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Protease) Side Effects

The most commonly reported side effects of protease) include diarrhoea, death, and nausea, based on 40,499 FDA adverse event reports from 2004 to 2025. 2.9% of reports found the drug to be ineffective.

Protease) side effects

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

1
Diarrhoea8.7%3,536
2
Death5.1%2,070
3
Nausea4.5%1,827
4
Weight Decreased4.2%1,719
5
Infective Pulmonary Exacerbation Of Cystic Fibrosis4.2%1,714
6
Fatigue4.1%1,642
7
Abdominal Pain3.7%1,507
8
Vomiting3.4%1,383
9
Hospitalisation3.1%1,251
10
Pain3.0%1,233
11
Abdominal Pain Upper3.0%1,229
12
Pneumonia2.9%1,176
13
Dyspnoea2.9%1,173
14
Drug Ineffective2.9%1,158
15
Off Label Use2.9%1,157

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

Report severity

70.7%Serious28,625 reports
38.3%Hospitalizations15,514 reports
9.7%Fatal3,909 reports

Seriousness is determined by the reporter, not by OpenClaim.

Protease) drug interactions

Other drugs that appear in adverse event reports alongside protease). 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
Pancrelipase-amylase46.8%18,963
3
Ivacaftor17.8%7,203
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%702
10
Paclitaxel1.3%513
11
Adalimumab1.0%389
12
Omeprazole0.9%373
13
Capecitabine0.8%339
14
Lenalidomide0.8%325
15
Oxaliplatin0.8%321

Taken alongside

1
Lipase53.4%21,620
2
Pancrelipase-amylase53.3%21,605
3
Albuterol22.0%8,895
4
Dornase-alfa18.2%7,363
5
Ergocalciferol15.0%6,057
6
Omeprazole13.1%5,286
7
Fluticasone12.2%4,930
8
Azithromycin11.3%4,596
9
Insulin10.6%4,287
10
Sodium-chloride9.9%4,006
11
Acetaminophen8.3%3,354
12
Tobramycin7.7%3,133
13
Pantoprazole-sodium6.6%2,693
14
Ondansetron6.2%2,522
15
Levothyroxine-sodium6.1%2,452

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 protease) side effects

51.6% of protease) 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 protease) used for

Conditions and purposes for which patients were taking protease) 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 528 indications

Protease) brand names and reporting trend

Protease) is sold under the brand name Cotazym.

Brand names

Cotazym73

Quarterly reports (20042025)

20052010201520202025

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

Taking protease) with another medication?

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