Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS The following adverse reactions associated with the use of sacrosidase were identified in clinical studies or postmarketing reports.
Because some of these reactions were 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.
In clinical studies of up to 54 months duration, a total of 52 patients were treated with Sucraid.
The reported adverse reactions (number of patients) were as follows: abdominal pain (4), vomiting (3), nausea (2), diarrhea (2), constipation (2), insomnia (1), headache (1), nervousness (1), and dehydration (1).
Hypersensitivity reactions (wheezing, rash, and pruritis) have been reported (see WARNINGS).
WARNINGS Severe Hypersensitivity Reactions Severe hypersensitivity reactions, including wheezing, rash, and pruritis, have been reported with administration of Sucraid.
Sucraid contains papain, which is associated with hypersensitivity reactions (see DESCRIPTION).
A pediatric patient in the clinical trials experienced a hypersensitivity reaction of severe wheezing that required hospitalization.
Postmarketing cases of cutaneous hypersensitivity reactions have also been reported.
Instruct patients or caregivers to stop Sucraid and seek medical attention if symptoms suggestive of a hypersensitivity reaction occur.
Like all medications, Sucraid can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: