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Pancrelipase Side Effects

The most commonly reported side effects of pancrelipase include diarrhoea, death, and nausea, based on 40,514 FDA adverse event reports from 2004 to 2025. 2.9% of reports found the drug to be ineffective.

Pancrelipase side effects

Percentages show how often each reaction appears relative to total reports for pancrelipase.

1
Diarrhoea8.7%3,536
2
Death5.1%2,067
3
Nausea4.5%1,833
4
Weight Decreased4.2%1,721
5
Infective Pulmonary Exacerbation Of Cystic Fibrosis4.2%1,714
6
Fatigue4.1%1,646
7
Abdominal Pain3.7%1,511
8
Vomiting3.4%1,387
9
Hospitalisation3.1%1,251
10
Pain3.0%1,232
11
Abdominal Pain Upper3.0%1,231
12
Pneumonia2.9%1,175
13
Dyspnoea2.9%1,174
14
Drug Ineffective2.9%1,157
15
Malaise2.9%1,155

These are voluntary reports and do not establish that pancrelipase caused these reactions.

Report severity

70.7%Serious28,644 reports
38.3%Hospitalizations15,521 reports
9.7%Fatal3,911 reports

Seriousness is determined by the reporter, not by OpenClaim.

Pancrelipase drug interactions

Other drugs that appear in adverse event reports alongside pancrelipase. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Lipase46.8%18,963
2
Protease46.8%18,963
3
Ivacaftor17.8%7,204
4
Lumacaftor6.1%2,483
5
Elexacaftor-ivacaftor-tezacaftor5.4%2,170
6
Aztreonam4.7%1,886
7
Tobramycin3.8%1,552
8
Dornase-alfa2.3%928
9
Gemcitabine1.7%703
10
Paclitaxel1.3%515
11
Adalimumab1.0%388
12
Omeprazole0.9%374
13
Capecitabine0.8%339
14
Lenalidomide0.8%327
15
Oxaliplatin0.8%320

Taken alongside

1
Lipase53.4%21,629
2
Protease53.3%21,605
3
Albuterol22.0%8,898
4
Dornase-alfa18.2%7,364
5
Ergocalciferol14.9%6,051
6
Omeprazole13.0%5,285
7
Fluticasone12.2%4,937
8
Azithromycin11.4%4,599
9
Insulin10.6%4,295
10
Sodium-chloride9.9%4,006
11
Acetaminophen8.3%3,360
12
Tobramycin7.7%3,134
13
Pantoprazole-sodium6.6%2,694
14
Ondansetron6.2%2,524
15
Levothyroxine-sodium6.0%2,450

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports pancrelipase side effects

51.6% of pancrelipase adverse event reports involve female patients and 40.2% involve male patients. The largest age group is adult at 48%. These figures reflect who reports side effects, not underlying risk.

Sex

Female51.6%
Male40.2%
Unknown8.2%

Age group

< 20.8%
2–116.8%
12–177.1%
18–6447.5%
65+37.8%

What is pancrelipase used for

Conditions and purposes for which patients were taking pancrelipase when the adverse event was reported.

Abdominal DiscomfortAbdominal DistensionAbdominal PainAbdominal Pain UpperAbnormal FaecesAcneAdenocarcinomaAdenocarcinoma PancreasAdverse EventAlcoholic PancreatitisAmino Acid Catabolism DisorderAmino Acid Metabolism DisorderAmylaseAmylase DecreasedAmylase Increased

Showing 15 of 527 indications

Pancrelipase brand names and reporting trend

Pancrelipase is sold under the brand name Cotazym.

Brand names

Cotazym89

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking pancrelipase with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.