Nexium Side Effects
Many Nexium users experience side effects such as headaches and gastrointestinal discomfort, including nausea, vomiting and diarrhea. In severe cases, users reported bone fractures, low magnesium and bloody stool. This heartburn medication includes a boxed warning for these serious side effects.
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- Common Side Effects
- Diarrhea, vomiting, nausea, stomach pain, headaches and dry mouth
- Serious Side Effects
- Loss of bone density, chronic kidney disease, lupus, muscle weakness and seizures
- Boxed Warning
- Atrophic gastritis, clostridium difficile-associated diarrhea and magnesium deficiency
Most Recent Nexium Side Effects Information
The majority of Nexium side effects reported to the U.S. Food & Drug Administration’s FAERS database are related to kidney disorders. Chronic kidney disease, acute kidney injury, renal failure and end-stage renal disease are the top 4 complaints as of June 30, 2024.
Together, these side effects total nearly 88% of all adverse events reported to the agency’s FAERS database.
- Chronic kidney disease: 39.55%
- Acute kidney injury: 19.87%
- Renal failure: 16.49%
- End-stage renal disease: 11.59%
- All other side effects: 12.5%
As of June 2024, the FDA had received over 88,000 adverse event reports for five different brand name versions of Nexium. The agency considered more than two-thirds of them to be serious.
Gastroesophageal reflux disease (GERD), headache, osteoporosis and increased stomach acid were also commonly reported.
FDA Adverse Events Reporting System (FAERS) Data for Nexium Side Effects | |
---|---|
Total cases reported | 82,664 |
Serious cases (including deaths) | 56,603 |
Deaths | 6,150 |
Disclaimer: Reports sent to the FDA don’t necessarily mean the drug caused an adverse event. Consult a health care professional before stopping or changing medication.
FAERS data tend to skew towards more severe symptoms. For instance, the database reports 16,428 instances of acute kidney injury from among 82,664 total reports, or almost 20% of side effects. However, clinical trial results reported in Nexium’s prescribing information demonstrated less than a 1% chance of acute kidney injury.
FDA Actions, Statements and Recalls
The FDA has previously released several statements regarding Nexium and has required Nexium manufacturers to disclose extra health and safety information on their labels. These statements include warnings about side effects such as drug-induced hypersensitivity syndrome, erectile dysfunction, acute interstitial nephritis and vitamin deficiencies.
Common Nexium Side Effects
According to its prescribing information, clinical trials revealed headache, diarrhea and abdominal pain as the most common side effects of Nexium. These tend to be mild and generally diminish as your body adjusts to the medication.
- Diarrhea
- Dry mouth
- Fatigue
- Headaches
- Stomach pain
- Vomiting
A 2022 double-blind study published in the Journal of Gut and Liver found that nausea was the most commonly reported side effect after 4 weeks of treatment.
“For patients experiencing minor side effects from short-term PPI use, my advice would be to take the lowest effective dose for the shortest time necessary,” Sazan Sylejmani, owner of Westmont Pharmacy in Westmont, Ill., told Drugwatch.
Contact your health care provider if these symptoms persist or get worse, as it could be a sign of a more serious concern.
Serious But Rare Side Effects
Nexium prescribing information warns of rare side effects including fluid buildup, irregular heart rhythms and anemia in less than 1% of clinical trial participants. Other reports include vitamin B12 deficiency, fungal infections and vision disturbances.
- Agranulocytosis
- Low white blood cell count
- Anaphylaxis
- A potentially lethal allergic reaction
- C. Difficile Infection
- Colon infection from the bacteria clostridium difficile - causes severe diarrhea
- Fundic gland polyps
- Growth on the upper stomach lining
- Gynecomastia
- Abnormal growth of breast tissue in individuals assigned male at birth
- Hepatic encephalopathy
- A brain impairment caused by liver dysfunction
- Hepatitis
- Inflammation of the liver
- Magnesium deficiency
- Can cause loss of appetite, weakness, vomiting and fatigue
- Osteoporosis
- Bone fractures and loss of bone density
- Pancreatitis
- Inflammation of the pancreas
- Psychiatric effects
- Increased aggression, agitation, depression or hallucinations
- Seizures
- Muscle spasms caused by a burst of electrical activity in the brain - may affect awareness and behavior
- Skin conditions
- Toxic epidermal necrosis, pustulosis, Stevens-Johnson syndrome
- Stomatitis
- Inflammation of mucous membranes in the mouth
- Systemic lupus erythematosus
- Autoimmune condition that causes organ damage
- Ulcerative colitis
- Inflammation of the inner lining of the colon
Most serious side effects come from long-term use. Proton Pump Inhibitors, including Nexium, are not meant for daily use for extended periods.
