Prilosec Otc

Zollinger-Ellison Syndrome, Curling Ulcer, Heartburn + 15 more

Treatment

15 FDA approvals

20 Active Studies for Prilosec Otc

What is Prilosec Otc

Omeprazole

The Generic name of this drug

Treatment Summary

Omeprazole is a medication used to reduce the production of stomach acid in patients with gastrointestinal disorders. It was the first drug approved by the FDA in 1989 for treating gastric-acid related conditions. Omeprazole is typically used to treat gastroesophageal reflux disease (GERD) and peptic ulcer disease. It is considered a safe and effective drug that can be prescribed to both adults and children.

Prilosec

is the brand name

image of different drug pills on a surface

Prilosec Otc Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Prilosec

Omeprazole

1990

669

Approved as Treatment by the FDA

Omeprazole, otherwise called Prilosec, is approved by the FDA for 15 uses which include multiple endocrine adenomas and Gastro-esophageal Reflux Disease (GERD) .

multiple endocrine adenomas

Gastro-esophageal Reflux Disease (GERD)

Gastric Ulcer

Gastroesophageal Reflux

Healing

Zollinger-Ellison Syndrome

Helps manage Zollinger-Ellison Syndrome

Heartburn

Helps manage Heartburn

Stomach Ulcer

Duodenal Ulcer

Helicobacter Pylori Infection

Used to treat Helicobacter Pylori Infection in combination with Amoxicillin

Heartburn

Helps manage Heartburn

Heartburn

Erosive Esophagitis

Adenoma

Curling Ulcer

Effectiveness

How Prilosec Otc Affects Patients

Omeprazole helps decrease the amount of acid in the stomach. Its effects usually start within one hour of taking it and are strongest after two hours. Taking omeprazole once daily can increase effectiveness over time. It can also raise gastrin levels in the blood, which can lead to false positive results when testing for certain tumors. Studies of over 3,000 people taking omeprazole long-term have not shown any cases of cancer related to the drug. Omeprazole does not seem to have any effects on the nervous system, heart or lungs, and does not affect thyroid, hormone, or other bodily functions.

How Prilosec Otc works in the body

Hydrochloric acid, or stomach acid, is produced by the parietal cells of the stomach and regulated by an enzyme called the H(+)/K(+)-ATPase. Omeprazole, a type of antisecretory drug, stops stomach acid production by blocking the H+/K+ ATPase enzyme system. This effect can last up to 36 hours. Helicobacter pylori is a bacteria that is associated with peptic ulcer disease. Omeprazole can be used as part of the treatment regimen for H. pylori infection. This is because it raises the

When to interrupt dosage

The suggested dosage of Prilosec Otc is contingent upon the established condition, including Stomach Ulcer, Heartburn and Zollinger-Ellison Syndrome. The amount of dosage is contingent upon the method of delivery, as outlined in the table beneath.

Condition

Dosage

Administration

Rheumatoid Arthritis

40.0 mg, , 10.0 mg, 20.0 mg, 20.6 mg, 2.5 mg

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Prophylaxis of NSAID gastric ulceration

40.0 mg, , 10.0 mg, 20.0 mg, 20.6 mg, 2.5 mg

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Heartburn

40.0 mg, , 10.0 mg, 20.0 mg, 20.6 mg, 2.5 mg

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Ankylosing Spondylitis

40.0 mg, , 10.0 mg, 20.0 mg, 20.6 mg, 2.5 mg

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hypersecretory conditions

40.0 mg, , 10.0 mg, 20.0 mg, 20.6 mg, 2.5 mg

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Gastroesophageal Reflux

40.0 mg, , 10.0 mg, 20.0 mg, 20.6 mg, 2.5 mg

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Heartburn

40.0 mg, , 10.0 mg, 20.0 mg, 20.6 mg, 2.5 mg

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Mastocytosis, Systemic

40.0 mg, , 10.0 mg, 20.0 mg, 20.6 mg, 2.5 mg

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Stomach Ulcer

40.0 mg, , 10.0 mg, 20.0 mg, 20.6 mg, 2.5 mg

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Helicobacter Pylori Infection

40.0 mg, , 10.0 mg, 20.0 mg, 20.6 mg, 2.5 mg

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Osteoarthritis

40.0 mg, , 10.0 mg, 20.0 mg, 20.6 mg, 2.5 mg

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Zollinger-Ellison Syndrome

40.0 mg, , 10.0 mg, 20.0 mg, 20.6 mg, 2.5 mg

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Curling Ulcer

40.0 mg, , 10.0 mg, 20.0 mg, 20.6 mg, 2.5 mg

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Adenoma

40.0 mg, , 10.0 mg, 20.0 mg, 20.6 mg, 2.5 mg

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Erosive Esophagitis

40.0 mg, , 10.0 mg, 20.0 mg, 20.6 mg, 2.5 mg

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Stomach Ulcer

40.0 mg, , 10.0 mg, 20.0 mg, 20.6 mg, 2.5 mg

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Healing

40.0 mg, , 10.0 mg, 20.0 mg, 20.6 mg, 2.5 mg

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Peptic Ulcer

40.0 mg, , 10.0 mg, 20.0 mg, 20.6 mg, 2.5 mg

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Warnings

Prilosec Otc has two contraindications and should not be consumed in conjunction with the conditions noted in the following table.

Prilosec Otc Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Omeprazole may interact with Pulse Frequency

Severe Hypersensitivity Reactions

Do Not Combine

Omeprazole may interact with Pulse Frequency

There are 20 known major drug interactions with Prilosec Otc.

Common Prilosec Otc Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The metabolism of Abemaciclib can be increased when combined with Omeprazole.

Acalabrutinib

Major

The metabolism of Acalabrutinib can be increased when combined with Omeprazole.

Alectinib

Major

The metabolism of Alectinib can be increased when combined with Omeprazole.

Aminophylline

Major

The metabolism of Aminophylline can be increased when combined with Omeprazole.

Amoxapine

Major

The metabolism of Amoxapine can be decreased when combined with Omeprazole.

Prilosec Otc Toxicity & Overdose Risk

The toxic dose of omeprazole for rats is 2210mg/kg and 4000mg/kg in mice. Overdosing can cause confusion, drowsiness, blurred vision, rapid heartbeat, nausea, sweating, flushing, headache, and dry mouth. Long-term use of omeprazole in rats has been linked to an increased risk of gastric cancer and abnormal cell growth. Omeprazole can be found in breast milk, but it is unknown how this may affect an infant. Studies have shown that omeprazole does not have an effect on fertility or reproduction in rats.

image of a doctor in a lab doing drug, clinical research

Prilosec Otc Novel Uses: Which Conditions Have a Clinical Trial Featuring Prilosec Otc?

96 active clinical trials are currently being conducted to assess the potential of Prilosec OTC to combat Rheumatoid Arthritis, Acid-mediated Gastroesophageal Reflux Disease (GERD) and Curling Ulcer.

Condition

Clinical Trials

Trial Phases

Rheumatoid Arthritis

58 Actively Recruiting

Not Applicable, Phase 3, Phase 2, Phase 1, Phase 4

Heartburn

14 Actively Recruiting

Phase 3, Phase 2, Not Applicable, Phase 1

Gastroesophageal Reflux

0 Actively Recruiting

Prophylaxis of NSAID gastric ulceration

0 Actively Recruiting

Mastocytosis, Systemic

0 Actively Recruiting

hypersecretory conditions

0 Actively Recruiting

Stomach Ulcer

2 Actively Recruiting

Phase 4, Not Applicable

Erosive Esophagitis

2 Actively Recruiting

Phase 2, Phase 3

Helicobacter Pylori Infection

2 Actively Recruiting

Not Applicable, Phase 4

Ankylosing Spondylitis

2 Actively Recruiting

Phase 3, Not Applicable

Stomach Ulcer

0 Actively Recruiting

Heartburn

2 Actively Recruiting

Phase 3, Not Applicable

Zollinger-Ellison Syndrome

0 Actively Recruiting

Osteoarthritis

0 Actively Recruiting

Curling Ulcer

0 Actively Recruiting

Peptic Ulcer

0 Actively Recruiting

Adenoma

0 Actively Recruiting

Healing

0 Actively Recruiting

Prilosec Otc Reviews: What are patients saying about Prilosec Otc?

