OpenClaim

Balsalazide Side Effects

The most commonly reported side effects of balsalazide include diarrhoea, colitis ulcerative, and injection site pain, based on 1,381 FDA adverse event reports from 2004 to 2025. 5.7% of reports found the drug to be ineffective.

Balsalazide side effects

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

1
Drug Ineffective5.7%79
2
Diarrhoea5.5%76
3
Colitis Ulcerative4.7%65
4
Injection Site Pain4.1%57
5
Off Label Use3.9%54
6
Fatigue3.8%52
7
Nausea3.3%45
8
Pain2.8%38
9
Drug Ineffective2.7%37
10
Pyrexia2.5%34
11
Injection Site Pain2.5%34
12
Arthralgia2.5%34
13
Headache2.4%33
14
Arthralgia2.3%32
15
Nausea2.3%32

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

Report severity

51.3%Serious708 reports
26.0%Hospitalizations359 reports
2.7%Fatal37 reports

Seriousness is determined by the reporter, not by OpenClaim.

Balsalazide drug interactions

Other drugs that appear in adverse event reports alongside balsalazide. 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
Adalimumab30.1%415
2
Infliximab12.1%167
3
Certolizumab-pegol2.8%39
4
Vedolizumab2.8%38
5
Azathioprine2.2%31
6
Mesalamine2.1%29
7
Lenalidomide2.0%27
8
Prednisone1.7%23
9
Ethinyl-estradiol1.3%18
10
Budesonide1.2%17
11
Golimumab1.1%15
12
Drospirenone1.1%15
13
Tofacitinib1.0%14
14
Acetaminophen0.8%11
15
Interferon0.8%11

Taken alongside

1
Prednisone18.0%249
2
Acetaminophen13.4%185
3
Ergocalciferol11.9%164
4
Omeprazole11.2%155
5
Mesalamine10.1%139
6
Aspirin9.2%127
7
Levothyroxine-sodium9.1%125
8
Folic-acid8.7%120
9
Hydrochlorothiazide7.5%103
10
Azathioprine7.3%101
11
Calcium7.3%101
12
Lisinopril7.0%96
13
Amlodipine6.7%92
14
Metoprolol6.6%91
15
Atorvastatin-calcium6.5%90

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 balsalazide side effects

55.2% of balsalazide adverse event reports involve female patients and 40.5% involve male patients. The largest age group is adult at 67%. These figures reflect who reports side effects, not underlying risk.

Sex

Female55.2%
Male40.5%
Unknown4.3%

Age group

< 20.7%
2–112.0%
12–172.7%
18–6467.4%
65+27.2%

What is balsalazide used for

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

Antiinflammatory TherapyAnxietyCardiac DisorderColitisColitis MicroscopicColitis UlcerativeCrohn's DiseaseCrohn^s DiseaseColitisColitis UlcerativeCrohn^s DiseaseDiarrhoeaDiverticulumDrug Use For Unknown IndicationDyspepsia

Showing 15 of 42 indications

Balsalazide brand names and reporting trend

Balsalazide is sold under the brand name Giazo.

Brand names

Giazo532

Quarterly reports (20042025)

20052010201520202025

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

Taking balsalazide with another medication?

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