Drug Safety Information for COLAZAL (Balsalazide disodium)

Safety-related Labeling Changes for GIAZO (BALSALAZIDE DISODIUM) Discontinued Drug: FDA Link

Adverse Drug Reactions for COLAZAL* (Balsalazide disodium)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with COLAZAL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Injection site pain120
2Drug ineffective*103
3Diarrhoea*86
4Colitis ulcerative76
5Fatigue70
6Nausea60
7Arthralgia*58
8Dyspnoea56
9Crohn's disease56
10Pain56
11Headache54
12Pyrexia52
13Abdominal pain50
14Pain in extremity46
15Injection site erythema41
16Incorrect dose administered40
17Injection site haematoma40
18Vomiting38
19Rash*37
20Chest pain36

* This side effect also appears in "Top 10 Side Effects of COLAZAL " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking COLAZAL
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Colitis ulcerative*1220
2Product used for unknown indication991
3Crohn's disease643
4Colitis212
5Rectal haemorrhage29
6Ill-defined disorder21
7Abdominal pain18
8Proctocolitis18
9Inflammation17
10Irritable bowel syndrome16

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for COLAZAL

Total Reports Filed with FDA: 5083


Number of FDA Adverse Event Reports by Patient Age for COLAZAL

Total Reports Filed with FDA: 5083*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Balsalazide disodium (Colazide, Giazo, Balsalazide, Balsalazide disodium, Colazal)

Charts are based on 5083 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and COLAZAL Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.