Home FDA labels 3249e47e-0ac1-e2a5-e063-6394a90a9993 Ipratropium Bromide openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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Brand name Ipratropium Bromide
Generic name IPRATROPIUM BROMIDE
Manufacturer Nephron Pharmaceuticals Corporation
Product type HUMAN PRESCRIPTION DRUG
SPL set ID db8095db-d1fd-4099-9fb1-d1ad4e284976
SPL ID 3249e47e-0ac1-e2a5-e063-6394a90a9993
Version 6
Effective date 2025-04-08
Source export date 2026-09-28
Source partition 7
Source file https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:47:30 Harmonized routes table Harmonized routes RESPIRATORY (INHALATION)
Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
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warnings WARNINGS The use of ipratropium bromide inhalation solution as a single agent for the relief of bronchospasm in acute COPD exacerbation has not been adequately studied. Drugs with faster onset of action may be preferable as initial therapy in this situation. Combination of ipratropium bromide inhalation solution and beta agonists has not been shown to be more effective than either drug alone in reversing the bronchospasm associated with acute COPD exacerbation. Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal edema.
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adverse reactions ADVERSE REACTIONS Adverse reaction information concerning ipratropium bromide inhalation solution is derived from 12-week active-controlled clinical trials. Additional information is derived from foreign post-marketing experience and the published literature. All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials appear in the table below. Additional adverse reactions reported in less than three percent of the patients treated with ipratropium bromide include tachycardia, palpitations, eye pain, urinary retention, urinary tract infection and urticaria. Cases of precipitation or worsening of narrow-angle glaucoma and acute eye pain have been reported. Lower respiratory adverse reactions (bronchitis, dyspnea and bronchospasm) were the most common events leading to discontinuation of ipratropium bromide therapy in the 12-week trials. Headache, mouth dryness and aggravation of COPD symptoms are more common when the total daily dose of ipratropium bromide equals or exceeds 2,000 mcg. Allergic-type reactions such as skin rash, angioedema of tongue, lips and face, urticaria, laryngospasm and anaphylactic reaction have been reported. Many of the patients had a history of allergies to other drugs and/or foods. All Adverse Events, from a Double-blind, Parallel, 12-week Study of Patients with COPD* PERCENT OF PATIENTS Ipratropium Bromide (500 mcg t.i.d) n=219 Metaproterenol (15 mg t.i.d) n=212 Ipratropium Bromide/ Metaproterenol (500 mcg t.i.d/15 mg t.i.d) n=108 Albuterol (2.5 mg t.i.d) n=205 Ipratropium Bromide/ Albuterol (500 mcg t.i.d/ 2.5 mg t.i.d) n=100 *All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trial. Body as a Whole-General Disorders Headache 6.4 5.2 6.5 6.3 9.0 Pain 4.1 3.3 0.9 2.9 5.0 Influenza-like symptoms 3.7 4.7 6.5 0.5 1.0 Back Pain 3.2 1.9 1.9 2.4 0.0 Chest Pain 3.2 4.2 5.6 2.0 1.0 Cardiovascular Disorders Hypertension/ hypertension Aggravated 0.9 1.9 0.9 1.5 4.0 Central & Peripheral Nervous System Dizziness 2.3 3.3 1.9 3.9 4.0 Insomnia 0.9 0.5 4.6 1.0 1.0 Tremor 0.9 7.1 8.3 1.0 0.0 Nervousness 0.5 4.7 6.5 1.0 1.0 Gastrointestinal System Disorders Mouth Dryness 3.2 0.0 1.9 2.0 3.0 Nausea 4.1 3.8 1.9 2.9 2.0 Constipation 0.9 0.0 3.7 1.0 1.0 Musculo-skeletal System Disorders Arthritis 0.9 1.4 0.9 0.5 3.0 Respiratory System Disorders (Lower) Coughing 4.6 8.0 6.5 5.4 6.0 Dyspnea 9.6 13.2 16.7 12.7 9.0 Bronchitis 14.6 24.5 15.7 16.6 20.0 Bronchospasm 2.3 2.8 4.6 5.4 5.0 Sputum Increased 1.4 1.4 4.6 3.4 0.0 Respiratory Disorder 0.0 6.1 6.5 2.0 4.0 Respiratory System Disorders (Upper) Upper Respiratory Tract Infection 13.2 11.3 9.3 12.2 16.0 Pharyngitis 3.7 4.2 5.6 2.9 4.0 Rhinitis 2.3 4.2 1.9 2.4 0.0 Sinusitis 2.3 2.8 0.9 5.4 4.0
adverse reactions table <table frame="void" width="679"><caption> All Adverse Events, from a Double-blind, Parallel, 12-week Study of Patients with COPD* </caption><thead><tr><td align="center" colspan="6" styleCode="BotruleLruleRruleToprule" valign="top"><content styleCode="bold">PERCENT OF PATIENTS</content></td></tr><tr><td align="left" styleCode="BotruleLruleRrule" valign="top"/><td align="center" styleCode="BotruleLruleRrule" valign="top"> Ipratropium Bromide (500 mcg t.i.d) n=219 </td><td align="center" styleCode="BotruleLruleRrule" valign="top"> Metaproterenol (15 mg t.i.d) n=212 </td><td align="center" styleCode="BotruleLruleRrule" valign="top"> Ipratropium Bromide/ Metaproterenol (500 mcg t.i.d/15 mg t.i.d) n=108 </td><td align="center" styleCode="BotruleLruleRrule" valign="top"> Albuterol (2.5 mg t.i.d) n=205 </td><td align="center" styleCode="BotruleLruleRrule" valign="top"> Ipratropium Bromide/ Albuterol (500 mcg t.i.d/ 2.5 mg t.i.d) n=100 </td></tr></thead><tfoot><tr><td align="left" colspan="6" styleCode="Toprule" valign="top"> *All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trial. </td></tr></tfoot><tbody><tr><td colspan="6" styleCode="BotruleLruleRruleToprule" valign="top"><content styleCode="underline">Body as a Whole-General Disorders</content></td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Headache</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">6.4</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">5.2</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">6.5</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">6.3</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">9.0</td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Pain</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">4.1</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">3.3</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">2.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">5.0</td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Influenza-like symptoms</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">3.7</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">4.7</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">6.5</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.5</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.0</td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Back Pain</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">3.2</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">2.4</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.0</td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Chest Pain</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">3.2</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">4.2</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">5.6</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">2.0</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.0</td></tr><tr><td colspan="6" styleCode="BotruleLruleRruleToprule" valign="top"><content styleCode="underline">Cardiovascular Disorders</content></td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Hypertension/ hypertension Aggravated</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.5</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">4.0</td></tr><tr><td colspan="6" styleCode="BotruleLruleRruleToprule" valign="top"><content styleCode="underline">Central & Peripheral Nervous System</content></td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Dizziness</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">2.3</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">3.3</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">3.