What the label lists and what reports show

Sacrosidase side effects

Sacrosidase's FDA label lists its adverse reactions in its own words. FAERS holds 168 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 diarrhoea (31 reports).

No generic listed

Check it at the source: the sacrosidase FDA label on DailyMed (effective December 29, 2025, QOL Medical, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: 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).

Source: FDA drug label, BLA020772 (Qol Medcl), as published by QOL Medical, LLC, effective December 29, 2025 (SPL set d613bb7f-c3f4-462e-81a2-da2347cc4b6b), via openFDA; the full label on DailyMed

What do FAERS reports show?

168 reports list sacrosidase among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 14 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, 9 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.

The 25 most reported reactions

Diarrhoea (named in the label)31
Abdominal Pain (named in the label)30
Nausea (named in the label)18
Abdominal Distension14
Drug Ineffective (a use or a product term, not a reaction)14
Flatulence14
Headache (named in the label)12
Product Quality Issue (a use or a product term, not a reaction)12
Vomiting (named in the label)11
Dizziness9
Insomnia (named in the label)9
Fatigue8
Product Taste Abnormal8
Decreased Appetite7
Pruritus7
Rash (named in the label)7
Constipation (named in the label)6
Urticaria6
Weight Decreased6
Dehydration (named in the label)5
Erythema5
Gastrooesophageal Reflux Disease5
Product Dose Omission Issue (a use or a product term, not a reaction)5
Throat Irritation5
Dyspnoea4

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Sacrosidase: 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