FDA Adverse Events Summary for NEXIUM* (Esomeprazole magnesium)
(based on 434958 reports filed with the FDA between 2004 and June 2015)
These charts and graphs provide data on adverse effects and events attributed to NEXIUM. They are based on FDA Adverse Event reports received through the FDA Adverse Event Reporting System (FAERS) program.
Adverse Event Reports are submitted 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). 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.
Top 20 Adverse Effects Associated with NEXIUM
(reported in FDA Medwatch Reports)
| Side Effect | # of FDA Reports | |
|---|---|---|
| 1 | Drug dose omission | 10289 |
| 2 | Gastrooesophageal reflux disease | 7377 |
| 3 | Drug ineffective | 6942 |
| 4 | Nausea* | 6067 |
| 5 | Malaise | 5414 |
| 6 | Pain* | 5002 |
| 7 | Vomiting | 4462 |
| 8 | Dyspepsia | 4358 |
| 9 | Diarrhoea* | 4215 |
| 10 | Dyspnoea | 4211 |
| 11 | Headache* | 3754 |
| 12 | Fatigue | 3573 |
| 13 | Abdominal pain upper | 3353 |
| 14 | Dizziness* | 3267 |
| 15 | Fall | 3149 |
| 16 | Off label use | 3057 |
| 17 | Chest pain | 3050 |
| 18 | Asthenia | 2644 |
| 19 | Osteoporosis | 2618 |
| 20 | Weight decreased | 2584 |
* This side effect also appears in "Top 10 Side Effects of NEXIUM " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking NEXIUM
(associated with FDA Medwatch Reports)
| Reason | # of FDA Reports | |
|---|---|---|
| 1 | Gastrooesophageal reflux disease* | 80686 |
| 2 | Product used for unknown indication | 28475 |
| 3 | Dyspepsia* | 5923 |
| 4 | Gastric disorder | 5467 |
| 5 | Ulcer* | 3164 |
| 6 | Barrett's oesophagus* | 2995 |
| 7 | Prophylaxis | 2945 |
| 8 | Gastritis* | 2310 |
| 9 | Gastric ulcer* | 1783 |
| 10 | Prophylaxis against gastrointestinal ulcer | 1591 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for NEXIUM
Total Reports Filed with FDA: 434958
- Male
- Female
- Unknown
Number of FDA Adverse Event Reports by Patient Age for NEXIUM
Total Reports Filed with FDA: 434958*
Note: * Reports include 75,010 reports of unknown age.
