This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Esomeprazole magnesium for delayed release oral suspension is a proton pump inhibitor (PPI). Esomeprazole magnesium for delayed release oral suspension is indicated for the: Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 1 year to 17 years of age and of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age. ( 1.1 ) Maintenance of healing of EE in adults. ( 1.2 ) Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 1 year to 17 years of age. ( 1.3 ) Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. ( 1.4 ) Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. ( 1.5 ) Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. ( 1.6 ) 1.1 Healing of Erosive Esophagitis (EE) Adults Esomeprazole magnesium for delayed release oral suspension is indicated...
Esomeprazole magnesium for delayed release oral suspension is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions ( 5.2 ),Adverse Reactions ( 6.2 )]. For information about contraindications of amoxicillin and clarithromycin, indicated in combination with esomeprazole magnesium for delayed release oral suspension for H. pylori eradication to reduce the risk of duodenal ulcer recurrence, refer to the Contraindications section of the respective prescribing information. Proton pump inhibitors (PPIs), including Esomeprazole magnesium, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions ( 7 )]. Known hypersensitivity to substituted benzimidazoles or any component of the formulation. ( 4 ) Patients receiving rilpivirine-containing products. ( 4 , 7 ) Refer to the Contraindications section of the prescribing information for amoxicillin and clarithromycin, when administered in combination with esome...
Gastric Malignancy : In adults, symptomatic response does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 ) Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients. ( 5.2 ) Clostridium difficile -Associated Diarrhea : PPI therapy may be associated with increased risk. ( 5.3 ) Bone Fracture : Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. ( 5.4 ) Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. ( 5.5 ) Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous; new onset or exacerbation of existing disease; discontinue esomeprazole magnesium for delayed release oral suspension and refer to specialist for evaluation. ( 5.6 ) Interaction with Clopidogrel : Avoid concomitant use of esomeprazole magnesium for delayed release oral suspension. ( 5.7 ) Cyanocobalamin (Vitamin B-12) Deficiency : Daily long-term use (e.g., longer than 3 years) may lead to malabsorption...
The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions ( 5.2 )] Clostridium difficile -Associated Diarrhea [see Warnings and Precautions ( 5.3 )] Bone Fracture [see Warnings and Precautions ( 5.4 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.5 )] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.6 )] Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ( 5.8 )] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions ( 5.9 )] Fundic Gland Polyps [see Warnings and Precautions ( 5.13 )] Most common adverse reactions ( 6.1 ): Adults (≥ 18 years) (>1%) are: headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth. Pediatrics (1 to 17 years) (≥2%) are: headache, diarrhea, abdominal pain, nausea, and somnolence. Pediatrics (1 month to less than 1 year) (>1%) are: abdominal pain, regurgitation, tachypnea, and increased ALT. To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because ...
Source: FDA SPL label for ESOMEPRAZOLE MAGNESIUM (Cipla USA Inc.), effective 20240516. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 29,126 | 14,408 | 11,188 | 8,863 | 7,527 | 7,896 | 8,287 | 3,683 |
6,493 reports blaming this drug for every million Medicare prescriptions filled, which is 2.3× the typical drug on this site. (19,549 reports in 2024–2026, against 3,010,604 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 05/2025 | Class II | Zydus Pharmaceuticals (USA) Inc | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability. |
| 05/2025 | Class II | Zydus Pharmaceuticals (USA) Inc | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability. |
| 11/2024 | Class III | Zydus Pharmaceuticals (USA) Inc | Labeling: Not Elsewhere Classified - Wrong NDC number |
| 06/2022 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Superpotent Drug: Out of specification for assay at the 12-month timepoint. |
| 06/2022 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Superpotent Drug: Out of specification for assay at the 12-month timepoint. |
| 12/2020 | Class II | CIPLA | Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline |
| 12/2020 | Class II | CIPLA | Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline |
| 12/2020 | Class II | CIPLA | Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline |
| 04/2020 | Class III | Dr. Reddy's Laboratories, Inc. | Discoloration: product contains brown pellets |
| 02/2019 | Class III | Dr. Reddy's Laboratories, Inc. | Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets. |
| 07/2012 | Class III | ASTRA ZENECA Lp | Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $2,463 in payments to US physicians and hospitals tied to this drug across 105 transactions (Nexium $2,463).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Esomeprazole Magnesium | 2,912,529 | $43 |
| Nexium | 97,946 | $610 |
| Esomeprazole Sodium | 129 | $240 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.