Omeprazole 20mg (otc) Tablets

Omeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase (proton pump) in the gastric parietal cells. It is a weak base that is activated in the acidic secretory canaliculi of the parietal cells, where it is converted to its active sulfenamide form. This active form then irreversibly binds to and inhibits the proton pump, blocking the final step in acid production.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Electrolyte Imbalance: Mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance problems, abnormal heartbeat, seizures, loss of appetite, or severe nausea and vomiting.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or unhealing wounds.
Liver Problems: Dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellowing of the skin and eyes.
Pancreatitis: Severe stomach pain, severe back pain, or severe nausea and vomiting.
Other Serious Symptoms: Severe dizziness, fainting, bone pain, significant weight loss, or extreme fatigue and weakness.

Severe Skin Reactions: This medication can cause rare but potentially life-threatening skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions. If you experience any of the following symptoms, seek medical help immediately: red, swollen, blistered, or peeling skin; red or irritated eyes; sores in the mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Other Possible Side Effects

Most people taking this medication do not experience severe side effects, and some may have only minor or no side effects at all. However, if you notice any of the following symptoms or any other unusual effects, contact your doctor for advice:

Headache
Nausea or vomiting
Stomach pain or diarrhea
* Gas

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you have a history of certain health issues, including:
+ Black or bloody stools
+ Heartburn accompanied by lightheadedness, sweating, dizziness, or wheezing
+ Chest pain
+ Shoulder pain with shortness of breath
+ Pain that radiates to the arms, neck, or shoulders
+ Lightheadedness
+ Excessive sweating
+ Vomiting blood
+ Difficulty or pain when swallowing food
If you have previously experienced kidney problems caused by this medication or a similar drug.
If you are currently taking any of the following medications:
+ Atazanavir
+ Clopidogrel
+ Methotrexate
+ Nelfinavir
+ Rifampin
+ Rilpivirine
+ St. John's wort
+ Warfarin
Note: This list is not exhaustive, and you should inform your doctor about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.

To ensure your safety, it is crucial to discuss all your medications and health problems with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your existing medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.

Important Warnings and Precautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial because it may affect certain laboratory tests. Be sure to notify all your healthcare providers and laboratory personnel that you are taking this drug.

Risk of Fractures

This medication may increase the risk of hip, spine, and wrist fractures, particularly in individuals with weak bones (osteoporosis). The risk may be higher if you take this medication in high doses or for an extended period (more than a year), or if you are over 50 years old. If you have risk factors for osteoporosis, such as a history of alcohol consumption, smoking, steroid use, or seizure medication, or a family history of osteoporosis, exercise caution and discuss your risks with your doctor.

Diarrhea and C. diff-associated Diarrhea (CDAD)

This medication may increase the risk of a severe form of diarrhea called C. diff-associated diarrhea (CDAD). If you experience stomach pain or cramps, very loose or watery stools, or bloody stools, contact your doctor immediately. Do not attempt to treat diarrhea without first consulting your doctor.

Low Magnesium and Vitamin B-12 Levels

Rarely, long-term use of this medication (at least 3 months) has been associated with low magnesium levels, which may lead to other electrolyte problems. Your doctor may recommend regular blood tests to monitor your magnesium levels. Additionally, long-term treatment (more than 3 years) with this medication has been linked to low vitamin B-12 levels. If you experience symptoms such as shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, tiredness, mood changes, or numbness or tingling in the arms or legs, contact your doctor immediately.

Duration of Treatment

Do not take this medication for longer than prescribed by your doctor.

Lupus

This medication has been associated with the development or worsening of lupus. If you have lupus, inform your doctor. Be aware of the signs of lupus, such as a rash on the cheeks or other body parts, changes in skin color, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs, and contact your doctor immediately if you experience any of these symptoms.

Pancreas, Liver, and White Blood Cell Problems

Rarely, this medication has been linked to severe pancreas, liver, and white blood cell problems, which can be fatal. If you have questions or concerns, discuss them with your doctor.

