What the label lists and what reports show
Terbutaline side effects
Terbutaline's FDA label lists its adverse reactions in its own words. FAERS holds 1,823 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (423 reports).
- Generic listed
- Boxed warning
Check it at the source: the terbutaline FDA label on DailyMed (effective November 15, 2019, ANI Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsAdverse 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. …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | Percent Incidence of Adverse Reactions (Total Daily Dosage Range 5 to 15 mg) Terbutaline… % Nervous System |
|---|---|
| Nervousness | 35.0 |
| Tremor | 15.0 |
| Somnolence | 5.5 |
| Dizziness | 3.5 |
| Anxiety | 1.0 |
| Insomnia | 1.5 |
| Palpitations | 5.0 |
| Tachycardia | 3.5 |
| Extrasystoles ventricular | 1.5 |
| Vasodilations | 1.0 |
| Nausea | 3.0 |
| Dry mouth | 1.5 |
| Headache | 7.5 |
| Asthenia | 2.0 |
| Sweating | 1.0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, 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?
1,823 reports list terbutaline among the medicines taken, 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. Of the 22 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Terbutaline: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions