Drug Safety Information for NEXIUM IV (Esomeprazole sodium)

FDA Safety-related Labeling Changes for NEXIUM IV (ESOMEPRAZOLE SODIUM) Rx Drug: Safety Information Link

Adverse Drug Reactions for NEXIUM IV* (Esomeprazole 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 NEXIUM IV
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Off label use	11
2	Drug dose omission	7
3	Metabolic acidosis	6
4	Nausea	6
5	Condition aggravated	5
6	Gait disturbance	5
7	Anaemia	5
8	Fall	5
9	Infusion site extravasation	4
10	Pyrexia	4
11	Dyspepsia	4
12	Abdominal pain upper	4
13	Cardiac arrest	4
14	Drug ineffective	4
15	Hypotension	4
16	Hyperhidrosis	4
17	Pain	4
18	Weight decreased	4
19	Chest pain	4
20	Abdominal pain	4

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	25
2	Hiatus hernia	9
3	Abdominal pain	7
4	Upper gastrointestinal haemorrhage	7
5	Gastritis erosive	6
6	Duodenal ulcer	6
7	Gastrooesophageal reflux disease	6
8	Perforated ulcer	5
9	Abdominal pain upper	5
10	Gastritis prophylaxis	5

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

Types of Adverse Events for NEXIUM IV

Total Reports Filed with FDA: 547

Number of FDA Adverse Event Reports by Patient Age for NEXIUM IV

Total Reports Filed with FDA: 547*

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

Charts are based on 547 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.