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 Disorders	Inhalation Site Sensation Inhalation Taste Sensation	6 4	9 3	2 3
Body as a Whole	Allergic Reaction/Symptoms Back Pain Fever	6 4 6	4 2 2	<1 3 5
Central and Peripheral Nervous System	Tremor	7	8	2
Gastrointestinal System	Nausea Vomiting	10 7	9 2	5 3
Heart Rate and Rhythm Disorder	Tachycardia	7	2	<1
Psychiatric Disorders	Nervousness	7	9	3
Respiratory System Disorders	Respiratory Disorder (unspecified) Rhinitis Upper Resp Tract Infection	6 16 21	4 22 20	5 14 18
Urinary System Disorder	Urinary Tract Infection	3	4	2

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 SIDE EFFECTS / ADVERSE REACTIONS RELATED TO PROVENTIL

Possible Proventil side effects / adverse reactions in 45 year old male

Reported by a pharmacist from United States on 2007-01-05

Patient: 45 year old male

Reactions: Dyspnoea, Drug Ineffective, Pharmaceutical Product Complaint

Suspect drug(s):
Proventil

Possible Proventil side effects / adverse reactions in 55 year old female

Reported by a consumer/non-health professional from United States on 2007-01-08

Patient: 55 year old female weighing 59.0 kg (129.7 pounds)

Reactions: Device Failure, Pharmaceutical Product Complaint

Adverse event resulted in: life threatening event

Suspect drug(s):
Proventil

Other drugs received by patient: Epipen

Possible Proventil side effects / adverse reactions in 31 year old female

Reported by a individual with unspecified qualification from United States on 2007-02-21

Patient: 31 year old female weighing 90.7 kg (199.6 pounds)

Reactions: Drug Ineffective, Headache, Pharmaceutical Product Complaint, Feeling Abnormal

Suspect drug(s):
Proventil

Possible Proventil side effects / adverse reactions in 54 year old female

Reported by a consumer/non-health professional from United States on 2007-07-02

Patient: 54 year old female weighing 81.6 kg (179.6 pounds)

Reactions: Systemic Candida, Asthma, Lung Infection, Condition Aggravated, Fungal Infection, Choking, Gastrointestinal Fungal Infection, Pharyngitis

Suspect drug(s):
Proventil

Possible Proventil side effects / adverse reactions in 59 year old male

Reported by a physician from United States on 2007-07-06

Patient: 59 year old male

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
K-DUR (Potassium Chloride) (20 Meq)
    Indication: Drug USE FOR Unknown Indication

Proventil
    Indication: Drug USE FOR Unknown Indication

Possible Proventil side effects / adverse reactions in 66 year old female

Reported by a physician from United States on 2007-07-09

Patient: 66 year old female

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Imdur
    Dosage: 60 mg;
    Indication: Drug USE FOR Unknown Indication

Proventil
    Dosage: 105 mg;
    Indication: Drug USE FOR Unknown Indication

Possible Proventil side effects / adverse reactions in 59 year old male

Reported by a physician from United States on 2007-07-20

Patient: 59 year old male weighing 136.1 kg (299.4 pounds)

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
K-DUR (Potassium Chloride) (20 Meq)
    Indication: Drug USE FOR Unknown Indication

Proventil
    Indication: Drug USE FOR Unknown Indication

Possible Proventil side effects / adverse reactions in 64 year old female

Reported by a individual with unspecified qualification from United States on 2007-10-04

Patient: 64 year old female

Reactions: Cranial Nerve Disorder, Dyskinesia, Shared Psychotic Disorder, Breakthrough Pain, Facial Pain, Obstructive Chronic Bronchitis With Acute Exacerbation, Pain in JAW

Adverse event resulted in: hospitalization

Suspect drug(s):
Ambien CR
    Start date: 2007-06-01
    End date: 2007-09-01

Fentanyl
    Start date: 2007-06-01
    End date: 2007-09-01

Prednisone
    End date: 2007-09-01

Proventil

Rebif
    Dosage: 44 mcg, 3 in 1 weeks, subcutaneous
    Indication: Multiple Sclerosis
    Start date: 2002-06-03

Wellbutrin
    End date: 2007-09-01

Other drugs received by patient: Advair (Seretide); Spiriva; Restoril; Aspirin; Toprol-XL; Coumadin

Possible Proventil side effects / adverse reactions in 46 year old female

Reported by a individual with unspecified qualification from United States on 2007-10-10

Patient: 46 year old female weighing 82.1 kg (180.6 pounds)

Reactions: Asthma, Dyspnoea, Drug Ineffective, Respiratory Arrest, Pharmaceutical Product Complaint, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization, disablity

Suspect drug(s):
Levalbuterol HCL

Proair HFA

Proventil
    Indication: Asthma

Proventil
    Indication: Chronic Obstructive Pulmonary Disease

Possible Proventil side effects / adverse reactions in 50 year old male

Reported by a consumer/non-health professional from United States on 2007-10-25

Patient: 50 year old male

Reactions: Drug Ineffective, Wheezing, Pharmaceutical Product Complaint

Suspect drug(s):
Advair Diskus 100/50
    Dosage: 1puff twice per day
    Indication: Asthma
    Start date: 2004-01-01

Proventil
    Dosage: 2puff as required
    Administration route: Oral
    Indication: Asthma
    Start date: 2007-01-01

Other drugs received by patient: Prevacid; Albuterol

Possible Proventil side effects / adverse reactions in 37 year old female

Reported by a consumer/non-health professional from United States on 2007-10-26

Patient: 37 year old female

Reactions: Anxiety, Dyspnoea, Thinking Abnormal, Palpitations, Crying

Suspect drug(s):
Advair Diskus 100/50
    Dosage: 1puff twice per day
    Indication: Upper Respiratory Tract Infection
    Start date: 2007-04-11
    End date: 2007-04-11

Proventil
    Dosage: 2puff as required
    Start date: 2007-04-11
    End date: 2007-04-13

Other drugs received by patient: Claritin; Protonix; Levaquin