5

Patient Review

11/11/2014

Prilosec Otc for Stomach Ulcer from Aspirin or Ibuprofen-Like Drugs

I had a really severe case of Barret's esophagus, but after eight to ten endoscopies with ablation, I'm now cell-free. I still take the medication twice a day, but I'm wondering if it's safe to do so.

5

Patient Review

11/18/2017

Prilosec Otc for Heartburn

I've been taking this for two decades now. It's the only thing that really helps with my indigestion and heartburn. I find it starts working on me within half an hour, which is much quicker than the commercials claim.

5

Patient Review

11/28/2013

Prilosec Otc for Treatment to Prevent Heartburn

I have had great success in managing my heartburn by taking two Prilosec pills in the morning and two more in the evening. My doctor says that, on a molecular level, this is equivalent to taking Nexium minus one molecule.

5

Patient Review

6/14/2013

Prilosec Otc for Condition in which Stomach Acid is Pushed Into the Esophagus

5

Patient Review

11/9/2017

Prilosec Otc for Heartburn

I've been taking this medication for a little under two weeks now for gastritis caused by a stomach flu. There's definitely been slow and gradual improvement, but some days I feel like I'm back at square one. Here's hoping that by the end of the month-long course it prescribed, I'll be feeling much better.

4.7

Patient Review

11/26/2018

Prilosec Otc for Inflammation of the Esophagus with Erosion

I've been using this medication for years now, and it has really helped me with my swallowing problem. However, I have recently developed a dry mouth and throat. The manufacturer told me that the 14-day advertised limit is only because that's the extent of its clinical trials. My doctor advises 'permanent' dosing no problem. We'll see, as eliminating swallowing problem is worth some side effects.

4.7

Patient Review

10/18/2013

Prilosec Otc for Conditions of Excess Stomach Acid Secretion

This pill has saved me from daily bouts of heartburn, nausea, vomiting. But I have recently been diagnosed with Osteoporosis. I don't know if it is from taking Prilosec as I have been told by a relative, happens when taking the pill.

4

Patient Review

2/2/2014

Prilosec Otc for Conditions of Excess Stomach Acid Secretion

I was hospitalized with interstitial nephritis, and this treatment really helped me recover.

3.7

Patient Review

10/1/2016

Prilosec Otc for Inflammation of the Esophagus with Erosion

I was taking 20 mg. of Prilosec as needed for the past six months, but my doctor increased it to 40 mg./day. After only two weeks of this dosage, I had a headache every day and felt like there was a lump in my throat. By the end of the two weeks, I felt like someone was choking me and my symptoms got much worse.

3.7

Patient Review

1/9/2017

Prilosec Otc for Condition in which Stomach Acid is Pushed Into the Esophagus

I recently developed chronic diarrhea and have been struggling with it for the last six months. In the last month, I've lost fifteen pounds despite having a good appetite. No matter what I eat, it seems to just come right back out.

3.3

Patient Review

8/28/2013

Prilosec Otc for Treatment to Prevent Heartburn

2.3

Patient Review

7/3/2014

Prilosec Otc for Condition in which Stomach Acid is Pushed Into the Esophagus

I take Prilosec for a chronic cough, which developed into atelectasis. I have a tremor and have difficulty writing. Is there a substitute????

1.7

Patient Review

6/23/2020

Prilosec Otc for Excessive Production of Stomach Acid

After using this treatment for ten years, I developed chronic kidney disease. Definitely would not recommend it to others.

1

Patient Review

5/9/2015

Prilosec Otc for Treatment to Prevent Heartburn

I've been taking this medication for over five years now, and it doesn't help me at all anymore.

1

Patient Review

8/19/2016

Prilosec Otc for Condition in which Stomach Acid is Pushed Into the Esophagus

I'm not sure when the best time to take this medication is.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about prilosec otc

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are side effects of Prilosec OTC?

