Index
It is part of a powerful class of heartburn medications called proton pump inhibitors.
Studies link these drugs to side effects ranging from kidney damage to cancer .
The generic name for Nexium is esomeprazole. It is almost chemically identical to Prilosec (omeprazole). AstraZeneca manufactures prescription versions of Nexium and Prilosec. Prevacid and Protonix are two other related drugs.
In 2018, FiercePharma ranked Nexium as the third best-selling drug in the last 25 years. He estimated that Nexium sales totaled $ 72.5 billion through 2017.
How does this medicine work? What will it do for me?
In adults and children, it is used to treat conditions such as reflux esophagitis (tissue damage caused by stomach contents flowing back into the esophagus) and symptoms of gastroesophageal reflux disease in people with reflux esophagitis .
It is also used to treat non-erosive reflux disease (heartburn and regurgitation not related to tissue damage) in children and adults.
When combined with other medications, Nexium is used to treat duodenal ulcers that are caused by a bacteria known as Helicobacter pylori (H. pylori).
Nexium can be used to treat or reduce the risk of stomach ulcers due to medications known as non-steroidal anti-inflammatory drugs (NSAIDs, eg ibuprofen, naproxen, ketorolac) that irritate the stomach.
It is also used to treat conditions associated with overproduction of stomach acid, including Zollinger-Ellison syndrome.
Nexium Presentations Available
20 mg tablets
Each pink, oblong, biconvex delayed-release tablet, debossed with “20 mg” on one side and “A” for “EH” on the other side, contains 20 mg of esomeprazole.
40 mg tablets
Each pink, oblong, biconvex delayed-release tablet, debossed with “40 mg” on one side and “A” over “EI” on the other side, contains 40 mg of esomeprazole.
Non-medicinal ingredients of both tablets : microcrystalline cellulose, crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, methacrylic acid ethyl acrylate copolymer, polyethylene glycol, polysorbate, sugar stearyl fumarate, sodium paraphine, spheres synthetic, talc, titanium dioxide and triethyl citrate.
Sachet (granules) for oral suspension
Each sachet of pale yellow (can also be brownish) slow-release granules contains 10 mg of esomeprazole.
Non-medicinal ingredients : dextrose, crospovidone, citric acid, glycerol monostearate, hypromellose, hydroxypropylcellulose, iron oxide, magnesium stearate, type C methacrylic acid copolymer, polysorbate, sugar spheres, talc, triethyl citrate and xanthan gum.
How should I use this medicine?
The recommended dose of Nexium to treat reflux esophagitis and symptoms of gastroesophageal reflux disease is 40 mg once a day for 4 to 8 weeks.
After 8 weeks, treatment can be continued at a dose of 20 mg once a day for an additional 4 weeks.
To treat non-erosive reflux disease or heartburn, the recommended dose is 20 mg once a day for 2 to 4 weeks.
After this, Nexium can be taken at a dose of 20 mg once a day as needed to control symptoms.
To treat stomach ulcers associated with the use of non-steroidal anti-inflammatory drugs, the dose is 20 mg once a day for 4 to 8 weeks. To prevent such ulcers, the dose is 20 mg once a day.
To treat duodenal ulcers caused by H. pylori in adults, the dose of Nexium is 20 mg twice a day with amoxicillin 1,000 mg twice a day and clarithromycin 500 mg twice a day, all for 7 days.
For children 12 months to 11 years of age, the recommended dose of esomeprazole to treat reflux esophagitis is 10 mg to 20 mg (depending on the child’s weight) once a day for 8 weeks.
For non-erosive reflux disease (heartburn and reflux), the recommended dose is 10 mg once a day for up to 8 weeks.
For children 11 to 17 years of age, the recommended dose of esomeprazole to treat reflux esophagitis is 20 mg to 40 mg once a day for 4 to 8 weeks.
For non-erosive reflux disease (heartburn and reflux), the recommended dose is 20 mg once a day for 2 to 4 weeks.
Nexium tablets can be taken with or without food. They must be swallowed whole; do not crush or chew them. Alternatively, the tablet can be shaken in half a glass of non-carbonated water until it disintegrates.
Drink the liquid that contains the small medicine granules right away, or within 30 minutes.
Nexium sachets contain granules for oral suspension. Pour all the granules from one sachet into a glass containing one tablespoon (15 ml) of water, stir and leave for a few minutes to allow the mixture to thicken.
Stir again and drink within 30 minutes. It is important that you take this medicine exactly as prescribed by your doctor. If you are not sure what to do after you miss a dose, contact your doctor or pharmacist.
Precautions before taking Nexium
People should not take Nexium if they are allergic to esomeprazole magnesium. They should also avoid taking Nexium if they are allergic to any of its other ingredients.
People who are allergic to any other proton pump inhibitor (PPI) should not take Nexium. People should check with their doctor if Nexium is the best option for their condition.
What side effects are possible with this drug?
