TARPEYO SIDE EFFECTS
- Generic Name: budesonide delayed release capsules
- Brand Name: Tarpeyo
SIDE EFFECTS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypercorticism and adrenal suppression
- Risks of immunosuppression
- Other corticosteroid effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of TARPEYO has been evaluated in a randomized controlled study in 197 patients.
The most common adverse reactions reported in greater than or equal to 5% of TARPEYO-treated patients are listed in Table 1.
The majority of adverse reactions were mild or moderate in severity.
Table 1: Reported adverse reactions occurring in greater than or equal to 5% of TARPEYO treated patients, and greater than or equal to 2% higher than Placebo
| Adverse Reaction | TARPEYO 16 mg (N=97) |
Placebo (N=100) |
| n (%) | n (%) | |
| Patients with any Adverse Reaction | 84 (87) | 73 (73) |
| Hypertension | 15 (16) | 2 (2) |
| Peripheral edema | 14 (14) | 4 (4) |
| Muscle spasms | 13 (13) | 4 (4) |
| Acne | 11 (11) | 2 (2) |
| Dermatitis | 7 (7) | 1 (1) |
| Weight increased | 7 (7) | 3 (3) |
| Dyspnea | 6 (6) | 0 (0) |
| Face edema | 6 (6) | 1 (1) |
| Dyspepsia | 5 (5) | 2 (2) |
| Fatigue | 5 (5) | 2 (2) |
| Hirsutism | 5 (5) | 0 (0) |
Most adverse reactions that occurred at a greater incidence for TARPEYO compared to placebo were consistent with hypercortisolism.
SRC: NLM .