Home FDA labels 3a79526b-bcfe-4635-82a6-73cafe9b13eb FDA label 3a79526b-bcfe-4635-82a6-73cafe9b13eb 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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SPL set ID 769febba-671d-476b-b0c8-71489a2f9d20
SPL ID 3a79526b-bcfe-4635-82a6-73cafe9b13eb
Version 1
Effective date 2013-10-06
Source export date 2026-09-28
Source partition 12
Source file https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
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Import run 20260929T050834Z
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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 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, mydriasis, 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 All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials. PERCENT OF PATIENTS Ipratropium Metaproterenol Ipratropium/ Metaproterenol Albuterol Ipratropium/ Albuterol (500 mcg t.i.d.) (15 mg t.i.d.) (500 mcg t.i.d./ 15 mg t.i.d.) (2.5 mg t.i.d.) (500 mcg t.i.d./ 2.5 mg t.i.d.) n = 219 n = 212 n = 108 n = 205 n = 100 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 Sinusitus 2.3 2.8 0.9 5.4 4.0
adverse reactions table <table> <caption>All Adverse Events, from a Double-blind, Parallel, 12-week Study of patients with COPD<footnote ID="FOOT_5659">All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials.</footnote> </caption> <col/> <col/> <col/> <col/> <col/> <col/> <thead> <tr> <th valign="top"/> <th align="center" valign="top" colspan="5"> PERCENT OF PATIENTS</th> </tr> <tr> <th valign="bottom"/> <th align="center" valign="bottom"> <content styleCode="underline">Ipratropium</content> </th> <th align="center" valign="bottom"> <content styleCode="underline">Metaproterenol</content> </th> <th align="center" valign="bottom"> <content styleCode="underline">Ipratropium/ Metaproterenol</content> </th> <th align="center" valign="bottom"> <content styleCode="underline">Albuterol</content> </th> <th align="center" valign="bottom"> <content styleCode="underline">Ipratropium/ Albuterol</content> </th> </tr> <tr> <th valign="top"/> <th align="center" valign="top"> (500 mcg t.i.d.)</th> <th align="center" valign="top"> (15 mg t.i.d.)</th> <th align="center" valign="top"> (500 mcg t.i.d./ 15 mg t.i.d.)</th> <th align="center" valign="top"> (2.5 mg t.i.d.)</th> <th align="center" valign="top"> (500 mcg t.i.d./ 2.5 mg t.i.d.)</th> </tr> <tr> <th valign="top"/> <th align="center" valign="top"> n = 219</th> <th align="center" valign="top"> n = 212</th> <th align="center" valign="top"> n = 108</th> <th align="center" valign="top"> n = 205</th> <th align="center" valign="top"> n = 100</th> </tr> </thead> <tbody> <tr> <td valign="top"> <content styleCode="underline">Body as a Whole-General Disorders</content> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> </tr> <tr> <td valign="top"> Headache</td> <td align="center" valign="top"> 6.4</td> <td align="center" valign="top"> 5.2</td> <td align="center" valign="top"> 6.5</td> <td align="center" valign="top"> 6.3</td> <td align="center" valign="top"> 9.0</td> </tr> <tr> <td valign="top"> Pain</td> <td align="center" valign="top"> 4.1</td> <td align="center" valign="top"> 3.3</td> <td align="center" valign="top"> 0.9</td> <td align="center" valign="top"> 2.9</td> <td align="center" valign="top"> 5.0</td> </tr> <tr> <td valign="top"> Influenza-like symptoms</td> <td align="center" valign="top"> 3.7</td> <td align="center" valign="top"> 4.7</td> <td align="center" valign="top"> 6.5</td> <td align="center" valign="top"> 0.5</td> <td align="center" valign="top"> 1.0</td> </tr> <tr> <td valign="top"> Back Pain</td> <td align="center" valign="top"> 3.2</td> <td align="center" valign="top"> 1.9</td> <td align="center" valign="top"> 1.9</td> <td align="center" valign="top"> 2.4</td> <td align="center" valign="top"> 0.0</td> </tr> <tr> <td valign="top"> Chest Pain</td> <td align="center" valign="top"> 3.2</td> <td align="center" valign="top"> 4.2</td> <td align="center" valign="top"> 5.6</td> <td align="center" valign="top"> 2.0</td> <td align="center" valign="top"> 1.0</td> </tr> <tr> <td valign="top"> <content styleCode="underline">Cardiovascular Disorders</content> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> </tr> <tr> <td valign="top"> Hypertension/Hypertension Aggravated</td> <td align="center" valign="top"> 0.9</td> <td align="center" valign="top"> 1.9</td> <td align="center" valign="top"> 0.9</td> <td align="center" valign="top"> 1.5</td> <td align="center" valign="top"> 4.0</td> </tr> <tr> <td valign="top"> <content styleCode="underline">Central & Peripheral Nervous System</content> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> </tr> <tr> <td valign="top"> Dizziness</td> <td align="center" valign="top"> 2.3</td> <td align="center" valign="top"> 3.3</td> <td align="center" valign="top"> 1.9</td> <td align="center" valign="top"> 3.9</td> <td align="center" valign="top"> 4.0</td> </tr> <tr> <td valign="top"> Insomnia</td> <td align="center" valign="top"> 