Prilosec reviews side effects



Generic Name: omeprazole (oh MEP ra zol)
Brand Names: FIRST Omeprazole, Omeprazole + SyrSpend SF Alka, Prilosec, Prilosec OTC

Medically reviewed by Sophia Entringer, PharmD Last updated on May 1, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Tips
  • Interactions
  • More

What is Prilosec?

Prilosec (omeprazole) is a proton pump inhibitor that decreases the amount of acid produced in the stomach.

Prilosec is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions caused by excess stomach acid. Prilosec is also used to promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid).

Prilosec may also be given together with antibiotics to treat gastric ulcer caused by infection with Helicobacter pylori (H. pylori).

Over-the-counter Prilosec OTC is used to help control heartburn that occurs 2 or more days per week. Prilosec OTC must be taken as a course for 14 days in a row.

Prilosec may also be used for purposes not listed in this medication guide.

Important Information

Prilosec is not for immediate relief of heartburn symptoms.

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

Omeprazole was associated with kidney problems with long-term use. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.

Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.

Prilosec may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

You may be more likely to have a broken bone while taking this medicine long term or more than once per day.

Prilosec OTC (over-the-counter) should be taken for no longer than 14 days in a row. Allow at least 4 months to pass before you start another 14-day treatment.

Before taking this medicine

You should not use Prilosec if you are allergic to omeprazole, or if:

  • you are also allergic to medicines like omeprazole, such as esomeprazole, lansoprazole, pantoprazole, rabeprazole, Nexium, Prevacid, Protonix, and others; or

  • you also take HIV medication that contains rilpivirine (such as Complera, Edurant, Odefsey, Juluca).

Heartburn can mimic early symptoms of a heart attack. Get emergency medical help if you have chest pain that spreads to your jaw or shoulder and you feel sweaty or light-headed.

Ask a doctor or pharmacist if it is safe for you to use Prilosec if you have other medical conditions, especially:

  • trouble or pain with swallowing;

  • bloody or black stools, vomit that looks like blood or coffee grounds;

  • heartburn that has lasted for over 3 months;

  • frequent chest pain, heartburn with wheezing;

  • unexplained weight loss;

  • nausea or vomiting, stomach pain;

  • liver disease;

  • low levels of magnesium in your blood; or

  • osteoporosis or low bone mineral density (osteopenia).

You may be more likely to have a broken bone in your hip, wrist, or spine while taking a proton pump inhibitor long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy.

Ask a doctor before using Prilosec if you are pregnant or breast-feeding.

Do not give this medicine to a child without medical advice.

How should I take Prilosec?

Prilosec is usually taken before eating (at least 1 hour before a meal). Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Use Prilosec OTC (over-the-counter) exactly as directed on the label, or as prescribed by your doctor.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

You must dissolve Prilosec powder in a small amount of water. This mixture can either be swallowed or given through a nasogastric (NG) feeding tube using a catheter-tipped syringe.

Prilosec OTC should be taken for only 14 days in a row. Allow at least 4 months to pass before you start a new 14-day course of treatment.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

Call your doctor if your symptoms do not improve, or if they get worse.

Some conditions are treated with a combination of omeprazole and antibiotics. Use all medications as directed.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Prilosec.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Prilosec?

Omeprazole can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Prilosec side effects

Get emergency medical help if you have signs of an allergic reaction to Prilosec: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Prilosec and call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;

  • new or unusual pain in your wrist, thigh, hip, or back;

  • seizure (convulsions);

  • kidney problems – little or no urination, blood in your urine, swelling, rapid weight gain;

  • low magnesium – dizziness, irregular heartbeats, feeling jittery, muscle cramps, muscle spasms, cough or choking feeling; or

  • new or worsening symptoms of lupus – joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking omeprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use omeprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common Prilosec side effects may include:

  • stomach pain, gas;

  • nausea, vomiting, diarrhea; or

  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Prilosec?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can interact with omeprazole, especially:

  • clopidogrel;

  • methotrexate;

  • St. John’s wort; or

  • an antibiotic – amoxicillin, clarithromycin, rifampin.

This list is not complete and many other drugs may interact with omeprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Prilosec only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 20.01.

Related questions

  • When is the best time to take my omeprazole, before I eat or after a meal?
  • What is the difference between Nexium and Prilosec?

