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Omeprazole Magnesium

Also sold as omeprazole

From 1 official FDA drug label · RxNorm 198051

This comes from U.S. FDA labels. Brand names, strengths and advice can differ in your country; check with a local health professional. Set your country.

What it is used for

These are the uses the FDA has approved for this label. Using it for anything else is “off-label”: ask your prescriber why.

Use • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

How to take it

Directions • for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment • swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew or crush capsules. Repeated 14-Day Courses (if needed) • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

Do not take it if

Do not use if you have: • trouble or pain swallowing food, vomiting with blood, or bloody or black stools • heartburn with lightheadedness, sweating or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain These may be signs of a serious condition. See your doctor.

Ask a doctor or pharmacist before using it if

Ask a doctor before use if you have: • had heartburn over 3 months. This may be a sign of a more serious condition. • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain

Serious warnings and precautions

Warnings Allergy alert: • do not use if you are allergic to omeprazole. • Omeprazole may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use if you have: • trouble or pain swallowing food, vomiting with blood, or bloody or black stools • heartburn with lightheadedness, sweating or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have: • had heartburn over 3 months. This may be a sign of a more serious condition. • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if: • your heartburn continues or worsens • you need to take this product for more than 14 days • you need to take more than 1 course of treatment every 4 months • you get diarrhea • you develop a rash or joint pain If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Stop using it and ask a doctor if

Stop use and ask a doctor if: • your heartburn continues or worsens • you need to take this product for more than 14 days • you need to take more than 1 course of treatment every 4 months • you get diarrhea • you develop a rash or joint pain

If you are pregnant or breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Forms and strengths available

20 MG · Delayed Release Oral Capsule10 MG · Delayed Release Oral Capsule40 MG · Delayed Release Oral Capsule20 MG · Disintegrating Oral Tablet2 MG/ML / 84 MG/ML · Oral Suspension10 MG · Oral Tablet20 MG · Oral Tablet40 MG · Oral Tablet10 MG · Delayed Release Oral Tablet20 MG · Delayed Release Oral Tablet40 MG · Delayed Release Oral Tablet20 MG / 1100 MG · Oral Capsule40 MG / 1100 MG · Oral Capsule40 MG / 1680 MG · Oral Suspension20 MG / 1680 MG · Oral Suspension10 MG · Oral Suspension2.5 MG · Oral Suspension

From RxNorm. Which forms and strengths are actually stocked varies by pharmacy and country.

Reactions people have reported

pyrexia 8diarrhoea 7dyspnoea 7haemoglobin decreased 6nausea 6hypoaesthesia 5vomiting 5fatigue 5abdominal pain 5dizziness 5

These are counts from 69 voluntary reports to the FDA. They show what has been reported — they are not how common a side effect is, and they do not prove the medicine caused it.

Recalls

Class II · Jul 23, 2025
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10
Reason: Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class II · May 28, 2025
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94
Reason: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Class II · May 28, 2025
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94
Reason: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Class III · Dec 11, 2024
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets
Reason: Labeling: Not Elsewhere Classified - Wrong NDC number
Class III · Nov 29, 2023
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India,
Reason: Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
Class III · Oct 5, 2022
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90.
Reason: Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class III · Oct 5, 2022
Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90.
Reason: Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class II · Oct 27, 2021
Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1
Reason: CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.

Research & studies

Recent higher-quality studies about Omeprazole Magnesium, from PubMed. We link to the source — titles only. This is not medical advice.

Similar medicines

Omeprazole Magnesium belongs to the Proton pump inhibitors class. Other medicines in it:

Questions to ask your doctor or pharmacist

Why you can trust this

Everything above comes from official FDA drug labels (openFDA), not written by us. Here are the exact labels used.

This information explains the official label. It cannot tell you whether this medicine is right or safe for you personally — only a qualified health professional who knows your history can do that. Do not start, stop, or change a medicine based on this page alone.