Prescription medicine
Terbutaline First approved as Bricanyl
Terbutaline (Bricanyl) is a prescription medicine with an FDA approval on record since 1974. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $0.947 per terbutaline sulfate 2.5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the terbutaline FDA label on DailyMed (effective November 15, 2019, ANI Pharmaceuticals, Inc.); the NDA 17466 record on Drugs@FDA; every terbutaline label on DailyMed.
Highlights of the record
FDA label of November 15, 2019; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
TOCOYSIS Oral terbutaline sulfate has not been approved for and should not be used for acute or maintenance tocolysis. In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting. During pregnancy, serious adverse reactions, including death, have been reported after administration of terbutaline sulfate to pregnant women. In the mother, these adverse reactions include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia. Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration. [See Contraindications-Tocolysis ]
Used for
From the label: indications and usageTerbutaline Sulfate Tablets USP are indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.
Forms and strengths
- 2.5 mg
- 5 mg
- 1 mg/ml
Tablet; injection; injection (solution).
On the market
- Earliest approval on file
- March 25, 1974 Bricanyl, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first June 26, 2001; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 9 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.947 per tablet Terbutaline sulfate 2.5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest July 2, 2013
- FAERS reports
- 1,823 through July 30, 2026
What is terbutaline used for?
From the label: indications and usageTerbutaline Sulfate Tablets USP are indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.
Source: FDA drug label (Terbutaline Sulfate), NDA017849 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective November 15, 2019 (SPL set d810a15b-3e10-4f6c-a36e-8ddecbaba9c3), via openFDA; the full label on DailyMed
Is there a generic for terbutaline (Bricanyl)?
The FDA approved the first generic terbutaline on June 26, 2001. 9 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists terbutaline from 9 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1974 earliest approval on file
- 2001 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for terbutaline (Bricanyl)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.947 per Terbutaline sulfate 2.5 mg tablet, up 2% from $0.929 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Terbutaline sulfate 5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Terbutaline sulfate 2.5 mg tablet | Generic | $0.947 per tablet | $28.40 | +2% |
| Terbutaline sulfate 5 mg tablet | Generic | $0.638 per tablet | $19.13 | -50% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has terbutaline been recalled?
The FDA's Enforcement Report lists 1 recall naming terbutaline since 2013: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup: TERBUTALINE SULFATE, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: SOTALOL HCL, Tablet, 80 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the terbutaline label say about other medicines?
The terbutaline label names no other medicine on this site. The labels of 19 other medicines name terbutaline. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name terbutaline
Source: FDA drug label (Terbutaline Sulfate), NDA017849 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective November 15, 2019 (SPL set d810a15b-3e10-4f6c-a36e-8ddecbaba9c3), via openFDA; the full label on DailyMed
What do FAERS reports show for terbutaline?
The FDA Adverse Event Reporting System holds 1,823 reports that list terbutaline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 166 are coded as a death and 872 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Terbutaline side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other