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Proventil (Albuterol Sulfate Inhalation) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Adverse reaction information concerning PROVENTIL HFA Inhalation Aerosol is derived from a 12-week, double-blind, double-dummy study which compared PROVENTIL HFA Inhalation Aerosol, a CFC 11/12 propelled albuterol inhaler, and an HFA-134a placebo inhaler in 565 asthmatic patients. The following 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 PROVENTIL HFA Inhalation Aerosol treatment group and more frequently in the PROVENTIL HFA Inhalation Aerosol treatment group than in the placebo group. Overall, the incidence and nature of the adverse reactions reported for PROVENTIL HFA Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler were comparable.

Adverse Experience Incidences (% of patients) in a Large 12-week Clinical Trial*
Body System/
Adverse Event (Preferred Term)
PROVENTIL
HFA

Inhalation
Aerosol
(N=193)
CFC 11/12
Propelled
Albuterol Inhaler
(N=186)
HFA-134a
Placebo
Inhaler
(N=186)

*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 PROVENTIL HFA Inhalation Aerosol group and more frequently in the PROVENTIL HFA Inhalation Aerosol group than in the HFA-134a placebo inhaler group.

Application Site DisordersInhalation Site Sensation

Inhalation Taste Sensation
6

4
9

3
2

3
Body as a WholeAllergic
Reaction/Symptoms

Back Pain

Fever
6


4

6
4


2

2
<1


3

5
Central and Peripheral Nervous SystemTremor782
Gastrointestinal SystemNausea

Vomiting
10

7
9

2
5

3
Heart Rate and Rhythm DisorderTachycardia72<1
Psychiatric DisordersNervousness793
Respiratory System DisordersRespiratory Disorder
(unspecified)

Rhinitis

Upper Resp Tract
Infection
6


16

21
4


22

20
5


14

18
Urinary System DisorderUrinary Tract Infection342

Adverse events reported by less than 3% of the patients receiving PROVENTIL HFA Inhalation Aerosol, and by a greater proportion of PROVENTIL HFA Inhalation Aerosol patients thatn placebo patients, which have the potential to be related to PROVENTIL HFA Inhalation Aerosol include: dysphonia, increased sweating, dry mouth, chest pain, edema, rigors, ataxia, leg cramps, hyperkinesias, eructation, flatulence, tinnitus, diabetes mellitus, anxiety, depression, somnolence, rash. Palpitation and dizziness have also been observed with PROVENTIL HFA Inhalation Aerosol.

Adverse events reported in a 4-week pediatric clinical trail comparing PROVENTIL HFA Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler occurred at a low incidence rate and were similar to those seen in the adult trials.

In small, cumulative dose studies, tremor, nervousness, and headache appeared to be dose related.

Rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema 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.



REPORTS OF SUSPECTED PROVENTIL SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Proventil side effects / adverse reactions in 56 year old female

Reported by a consumer/non-health professional from United States on 2012-05-23

Patient: 56 year old female weighing 79.5 kg (174.9 pounds)

Reactions: Weight Decreased, Asthma, Dyspnoea, Hypersensitivity, Hypotension, Headache, Somnolence, Amnesia, Chronic Obstructive Pulmonary Disease, Bronchitis Chronic, Blood Glucose Increased, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Suspect drug(s):
Advair Diskus 100/50
    Indication: Asthma

Nardil
    Dosage: 15mg three times per day
    Administration route: Oral
    Indication: Panic Disorder

Proventil
    Indication: Asthma

Steroid
    Indication: Hypotension
    Start date: 2012-04-01

Other drugs received by patient: Xanax



Possible Proventil side effects / adverse reactions in 48 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-30

Patient: 48 year old female weighing 45.5 kg (100.1 pounds)

Reactions: Product Quality Issue, Drug Ineffective, Heart Rate Increased, Expired Drug Administered, Heart Rate Irregular

Suspect drug(s):
Proventil
    Indication: Product Used FOR Unknown Indication

Ventolin
    Dosage: 1puff at night
    Indication: Pneumothorax
    Start date: 2012-01-27
    End date: 2012-02-01

Other drugs received by patient: Spiriva



Possible Proventil side effects / adverse reactions in 60 year old male

Reported by a individual with unspecified qualification from United States on 2012-07-24

Patient: 60 year old male weighing 81.6 kg (179.5 pounds)

Reactions: OFF Label USE, Malaise

Suspect drug(s):
Proventil

Symbicort
    Dosage: 80/4.5, 2 puff, as needed

Symbicort
    Dosage: 80/4.5, 2 puff, twice a day
    Indication: Asthma

Other drugs received by patient: Losartan Potassium; Metformin Hydrochloride; Plavix



See index of all Proventil side effect reports >>

Drug label data at the top of this Page last updated: 2008-12-18

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