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What the label lists and what reports show

Pancrelipase amylase and pancrelipase lipase and pancrelipase protease side effects

Pancrelipase amylase and pancrelipase lipase and pancrelipase protease's FDA label: “Most Common Adverse R eactions ( 6.1 ) C ystic fibrosis adult and pediatric patients: 7 years and older (≥4%): vomiting, dizziness, cough.” FAERS holds 44,543 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 (4,180 reports).

  • No generic listed

Check it at the source: the pancrelipase amylase and pancrelipase lipase and pancrelipase protease FDA label on DailyMed (effective February 28, 2024); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of CREON?

CREON may cause serious side effects, including: See “ What is the most important information I should know about CREON? ” Irritation of the inside of your mouth. This can happen if CREON is not swallowed completely. Increase in blood uric acid levels (hyperuricemia). This may happen in people with gout, kidney problems, or those who take high doses of pancrelipase, the active ingredient in CREON. Call your healthcare provider if you have pain, stiffness, redness or swelling of your joints. Severe a llergic reactions. Severe allergic reactions have happened in people taking pancreatic enzyme products like CREON. Stop taking CREON and get emergency treatment right away if you have any of these symptoms: trouble with breathing, skin rashes, swollen lips, or itching. […]

Source: FDA drug label, AbbVie Inc., effective February 28, 2024 (SPL set 073201aa-556d-4a70-918e-84e9616fd88d), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most Common Adverse R eactions ( 6.1 ) C ystic fibrosis adult and pediatric patients: 7 years and older (≥4%): vomiting, dizziness, cough.

Table 2: Adverse Reactions* in a Clinical Trial of Adult Patients with Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or Pancreatectomy (Study 4)

Adverse ReactionCREON N = 25 n (%)Placebo N = 29 n (%)
Hyperglycemia2 (8%)2 (7%)
Hypoglycemia1 (4%)1 (3%)
Abdominal Pain1 (4%)1 (3%)
Abnormal Feces1 (4%)0 (0%)
Flatulence1 (4%)0 (0%)
Frequent Bowel Movements1 (4%)0 (0%)
Nasopharyngitis1 (4%)0 (0%)

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following serious or otherwise important adverse reactions are described elsewhere in the labeling: Fibrosing Colonopathy [see Warnings and Precautions ( 5.1 )] Irritation of the Oral Mucosa [see Warnings and Precautions ( 5.2 )] Hyperuricemia [see Warnings and Precautions ( 5.3 )] Risk of Viral Transmission [see Warnings and Precautions ( 5.4 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] Most Common Adverse R eactions ( 6.1 ) C ystic fibrosis adult and pediatric patients: 7 years and older (≥4%): vomiting, dizziness, cough. 4 months to 6 years (6%): vomiting, irritability, decreased appetite. C hronic pancreatitis or pancreatectomy patients: Adults (≥ 4%): hyperglycemia, hypoglycemia, abdominal pain, abnormal feces, flatulence, frequent bowel movements, nasopharyngitis. To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Source: FDA drug label, AbbVie Inc., effective February 28, 2024 (SPL set 073201aa-556d-4a70-918e-84e9616fd88d), via openFDA; the full label on DailyMed

What do FAERS reports show?

44,543 reports list pancrelipase amylase and pancrelipase lipase and pancrelipase protease among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4,263 are coded as a death and 17,057 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, 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.

Reports received each year

The 25 most reported reactions

  • Diarrhoea (named in the label)4,180
  • Death (an outcome recorded in the report)2,307
  • Nausea (named in the label)2,146
  • Weight Decreased2,007
  • Fatigue1,863
  • Infective Pulmonary Exacerbation Of Cystic Fibrosis1,759
  • Abdominal Pain (named in the label)1,753
  • Vomiting (named in the label)1,634
  • Abdominal Pain Upper1,478
  • Pain1,456
  • Dyspnoea1,381
  • Drug Ineffective (a use or a product term, not a reaction)1,365
  • Off Label Use (a use or a product term, not a reaction)1,355
  • Hospitalisation (an outcome recorded in the report)1,343
  • Malaise1,317
  • Pneumonia1,311
  • Pancreatic Carcinoma1,272
  • Headache1,238
  • Constipation (named in the label)1,219
  • Asthenia1,158
  • Cough (named in the label)1,148
  • Cystic Fibrosis (named in the label)1,079
  • Abdominal Distension1,052
  • Flatulence (named in the label)1,018
  • Dizziness (named in the label)983

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

What next?

Side effects hub
the most reported medicines and reactions