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Atrovent HFA (Ipratropium Bromide) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The adverse reaction information concerning ATROVENT HFA Inhalation Aerosol is derived from two 12-week, double-blind, parallel group studies and one open-label, parallel group study that compared ATROVENT HFA Inhalation Aerosol, ATROVENT Inhalation Aerosol CFC, and placebo (in one study only) in 1,010 COPD patients. The following table lists the incidence of adverse events that occurred at a rate of greater than or equal to 3% in any ipratropium bromide group. Overall, the incidence and nature of the adverse events reported for ATROVENT HFA Inhalation Aerosol, ATROVENT Inhalation Aerosol CFC, and placebo were comparable.

TABLE 1 Adverse Experiences Reported in ≥ 3% of Patients in any Ipratropium Bromide Group
  Placebo-controlled 12 week Study 244.1405 and
Active-controlled 12 week Study 244.1408
 
Active-controlled 1-year Study 244.2453
  Atrovent
HFA
(N=243)
%
Atrovent
CFC
(N=183)
%
Placebo

(N=128)
%
Atrovent
HFA
(N=305)
%
Atrovent
CFC
(N=151)
%
Total With Any Adverse Event 63 68 72 91 87
BODY AS A WHOLE - GENERAL DISORDERS
   Back pain 2 3 2 7 3
   Headache 6 9 8 7 5
   Influenza-like symptoms 4 2 2 8 5
CENTRAL & PERIPHERAL NERVOUS SYSTEM DISORDERS
   Dizziness 3 3 2 3 1
GASTROINTESTINAL SYSTEM DISORDERS
   Dyspepsia 1 3 1 5 3
   Mouth dry 4 2 2 2 3
   Nausea 4 1 2 4 4
RESPIRATORY SYSTEM DISORDERS
   Bronchitis 10 11 6 23 19
   COPD exacerbation 8 14 13 23 23
   Coughing 3 4 6 5 5
   Dyspnea 8 8 4 7 4
   Rhinitis 4 2 4 6 2
   Sinusitis 1 4 3 11 14
   Upper respiratory tract infection 9 10 16 34 34
URINARY SYSTEM DISORDERS
   Urinary tract infection 2 3 1 10 8

In the one open label controlled study in 456 COPD patients, the overall incidence of adverse events was also similar between Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol and Atrovent® (ipratropium bromide) Inhalation Aerosol CFC formulations.

Overall, in the above mentioned studies, 9.3% of the patients taking 42 mcg ATROVENT HFA Inhalation Aerosol and 8.7% of the patients taking 42 mcg ATROVENT Inhalation Aerosol CFC reported at least one adverse event that was considered by the investigator to be related to the study drug. The most common drug-related adverse events were dry mouth (1.6% of ATROVENT HFA Inhalation Aerosol and 0.9% of ATROVENT Inhalation Aerosol CFC patients), and taste perversion (bitter taste) (0.9% of ATROVENT HFA Inhalation Aerosol and 0.3% of ATROVENT Inhalation Aerosol CFC patients).

As an anticholinergic drug, cases of precipitation or worsening of narrow-angle glaucoma, glaucoma, halo vision, conjunctival hyperaemia, corneal edema, mydriasis, acute eye pain, dry throat, hypotension, palpitations, urinary retention, tachycardia, constipation, bronchospasm, including paradoxical bronchospasm have been reported. Additional cases identified for ATROVENT seen in clinical trials include throat irritation, stomatitis, mouth edema, and vision blurred.

Allergic-type reactions such as skin rash, pruritus, angioedema including that of tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reactions have been reported (see CONTRAINDICATIONS ).

Post-Marketing Experience

In a 5-year placebo-controlled trial, hospitalizations for supraventricular tachycardia and/or atrial fibrillation occurred with an incidence rate of 0.5% in COPD patients receiving ATROVENT Inhalation Aerosol CFC.

Allergic-type reactions such as skin rash, angioedema including that of tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reactions have been reported, with positive rechallenge in some cases.

Additionally, urinary retention, mydriasis, gastrointestinal distress (diarrhea, nausea, vomiting), and bronchospasm, including paradoxical bronchospasm, hypersensitivity reactions, intraocular pressure increased, accommodation disorder, heart rate increased, pharyngeal edema, and gastrointestinal motility disorders have been reported during the post-marketing period with use of ATROVENT.



REPORTS OF SUSPECTED ATROVENT HFA SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Atrovent HFA side effects / adverse reactions in 63 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-14

Patient: 63 year old male

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Atrovent HFA



Possible Atrovent HFA side effects / adverse reactions in 82 year old male

Reported by a consumer/non-health professional from United States on 2011-10-19

Patient: 82 year old male

Reactions: Drug Ineffective

Suspect drug(s):
Atrovent HFA



Possible Atrovent HFA side effects / adverse reactions in 64 year old male

Reported by a physician from United States on 2011-12-12

Patient: 64 year old male

Reactions: Pharyngeal Oedema, Angioedema, Drug Interaction

Suspect drug(s):
Atrovent HFA

Spiriva
    Indication: Chronic Obstructive Pulmonary Disease

Other drugs received by patient: Lisinopril; Lopid; Perfor0mist; Simvastatin; Plavix; Metformin HCL; Pulmicort



See index of all Atrovent HFA side effect reports >>

Drug label data at the top of this Page last updated: 2010-07-28

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