"or, jaundice (yellowing of the skin or eyes).

You may have a serious reaction to ibuprofen if you experience severe stomach pain, watery or bloody diarrhea, new or unusual pain in your wrist, thigh, hip, or back, or a seizure. Kidney problems can also occur, manifesting as fever, rash, nausea, loss of appetite, joint pain, urinating less than usual, blood in your urine, or weight gain. Jaundice (yellowing of the skin or eyes) is another possible symptom of a serious reaction to ibuprofen."

Answered by AI

Why is Prilosec OTC only 14 days?

"Since Prilosec OTC works by shutting off many of the pumps that produce acid, it is not likely that you will have too little acid.

Prilosec OTC begins working on the first day of treatment, but it may take 1-4 days to reach its full effect. Taking Prilosec OTC every day for 14 days helps keep acid production under control.

Since Prilosec OTC works by shutting off pumps that produce acid, it's unlikely you'll have too little acid."

Answered by AI

Why you should not take Prilosec?

"Prilosec dangers include an increased risk of kidney disease and long-term kidney damage. A study looked at 125,000 PPI users over five years and found kidney problems developed silently in many cases. Half of those who developed chronic kidney damage never had any kidney problems before taking PPIs."

Answered by AI

What is the difference between Prilosec and Prilosec OTC?

"Both prescription Prilosec and Prilosec OTC contain the same active ingredient, omeprazole, which effectively stops acid production. Prescription Prilosec is used to treat diseases that require diagnosis and supervision by a doctor, while Prilosec OTC is only used to treat symptoms of frequent heartburn."

Answered by AI

Clinical Trials for Prilosec Otc

Have you considered Prilosec Otc clinical trials?

We made a collection of clinical trials featuring Prilosec Otc, we think they might fit your search criteria.
Go to Trials
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Steroids for Rheumatoid Arthritis

18+
All Sexes
Toronto, Canada

People living with rheumatoid arthritis (RA) often experience flares-periods where their symptoms suddenly get worse. These flares can cause significant pain, make it harder to move and do daily activities, and lower overall quality of life. Doctors often treat flares with medications called glucocorticoids (GCs), which reduce inflammation. These medications can be taken by mouth (oral/PO) or given as a single injection into the muscle (intramuscular/IM). However, it's not clear which option works better from the patient's point of view-especially when it comes to relief of symptoms, improvements in function, and satisfaction with treatment. Most research so far has focused on how well the drugs control the disease, rather than how they impact the patient's overall experience. Research Questions: 1. Does a single GC injection work just as well as taking pills over a few weeks in improving symptoms reported by patients? 2. How do the two treatments compare in terms of symptom relief, ability to function, and patient satisfaction? 3. What do patients think and feel about using GCs to treat RA flares? What the Investigators Think: The investigators believe that a one-time GC injection is just as good as taking pills for a few weeks when it comes to managing RA flares. In fact, the injection might even be safer and preferred by patients. What the Investigators are Doing: The investigators will study 220 adults with RA who are currently having a flare (with at least 3 swollen and tender joints). These patients will be recruited from rheumatology clinics at the University of Toronto and must not have used GCs in the past month. They will be randomly assigned to receive either: A single injection (Methylprednisolone 120 mg), or Oral pills (Prednisone starting at 15 mg daily and tapering down over 3 weeks). The main thing the investigators will look at is how much better patients feel after 6 weeks, based on a questionnaire designed to measure RA flares. The investigators will also look at how well they function, how satisfied they are with the treatment, and whether they had any side effects. In addition, 20 patients (10 from each group) will be interviewed to understand their experiences and opinions about flare treatment in more detail. Why This Is Possible: The investigators have already surveyed University of Toronto rheumatologists who support the idea and provided input on study design. The investigators have also partnered with experts in research methods, national arthritis organizations, and patient groups to make sure the study is relevant and meaningful. Ethics approval has been obtained. Why It Matters: RA flares can have a major impact on people's lives. While current treatments help control inflammation, the investigators need to better understand how these treatments affect people from their own perspective. This study will shift the focus to what matters most to patients, helping doctors and patients choose the best treatment based not only on medical results but also on the patient's experience. This could lead to more effective and personalized care for people living with RA.