Medical Disclaimer

More about Prilosec (omeprazole)

  • Side Effects
  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Patient Tips
  • Drug Images
  • Drug Interactions
  • Compare Alternatives
  • Support Group
  • Pricing & Coupons
  • En Español
  • 40 Reviews
  • Drug class: proton pump inhibitors
  • FDA Alerts (6)

Consumer resources

  • Prilosec (Omeprazole Delayed-Release Capsules)
  • Prilosec (Omeprazole Powder for Oral Suspension)
  • Prilosec (Advanced Reading)

Professional resources

  • Prilosec (FDA)
  • … +1 more

Other Formulations

  • Prilosec OTC

Related treatment guides

  • Barrett’s Esophagus
  • Duodenal Ulcer
  • Erosive Esophagitis
  • GERD
  • … +6 more

Omeprazole Side Effects

Medically reviewed by Last updated on Feb 9, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Tips
  • Interactions
  • More

For the Consumer

Applies to omeprazole: oral capsule delayed release, oral packet, oral powder for suspension, oral tablet delayed release

Along with its needed effects, omeprazole may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking omeprazole:


  • Back, leg, or stomach pain
  • bleeding or crusting sores on the lips
  • blisters
  • bloody or cloudy urine
  • chills
  • continuing ulcers or sores in the mouth
  • difficult, burning, or painful urination
  • fever
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • itching, skin rash
  • joint pain
  • loss of appetite
  • muscle aches or cramps
  • pain
  • red or irritated eyes
  • redness, tenderness, itching, burning, or peeling of the skin
  • sore throat
  • sores, ulcers, or white spots on the lips, in the mouth, or on the genitals
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Incidence not known

  • Blistering, peeling, or loosening of the skin
  • drowsiness
  • fast, racing, or uneven heartbeat
  • mood or mental changes
  • muscle spasms (tetany) or twitching seizures
  • nausea
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • trembling
  • vomiting

Get emergency help immediately if any of the following symptoms of overdose occur while taking omeprazole:

Symptoms of overdose

  • Blurred vision
  • confusion
  • dryness of the mouth
  • flushing
  • headache
  • increased sweating

Some side effects of omeprazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • Body aches or pain
  • chest pain
  • constipation
  • cough
  • diarrhea or loose stools
  • difficulty with breathing
  • dizziness
  • ear congestion
  • gas
  • heartburn
  • loss of voice
  • muscle pain
  • nasal congestion
  • runny nose
  • sneezing
  • unusual drowsiness

For Healthcare Professionals

Applies to omeprazole: compounding powder, oral delayed release capsule, oral delayed release tablet, oral powder for reconstitution, oral powder for reconstitution delayed release, oral suspension


The most commonly reported side effects included headache, abdominal pain, nausea, and diarrhea.


Otitis media occurred most frequently in patients 1 month to less than 1 year of age.

Fever most commonly occurred in patients 1 to less than 2 years of age.

Accidental injury most commonly occurred in patients 2 to 16 years of age.

Very common (10% or more): Fever (up to 33%), otitis media (up to 22%)

Common (1% to 10%): Accidental injury, asthenia

Uncommon (0.1% to 1%): Malaise

Very rare (less than 0.01%): Elevated body temperature

Postmarketing reports: Pain, fatigue, tinnitus


Very common (10% or more): Respiratory system reactions (up to 75%)

Common (1% to 10%): Cough, pharyngitis/pharyngeal pain, rhinitis, upper respiratory infection

Rare (0.01% to 0.1%): Bronchospasm

Very rare (less than 0.01%): Dyspnea

Postmarketing reports: Epistaxis

Patients 1 to less than 2 years of age had the highest frequency of adverse reactions of the respiratory system, followed by patients 1 month to less than 1 year and patients 2 to 16 years of age.

Nervous system

Lightheadedness occurred predominantly in severely ill or elderly patients.

Taste disturbance usually resolved when treatment was stopped.

Taste perversion most commonly occurred in patients given concomitant treatment with clarithromycin.

Hepatic encephalopathy occurred in patients with preexisting liver disease.

Very common (10% or more): Taste perversion (up to 15%)

Common (1% to 10%): Dizziness, drowsiness, headache, somnolence

Uncommon (0.1% to 1%): Paresthesia, taste disturbances, vertigo

Rare (0.01% to 0.1%): Hepatic encephalopathy, lightheadedness

Postmarketing reports: Tremor


Hemorrhagic necrotic gastritis has been reported in pediatric patients.

