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

 
 



ADVERSE REACTIONS

Use of VENTOLIN HFA may be associated with the following:

•Paradoxical bronchospasm

[see Warnings and Precautions ]

•Cardiovascular effects

[see Warnings and Precautions]

•Immediate hypersensitivity reactions

[see Warnings and Precautions ]

•Hypokalemia

[see Warnings and Precautions]

 

The safety data described below reflects exposure to VENTOLIN HFA in 248 patients treated with VENTOLIN HFA in 3 placebo-controlled clinical trials of 2 to 12 weeks’ duration. The data from adults and adolescents is based upon 2 clinical trials in which 202 patients with asthma 12 years of age and older were treated with VENTOLIN HFA 2 inhalations 4 times daily for 12 weeks’ duration. The adult/adolescent population was 92 female, 110 male and 163 white, 19 black, 18 Hispanic, 2 other. The data from pediatric patients are based upon 1 clinical trial in which 46 patients with asthma 4 to 11 years of age were treated with VENTOLIN HFA 2 inhalations 4 times daily for 2 weeks’ duration. The population was 21 female, 25 male and 25 white, 17 black, 3 Hispanic, 1 other.

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 two 12-week, randomized, double-blind studies in 610 adolescent and adult patients with asthma that compared VENTOLIN HFA, a CFC 11/12-propelled albuterol inhaler, and an HFA-134a placebo inhaler. Overall, the incidence and nature of the adverse reactions reported for VENTOLIN HFA and a CFC 11/12-propelled albuterol inhaler were comparable. Table 1 lists the incidence of all adverse reactions (whether considered by the investigator to be related or unrelated to drug) from these studies that occurred at a rate of 3% or greater in the group treated with VENTOLIN HFA and more frequently in the group treated with VENTOLIN HFA than in the HFA-134a placebo inhaler group.

Table 1. Overall Adverse Reactions With ≥3% Incidence in 2 Large 12-Week Clinical Trials in Adolescents and Adultsa

Adverse Reaction

Percent of Patients

VENTOLIN HFA

(n = 202)

%

CFC 11/12-Propelled

Albuterol Inhaler

(n = 207)

%

Placebo HFA-134a

(n = 201)

%

Ear, nose, and throat

Throat irritation

10

6

7

Upper respiratory inflammation

5

5

2

Lower respiratory

Viral respiratory infections

7

4

4

Cough

5

2

2

Musculoskeletal

Musculoskeletal pain

5

5

4

aThis table includes all adverse reactions (whether considered by the investigator to be drug-related or unrelated to drug) that occurred at an incidence rate of at least 3.0% in the group treated with VENTOLIN HFA and more frequently in the group treated with VENTOLIN HFA than in the HFA-134a placebo inhaler group.

Adverse reactions reported by less than 3% of the adolescent and adult patients receiving VENTOLIN HFA and by a greater proportion of patients receiving VENTOLIN HFA than receiving HFA-134a placebo inhaler and that have the potential to be related to VENTOLIN HFA include diarrhea, laryngitis, oropharyngeal edema, cough, lung disorders, tachycardia, and extrasystoles. Palpitation and dizziness have also been observed with VENTOLIN HFA.

Pediatric Patients: Results from the 2-week pediatric clinical study in patients with asthma 4 to 11 years of age showed that this pediatric population had an adverse reaction profile similar to that of the adolescent and adult populations.

Three studies have been conducted to evaluate the safety and efficacy of VENTOLIN HFA in patients between birth and 4 years of age. The results of these studies did not establish the efficacy of VENTOLIN HFA in this age-group [see Pediatric Use]. Since the efficacy of VENTOLIN HFA has not been demonstrated in children between birth and 48 months of age, the safety of VENTOLIN HFA in this age-group cannot be established. However, the safety profile observed in the pediatric population under 4 years of age was comparable to that observed in the older pediatric patients and in adolescents and adults. Where adverse reaction incidence rates were greater in patients under 4 years of age compared with older patients, the higher incidence rates were noted in all treatment arms, including placebo. These adverse reactions included upper respiratory tract infection, nasopharyngitis, pyrexia, and tachycardia.

 

In addition to the adverse reactions listed in section 6.1, the following adverse reactions have been identified during postapproval use of VENTOLIN 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.

Cases of paradoxical bronchospasm, hoarseness, arrhythmias (including atrial fibrillation, supraventricular tachycardia), and hypersensitivity reactions (including urticaria, angioedema, rash) have been reported after the use of VENTOLIN HFA.

In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypokalemia, hypertension, peripheral vasodilatation, angina, tremor, central nervous system stimulation, hyperactivity, sleeplessness, headache, muscle cramps, drying or irritation of the oropharynx, and metabolic acidosis.

 



REPORTS OF SUSPECTED VENTOLIN HFA SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Ventolin HFA side effects / adverse reactions in 31 year old male

Reported by a consumer/non-health professional from Canada on 2011-10-05

Patient: 31 year old male

Reactions: Infertility

Suspect drug(s):
Ventolin HFA
    Indication: Respiratory Disorder
    End date: 2008-01-01

Advair Diskus 100/50
    Indication: Respiratory Disorder
    End date: 2008-01-01



Possible Ventolin HFA side effects / adverse reactions in 32 year old male

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

Patient: 32 year old male

Reactions: Overdose, Dyspnoea, Self-Medication

Suspect drug(s):
Ventolin HFA
    Indication: Product Used FOR Unknown Indication

Advair Diskus 100/50
    Indication: Product Used FOR Unknown Indication



Possible Ventolin HFA side effects / adverse reactions in 62 year old male

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

Patient: 62 year old male

Reactions: Multiple Allergies

Suspect drug(s):
Advair Diskus 100/50
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-02-13

Ventolin HFA
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-02-13

Veramyst
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-02-19



See index of all Ventolin HFA side effect reports >>

Drug label data at the top of this Page last updated: 2014-10-08

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