Omeprazole Side Effects and Safety: What the FDA Record Shows

Omeprazole Side Effects are documented on the FDA prescribing label, and reported separately by patients and doctors to the FDA’s adverse event system. This page sets out what the official record actually says about Omeprazole: what it is approved to treat, what the label warns about, its recall history, and what the reported side effects are — along with what those figures do and do not mean.

What Omeprazole Is Prescribed For, and Where Omeprazole Side Effects Come From

According to the FDA label, meprazole is a proton pump inhibitor indicated for: Treatment in adults of duodenal ulcer ( 1.1 ) and gastric ulcer ( 1.2 ) Treatment in adults and children of gastroesophageal reflux disease (GERD) ( 1.3 ) and maintenance of healing of erosive esophagitis ( 1.4 ) The safety and effectiveness of omeprazole in pediatric patients <1 year of age have not been established.

( 8.4 ) 1.1 Duodenal Ulcer (adults) Omeprazole delayed-release capsules, USP are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. […]

Two separate official sources describe omeprazole side effects. The prescribing label records what was observed in clinical trials, where the drug was compared against a control group. The FDA’s adverse event database records what patients and clinicians have reported since approval, which is a much larger but far less controlled picture. Both appear below, and they answer different questions.

The FDA has revised this label recently. The label’s own record of recent major changes reads: Warnings and Precautions, Interaction with Clopidogrel ( 5.4 ) 10/2012 Warnings and Precautions, Clostridium difficile associated diarrhea ( 5.3 ) 09/2012 A recent revision usually means new safety information was added.

Warnings on the Omeprazole Label

The FDA prescribing label carries the full set of warnings and precautions for Omeprazole. Because a medicine can have several approved labels from different manufacturers and formulations, the safest way to see the warnings that apply to the exact product you have is to read the label for that product.

You can look up any product’s current FDA label on DailyMed, the National Library of Medicine’s official label database, using the name on your bottle or box.

Warnings Beyond the Common Omeprazole Side Effects

The label’s warnings and precautions section describes risks the FDA requires prescribers to weigh. For Omeprazole it covers: ymptomatic response does not preclude the presence of gastric malignancy ( 5.1 ) Atrophic gastritis: has been noted with long-term therapy ( 5.2 ) PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea.

( 5.3 ) Avoid concomitant use of omeprazole with clopidogrel. ( 5.4 ) 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.

( 5.5 ) Hypomagnesemia has been reported rarely with prolonged treatment with PPIs ( 5.6 ) Avoid concomitant use of omeprazole with St John’s Wort or rifampin due to the potential reduction in omeprazole concentrations ( 5.7 , 7.3 ) Interactions with diagnostic investigations for Neuroendocrine Tumors: Increases in intragastric pH may result in hypergastrinemia and enterochromaffin-like cell hyperplasia and increased Choromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors. […]

These are the risks the FDA has judged significant enough to state formally, and they sit apart from the routine omeprazole side effects most people ask about. They apply to different patients to very different degrees, which is why the same medicine can be routine for one person and unsuitable for another.

Omeprazole Side Effects Listed on the FDA Label

The label’s adverse reactions section records what was observed in clinical trials: dults: Most common adverse reactions in adults (incidence ≥ 2%) are Headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence ( 6 ) Pediatric patients (2 to 16 years of age): Safety profile similar to that in adults, except that respiratory system events and fever were the most frequently reported reactions in pediatric studies ( 8.4 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex at 1-800-667-4708 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience with Omeprazole Monotherapy Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. […]

Trial data is the most reliable source for how common omeprazole side effects are, because the people taking the drug were compared against people who were not. A symptom that appeared just as often in the control group is not caused by the medicine.

Reported Omeprazole Side Effects in the FDA Database

Who the Label Says Should Take Extra Care

Contraindications. The label states that Omeprazole should not be used in certain situations: meprazole delayed-release capsules are 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, interstitial nephritis, and urticaria [ See Adverse Reactions (6) ]. […]

Interactions with other medicines. Atazanavir and nelfinavir: Omeprazole reduces plasma levels of atazanavir and nelfinavir. Concomitant use is not recommended ( 7.1 ) Saquinavir: Omeprazole increases plasma levels of saquinavir. Monitor for toxicity and consider dose reduction of saquinavir ( 7.1 ) May interfere with drugs for which gastric pH affects bioavailability (e.g., ketoconazole, iron salts, erlotinib, ampicillin esters, and digoxin). […]

Older adults. 8.5 Geriatric Use Omeprazole was administered to over 2000 elderly individuals (≥ 65 years of age) in clinical trials in the U.S. and Europe. There were no differences in safety and effectiveness between the elderly and younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. […]

Your pharmacist can check your full medicine list against this in a couple of minutes, including anything bought over the counter, and that check is free.

Omeprazole Recall History

The FDA enforcement database records 5 recall entries involving Omeprazole products (5 Class II). A recall almost always concerns specific manufactured batches rather than the medicine itself, and different manufacturers of the same generic drug have separate recall records.

The FDA classifies recalls by how serious the potential consequence is. Class I means a reasonable probability of serious harm or death; Class II means temporary or reversible harm is possible; Class III means the product breaks a regulation but is unlikely to cause harm.

If a batch you have was recalled, the pharmacy that dispensed it is the fastest way to find out and to get a replacement. Do not simply stop taking a prescribed medicine because a recall notice exists — the recall may not affect your batch, and stopping can carry its own risk.

Is There Litigation Involving Omeprazole?

Lawsuits involving Omeprazole have been filed in the United States. A lawsuit is an allegation: it means claimants assert that a manufacturer failed to warn adequately or that a product was defective. It is not a finding that the medicine caused any particular person’s illness, and courts have not necessarily reached any conclusion.

Whether any individual claim has merit depends on medical records, timing and the law in that person’s state. Our case pages track the current status of the litigation itself.

Read the current case status and filing information →

If You Are Worried About Omeprazole Side Effects

Concern about omeprazole side effects is a good reason to have a conversation, and not a reason to act alone. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first. Stopping some medicines abruptly carries risks of its own, and your prescriber can tell you whether that applies to yours.

Write down what you have noticed and when it started before the appointment. Not everything that happens while taking a medicine is one of its omeprazole side effects, and a specific account — what changed, when, and how often — is what lets a clinician tell the difference.

You can also report a side effect directly to the FDA through MedWatch. Reports from patients are part of how safety signals are detected, and filing one takes a few minutes.

Frequently Asked Questions

What are the most commonly reported omeprazole side effects?

In FDA reports, the most frequently mentioned are chronic kidney disease, nausea, fatigue. The label’s own adverse reactions section, drawn from clinical trials, is the better guide to how common a side effect actually is, because reports to the FDA are not collected in a way that supports rates.

Has Omeprazole been recalled?

There are 5 recall records for Omeprazole products, the most recent dated 2025-07-23. Recalls generally affect specific manufactured batches rather than the medicine as a whole. Your pharmacy can tell you whether a batch you have was affected.

Does Omeprazole have a boxed warning?

A medicine can have several approved labels from different manufacturers, so the reliable answer for the exact product you have is on that product’s label. You can look it up on DailyMed using the name on your packaging.

Do the FDA report numbers tell me how common these omeprazole side effects are?

No. Reports are unverified, anyone can file one, and the total mostly reflects how many people take the medicine and how much attention it is getting. A high count is not evidence of danger, and a low one is not evidence of safety. Clinical trial data on the label is the source that supports rates.

Where can I check omeprazole side effects for the exact product I have?

DailyMed holds the current FDA label for every marketed product, searchable by the name on your packaging. Different manufacturers and formulations of the same medicine can have slightly different labels, so checking the one you actually have is worth the two minutes.

Official Sources

• DailyMed (National Library of Medicine) — the current FDA prescribing label for every product
• FDA Adverse Event Reporting System dashboard — the public report data summarised above
• FDA recalls and safety alerts — current recall notices
• FDA MedWatch — how to report a side effect yourself

Related Guides

• All Drug Safety Profiles
• Drug Safety Explainers
• Product Recalls
• Active Case Pages

Medical and legal disclaimer. This page summarises publicly available FDA data about Omeprazole and is general information, not medical advice, and not legal advice. It is not a substitute for the judgement of a clinician who knows your medical history. Nothing here states that Omeprazole caused any illness or injury in any individual. Adverse event reports are unverified and do not establish causation.

FDA labels are revised regularly; confirm current information on DailyMed or with your pharmacist. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first.