Drug Safety Information for OMNISCAN (Gadodiamide)

Safety-related Labeling Changes for OMNISCAN (GADODIAMIDE) Rx Drug: FDA Link

Adverse Drug Reactions for OMNISCAN* (Gadodiamide)

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 OMNISCAN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nephrogenic systemic fibrosis*2319
2Pain592
3Anxiety344
4Mobility decreased311
5Emotional distress310
6Fibrosis309
7Oedema peripheral299
8Skin hypertrophy285
9General physical health deterioration281
10Skin induration277
11Skin tightness245
12Injury239
13Scar229
14Skin fibrosis211
15Joint range of motion decreased209
16Pain in extremity197
17Arthralgia183
18Joint contracture181
19Pruritus172
20Gait disturbance168

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

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

Reason # of FDA Reports
1Nuclear magnetic resonance imaging4456
2Product used for unknown indication3107
3Nuclear magnetic resonance imaging brain1450
4Angiogram1381
5Imaging procedure543
6Nuclear magnetic resonance imaging abdominal412
7Diagnostic procedure351
8Renal transplant208
9Venogram195
10Fistulogram158

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


Types of Adverse Events for OMNISCAN

Total Reports Filed with FDA: 15811


Number of FDA Adverse Event Reports by Patient Age for OMNISCAN

Total Reports Filed with FDA: 15811*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Gadodiamide (Omniscan)

Charts are based on 15811 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 OMNISCAN Reviews and Review Summary .

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.

Visit   DrugInformer.com more on OMNISCAN's side effects.