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Esomeprazole 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 cell. It is the S-isomer of omeprazole. By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity regardless of the stimulus.

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:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain, cramps, or spasms
+ Weakness
+ Shakiness
+ Balance changes
+ Abnormal heartbeat
+ Seizures
+ Loss of appetite
+ Severe nausea or vomiting
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Severe dizziness or fainting
Bone pain
Significant weight loss
Severe diarrhea (possibly due to Clostridioides difficile-associated diarrhea, or CDAD), characterized by:
+ Stomach pain or cramps
+ Very loose or watery stools
+ Bloody stools
+ Do not attempt to treat diarrhea without consulting your doctor
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which may also affect internal organs
+ Symptoms may include:
- 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
- Swollen glands

Other Possible Side Effects

Most people experience either no side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Headache
Stomach pain or diarrhea
Constipation
Gas
Dry mouth
Upset stomach

This is not an exhaustive list of possible side effects. If you have 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. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are currently taking any of the following medications: Atazanavir, clopidogrel, methotrexate, nelfinavir, rifampin, rilpivirine, St. John's wort, or warfarin.
* If you have a history of any of the following health issues:
+ Black or bloody stools
+ Heartburn accompanied by symptoms such as lightheadedness, sweating, dizziness, or wheezing
+ Chest pain
+ Shoulder pain that is associated with shortness of breath
+ Pain that radiates to the arms, neck, or shoulders
+ Lightheadedness
+ Excessive sweating
+ Vomiting blood
+ Difficulty or pain when swallowing food

Please note that this list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help ensure that it is safe for you to take this medication in conjunction with your other treatments. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the prescribed duration of treatment, as taking this drug for longer than recommended by your doctor may lead to adverse effects.

This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.

Patients with weak bones (osteoporosis) should be aware that this medication may increase the risk of fractures in the hip, spine, and wrist. This risk may be higher if you take high doses of this medication, use it for more than a year, or are over 50 years old. If you have risk factors for osteoporosis, such as alcohol consumption, smoking, steroid use, seizure medication, or a family history of osteoporosis, discuss your risks with your doctor and take necessary precautions.

Prolonged use of this medication (typically more than 3 months) may lead to rare but potentially serious side effects, including low magnesium levels. Most cases occur after at least 1 year of treatment, which may cause other electrolyte problems. Your doctor may recommend regular blood tests to monitor your magnesium levels.

Long-term treatment with this medication (usually more than 3 years) may cause low vitamin B-12 levels. Be aware of the signs of vitamin B-12 deficiency, such as shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, tiredness, mood changes, or numbness or tingling in the arms or legs. If you experience any of these symptoms, contact your doctor immediately.

This medication has been associated with the development or worsening of lupus. If you have lupus, inform your doctor, and seek medical attention immediately if you notice any symptoms, 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.

Taking this medication for more than 1 year may increase the risk of stomach growths called fundic gland polyps. If you have concerns, discuss them with your doctor.

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

• Nelfinavir
• Atazanavir
• Rilpivirine
• Clopidogrel (potential reduced antiplatelet effect, although clinical significance debated)

• Warfarin (increased INR/PT)
• Digoxin (increased digoxin levels)
• Methotrexate (increased methotrexate levels)
• Tacrolimus (increased tacrolimus levels)
• Citalopram (increased citalopram levels)
• Diazepam (increased diazepam levels)
• Cilostazol (increased cilostazol levels)
• Iron salts (decreased absorption)
• Ketoconazole, Itraconazole, Erlotinib (decreased absorption due to increased gastric pH)
• Mycophenolate mofetil (reduced exposure of active metabolite)

• St. John's Wort (potential decreased esomeprazole levels)
• Rifampin (potential decreased esomeprazole levels)

• Persistent or worsening heartburn
• Dysphagia (difficulty swallowing)
• Odynophagia (painful swallowing)
• Unexplained weight loss
• Gastrointestinal bleeding (black, tarry stools; coffee-ground vomit)
• New or worsening abdominal pain
• Diarrhea (especially severe or persistent, suggestive of C. difficile infection)
• Muscle cramps, weakness, tremors, or arrhythmias (signs of hypomagnesemia)
• Fatigue, pallor, numbness/tingling (signs of B12 deficiency)

Esomeprazole is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed.

Esomeprazole is excreted into human milk. The amount is small, but potential for adverse effects on the infant exists. The American Academy of Pediatrics considers omeprazole (racemic mixture) to be compatible with breastfeeding. Use with caution, weighing benefits to mother against potential risks to infant. L3 (Moderately Safe).

Dosing varies by age and weight. Generally safe and effective for GERD in children 1 month to 17 years. Long-term use in children should be carefully considered due to potential risks (e.g., bone fractures, hypomagnesemia).

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment is generally needed based solely on age, but consider potential for polypharmacy and comorbidities.

• Instruct patients to take esomeprazole at least 1 hour before a meal for optimal absorption and efficacy.
• For powder for suspension, ensure patients understand how to properly mix the granules with water and consume immediately. Do not crush or chew.
• Long-term PPI use (typically >1 year) has been associated with increased risks of bone fractures, C. difficile infection, hypomagnesemia, and vitamin B12 deficiency. Periodically assess the need for continued therapy.
• Consider tapering PPIs when discontinuing long-term use to avoid rebound acid hypersecretion.
• Be mindful of drug interactions, especially with clopidogrel, HIV antivirals (atazanavir, nelfinavir, rilpivirine), and methotrexate.

• Other Proton Pump Inhibitors (PPIs): Omeprazole, Lansoprazole, Pantoprazole, Rabeprazole, Dexlansoprazole.
• H2-receptor antagonists (H2RAs): Famotidine, Ranitidine (if available), Cimetidine, Nizatidine.
• Antacids (for symptomatic relief): Calcium carbonate, Aluminum hydroxide/Magnesium hydroxide.
• Prokinetics (e.g., Metoclopramide, for specific motility disorders, not first-line for GERD).

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.