0.9</td> <td align="center" valign="top"> 0.5</td> <td align="center" valign="top"> 4.6</td> <td align="center" valign="top"> 1.0</td> <td align="center" valign="top"> 1.0</td> </tr> <tr> <td valign="top"> Tremor</td> <td align="center" valign="top"> 0.9</td> <td align="center" valign="top"> 7.1</td> <td align="center" valign="top"> 8.3</td> <td align="center" valign="top"> 1.0</td> <td align="center" valign="top"> 0.0</td> </tr> <tr> <td valign="top"> Nervousness</td> <td align="center" valign="top"> 0.5</td> <td align="center" valign="top"> 4.7</td> <td align="center" valign="top"> 6.5</td> <td align="center" valign="top"> 1.0</td> <td align="center" valign="top"> 1.0</td> </tr> <tr> <td valign="top"> <content styleCode="underline">Gastrointestinal System Disorders</content> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> </tr> <tr> <td valign="top"> Mouth Dryness</td> <td align="center" valign="top"> 3.2</td> <td align="center" valign="top"> 0.0</td> <td align="center" valign="top"> 1.9</td> <td align="center" valign="top"> 2.0</td> <td align="center" valign="top"> 3.0</td> </tr> <tr> <td valign="top"> Nausea</td> <td align="center" valign="top"> 4.1</td> <td align="center" valign="top"> 3.8</td> <td align="center" valign="top"> 1.9</td> <td align="center" valign="top"> 2.9</td> <td align="center" valign="top"> 2.0</td> </tr> <tr> <td valign="top"> Constipation</td> <td align="center" valign="top"> 0.9</td> <td align="center" valign="top"> 0.0</td> <td align="center" valign="top"> 3.7</td> <td align="center" valign="top"> 1.0</td> <td align="center" valign="top"> 1.0</td> </tr> <tr> <td valign="top"> <content styleCode="underline">Musculo-skeletal System Disorders</content> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> </tr> <tr> <td valign="top"> Arthritis</td> <td align="center" valign="top"> 0.9</td> <td align="center" valign="top"> 1.4</td> <td align="center" valign="top"> 0.9</td> <td align="center" valign="top"> 0.5</td> <td align="center" valign="top"> 3.0</td> </tr> <tr> <td valign="top"> <content styleCode="underline">Respiratory System Disorders (Lower)</content> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> </tr> <tr> <td valign="top"> Coughing</td> <td align="center" valign="top"> 4.6</td> <td align="center" valign="top"> 8.0</td> <td align="center" valign="top"> 6.5</td> <td align="center" valign="top"> 5.4</td> <td align="center" valign="top"> 6.0</td> </tr> <tr> <td valign="top"> Dyspnea</td> <td align="center" valign="top"> 9.6</td> <td align="center" valign="top"> 13.2</td> <td align="center" valign="top"> 16.7</td> <td align="center" valign="top"> 12.7</td> <td align="center" valign="top"> 9.0</td> </tr> <tr> <td valign="top"> Bronchitis</td> <td align="center" valign="top"> 14.6</td> <td align="center" valign="top"> 24.5</td> <td align="center" valign="top"> 15.7</td> <td align="center" valign="top"> 16.6</td> <td align="center" valign="top"> 20.0</td> </tr> <tr> <td valign="top"> Bronchospasm</td> <td align="center" valign="top"> 2.3</td> <td align="center" valign="top"> 2.8</td> <td align="center" valign="top"> 4.6</td> <td align="center" valign="top"> 5.4</td> <td align="center" valign="top"> 5.0</td> </tr> <tr> <td valign="top"> Sputum Increased</td> <td align="center" valign="top"> 1.4</td> <td align="center" valign="top"> 1.4</td> <td align="center" valign="top"> 4.6</td> <td align="center" valign="top"> 3.4</td> <td align="center" valign="top"> 0.0</td> </tr> <tr> <td valign="top"> Respiratory Disorder</td> <td align="center" valign="top"> 0.0</td> <td align="center" valign="top"> 6.1</td> <td align="center" valign="top"> 6.5</td> <td align="center" valign="top"> 2.0</td> <td align="center" valign="top"> 4.0</td> </tr> <tr> <td valign="top"> <content styleCode="underline">Respiratory System Disorders (Upper)</content> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> <td align="center" valign="top"> </td> </tr> <tr> <td valign="top"> Upper Respiratory Tract Infection</td> <td align="center" valign="top"> 13.2</td> <td align="center" valign="top"> 11.3</td> <td align="center" valign="top"> 9.3</td> <td align="center" valign="top"> 12.2</td> <td align="center" valign="top"> 16.0</td> </tr> <tr> <td valign="top"> Pharyngitis</td> <td align="center" valign="top"> 3.7</td> <td align="center" valign="top"> 4.2</td> <td align="center" valign="top"> 5.6</td> <td align="center" valign="top"> 2.9</td> <td align="center" valign="top"> 4.0</td> </tr> <tr> <td valign="top"> Rhinitis</td> <td align="center" valign="top"> 2.3</td> <td align="center" valign="top"> 4.2</td> <td align="center" valign="top"> 1.9</td> <td align="center" valign="top"> 2.4</td> <td align="center" valign="top"> 0.0</td> </tr> <tr> <td valign="top"> Sinusitus</td> <td align="center" valign="top"> 2.3</td> <td align="center" valign="top"> 2.8</td> <td align="center" valign="top"> 0.9</td> <td align="center" valign="top"> 5.4</td> <td align="center" valign="top"> 4.0</td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.