“As a pharmacist, I have seen how long-term PPI use can negatively impact patient health. These drugs reduce stomach acid production, which our bodies actually need to properly absorb nutrients like calcium, magnesium and B12,” Sylejmani told Drugwatch. “Prolonged PPI use has been linked to bone fractures, kidney disease and even an increased risk of dementia because of nutrient malabsorption and changes in gut bacteria.”
Serious Nexium side effects can affect major organs. Some may be fatal if untreated. If you experience symptoms such as a severe rash, difficulty breathing or high fever, it could be a sign of a serious side effect. Consult with your doctor to find the right course of action.
“Clinicians must weigh PPI benefits and risks carefully, especially long-term. PPIs should only be used when medically necessary and at the lowest effective doses,” Sylejmani said. “Patients need close monitoring and alternative treatments when possible.”
Kidney Disorders
Nexium and other proton pump inhibitors are associated with a higher risk of kidney disorders. Prescribing information for Nexium warns of the risk of acute tubulointerstitial nephritis (TIN). This kidney disorder involves inflammation of specific parts of the kidneys that can impair their ability to filter blood. TIN can occur at any time while taking Nexium, but there is mixed evidence for chronic kidney disease.
A 2023 review in the Journal of Clinical Medicine looked at data from previous studies on proton pump inhibitors and kidney disease. It showed a significant increase in rates of chronic kidney disease among patients taking esomeprazole, the active ingredient of Nexium. Researchers believe this is due to the drug’s disruption of the gut’s microbiome.
However, a 2023 study in the Journal of Scientific Reports failed to show an increased risk of CKD in patients taking PPIs compared to those taking histamine-2 receptor antagonists. Both medications are used to treat gastroesophageal reflux disease and peptic ulcers.
Case Study: Nexium and Chronic Kidney Disease
James Rieder, a Nexium user, developed chronic kidney disease (CKD) after nearly five years of using the drug. This case is part of broader litigation involving proton pump inhibitors (PPIs) and their potential side effects.
Legal Action
In court documents, Rieder claimed that his prolonged use of Nexium led to his CKD diagnosis. The Nexium lawsuit complaint includes allegations of strict product liability, negligence and failure to warn on the part of AstraZeneca.
Chronic Kidney Disease from PPIs
In court documents, Rieder claimed that his prolonged use of Nexium led to his CKD diagnosis. The Nexium lawsuit complaint includes allegations of strict product liability, negligence and failure to warn on the part of AstraZeneca.
Outcome and Implications
This case highlights the potential risks associated with long-term PPI use. Regulatory authorities have advised caution and recommended monitoring for kidney-related side effects. A global PPI settlement is anticipated to resolve many similar lawsuits before trials proceed.
Conclusion
Patients using PPIs like Nexium should be aware of the possible risks and consult their healthcare providers for appropriate monitoring and alternative treatments if necessary.
Cardiovascular Complications
There are rare instances of heart-related reactions to Nexium. A 2020 case report published in Case Reports in Gastrointestinal Medicine details an unusual case of a woman who developed severe chest pains after taking Nexium. Along with her condition, she also had electrocardiogram changes, indicating the possibility of reduced blood flow to the heart.
A study published in Pharmacia in 2021 details how long-term esomeprazole use for peptic ulcers disrupted the lipid metabolism in otherwise healthy patients. Lipid metabolism involves the storage and synthesis of lipids, an energy source in your cells, and can affect heart health. The researchers recommended doctors access high-risk patients using lipid profile tests before administering Nexium.
Another study in the International Journal of General Medicine highlights the increased risk of cardiovascular events associated with proton pump inhibitors like Nexium. In this case, the risk was directly associated with misuse of the medications, which is common. It is important to take Nexium exactly as instructed by your doctor or according to package instructions.
Clopidogrel Interactions
Nexium and the similar medication omeprazole may interact with the heart medication clopidogrel by interfering with the body’s antiplatelet activity. This can cause serious complications and may result in blood clots.
However, many doctors prescribe PPIs to patients who are on clopidogrel to reduce the gastrointestinal symptoms clopidogrel causes. Therefore, it is important to note that lansoprazole, pantoprazole and rabeprazole are safer PPIs for patients on clopidogrel compared to Nexium.
Nexium Lawsuits
Though there are no active Nexium lawsuits as of August 2024, despite the MDL still being open, plaintiffs have filed multiple lawsuits against manufacturer AstraZeneca for serious side effects related to the use of the drug. In 2022, AstraZeneca faced a suit for kidney failure and chronic kidney disease caused by Nexium. In 2023, the company agreed to pay $425 million in settlements.
The first lawsuit for this drug in 2011 was in regard to bone fractures and loss of bone density caused by Nexium. However, in 2014, the courts ruled in favor of AstraZeneca concerning bone loss allegations.
Editor Lindsay Donaldson contributed to this article.
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