Change in sense of taste, diarrhea, dizziness, drowsiness, dry mouth, headache, increased sweating, nausea, mouth pain, spinning sensation, swollen ankles, feet and hands, and trouble sleeping
Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you don’t seek medical attention.
Check with your doctor as soon as possible if you experience any of the following side effects:
Blurred vision, confusion, diarrhea (watery and severe, may also be bloody), burning or tingling sensation, sensitivity to the sun, trouble breathing.
Signs of depression (for example, poor concentration, weight changes, sleep changes, decreased interest in activities, thoughts of suicide).
Signs of electrolyte imbalance (such as muscle pain or cramps, weakness, irregular heartbeat). Skin reactions (such as rash, itching, or hives) and joint pain.
Signs of liver problems (eg, nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools).
Stop taking the medicine and seek medical attention immediately if any of the following occur:
Severe skin problems (blisters, ulcers, or lesions), signs of a severe allergic reaction such as hives; labored breathing; or swelling of the tongue, face, mouth, or throat.
Some people may experience side effects other than those listed.
Other common side effects of Nexium
Other Nexium side effects are more common, but serious Nexium side effects are rare. But they can be life threatening if left untreated.
In clinical trials, less than 1 percent of adults reported dyspepsia or indigestion.
Bone health : Studies suggest that the use of Nexium, like other proton pump inhibitors, may be linked to an increased risk of fractures, especially in people taking this drug for a year or more.
The lowest dose of this medicine to control symptoms, taken over the shortest period of time, is less likely to cause these problems.
Diarrhea : When gastric acid decreases, the number of bacteria normally in the digestive system increases. Occasionally, this can cause a serious infection in the digestive tract.
If you experience foul smelling and watery stools after starting Nexium, contact your doctor as soon as possible.
Fluid and Electrolyte Balance : Nexium can cause the levels of electrolytes such as potassium, magnesium, and calcium in your blood to change while you are taking this drug.
If you experience symptoms of fluid and electrolyte imbalance, such as muscle aches or cramps; dry mouth; numb hands, feet, or lips; or fast heartbeat, contact your doctor as soon as possible.
Interaction with methotrexate : Nexium, like other drugs in this group, can interact with methotrexate when the two drugs are used at the same time.
This combination can cause higher than expected amounts of methotrexate in the body and can cause serious side effects, including kidney damage, irregular heartbeat, anemia, or infection.
More serious stomach and intestinal conditions : if you experience symptoms of a more serious stomach and intestinal condition (such as difficulty swallowing, unplanned weight loss, persistent vomiting, vomiting, or black stools) while taking this medicine, contact your doctor immediately
Vitamin B12 : Long-term use of Nexium can lead to vitamin B12 deficiency. If you are a vegetarian or have low vitamin B12 levels, talk to your doctor if special monitoring is required.
Long-term side effects of Nexium
Studies have linked Nexium and other proton pump inhibitors to various long-term side effects. Not all of these possible side effects of Nexium are listed on the drug label.
Liver function
The liver is partially responsible for removing esomeprazole from the body. Liver disease or reduced liver function can cause this drug to build up in the body and cause side effects.
Your doctor may want to check your liver function regularly with blood tests while taking this medicine.
Chronic kidney disease and damage
A 2017 study looked at 125,000 proton pump inhibitor users over five years. Half who developed chronic kidney damage never had kidney problems before taking proton pump inhibitors.
A 2016 study found that long-term use of the proton pump inhibitor nearly doubled a patient’s chances of kidney failure.
The risk of stroke
In 2016, researchers linked the use of proton pump inhibitors with a 21 percent increased risk of a risk of stroke. They presented their findings at the 2016 American Heart Association scientific sessions.
Risk of heart attack
A 2015 study found that the use of proton pump inhibitors increases heart attack rates from 16 percent to 21 percent. The researchers published their findings in the journal PLOS One.
Gastric cancer
A 2017 study found that proton pump inhibitors can double the risk of gastric cancer in some patients.
The researchers found an increased risk among people with previous Helicobacter pylori infections. They published their results in the journal BMJ Gut.
Esophageal cancer risk
A 2018 study found that proton pump inhibitors taken to prevent esophageal cancer can actually cause it.
Researchers in Sweden found that proton pump inhibitors may be responsible for five percent of all cases there. They published their results in Cancer Epidemiology.
Long-term use of the Nexium
Using Nexium for an extended period of time can increase the risk of inflammation of the stomach lining, according to the Food and Drug Administration.
At least one study showed that long-term use of Nexium and other proton pump inhibitors could also increase the risk of death.
The Food and Drug Administration advises that patients should never take Nexium 24HR for more than 14 days at a time. And they should never take more than three 14-day courses in a year.
Drug interactions
People should not take Nexium if they take other medications. They should also avoid Nexium if they take certain dietary supplements.
Nexium interactions can affect the performance of one or both substances. People should tell their doctor what medications and supplements they are taking before using Nexium. Nexium can interact with the following products:
- Any product that contains iron. Cellcept (mycophenolate mofetil). Coumadin, Jantoven (warfarin). Fortovase (saquinavir). Lanoxin (digoxin). Methotrexate Nizoral (ketoconazole). Plavix (clopidogrel). Pletal (cilostazol). Prograf (tacrolimus).