Diarrhea most commonly occurred in patients given concomitant treatment with clarithromycin and amoxicillin.

Benign gastric fundic gland polyps appeared to be reversible when omeprazole was discontinued.

Very common (10% or more): Diarrhea (Up to 14%)

Rare (0.01% to 0.1%): Dry mouth, gastrointestinal candidiasis, microscopic colitis, stomatitis

Very rare (less than 0.01%): Dyspepsia, hemorrhagic necrotic gastritis

Postmarketing reports: Abdominal swelling, Clostridium difficile associated diarrhea, esophageal candidiasis, fecal discoloration, fundic gland polyps, irritable colon, mucosal atrophy of the tongue, pancreatitis (sometimes fatal)


Common (1% to 10%): Rash

Rare (0.01% to 0.1%): Allergic vasculitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal)

Frequency not reported: Subacute cutaneous lupus erythematosus

Postmarketing reports: Cutaneous lupus erythematosus, dry skin, hyperhidrosis, petechia, skin inflammation, severe generalized skin reactions, systemic lupus erythematosus


Common (1% to 10%): Back pain

Uncommon (0.1% to 1%): Fracture of the hip/wrist/spine

Rare (0.01% to 0.1%): Arthralgia, joint pain, muscular weakness, myalgia

Postmarketing reports: Bone fracture, leg pain, muscle cramps


Common (1% to 10%): Insomnia

Rare (0.01% to 0.1%): Aggression, agitation, confusion/reversible mental confusion, depression, hallucinations

Postmarketing reports: Anxiety, apathy, dream abnormalities, nervousness, psychiatric and sleep disturbances

Confusion, agitation, aggression, depression, and hallucinations occurred predominantly in severely ill or elderly patients.


Common (1% to 10%): Flu syndrome


Uncommon (0.1% to 1%): Increased liver enzymes (ALT, alkaline phosphatase, AST, bilirubin, gamma glutamyl transferase)

Rare (0.01% to 0.1%): Hepatic failure, hepatitis with/without jaundice

Postmarketing reports: Cholestatic disease, fatal hepatic failure, hepatocellular disease, jaundice, liver disease, liver necrosis (some fatal), mixed hepatitis


Uncommon (0.1% to 1%): Peripheral edema

Postmarketing reports: Bradycardia, chest pain/angina, elevated blood pressure/hypertension, palpitations, tachycardia

Peripheral edema usually resolved when treatment was stopped.


Rare (0.01% to 0.1%): Agranulocytosis, hypochromic/microcytic anemia, leukopenia, pancytopenia, thrombocytopenia

Postmarketing reports: Anemia, fatal agranulocytosis, hemolytic anemia, leukocytosis, neutropenia, purpura


Rare (0.01% to 0.1%): Anaphylactic reaction/shock, angioedema, hypersensitivity reactions

Postmarketing reports: Anaphylaxis


Severe hypomagnesemia may result in hypocalcemia, and this condition may be associated with hypokalemia.

Hypokalemia was reported in pediatric patients.

Rare (0.01% to 0.1%): Hyponatremia

Very rare (less than 0.01%): Hypocalcemia, hypokalemia, hypomagnesemia with/without hypocalcemia and/or hypokalemia, weight increase

Postmarketing reports: Anorexia, cyanocobalamin (vitamin B12) deficiency, hypoglycemia


Rare (0.01% to 0.1%): Interstitial nephritis

Very rare (less than 0.01%): Impaired renal function, nephrosis

Postmarketing reports: Elevated serum creatinine, glycosuria


Irreversible visual impairment has been reported in critically ill patients who generally received high doses of the IV formulation as a bolus; however, no causal relationship has been established.

Rare (0.01% to 0.1%): Blurred vision

Frequency not reported: Irreversible visual impairment

Postmarketing reports: Anterior ischemic optic neuropathy, double vision, dry eye syndrome, ocular irritation, optic atrophy, optic neuritis


Rare (0.01% to 0.1%): Gynecomastia


Very rare (less than 0.01%): Impotence

Postmarketing reports: Hematuria, microscopic pyuria, proteinuria, testicular pain, urinary frequency, urinary tract infection

A causal relationship between this drug and impotence has not been established.


Postmarketing reports: Gastroduodenal carcinoids

Gastroduodenal carcinoids have been reported in patients with Zollinger-Ellison syndrome on long-term therapy. This condition may be a manifestation of the underlying condition, which is known to be associated with tumors.

1. Cerner Multum, Inc. “Australian Product Information.” O 0

2. “Product Information. Zegerid (omeprazole).” Santarus Inc, San Diego, CA.

3. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

4. “Product Information. Prilosec (omeprazole).” Merck & Co, Inc, West Point, PA.

5. “Product Information. Omeprazole (omeprazole).” Mylan Pharmaceuticals Inc, Morgantown, WV.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

  • When is the best time to take my omeprazole, before I eat or after a meal?
  • What is the difference between Nexium and Prilosec?

Medical Disclaimer

More about omeprazole

  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Patient Tips
  • Drug Images
  • Drug Interactions
  • Compare Alternatives
  • Support Group
  • Pricing & Coupons
  • 218 Reviews
  • Drug class: proton pump inhibitors
  • FDA Alerts (6)
  • Omeprazole
  • Omeprazole Delayed-Release Capsules and Tablets (OTC)
  • Omeprazole Orally-Disintegrating Tablets
  • Omeprazole Delayed-Release Capsules
  • Omeprazole Powder for Oral Suspension
  • Omeprazole (Advanced Reading)

Other brands: Prilosec, Prilosec OTC

  • Omeprazole (AHFS Monograph)
  • … +3 more
  • GERD
  • Erosive Esophagitis
  • Duodenal Ulcer
  • Barrett’s Esophagus
  • … +9 more

About omeprazole

Type of medicine Proton pump inhibitor
Used for Healing or prevention of gastric or duodenal ulcers; gastro-oesophageal reflux disease; Helicobacter pylori infection; Zollinger-Ellison syndrome; acid-related dyspepsia; reduction of gastric acid during surgery
Also called (UK) Losec®; Mepradec®; Mezzopram®
Also called (USA) Genozol®; Prilosec®
Combination brands include: Yosprala® (omeprazole with aspirin); Zegerid® (omeprazole with sodium bicarbonate)
Available as Capsules, tablets, dispersible tablets, and injection

Acid is produced naturally in your stomach to help you digest food and to kill bacteria. This acid is irritant so your body produces a natural mucous barrier which protects the lining of your stomach. In some people, this barrier can break down allowing the acid to damage the stomach, causing inflammation, ulcers and other conditions. Other people can have a problem with the muscular band at the top of the stomach that keeps the stomach tightly closed. This may allow the acid to escape and irritate the oesophagus, causing heartburn. This is often referred to as ‘acid reflux’.

Proton pump inhibitors such as omeprazole stop cells in the lining of the stomach from producing too much acid. This can help to prevent ulcers from forming, or assist the healing process where damage has already occurred. By decreasing the amount of acid, they can also help to reduce the symptoms of acid reflux disease, such as heartburn. Omeprazole is also given as one part of a treatment to get rid of Helicobacter pylori, a bacterium found in the stomach, which can cause ulcers.

Omeprazole is available on prescription. You can also buy short courses of omeprazole at a pharmacy for the treatment of reflux symptoms (such as heartburn) in adults.

Before taking omeprazole

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking omeprazole it is important that your doctor or pharmacist knows:

  • If you are pregnant, trying for a baby or breast-feeding.
  • If you have any of the following symptoms: difficulty swallowing, loss of blood, weight loss, or if you are being sick (vomiting).
  • If you have any problems with the way your liver works.
  • If you have ever had an allergic reaction to a medicine.
  • If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.

How to take omeprazole

  • Before you start this treatment, read the manufacturer’s printed information leaflet from inside the pack. It will give you more information about omeprazole and will provide you with a full list of the side-effects which you may experience from taking it.
  • If you have bought omeprazole for reflux symptoms such as heartburn, take one or two (10 mg) tablets daily, preferably in a morning. You may need to take omeprazole for a day or so to control your symptoms. If your symptoms do not improve within this time, you should talk to your doctor about this. Swallow the tablet with a drink of water – do not chew or crush the tablet before you swallow. Do not take omeprazole for more than four weeks without speaking with a doctor.
  • If you have been prescribed omeprazole, take it exactly as your doctor tells you to. There are different strengths of tablets and capsules available so your doctor will tell you which is right for you. It is usually taken once a day. If you are taking it for either Helicobacter pylori eradication or for Zollinger-Ellison syndrome, it is likely you will be asked to take two doses a day. Your doctor will tell you which dose is right for you and the directions will also be on the label of the pack to remind you.
  • Omeprazole tablets and capsules contain small pellets which are specially coated to make sure that the medicine is absorbed correctly by your body. Do not chew the pellets. If you find capsules or tablets difficult to swallow, let your doctor know. Some omeprazole capsules and tablets can be mixed with water or fruit juice to make swallowing easier and your doctor can prescribe these for you.
  • Omeprazole can be taken before or after food, although taking it before food can be preferable.
  • If you forget to take a dose at your usual time, you can take it when you remember (unless it is nearly time for your next dose, in which case leave out the missed dose). Do not take two doses together to make up for a forgotten dose.

Getting the most from your treatment

  • Try to keep your regular appointments with your doctor. This is so your progress can be checked. If you are taking omeprazole on a long-term basis your doctor will want to review your treatment at least once a year to make sure it is still right for you.
  • A typical course of treatment lasts for one or two weeks if you are taking omeprazole for Helicobacter pylori eradication. It will last for one or two months if it is to allow an ulcer to heal. For all other reasons for taking omeprazole, your treatment will last for as long as is necessary to control your symptoms.
  • Some foods may make your symptoms worse. Foods and drinks that have been suspected of this include peppermint, tomatoes, chocolate, spicy foods, hot drinks, coffee, and alcoholic drinks. If it seems that a food is aggravating your symptoms, try avoiding it for a while to see if your symptoms improve. Also, try avoiding eating large meals, as these can make your symptoms worse too.
  • If you are overweight, it puts extra pressure on your stomach and encourages the symptoms of acid reflux. Losing some weight and eating a healthy balanced diet may help you.
  • Smoking increases the amount of acid produced by the stomach and may make your symptoms worse. If you are a smoker, speak with your doctor or pharmacist about how to quit.
  • Recent studies suggest that there may be a slight increase in the risk of bone fractures when proton pump inhibitors like omeprazole are taken for longer than a year. If this affects you, your doctor will check that you are taking enough vitamin D and calcium to reduce this risk.
  • If you buy any medicines ‘over the counter’, always check with a pharmacist that they are safe to take alongside your other medicines.

Can omeprazole cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with omeprazole. You will find a full list in the manufacturer’s information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

Common omeprazole side-effects (these affect less than 1 in 10 people) What can I do if I experience this?
Stomach upset, such as feeling sick (nausea), stomach ache, or wind (flatulence); tummy (abdominal) pain, being sick (vomiting) Stick to simple meals – avoid rich or spicy foods. If symptoms are severe or do not go away, let your doctor know
Diarrhoea Drink plenty of water. If it continues or becomes severe, let your doctor know
Constipation Try to eat a well-balanced diet and drink several glasses of water each day
Headache Drink plenty of water and ask your pharmacist to recommend a suitable painkiller. If the headaches continue let your doctor know

If you experience any other symptoms which you think may be due to the medicine, speak with your doctor or pharmacist for further advice.

How to store omeprazole

  • Keep all medicines out of the reach and sight of children.
  • Store in a cool, dry place, away from direct heat and light.

Important information about all medicines

Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty.

This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.

If you are having an operation or any dental treatment, tell the person carrying out the treatment which medicines you are taking.

Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.

If you have any questions about this medicine ask your pharmacist.


Clinical Trials Experience With PRILOSEC 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.

The safety data described below reflects exposure to PRILOSEC Delayed-Release Capsules in 3096 patients from worldwide clinical trials (465 patients from US studies and 2,631 patients from international studies). Indications clinically studied in US trials included duodenal ulcer, resistant ulcer, and Zollinger-Ellison syndrome. The international clinical trials were double blind and open-label in design. The most common adverse reactions reported (i.e., with an incidence rate ≥ 2%) from PRILOSEC-treated patients enrolled in these studies included headache (6.9%), abdominal pain (5.2%), nausea (4.0%), diarrhea (3.7%), vomiting (3.2%), and flatulence (2.7%).

The clinical trial safety profile in patients greater than 65 years of age was similar to that in patients 65 years of age or less.

