ADVERSE REACTIONS
Adverse reactions observed with terbutaline sulfate injection are similar to those commonly seen with other sympathomimetic agents. All these reactions are transient in nature and usually do not require treatment.
The following table compares adverse reactions seen in patients treated with terbutaline sulfate injection (0.25 mg and 0.5 mg), with those seen in patients treated with epinephrine injection (0.25 mg and 0.5 mg), during eight double-blind crossover studies involving a total of 214 patients.
| Incidence (%) of Adverse Reactions |
| Terbutaline (%) | Epinephrine (%) |
|
0.25 mg
N=77 |
0.5 mg
N=205 |
0.25 mg
N=153 |
0.5 mg
N=61 |
|
Reaction
Central Nervous System | | | | |
| Tremor | 7.8 | 38.0 | 16.3 | 18.0 |
| Nervousness | 16.9 | 30.7 | 8.5 | 31.1 |
| Dizziness | 1.3 | 10.2 | 7.8 | 3.3 |
| Headache | 7.8 | 8.8 | 3.3 | 9.8 |
| Drowsiness | 11.7 | 9.8 | 14.4 | 8.2 |
| Cardiovascular | | | | |
| Palpitations | 7.8 | 22.9 | 7.8 | 29.5 |
| Tachycardia | 1.3 | 1.5 | 2.6 | 0.0 |
| Respiratory | | | | |
| Dyspnea | 0.0 | 2.0 | 2.0 | 0.0 |
| Chest discomfort | 1.3 | 1.5 | 2.6 | 0.0 |
| Gastrointestinal | | | | |
| Nausea/vomiting | 1.3 | 3.9 | 1.3 | 11.5 |
| Systemic | | | | |
| Weakness | 1.3 | 0.5 | 2.6 | 1.6 |
| Flushed feeling | 0.0 | 2.4 | 1.3 | 0.0 |
| Sweating | 0.0 | 2.4 | 0.0 | 0.0 |
| Pain at injection site | 2.6 | 0.5 | 2.6 | 1.6 |
Note: Some patients received more than one dosage strength of terbutaline sulfate and epinephrine. In addition, there were reports of anxiety, muscle cramps, and dry mouth (<0.5%). There have been rare reports of elevations in liver enzymes and of hypersensitivity vasculitis with terbutaline administration.
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