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Atrovent HFA

Last reviewed on RxList: 10/18/2016
Atrovent HFA Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 7/8/2016

Atrovent HFA (ipratropium bromide HFA) is an anticholinergic bronchodilator, packaged in an inhaler, used for maintenance and treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis, and emphysema. Atrovent HFA is available as a generic termed ipratropium bromide. Common side effects of Atrovent HFA include:

Tell your doctor if you experience serious side effects of Atrovent HFA including bronchospasm (wheezing, chest tightness, trouble breathing), eye pain, seeing halos around lights, pain or burning when you urinate, urinating less than usual or not at all, or worsening of your symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Atrovent HFA Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using ipratropium and call your doctor at once if you have a side effect such as:

  • bronchospasm (wheezing, chest tightness, trouble breathing), especially after starting a new canister of this medicine;
  • blurred vision, eye pain, or seeing halos around lights;
  • pain or burning when you urinate;
  • urinating less than usual or not at all; or
  • worsening of your symptoms.

Other common side effects may include:

  • headache, dizziness;
  • stuffy nose, sinus pain, dry mouth, cough, hoarseness;
  • nausea, upset stomach, constipation;
  • back pain; or
  • fever, chills, body aches, flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Atrovent HFA (Ipratropium Bromide Inhalation Aerosol)

Atrovent HFA Professional Information

SIDE EFFECTS

The following adverse reactions are described, or described in greater detail, in other sections:

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 patients.

Clinical Trials Experience

The adverse reaction information concerning ATROVENT HFA is derived from two 12-week, double-blind, parallel group studies and one 1-year open-label, parallel group study. These studies compared ATROVENT HFA Inhalation Aerosol, ATROVENT CFC Inhalation Aerosol, and placebo (in one study only) in 1010 COPD patients. The following table lists the incidence of adverse reactions that occurred at a rate of greater than or equal to 3% in any ipratropium bromide group and greater than placebo in the 12-week study. The frequency of corresponding reactions in the 1-year open label study is included for comparison.

TABLE 1 : Adverse Reactions (% Patients) in ATROVENT HFA Clinical Trials

  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)
%
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
  Dyspnea 8 8 4 7 4
  Sinusitis 1 4 3 11 14
URINARY SYSTEM DISORDERS
  Urinary tract infection 2 3 1 10 8

Cough, rhinitis, and upper respiratory infection occurred in greater than or equal to 3% of patients in either ipratropium treatment group but not greater than placebo in the 12-week study.

In the one open label controlled study in 456 COPD patients, the overall incidence of adverse events was also similar between ATROVENT HFA and ATROVENT CFC formulations.

Overall, in the above mentioned studies, 9.3% of the patients taking 42 mcg ATROVENT HFA and 8.7% of the patients taking 42 mcg ATROVENT 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 and 0.9% of ATROVENT CFC patients), and taste perversion (bitter taste) (0.9% of ATROVENT HFA and 0.3% of ATROVENT 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 with the use of ATROVENT. Additional adverse reactions 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 WARNINGS AND PRECAUTIONS].

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 CFC.

In addition to the adverse reactions reported in the controlled clinical trials, adverse reactions have been identified during post approval use of ATROVENT. 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.

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), cough 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.

Read the entire FDA prescribing information for Atrovent HFA (Ipratropium Bromide Inhalation Aerosol)

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