Terbutaline is a prescription medicine 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. MedsAcross supplies Terbutaline for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Terbutaline 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: US FDA prescribing information
Adults The usual oral dose of terbutaline sulfate tablets for adults is 5 mg administered at approximately six-hour intervals, three times daily, during the hours the patient is usually awake. If side effects are particularly disturbing, the dose may be reduced to 2.5 mg three times daily, and still provide a clinically significant improvement in pulmonary function. The total dose within 24 hours should not exceed 15 mg. Children Terbutaline sulfate tablets are not recommended for use in children below the age of 12 years. A dosage of 2.5 mg three times daily is recommended for children 12 to 15 years of age. The total dose within 24 hours should not exceed 7.5 mg. If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma that would require reassessment of therapy.
Source: US FDA prescribing information
1. Tocolysis Oral terbutaline sulfate is contraindicated for the treatment of acute or maintenance tocolysis. 2. Hypersensitivity Terbutaline sulfate is contraindicated in patients known to be hypersensitive to sympathomimetic amines or any component of this drug product.
Source: US FDA prescribing information
Boxed warning (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. Deterioration of Asthma Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of terbutaline sulfate tablets than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
Source: US FDA prescribing information
Adverse reactions observed with terbutaline sulfate are similar to those commonly seen with other sympathomimetic amines. All of these reactions are generally transient in nature and usually do not require treatment. The frequency of these side effects appears to diminish with continued therapy. The following table lists the adverse reactions seen in 199 patients treated with terbutaline sulfate tablets during six double-blind crossover studies and four double-blind parallel studies (short- and long-term) performed in the United States. Percent Incidence of Adverse Reactions (Total Daily Dosage Range 5 to 15 mg) Terbutaline N=199 Reaction % Nervous System Nervousness
Source: US FDA prescribing information
The concomitant use of terbutaline sulfate tablets with other sympathomimetic agents is not recommended, since the combined effect on the cardiovascular system may be deleterious to the patient. However, this does not preclude the use of an aerosol bronchodilator of the adrenergic-stimulant type for the relief of an acute bronchospasm in patients receiving chronic oral therapy with terbutaline sulfate tablets.
Source: US FDA prescribing information
Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
3 presentations of Terbutaline, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Terbutaline 2.5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Terbutaline 5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Terbutaline 1 mg/1 mL injectionSubcutaneousGeneric name | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 25 March 1974 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Terbutaline in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 3 presentations of Terbutaline and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Terbutaline on 25 March 1974, according to Drugs@FDA.
No listed presentation of Terbutaline is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Terbutaline is classified under ATC code R03AC03 (Terbutaline).
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