The following serious adverse reactions are described elsewhere in the labeling:
- Constipation or intestinal pseudo-obstruction [see WARNINGS AND PRECAUTIONS]
- Incomplete mechanical intestinal obstruction [see WARNINGS AND PRECAUTIONS]
The most common adverse reactions reported with CUVPOSA are dry mouth, vomiting, constipation, flushing, and nasal congestion.
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 data described below reflect exposure to CUVPOSA in 151 subjects, including 20 subjects who participated in a 8-week placebo-controlled study (Study 1) and 137 subjects who participated in a 24-week open-label study (six subjects who received CUVPOSA in the placebo-controlled study and 131 new subjects).
Table 2 presents adverse reactions reported by ≥ 15% of CUVPOSA-treated subjects from the placebo-controlled clinical trial.
Table 2: Adverse Reactions Occurring in ≥15% of CUVPOSA-Treated Subjects and at a Greater Frequency than Placebo in Study 1
|Dry Mouth||8 (40%)||2 (11%)|
|Constipation||7 (35%)||4 (22%)|
|Flushing||6 (30%)||3 (17%)|
|Headache||3 (15%)||1 (6%)|
|Sinusitis||3 (15%)||1 (6%)|
|Upper Respiratory Tract Infection||3 (15%)||0|
|Urinary Retention||3 (15%)||0|
The following adverse reactions occurred at a rate of < 2% of patients receiving CUVPOSA in the open-label study.
Gastrointestinal: Abdominal distention, abdominal pain, stomach discomfort, chapped lips, flatulence, retching, dry tongue
General Disorders: Irritability, pain
Infections: Pneumonia, sinusitis, tracheostomy infection, upper respiratory tract infection, urinary tract infection
Investigations: Heart rate increased
Metabolism and Nutrition: Dehydration
Nervous System: Headache, convulsion, dysgeusia, nystagmus
Psychiatric: Agitation, restlessness, abnormal behavior, aggression, crying, impulse control disorder, moaning, mood altered
Respiratory: Increased viscosity of bronchial secretion, nasal congestion, nasal dryness
Skin: Dry skin, pruritus, rash
The following adverse reactions have been identified during postapproval use of other formulations of glycopyrrolate for other indications. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Additional adverse reactions identified during postapproval use of glycopyrrolate tablets include: loss of taste and suppression of lactation.