Drug Safety Information for DIPENTUM (Olsalazine sodium)

Safety-related Labeling Changes for DIPENTUM (OLSALAZINE SODIUM) Rx Drug: FDA Link

Adverse Drug Reactions for DIPENTUM* (Olsalazine sodium)

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 DIPENTUM
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Colitis ulcerative	16
2	Condition aggravated	12
3	Diarrhoea	10
4	Nausea	10
5	Pain	9
6	Weight decreased	9
7	Fatigue	9
8	Vomiting	8
9	Pyrexia	8
10	Drug ineffective	8
11	Arthralgia	7
12	Upper respiratory tract infection	7
13	Headache	7
14	Pain in extremity	6
15	Crohn's disease	6
16	Dehydration	6
17	Proctitis	6
18	Chest pain	6
19	Atrial fibrillation	5
20	Influenza like illness	5

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

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

	Reason	# of FDA Reports
1	Colitis ulcerative*	122
2	Product used for unknown indication	77
3	Crohn's disease*	76
4	Irritable bowel syndrome	26
5	Colitis	14
6	Leukocytoclastic vasculitis	7
7	Inflammatory bowel disease	6
8	Antiinflammatory therapy	5
9	Prophylaxis	3
10	Colectomy total	3

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

Types of Adverse Events for DIPENTUM

Total Reports Filed with FDA: 811

Number of FDA Adverse Event Reports by Patient Age for DIPENTUM

Total Reports Filed with FDA: 811*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Olsalazine sodium (Olsalazine, Olsalazine sodium, Dipentum)

Charts are based on 811 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.

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.