Drug Safety Information for GASTROGRAFIN (Diatrizoate meglumine; diatrizoate sodium)

Safety-related Labeling Changes for MD-76R (DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM) Discontinued Drug: FDA Link

Adverse Drug Reactions for GASTROGRAFIN* (Diatrizoate meglumine; diatrizoate 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 GASTROGRAFIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Urticaria37
2Nausea*27
3Vomiting25
4Dyspnoea21
5Pruritus17
6Diarrhoea*15
7Hypotension14
8Medication error13
9Rash12
10Incorrect route of drug administration10
11Erythema10
12Drug ineffective10
13Abdominal pain10
14Death9
15Multi-organ failure9
16Chills8
17Renal failure acute8
18Pain8
19Burning sensation8
20Sneezing8

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

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

Reason # of FDA Reports
1Computerised tomogram144
2Product used for unknown indication138
3Computerised tomogram abdomen135
4Scan with contrast28
5Gallbladder disorder25
6Diagnostic procedure22
7Constipation18
8X-ray with contrast upper gastrointestinal tract18
9Catheterisation cardiac13
10Colonoscopy12

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


Types of Adverse Events for GASTROGRAFIN

Total Reports Filed with FDA: 1269


Number of FDA Adverse Event Reports by Patient Age for GASTROGRAFIN

Total Reports Filed with FDA: 1269*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Diatrizoate meglumine; diatrizoate sodium (Hypaque-m,90%, Renovist, Renovist ii, Md-60, Hypaque-m,75%, Angiovist 292, Angiovist 370, Renografin-60, Diatrizoate-60, Renocal-76, Renografin-76, Md-76r, Md-gastroview, Md-76, Hypaque-76, Gastrovist, Gastrografin)

Charts are based on 1269 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 GASTROGRAFIN 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.