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Olsalazine Side Effects

The most commonly reported side effects of olsalazine include off label use, death, and pneumonia, based on 454 FDA adverse event reports from 2004 to 2025. 2.2% of reports found the drug to be ineffective.

Olsalazine side effects

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

1
Off Label Use3.7%17
2
Death3.5%16
3
Pneumonia3.1%14
4
Fall2.9%13
5
Condition Aggravated2.9%13
6
Colitis Ulcerative2.6%12
7
Colitis Ulcerative2.4%11
8
Diarrhoea2.4%11
9
Fatigue2.4%11
10
Hyponatraemia2.4%11
11
Cough2.2%10
12
Arthralgia2.2%10
13
Drug Ineffective2.2%10
14
Product Use Issue2.2%10
15
Pyrexia2.0%9

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

Report severity

86.3%Serious392 reports
49.6%Hospitalizations225 reports
9.5%Fatal43 reports

Seriousness is determined by the reporter, not by OpenClaim.

Olsalazine drug interactions

Other drugs that appear in adverse event reports alongside olsalazine. 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
Etanercept13.7%62
2
Adalimumab12.3%56
3
Infliximab7.0%32
4
Tofacitinib5.9%27
5
Golimumab4.4%20
6
Vedolizumab4.2%19
7
Sertraline-hydrochloride2.9%13
8
Abatacept2.6%12
9
Prednisolone2.4%11
10
Certolizumab-pegol2.4%11
11
Mesalamine2.2%10
12
Indapamide2.0%9
13
Lansoprazole2.0%9
14
Tocilizumab1.8%8
15
Atorvastatin-calcium1.5%7

Taken alongside

1
Prednisolone13.7%62
2
Hydroxychloroquine-sulfate12.1%55
3
Prednisone11.9%54
4
Celecoxib11.5%52
5
Methotrexate10.6%48
6
Folic-acid9.0%41
7
Aspirin8.4%38
8
Acetaminophen7.7%35
9
Levothyroxine-sodium7.0%32
10
Amlodipine5.7%26
11
Azathioprine5.5%25
12
Omeprazole5.3%24
13
Mesalamine4.6%21
14
Hydrochlorothiazide3.5%16
15
Tramadol-hydrochloride3.5%16

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 olsalazine side effects

56.2% of olsalazine adverse event reports involve female patients and 40.1% involve male patients. The largest age group is adult at 60%. These figures reflect who reports side effects, not underlying risk.

Sex

Female56.2%
Male40.1%
Unknown3.7%

Age group

< 20.8%
2–110.0%
12–170.5%
18–6460.1%
65+38.5%

What is olsalazine used for

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

Ankylosing SpondylitisAntiinflammatory TherapyArthritisAtrial FibrillationBipolar DisorderCardiac FailureChronic Spontaneous UrticariaColectomy TotalColitisColitis UlcerativeCoronary Artery DiseaseCrohn's DiseaseCrohn^s DiseaseChronic Spontaneous UrticariaColitis Ulcerative

Showing 15 of 40 indications

Olsalazine brand names and reporting trend

Olsalazine is sold under the brand name Dipentum.

Brand names

Dipentum286

Quarterly reports (20042025)

20052010201520202025

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

Taking olsalazine with another medication?

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