROAIR HFA Inhalation Aerosol group than in the placebo HFA Inhalation Aerosol group.
Body System/
Adverse Event (as Preferred Term)
PROAIR HFA Inhalation
Aerosol
(N = 58)
Marketed active comparator
HFA-134a
albuterol inhaler
(N = 56)
Matched Placebo
HFA-134a
Inhalation Aerosol
(N = 58)
Body as a Whole Headache 7 5 2
Cardiovascular Tachycardia 3 2 0
Musculoskeletal Pain 3 0 0
Nervous System Dizziness 3 0 0
Respiratory System Pharyngitis 14 7 9
Rhinitis 5 4 2

Adverse events reported by less than 3% of the patients receiving PROAIR HFA Inhalation Aerosol but by a greater proportion of PROAIR HFA Inhalation Aerosol patients than the matched placebo patients, which have the potential to be related to PROAIR HFA Inhalation Aerosol, included chest pain, infection, diarrhea, glossitis, accidental injury (nervous system), anxiety, dyspnea, ear disorder, ear pain, and urinary tract infection.

In small cumulative dose studies, tremor, nervousness, and headache were the most frequently occurring adverse events.

Pediatric Patients 4 to 11 Years of Age: Adverse events reported in a 3-week pediatric clinical trial comparing the same formulation of albuterol as in PROAIR HFA Inhalation Aerosol (180 mcg albuterol four times daily) to a matching placebo HFA inhalation aerosol occurred at a low incidence rate (no greater than 2% in the active treatment group) and were similar to those seen in adult and adolescent trials.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of PROAIR HFA. 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. Reports have included rare cases of aggravated bronchospasm, lack of efficacy, asthma exacerbation (reported fatal in one case), muscle cramps, and various oropharyngeal side-effects such as throat irritation, altered taste, glossitis, tongue ulceration, and gagging.

The following adverse events have been observed in postapproval use of inhaled albuterol: urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles). 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.



REPORTS OF SUSPECTED PROAIR HFA SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Proair HFA side effects / adverse reactions in 12 year old female

Reported by a physician from United States on 2011-10-03

Patient: 12 year old female

Reactions: Feeling Jittery, Cough

Suspect drug(s):
Proair HFA



Possible Proair HFA side effects / adverse reactions in 58 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-17

Patient: 58 year old male

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Proair HFA



Possible Proair HFA side effects / adverse reactions in 57 year old male

Reported by a physician from United States on 2011-11-03

Patient: 57 year old male

Reactions: Nausea

Suspect drug(s):
Enbrel
    Dosage: 50 mg, qwk
    Indication: Product Used FOR Unknown Indication

Proair HFA
    Dosage: unk

Other drugs received by patient: Lisinopril; Ibuprofen; Prednisone; Omeprazole; Gemfibrozil; Folic Acid; Methotrexate; Plaquenil; Symbicort; Naproxen



See index of all Proair HFA side effect reports >>

Drug label data at the top of this Page last updated: 2011-11-04

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