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">4.0</td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Insomnia</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.5</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">4.6</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.0</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.0</td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Tremor</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">7.1</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">8.3</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.0</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.0</td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Nervousness</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.5</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">4.7</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">6.5</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.0</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.0</td></tr><tr><td colspan="6" styleCode="BotruleLruleRruleToprule" valign="top"><content styleCode="underline">Gastrointestinal System Disorders</content></td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Mouth Dryness</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">3.2</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.0</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">2.0</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">3.0</td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Nausea</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">4.1</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">3.8</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">2.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">2.0</td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Constipation</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.0</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">3.7</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.0</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.0</td></tr><tr><td colspan="6" styleCode="BotruleLruleRruleToprule" valign="top"><content styleCode="underline">Musculo-skeletal System Disorders</content></td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Arthritis</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.4</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.5</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">3.0</td></tr><tr><td colspan="6" styleCode="BotruleLruleRruleToprule" valign="top"><content styleCode="underline">Respiratory System Disorders (Lower)</content></td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Coughing</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">4.6</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">8.0</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">6.5</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">5.4</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">6.0</td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Dyspnea</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">9.6</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">13.2</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">16.7</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">12.7</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">9.0</td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Bronchitis</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">14.6</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">24.5</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">15.7</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">16.6</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">20.0</td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Bronchospasm</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">2.3</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">2.8</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">4.6</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">5.4</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">5.0</td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Sputum Increased</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.4</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.4</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">4.6</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">3.4</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.0</td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Respiratory Disorder</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.0</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">6.1</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">6.5</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">2.0</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">4.0</td></tr><tr><td colspan="6" styleCode="BotruleLruleRruleToprule" valign="top"><content styleCode="underline">Respiratory System Disorders (Upper)</content></td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Upper Respiratory Tract Infection</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">13.2</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">11.3</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">9.3</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">12.2</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">16.0</td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Pharyngitis</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">3.7</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">4.2</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">5.6</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">2.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">4.0</td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Rhinitis</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">2.3</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">4.2</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">1.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">2.4</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.0</td></tr><tr><td styleCode="BotruleLruleRruleToprule" valign="middle">Sinusitis</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">2.3</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">2.8</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">0.9</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">5.4</td><td align="center" styleCode="BotruleLruleRruleToprule" valign="middle">4.0</td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.