Fundic Gland Polyps

The risk of stomach growths called fundic gland polyps may be higher in individuals who take this medication for more than a year. If you have questions, consult your doctor.

Asian Descent

If you are of Asian descent, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Breastfeeding

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the benefits and risks of this medication to you and your baby.

• Nelfinavir
• Rilpivirine

• Clopidogrel (reduced antiplatelet effect)
• Atazanavir (reduced absorption)
• Methotrexate (increased levels)
• Warfarin (increased INR/bleeding risk)
• Digoxin (increased absorption/levels)
• Tacrolimus (increased levels)

• Citalopram (increased QT prolongation risk)
• Diazepam (increased levels)
• Phenytoin (increased levels)
• Cilostazol (increased levels)
• Iron salts (reduced absorption)
• Mycophenolate mofetil (reduced absorption)
• Erlotinib (reduced absorption)
• Dasatinib (reduced absorption)
• Nilotinib (reduced absorption)
• Posaconazole (reduced absorption)

• Sucralfate (reduced omeprazole absorption if given concurrently)
• St. John's Wort (reduced omeprazole levels)

• Persistent heartburn despite 14-day course
• Heartburn with lightheadedness, sweating, or dizziness
• Chest pain or shoulder pain with shortness of breath
• Pain spreading to arms, neck, or shoulders
• Frequent chest pain
• Frequent wheezing, particularly with heartburn
• Unexplained weight loss
• Nausea or vomiting
• Stomach pain
• Difficulty or pain swallowing food
• Bloody or black stools
• Vomit that looks like coffee grounds

Omeprazole is classified as Pregnancy Category C. While animal studies have shown some adverse effects at high doses, human studies have not shown a consistent risk of major birth defects. It is generally considered acceptable for use during pregnancy when clearly needed, especially for severe symptoms not controlled by lifestyle changes or H2 blockers. Consult a healthcare provider.

Omeprazole is excreted into breast milk in small amounts. The amount is considered low and unlikely to cause adverse effects in breastfed infants. It is rated L3 (Moderately Safe) by Hale's classification. Monitor infant for any signs of adverse effects (e.g., diarrhea, drowsiness).

OTC omeprazole (20mg) is not indicated for use in children under 18 years of age. Prescription omeprazole is approved for certain conditions in children (e.g., GERD, erosive esophagitis) at specific weight-based doses.

No specific dose adjustment is generally needed for elderly patients with normal renal and hepatic function. However, elderly patients may be at increased risk for long-term adverse effects such as bone fractures, C. difficile infection, and hypomagnesemia with prolonged use.

• Omeprazole OTC is intended for frequent heartburn (2 or more days a week), not for immediate relief of occasional heartburn.
• It should be taken once daily in the morning before a meal for 14 consecutive days.
• The full effect of acid suppression may not be seen for 1-4 days.
• Do not take for more than 14 days or repeat a 14-day course more often than every 4 months unless directed by a doctor.
• Long-term use (beyond 14 days or repeated courses) should only be under medical supervision due to potential risks like bone fractures, C. difficile infection, hypomagnesemia, and vitamin B12 deficiency.
• Patients should be advised to seek medical attention if heartburn persists or worsens after 14 days, or if they experience alarming symptoms (e.g., difficulty swallowing, weight loss, bloody stools).

• Other Proton Pump Inhibitors (PPIs): Esomeprazole (Nexium 24HR), Lansoprazole (Prevacid 24HR), Pantoprazole (prescription), Rabeprazole (prescription), Dexlansoprazole (prescription)
• H2 Receptor Blockers (H2RAs): Famotidine (Pepcid AC), Cimetidine (Tagamet HB), Ranitidine (Zantac 360 - available again)
• Antacids (e.g., Tums, Rolaids, Maalox, Mylanta) for immediate, temporary relief
• Alginates (e.g., Gaviscon)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred, to facilitate prompt and appropriate treatment.