Prescription medicine
Methacholine Brand names: Provocholine
Methacholine (Provocholine) is a prescription medicine with an FDA approval on record since 1986. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the methacholine FDA label on DailyMed (effective July 15, 2026, Methapharm Inc.); the NDA 19193 record on Drugs@FDA; every methacholine label on DailyMed.
Highlights of the record
FDA label of July 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SEVERE BRONCHOCONSTRICTION WARNING: SEVERE BRONCHOCONSTRICTION.
Severe bronchoconstriction can result from Provocholine administration (including the lowest dose). The use of Provocholine is contraindicated in pediatric and adult patients with baseline FEV1 < 60% predicted or adults with FEV1 < 1.5 L. Because of the potential for severe bronchoconstriction, the use of Provocholine in patients with clinically apparent asthma or wheezing is not recommended [ see Warnings and Precautions (5.1) ]. Emergency equipment and medication should be immediately available to treat acute respiratory distress. If severe bronchoconstriction occurs, reverse immediately with a rapid-acting inhaled bronchodilator agent (β-agonist) [ see Warnings and Precautions (5.1) ]. If baseline spirometry is not performed or is measured inaccurately, the initial FEV1 may be underestimated. In this situation, decreases in FEV1 may not be detected after administration of escalating Provocholine doses, which may result in administration of unnecessary higher doses and an increased risk for excessive bronchoconstriction [ see Warnings and Precautions (5.1) ]. WARNING: SEVERE BRONCHOCONSTRICTION See full prescribing information for complete boxed warning. […]
Used for
From the label: indications and usageProvocholine, used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma.
Forms and strengths
- 100 mg
- 48 mg/3ml
Powder for solution; kit; solution.
On the market
- Earliest approval on file
- October 31, 1986 Provocholine, Methapharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 71 through July 30, 2026
What is methacholine used for?
From the label: indications and usageProvocholine, used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma. Provocholine, a cholinergic agonist used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma
FDA pharmacologic class: Cholinergic Receptor Agonist.
Source: FDA drug label (Provocholine), Methapharm Inc., effective July 15, 2026 (SPL set e8983096-65e6-41f2-8b6f-bbf0a7227307), via openFDA; the full label on DailyMed
Is there a generic for methacholine (Provocholine)?
No generic methacholine is approved (Drugs@FDA, October 8, 2026).
- 1986 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the methacholine label say about other medicines?
The methacholine label names 5 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Albuterol | drug interactions | Short-acting β-agonists (e.g., albuterol): Long-acting β-agonists (e.g., salmeterol): Short-acting anti-cholinergics (e.g., ipratropium): |
| Ipratropium | drug interactions | Short-acting β-agonists (e.g., albuterol): Long-acting β-agonists (e.g., salmeterol): Short-acting anti-cholinergics (e.g., ipratropium): |
| Salmeterol | drug interactions | Short-acting β-agonists (e.g., albuterol): Long-acting β-agonists (e.g., salmeterol): Short-acting anti-cholinergics (e.g., ipratropium): |
| Theophylline | drug interactions | Beta-Agonists, Anticholinergics, and Theophylline Beta-agonists, anticholinergics, and theophylline inhibit the response of airways to Provocholine; therefore, hold these drugs before Provocholine use for the following duration: |
| Tiotropium | drug interactions | Long-acting anti-cholinergics (e.g., tiotropium): ≥168 hours |
Source: FDA drug label (Provocholine), Methapharm Inc., effective July 15, 2026 (SPL set e8983096-65e6-41f2-8b6f-bbf0a7227307), via openFDA; the full label on DailyMed
What do FAERS reports show for methacholine?
The FDA Adverse Event Reporting System holds 71 reports that list methacholine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 14 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other cholinergic receptor agonists
- the pharmacologic class, with prices and generics
- Methacholine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other