The clinical trial safety profile in pediatric patients who received PRILOSEC Delayed-Release Capsules was similar to that in adult patients. Unique to the pediatric population, however, adverse reactions of the respiratory system were most frequently reported in both the 1 to < 2 and 2 to 16 year age groups (75.0% and 18.5%, respectively). Similarly, fever was frequently reported in the 1 to 2 year age group (33.0%), and accidental injuries were reported frequently in the 2 to 16 year age group (3.8%) .

Clinical Trials Experience With PRILOSEC In Combination Therapy For H. pylori Eradication

In clinical trials using either dual therapy with PRILOSEC and clarithromycin, or triple therapy with PRILOSEC, clarithromycin, and amoxicillin, no adverse reactions unique to these drug combinations were observed. Adverse reactions observed were limited to those previously reported with omeprazole, clarithromycin, or amoxicillin alone.

Dual Therapy (PRILOSEC/clarithromycin)

Adverse reactions observed in controlled clinical trials using combination therapy with PRILOSEC and clarithromycin (n = 346) that differed from those previously described for PRILOSEC alone were taste perversion (15%), tongue discoloration (2%), rhinitis (2%), pharyngitis (1%) and flu-syndrome (1%). (For more information on clarithromycin, refer to the clarithromycin prescribing information, Adverse Reactions section.)

Triple Therapy (PRILOSEC/clarithromycin/amoxicillin)

The most frequent adverse reactions observed in clinical trials using combination therapy with PRILOSEC, clarithromycin, and amoxicillin (n = 274) were diarrhea (14%), taste perversion (10%), and headache (7%). None of these occurred at a higher frequency than that reported by patients taking antimicrobial agents alone. (For more information on clarithromycin or amoxicillin, refer to the respective prescribing information, Adverse Reactions sections.)

Post-marketing Experience

The following adverse reactions have been identified during post-approval use of PRILOSEC Delayed-Release Capsules. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their actual frequency or establish a causal relationship to drug exposure.

Body As a Whole: Hypersensitivity reactions including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, urticaria, (see also Skin below); fever; pain; fatigue; malaise;

Cardiovascular: Chest pain or angina, tachycardia, bradycardia, palpitations, elevated blood pressure, peripheral edema

Endocrine: Gynecomastia

Gastrointestinal: Pancreatitis (some fatal), anorexia, irritable colon, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, stomatitis, abdominal swelling, dry mouth, microscopic colitis. During treatment with omeprazole, gastric fundic gland polyps have been noted rarely. These polyps are benign and appear to be reversible when treatment is discontinued.

Gastroduodenal carcinoids have been reported in patients with ZE syndrome on long-term treatment with PRILOSEC. This finding is believed to be a manifestation of the underlying condition, which is known to be associated with such tumors.

Hepatic: Liver disease including hepatic failure (some fatal), liver necrosis (some fatal), hepatic encephalopathy hepatocellular disease, cholestatic disease, mixed hepatitis, jaundice, and elevations of liver function tests

Infections and Infestations: Clostridium difficile associated diarrhea

Metabolism and Nutritional disorders: Hypoglycemia, hypomagnesemia, with or without hypocalcemia and/or hypokalemia, hyponatremia, weight gain

Musculoskeletal: Muscle weakness, myalgia, muscle cramps, joint pain, leg pain, bone fracture

Nervous System/Psychiatric: Psychiatric and sleep disturbances including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, apathy, somnolence, anxiety, and dream abnormalities; tremors, paresthesia; vertigo

Respiratory: Epistaxis, pharyngeal pain

Skin: Severe generalized skin reactions including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, and erythema multiforme; photosensitivity; urticaria; rash; skin inflammation; pruritus; petechiae; purpura; alopecia; dry skin; hyperhidrosis

Special Senses: Tinnitus, taste perversion

Ocular: Optic atrophy, anterior ischemic optic neuropathy, optic neuritis, dry eye syndrome, ocular irritation, blurred vision, double vision

Urogenital: Interstitial nephritis, hematuria, proteinuria, elevated serum creatinine, microscopic pyuria, urinary tract infection, glycosuria, urinary frequency, testicular pain

Hematologic: Agranulocytosis (some fatal), hemolytic anemia, pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia, leucocytosis

Read the entire FDA prescribing information for Prilosec (Omeprazole)

This Article is Written and/or Reviewed by RefluxMD Medical Authors Team and Reviewers

In this piece, originally published on, Dr. Dengler explains why it’s so important to develop a plan for managing your acid reflux disease and not just rely on PPIs medications like Prilosec or Nexium to relieve your symptoms.

