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What the label lists and what reports show

Sincalide side effects

Sincalide's FDA label: “Most common adverse reactions (≥20%) are: abdominal discomfort or pain, and nausea.” FAERS holds 153 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 drug effect decreased (35 reports).

  • No generic listed

Check it at the source: the sincalide FDA label on DailyMed (effective November 1, 2023, MAIA Pharmaceuticals, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common adverse reactions (≥20%) are: abdominal discomfort or pain, and nausea.

From the label: adverse reactions, continued

The following clinically significant adverse reactions are described elsewhere in labeling: • Anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions [see Warnings and Precautions (5.1)] • Evacuation of gallstones [see Warnings and Precautions (5.2)] • Adverse reactions with intravenous injection [see Warnings and Precautions (5.3)] • Preterm labor or spontaneous abortion [see Warnings and Precautions (5.4)] The following adverse reactions associated with the use of sincalide were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. The most frequent adverse reactions (20% or greater) are gastrointestinal: abdominal discomfort or pain, and nausea; these may not necessarily indicate an abnormality of the biliary tract unless there is other clinical or radiologic evidence of disease. Less common adverse reactions include: Hypersensitivity reactions: anaphylaxis and anaphylactic shock, hypotension, throat tightness, bradycardia, shortness of breath, nausea, abdominal cramping, diaphoresis, hives, rash, itching; and numbness of face, lips and eyes [see Contraindications (4)]. Neurological reactions: seizures, headache. …

Source: FDA drug label, MAIA Pharmaceuticals, Inc., effective November 1, 2023 (SPL set 4149af34-7b3d-4200-9609-ea856b1d6aab), via openFDA; the full label on DailyMed

What do FAERS reports show?

153 reports list sincalide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 17 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 21 reactions below, 5 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

  • Drug Ineffective (a use or a product term, not a reaction)38
  • Drug Effect Decreased35
  • Multiple Use Of Single-Use Product29
  • No Adverse Event (a use or a product term, not a reaction)24
  • Nausea (named in the label)13
  • Product Quality Issue (a use or a product term, not a reaction)11
  • Therapeutic Product Effect Decreased (a use or a product term, not a reaction)11
  • Diarrhoea (named in the label)8
  • Gallbladder Disorder8
  • Pain8
  • Abdominal Pain (named in the label)7
  • Chills7
  • Dizziness (named in the label)7
  • Hepatobiliary Scan Abnormal7
  • Product Physical Consistency Issue7
  • Myalgia6
  • Post Procedural Complication6
  • Pyrexia6
  • Hyperhidrosis5
  • Abdominal Discomfort (named in the label)4
  • Anxiety4
  • Asthenia4
  • Emotional Distress4
  • Erythema4
  • Feeling Abnormal4

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

What next?

Sincalide: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions