Description
Omeprazole is used to treat certain conditions where there is too much acid in the stomach. It is used to treat gastric and duodenal ulcers, erosive esophagitis, and gastroesophageal reflux disease (GERD). GERD is a condition where the acid in the stomach washes back up into the esophagus. Sometimes omeprazole is used in combination with antibiotics (eg, amoxicillin, clarithromycin) to treat ulcers associated with the infection caused by the H. pylori bacteria.
Omeprazole is also used to treat Zollinger-Ellison syndrome, a condition where the stomach produces too much acid.
Omeprazole is also used to treat dyspepsia, a condition that causes sour stomach, belching, heart burn, or indigestion.
In addition, omeprazole is used to prevent upper gastrointestinal tract bleeding in seriously ill patients.
Omeprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach.
This medicine is available both over-the-counter (OTC) and with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for Suspension
- Tablet Disintegrating, Delayed Release
- Capsule, Delayed Release
- Tablet, Delayed Release
- Packet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of omeprazole in children 1 to 16 years of age. Safety and efficacy have not been established in children younger than 1 month of age. .
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of omeprazole in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Rilpivirine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Acalabrutinib
- Amphetamine
- Atazanavir
- Atezolizumab
- Avacopan
- Belumosudil
- Belzutifan
- Benzphetamine
- Bosutinib
- Capecitabine
- Carbamazepine
- Cefuroxime Axetil
- Cilostazol
- Citalopram
- Clarithromycin
- Clopidogrel
- Clorazepate
- Conivaptan
- Dabrafenib
- Dacomitinib
- Darunavir
- Dasabuvir
- Dasatinib
- Delavirdine
- Dextroamphetamine
- Diazepam
- Digoxin
- Elagolix
- Erlotinib
- Escitalopram
- Eslicarbazepine Acetate
- Fedratinib
- Fexinidazole
- Fluconazole
- Fosnetupitant
- Fosphenytoin
- Gefitinib
- Indinavir
- Infigratinib
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Armodafinil
- Cyanocobalamin
- Disulfiram
- Ginkgo Biloba
- Iron
- Levothyroxine
- Raltegravir
- Tipranavir
- Triazolam
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Cranberry
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Diarrhea or
- Hypomagnesemia (low magnesium in the blood), history of or
- Osteoporosis (bone problem) or
- Seizures, history of or
- Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you are using this medicine without a prescription, follow the instructions on the medicine label.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take omeprazole capsules or delayed-release capsules before a meal, preferably in the morning. Omeprazole tablets may be taken with food or on an empty stomach. Take omeprazole powder for oral suspension on an empty stomach at least 1 hour before a meal. For patients receiving continuous feeding through a tube, feeding should be temporarily stopped about 3 hours before and 1 hour after administration of omeprazole powder for oral suspension.
It may take several days before this medicine begins to relieve stomach pain. To help relieve this pain, antacids may be taken with omeprazole, unless your doctor tells you otherwise.
If you are taking this medicine to treat an ulcer that is associated with an H. pylori infection, take it together with antibiotics (eg, amoxicillin, clarithromycin) at the same time of day.
Swallow the capsule and tablet forms of omeprazole whole. Do not open the capsule. Do not crush, break, or chew the capsule or the tablet.
If you cannot swallow the omeprazole delayed-release capsules, you may open it and sprinkle the pellets contained in the capsule on one tablespoon of applesauce. This mixture must be swallowed immediately with a glass of cool water. The applesauce should not be hot and should be soft enough to be swallowed without chewing. Do not chew or crush the pellets.
To use the powder for oral suspension:
- Empty packet of powder into a small cup containing 2 tablespoons of water.
- Do not use other liquids or foods.
- Stir well and drink immediately.
- Refill cup with water and drink.
To use the delayed-release oral suspension:
- Empty the contents of a 2.5 milligrams (mg) packet of powder into a container containing 5 mL of water.
- Empty the contents of a 10 mg packet of powder into a container containing 15 mL of water.
- Do not use other liquids or foods.
- Stir and leave it for 2 to 3 minutes to thicken.
- Stir well and drink within 30 minutes.
- If any medicine remains after drinking, add more water, stir, and drink immediately.
If you are using the delayed-release oral suspension with a nasogastric or gastric tube:
- Add 5 mL to a catheter tipped syringe and then add the contents of a 2.5 mg packet (or 15 mL of water for the 10 mg packet).
- Shake the syringe right away and leave it for 2 to 3 minutes to thicken.
- Shake the syringe and give the medicine through the nasogastric or gastric tube into the stomach with 30 minutes.
- Refill the syringe with an equal amount of water.
- Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage forms (capsules, delayed-release capsules or suspension, or tablets):
- To treat duodenal ulcers:
- Adults—20 milligrams (mg) once a day before a meal. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- To treat duodenal ulcers with H. pylori:
- Adults—20 or 40 milligrams (mg) one, two, or three times a day before a meal. The dose is usually taken together with clarithromycin or clarithromycin plus amoxicillin. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- To treat erosive esophagitis:
- Adults—20 milligrams (mg) once a day before a meal. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- To treat erosive esophagitis caused by acid-mediated GERD:
- Adults and children 17 years of age and older—20 milligrams (mg) once a day before a meal.
- Children 1 to 16 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 to 20 mg once a day before a meal.
- Children 1 month to younger than 1 year of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 2.5 to 10 mg once a day before a meal.
- Children younger than 1 month of age—Use and dose must be determined by your doctor.