Heartburn can become an escalating problem if ignored. It can also be a dangerous condition if it is masked by just taking antireflux medications.

Most people believe, however, that recurring acid reflux is a normal part of over-eating or sampling spicy food. These acid reflux sufferers don’t realize that one out of every three adults struggle with heartburn and regurgitation on a monthly basis, with 50 million people battling symptoms several times per week.

A nagging problem of heartburn and acid reflux seems easy to fix when watching the many pharmaceutical commercials claiming that their pill, taken daily, can solve the problem; in fact many Americans have accepted big pharma’s suggested solution as an easy fix to their woes.

Today, the drug industry sells over $14 billion in heartburn medications. The popular drug is in a class called proton pump inhibitors (PPIs) that work by reducing the amount of acid produced within the stomach.

Unfortunately, the millions of people who take these prescription drugs or over the counter medications are masking a serious and developing problem.

Unknown to millions of people regularly taking PPI pills to solve their heartburn is that the U.S. Food and Drug Administration warning labels on these prescription drugs clearly states that patients should take the pills for no more than 14 days of temporary relief. Nexium and Prilosec side effects are potentially a problem for many.

  • Direct side effects include headache, diarrhea and abdominal pain.
  • Decreased absorption of dietary calcium and an increased incidence of hip fractures.
  • Vitamin B12 absorption is decreased, potentially resulting in osteoporosis.
  • Increased incidence of pneumonias.
  • Increased incidence of a serious intestinal infection called Clostridium difficile.
  • Under absorption of magnesium can interfere with the function of medications and heart functions.
  • Researchers also have raised the concern of increased risks of heart attacks and kidney disease.

Two weeks of blocked calcium production in your stomach is the maximum timeframe recommended by medical doctors to mask acid reflux without being under the care of a physician—any longer can have serious negative consequences.

If you have heartburn for longer than 14 days then you have a bigger problem than a pill can help solve.

The stomach pains or burning sensation you feel are signals from your body that something is wrong. An acidic stomach is normal and is necessary for the efficient digestion of food.

So why are you getting those pains frequently? Simple, it is due to a small valve at the end of your esophagus called the LES, or your lower esophageal sphincter.

A healthy LES acts as barrier in keeping stomach contents where they belong — in your stomach.

The LES frequently becomes damaged, and when it does, those acidic stomach contents can flow up into the esophagus. When stomach acid leaves your stomach, it can be painful.

In fact, over 200,000 individuals visit emergency rooms each year believing they are having a heart attack only to learn that their pain was from acid reflux and not from a heart problem.

Unfortunately, for a segment of those with reflux disease, heartburn can progress to a precancerous condition called Barrett’s Esophagus, and in some cases, it can advance to adenocarcinoma, better known as esophageal cancer.

In fact, the incidence of esophageal cancer is the fastest growing of all cancers in the U.S., outpacing melanomas, breast and prostate cancers.

PPIs have proven to relieve symptoms, and for several medical conditions, they are highly valuable for short to mid-term use.

However, they are not a cure and well know brands like Nexium and Prilosec have the potential for negative side effects. In fact, check out the product insert to understand the significance of Nexium and Prilosec side effects, or those of other PPIs if you want to learn more.

As they cannot strengthen or repair the LES, the cause of gastroesophageal reflux disease, they can only mask the symptoms. As a result, the disease continues indefinitely.

At a recent gastroesophageal conference, Dr. David Kleiman with the Department of Surgery at New York Presbyterian Hospital and Weill Cornell Medical College presented a research study documenting that 32% of PPI use beyond an initial 8-week trial was unnecessary since there was “no evidence of reflux disease” with those individuals.

According to Dr. Kleiman, “PPIs continue to be misused and overused in a large percent of our population.”

If you are experiencing regular heartburn and think you are solving your problem by consistently taking an acid production blocker, you may be masking a serious problem.

Even worse, you could be increasing your troubles by subjecting yourself to the dangerous and common side-effects of routine PPI usage.

Instead of turning to costly, unnecessary, and often dangerous pills, you should consult your physician and create a real plan to manage your acid reflux.

Read more:

About the author

Leave a Reply

Your email address will not be published. Required fields are marked *