- Reyataz (atazanavir). Rimactane, Rifater, Rifamate (Rifampin). Hierba de San Juan (hypericum perforatum). Tarceva (erlotinib). Valium (diazepam). Vfend (voriconazol). Viracept (nelfinavir).
If you are taking any of these medications, talk to your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- Stop taking one of the medications.
- Change one of the drugs to another.
- Change the way you are taking one or both medicines.
- Leave everything as is.
An interaction between two drugs does not always mean that you should stop taking one of them. Talk to your doctor about how drug interactions are managed or should be controlled.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription and non-prescription medications you are taking.
Also tell them about any supplements you’re taking. Because caffeine, alcohol, nicotine from cigarettes, or illegal drugs can affect how many medications work, you should tell your doctor if you use them.
When to stop taking Nexium
Patients should always speak with their doctor before stopping Nexium. Doctors can prescribe Nexium for long periods of time.
Stopping suddenly can trigger a ‘bounce’ effect. This can cause the patient’s condition to return. Sometimes it can be worse than the original problem.
A 2018 review in current gastroenterology reports recommends ways to stop using Nexium. A doctor can develop a reduction plan.
Patients can take reduced doses on a two-week to one-month schedule. Or a doctor may recommend that the patient take Nexium every other day.
Patients should also talk to their doctor about possible Nexium alternatives. These can include diet and lifestyle changes.
Or the doctor may recommend different medications. For some patients, Nexium alternatives may include H4 blockers or antacids.
Nexium Food and Drug Administration Warnings
The Food and Drug Administration has added at least seven warnings to Nexium labels since 2010.
The Food and Drug Administration adds warnings and cautions when evidence shows that a drug can cause side effects. Timeline of Food and Drug Administration warnings
2016 – Literal erythematous events
Nexium users should call their doctor if they have joint pain, or if they develop a rash on their cheeks or arms that worsens in the sun.
2014 – Pregnancy Information
Based on animal data, Nexium may harm the fetus. This happens with very high doses. Doctors and patients should weigh the risks of Nexium during pregnancy.
2014 – Aguda interstitial nephritis
It can lead to kidney failure. Kidney problems can occur at any time while taking Nexium. Symptoms to look out for include a change in urination or sightings of blood in the urine.
2014 – Vitamin B12 deficiency
A deficiency in vitamin B12 can lead to cognitive difficulties. It can also cause memory loss.
2012 – Clostridium Difficiles Associated Diarrhea
Nexium can increase the risk of developing severe diarrhea. Hospitalized patients face a higher risk. Patients should call a doctor immediately if they experience certain symptoms. These include persistent watery stools, stomach pain, and fever.
2011 – Low magnesium levels
Low levels of magnesium in the blood can occur in some people who take Nexium for at least three months. Nexium users should inform their doctor of certain symptoms. These include seizures, dizziness, nervousness, tremors, or fast or abnormal heartbeats.
2010/2011 – Hips, wrists and spinal fractures
People who take multiple daily doses of Nexium for a year or more may be more prone to bone fractures.
The Food and Drug Administration cited studies that reported an increased risk of hip, wrist, and spine fractures with the use of proton pump inhibitors.
Lawsuits
The Nexium drug lawsuits claim the medication caused injury or damage to the kidneys. The lawsuits are part of a multidistrict litigation (MDL) in federal court. Multidistrict combines several similar lawsuits. This allows cases to move quickly through the legal system.
As of June 2018, the multidistrict included 4,517 lawsuits regarding Nexium and other proton pump inhibitors. The people who filed Nexium lawsuits claimed that the medicine caused serious kidney problems.
Kidney injuries in lawsuits
- Kidney disease
- Kidney injury
- Renal insufficiency.
- Aguda interstitial nephritis (NIA).
Nexium prescription, generic, and over-the-counter
The Nexium comes in several versions. It debuted as a prescription drug. Over-the-counter (OTC), generic and store brands were sold.
Nexium with prescription
The Food and Drug Administration approved the prescription version of Nexium on February 20, 2001. It is manufactured by AstraZeneca.
Generic Nexium
Teva Pharmaceuticals obtained Food and Drug Administration approval for the first generic Nexium in 2015. Its generic esomeprazole is a prescription drug. At least eight companies made Nexium generics for 2018.
Nexium 24HR without prescription
The Food and Drug Administration approved the first over-the-counter Nexium in 2015. The agency approved Nexium 24HR to treat frequent heartburn. Nexium 24HR is chemically identical to prescription Nexium. Pfizer manufactures Nexium 24HR.
Nexium 24HR Brand Store
Perrigo Company PLC obtained Food and Drug Administration approval for the first store brand version of Nexium 24HR in 2017.
Over-the-counter esomeprazole is packaged for retail stores that sell it. It is a cheaper alternative to the Nexium 24HR brand.
