Prilosec, the first of a class of heartburn drugs called Proton Pump Inhibitors (PPIs) is now available in both prescription and over-the –counter formulations. In recent years, some studies have linked PPIs like Prilosec to serious complications, including heart attacks and Chronic Kidney Disease.

What Is Prilosec?

Prilosec (omeprazole) was brought to market in 1988 by AstraZeneca. The medication works by blocking the proton pumps which release acid into the stomach. It is currently indicated for:

  • The treatment of related gastroesophageal reflux disease (GERD)
  • The treatment of other conditions caused by excess stomach acid
  • Promote healing of erosive esophagitis
  • In conjunction with antibiotics to treat gastric ulcer caused by infection with helicobacter pylori (H. pylori)

In 2001, AstraZeneca recorded sales of $6.1 billion from Prilosec. Prilosec OTC, an over-the-counter version of the medication, was approved in 2003. By 2013, sales of Prilosec OTC were nearly $400 million.

Prilosec Side Effects

Patients using Prilosec should contact their doctor if any of the following occur:

  • 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
  • Joint pain
  • Loss of appetite
  • Muscle aches or cramps
  • Pain
  • Red or irritated eyes
  • Redness, tenderness, itching, burning, or peeling of the skin
  • Skin rash or itching
  • 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
  • Drowsiness
  • Fast, racing, or uneven heartbeat
  • Mood or mental changes
  • Muscle spasms (tetany) or twitching seizures
  • Nausea or vomiting
  • Trembling

FDA Warning On Imodium – Prilosec Combo

June 2016: In the wake of a number of fatalities, the FDA has  has issued a warning regarding a potentially deadly drug combo consisting of Imodium (loperamide) and Prilosec. The proton pump inhibitor is one of several medications that opioid addicts have used in conjunction with Imodium to deal with opiate withdrawal.  Prilosec drastically reduces the amount of Imodium, needed to produce a heroin-like high. Read More

Prilosec Overdose

Prilosec overdose is a medical emergency that needs immediate attention. Symptoms include:

  • Blurred vision
  • Confusion
  • Dryness of the mouth
  • Flushing
  • Headache
  • Increased sweating

Blood Vessel Aging Tied to Proton Pump Inhibitors

New research  suggests that extended use of  proton pump inhibitors like Prilosec may accelerate aging of blood vessels. According to a study published in Circulation Research in May 2016, this could explain the possible association between the drugs and certain serious complications, including heart attacks and kidney failure. Read More

Women May Be Able to Reduce Prilosec Dose

A study published in May 2016 suggested that women who used Prilosec  and similar heartburn drugs may be able to lower their dose. Published in the  Journal of Clinical Gastroenterology, the study involved around 100 patients, half male and half female, who were taking proton pump inhibitors for  erosive esophagitis. During the experiment, half took a lower dose for  8 weeks. According to the authors of the report, women were three times more likely to tolerate the lower dosage compared to men. Read More

FDA Warnings for PPIs

  • Bone Fractures: The U.S. Food & Drug Administration (FDA) issued an alert regarding a possible association between long-term PPI use and fractures of the hip, spine and wrists. Patients older than 50, and those receiving the highest doses for a year or more appeared to face the greatest fracture risk. A similar association was not seen with over-the-counter PPIs.
  • Low Serum Magnesium Levels: In March 2011, the FDA warned that long-term use of PPIs could cause hypomagnesaemia (low serum magnesium levels). This condition can lead to muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures).
  • 2014 Label Update: The FDA added the following side effect information to the labels of prescription PPIs:
    • Clostridium difficile-associated diarrhea
    • Vitamin B12 deficiency
    • Acute interstitial nephritis (Kidney inflammation)
    • Recommended treatment length for gastroesophageal reflux disease (GERD)
    • Drug interactions with methotrexate (a cancer drug that can remain in the body and become toxic) and mycophenolate mofetil
    • Drug interactions with Plavix (clopidogrel), a blood-thinner that may be less effective in patients on heartburn drug

Prilosec and Kidney Disease

In 2016, a study involving 10,500 patients who used PPIs between 1996 and 2015 suggested those who used the drugs twice a day were 46% more likely to develop CKD. Those who used a PPI once per day had a 15% higher risk. The research appeared in JAMA: Internal Medicine.

Studies Point to Possible Prilosec Heart Risk

In June 2015, researcher published in PLOS One linked the use of PPIs to an increased risk of heart attack. According to the paper, two studies that encompassed medical records from 2.9 million patients found that those who used PPIs faced and a 16 to 21% increased risk of having a heart attack. The research was notable because it involved patients from the “general population,” rather than those who already had a history of heart disease.

Could Prilosec be Associated with Dementia?

A study published in the JAMA Neurology on April 2016 suggested that regular use of proton pump inhibitors might increase a senior’s risk of dementia by 44%. The popular heartburn drugs are known to affect levels of two proteins that play a role in Alzheimer’s disease, amyloid beta and tau. Medications like Prilosec have also been tied to B12 deficiency, which can lead to cognitive declines. Read More

  1. FDA (2014) “Prilosec: Highlights of Prescribing Information”
  2. com (2003) “FDA Approves Prilosec OTC to Treat Frequent Heartburn”
  3. FDA (2010) “FDA Drug Safety Communication: Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors”
  4. FDA (2011) FDA Drug Safety Communication: Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs (PPIs)
  5. JAMA: Internal Medicine (2016) “Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease”
  6. PLOS One (2015) “Proton Pump Inhibitor Usage and the Risk of Myocardial Infarction in the General Population”


Last Modified: July 27, 2016

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