- To treat gastric ulcers:
- Adults—40 milligrams (mg) once a day before a meal. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- To treat gastroesophageal reflux disease (GERD):
- Adults—20 milligrams (mg) once a day before a meal. Your doctor may want you to take omeprazole for more than 8 weeks for certain conditions.
- Children 1 year of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 to 20 mg once a day before a meal.
- Children younger than 1 year of age—Use and dose must be determined by your doctor.
- To treat Zollinger-Ellison syndrome:
- Adults—60 milligrams (mg) once a day before a meal. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- To treat duodenal ulcers:
- For oral dosage form (powder for suspension):
- To prevent upper gastrointestinal tract bleeding in seriously ill patients:
- Adults—The first day: 40 milligrams (mg) for the first dose, then after 6 to 8 hours, a second 40 mg dose. After the first day: 40 mg once a day for up to 14 days.
- Children—Use and dose must be determined by your doctor.
- To treat duodenal ulcer:
- Adults—20 milligrams (mg) once a day for 4 to 8 weeks.
- Children—Use and dose must be determined by your doctor.
- To treat gastric ulcers:
- Adults—40 milligrams (mg) once a day for 4 to 8 weeks.
- Children—Use and dose must be determined by your doctor.
- To treat gastroesophageal reflux disease (GERD) for erosive esophagitis:
- Adults—20 milligrams (mg) once a day for 4 to 8 weeks.
- Children—Use and dose must be determined by your doctor.
- To prevent upper gastrointestinal tract bleeding in seriously ill patients:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is important that your doctor check your or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood, urine, and other laboratory tests may be needed to check for unwanted effects. If your or your child's condition does not improve, or if it becomes worse, check with your doctor.
Tell your doctor if you have Asian relatives, such as Filipino, Chinese, Japanese, Korean, or Taiwanese. You may need a lower dose of this medicine to treat erosive esophagitis.
Do not use omeprazole if you are also using medicines containing rilpivirine (Edurant®, Complera®). Using these medicines together may cause unwanted side effects.
This medicine is sometimes given together with other medicines to treat ulcers. Be sure you understand about the risks and proper use of any other medicine your doctor gives you or your child together with omeprazole.
Omeprazole may cause a serious type of allergic reaction when used in patients with conditions treated with antibiotics. Call your doctor right away if you or your child has itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth.
Check with your doctor right away if you or your child has a change in frequency of urination or amount of urine, blood in the urine, fever, joint pain, loss of appetite, skin rash, swelling of the body, feet, or ankles, unusual tiredness or weakness, or unusual weight gain after receiving this medicine. These could be symptoms of a serious kidney problem called acute tubulointerstitial nephritis.
Taking this medicine for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you have concerns about vitamin B12 deficiency.
Serious stomach conditions may occur while taking this medicine alone or together with antibiotics. Check with your doctor immediately if you or your child has stomach cramps, bloated feeling, watery and severe diarrhea which may also be bloody sometimes, fever, nausea or vomiting, or unusual tiredness or weakness.
This medicine may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age and older, if you receive high doses of this medicine, or use it for one year or more. Call your doctor right away if you have severe bone pain or are unable to walk or sit normally.
This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.
This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking this medicine for more than 1 year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Check with your doctor right away if you have convulsions (seizures), fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.
Cutaneous or systemic lupus erythematosus may occur or get worse in patients receiving a PPI. Call your doctor right away if you have joint pain or a skin rash on your cheeks or arms that gets worse when exposed to the sun.
This medicine may increase your risk for fundic gland polyps (abnormal tissue growth in the upper part of your stomach). This is more likely if you are receiving this medicine for more than 1 year. Talk to your doctor if you have concerns.
Do not stop taking this medicine without first checking with your doctor, or unless told to do so by your doctor.
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before you have medical tests.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription (eg, atazanavir, nelfinavir, Reyataz®, Viracept®) or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects
Along with its needed effects, a medicine 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:
Rare
- 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
- Black, tarry stools
- bleeding gums
- blindness
- blistering, peeling, or loosening of the skin
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred or decreased vision
- chest pain or tightness
- confusion
- constipation
- cough
- dark urine
- decreased urine
- difficulty swallowing
- dizziness
- drowsiness
- eye pain
- fast, racing, or uneven heartbeat
- indigestion
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- lower back or side pain
- mood or mental changes
- muscle cramps in the hands, arms, feet, legs, or face
- muscle spasms (tetany) or twitching seizures
- numbness and tingling around the mouth , fingertips, or feet
- nausea
- pain or swelling in the arms or legs without any injury
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- red skin lesions, often with a purple center
- red, irritated eyes
- seizures
- stomach pain
- swollen glands
- trembling
- unpleasant breath odor
- vomiting
- vomiting of blood
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Blurred vision
- confusion
- dryness of the mouth
- flushing
- headache
- increased sweating
Some side effects 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
- diarrhea or loose stools
- difficulty with breathing
- dizziness
- ear congestion
- gas
- heartburn
- loss of voice
- muscle pain
- runny or stuffy nose
- sneezing
- unusual drowsiness
Incidence not known
- Bloody nose
- continuing ringing or buzzing or other unexplained noise in the ears
- decreased interest in sexual intercourse
- dry mouth
- hearing loss
- inability to have or keep an erection
- increased sensitivity of the skin to sunlight
- increased sweating
- loss in sexual ability, desire, drive, or performance
- redness or other discoloration of the skin
- severe sunburn
- swelling of the breasts or breast soreness in both females and males
- trouble sleeping
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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