Phase 4
Waitlist Available

Sunnybrook Health Sciences Centre (+4 Sites)

Image of Weill Cornell Medical College in New York, United States.

Health Coaching for Rheumatoid Arthritis

18+
All Sexes
New York, NY

The goal of this clinical trial is to learn if peer coaching works to reduce levels of anxiety and/or depression in adults diagnosed with Rheumatoid Arthritis (RA). The main questions it aims to answer are: Do people with RA who complete the intervention with a peer coach have lower levels of anxiety and/or depression at 6 months from baseline? Do people with RA who complete the intervention with a peer coach have lower levels of anxiety and/or depression at 6 months compared to those in the control arm? Researchers will compare the peer coaching intervention to an active-control arm (where people without RA coach participants on general health and nutrition topics) to see if peer coaching works to reduce anxiety and/or depression. Participants will meet with a coach every week for 9 weeks and complete several surveys before, during and after the intervention

Recruiting
Has No Placebo

Weill Cornell Medical College

Iris Y Navarro-Millán, MD

Bristol-Myers Squibb

Image of Humana Healthcare Research, Inc. in Louisville, United States.

Academic Detailing for Rheumatoid Arthritis

Any Age
All Sexes
Louisville, KY

The goal of this trial is to learn if an interactive evidence-based educational outreach visits to clinicians who prescribe biologics change prescribing of biosimilar medications. The main questions it aims to answer are: 1. Do educational outreach visits lead to a higher number of prescriptions for biosimilar versions of adalimumab? 2. Do in-person or virtual visits work better? Researchers will compare clinicians offered the educational outreach visit to those who are not offered the visit to see if there is a difference in prescribing of biosimilar versions of adalimumab instead of the original brand-name version. Participants will be offered the chance to meet with a trained clinician who will provide educational information tailored to their knowledge and attitudes on the topic. They will also be provided an educational brochure and patient educational materials.

Waitlist Available
Has No Placebo

Humana Healthcare Research, Inc. (+1 Sites)

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Image of University of California, Irvine - UCI Medical Center in Orange, United States.

Sling-Fiber Preservation vs. Conventional POEM for Achalasia

18+
All Sexes
Orange, CA

Peroral endoscopic myotomy (POEM) is an effective, minimally invasive treatment for achalasia, offering excellent rates of symptom relief. However, a significant drawback is the high incidence of gastroesophageal reflux disease (GERD) following the procedure. One proposed technical modification, the selective preservation of the sling fibers during gastric myotomy (SFP-POEM), may reduce this risk without compromising efficacy as compared to a conventional POEM procedure, which includes myotomy of the sling fibers. In this study, adults with achalasia will be randomly assigned to receive one of the two POEM technical approaches. Researchers will monitor whether preserving sling fibers reduces the rates of reflux esophagitis (classified as Los Angeles Grade B or higher) on follow-up endoscopy. Participants will be followed for up to 1 year after the procedure.

Waitlist Available
Has No Placebo

University of California, Irvine - UCI Medical Center

Jason Samarasena, MD, MBA

Image of University of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases in Minneapolis, United States.

Ultrasound Therapy for Rheumatoid Arthritis

18+
All Sexes
Minneapolis, MN

The At-Home ULTRA Study will evaluate performance of the MINI system as indicated for the treatment of adults with active, moderate to severe rheumatoid arthritis who are inadequate responders or are intolerant to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), or targeted synthetic DMARDs (tsDMARDs). The non-invasive study device delivers ultrasound stimulation to the spleen to reduce inflammation. The study will enroll at least 60 participants at up to 8 sites. There will be three arms consisting of two active stimulation groups (treatment) and one non-active stimulation group (sham-control). After completing the double-blinded primary endpoint assessment period at Week 12, there will be a one-way crossover of control participants to active stimulation and an additional 12 week follow-up with all participants to evaluate long-term outcomes.

Recruiting
Drug

University of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases (+4 Sites)

Daniel Zachs

SecondWave Systems Inc.

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