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Omeprazole Side Effects

Common Omeprazole Side Effects

The most commonly reported Omeprazole side effects (click to view or check a box to report):

Hypomagnesaemia (414)
Diarrhoea (307)
Hypocalcaemia (287)
Nausea (280)
Renal Failure Acute (241)
Vomiting (238)
Dyspnoea (223)
Dizziness (202)
Gastrooesophageal Reflux Disease (189)
Fatigue (167)
Abdominal Pain (161)
Pain (160)
Headache (156)
Malaise (155)
Dyspepsia (150)
Asthenia (145)
Rash (144)
Fall (137)
Abdominal Pain Upper (132)
Confusional State (127)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Omeprazole Side Effects Reported to FDA

The following Omeprazole reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Omeprazole on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Nightmare, Soft Tissue Injury
on Mar 10, 2014 Male from GB , 79 years of age, was diagnosed with and was treated with Omeprazole. Directly after, patient experienced the unwanted or unexpected Omeprazole side effects: nightmare, soft tissue injury. Omeprazole dosage: N/A.
Associated medications used:
  • Aspirin
  • Bendroflumethiazide
  • Losartan
  • Movicol
  • Paracetamol
  • Sertraline


Renal Failure Acute
Patient was taking Omeprazole. Patient felt the following Omeprazole side effects: renal failure acute on Mar 10, 2014 from GB Additional patient health information: Female , 70 years of age, weighting 140.9 lb, . Omeprazole dosage: N/A.
Multiple prescriptions taken:
  • Aveeno
  • Metoclopramide


Product Label Issue, Arthralgia, Gait Disturbance
Adverse event was reported on Mar 11, 2014 by a Female taking Omeprazole (Dosage: N/A) was diagnosed with and. Location: US , 27 years of age, weighting 125.0 lb, After Omeprazole was administered, patient encountered several Omeprazole side effects: product label issue, arthralgia, gait disturbance.

Oesophageal Candidiasis
on Mar 10, 2014 Female from ES , 40 years of age, was diagnosed with and was treated with Omeprazole. Directly after, patient experienced the unwanted or unexpected Omeprazole side effects: oesophageal candidiasis. Omeprazole dosage: 20 Mg, Interval: 1 Day.


Abdominal Pain Upper, Gastritis, Disease Recurrence
on Mar 10, 2014 Female from US , 55 years of age, weighting 232.0 lb, was diagnosed with and was treated with Omeprazole. Patient felt the following Omeprazole side effects: abdominal pain upper, gastritis, disease recurrence. Omeprazole dosage: N/A.

Stevens-johnson Syndrome
Patient was taking Omeprazole. After Omeprazole was administered, patient encountered several Omeprazole side effects: stevens-johnson syndrome on Mar 11, 2014 from SG Additional patient health information: Male , child 10 years of age, . Omeprazole dosage: N/A.
Multiple concurrent drugs taken:
  • Ceftazidime Sodium
  • Cloxacillin Sodium


Dizziness, Nausea, Musculoskeletal Stiffness, Malaise
Adverse event was reported on Mar 10, 2014 by a Female taking Omeprazole (Dosage: N/A) was diagnosed with and. Location: CA , 68 years of age, weighting 160.0 lb, Directly after, patient experienced the unwanted or unexpected Omeprazole side effects: dizziness, nausea, musculoskeletal stiffness, malaise.

Intestinal Obstruction, Pneumonia, Pulmonary Embolism, Malaise, Product Solubility Abnormal, Product Quality Issue
on Mar 11, 2014 Male from US , 54 years of age, weighting 249.1 lb, was diagnosed with and was treated with Omeprazole Magnesium Delayed Release Otc. Patient felt the following Omeprazole side effects: intestinal obstruction, pneumonia, pulmonary embolism, malaise, product solubility abnormal, product quality issue. Omeprazole Magnesium Delayed Release Otc dosage: N/A. Patient was hospitalized.

Subacute Cutaneous Lupus Erythematosus
on Mar 06, 2014 Female from GB , 60 years of age, was diagnosed with and was treated with Omeprazole (omeprazole). After Omeprazole was administered, patient encountered several Omeprazole side effects: subacute cutaneous lupus erythematosus. Omeprazole (omeprazole) dosage: Df.
Multiple concurrent drugs taken:
  • Dompreridone (domperidone) (Df)


Constipation, Pollakiuria, Weight Decreased, Achlorhydria, Malabsorption, Visual Acuity Reduced, Alopecia, Anxiety, Nail Disorder
Patient was taking Omeprazole Delayed-release. Directly after, patient experienced the unwanted or unexpected Omeprazole side effects: constipation, pollakiuria, weight decreased, achlorhydria, malabsorption, visual acuity reduced, alopecia, anxiety, nail disorder on Mar 07, 2014 from US Additional patient health information: Female , 68 years of age, weighting 107.0 lb, was diagnosed with and. Omeprazole Delayed-release dosage: N/A.
Associated medications used:
  • Prilosec


Angina Pectoris, Anxiety, Confusional State, Depression, Paranoia, Erectile Dysfunction
Adverse event was reported on Nov 18, 2013 by a Male taking Omeprazole (Dosage: N/A) . Location: GB , 56 years of age, Patient felt the following Omeprazole side effects: angina pectoris, anxiety, confusional state, depression, paranoia, erectile dysfunction.
Multiple prescriptions taken:
  • Cialis
  • Co-diovan
  • Diltiazem Hydrochloride
  • Rosuvastatin
  • Warfarin
Patient was hospitalized.

Malaise, Weight Decreased, Transaminases Increased
on Mar 10, 2014 Male from GB , 83 years of age, weighting 194.0 lb, was diagnosed with and was treated with Omeprazole. After Omeprazole was administered, patient encountered several Omeprazole side effects: malaise, weight decreased, transaminases increased. Omeprazole dosage: N/A.
Multiple concurrent drugs taken:
  • Adizem-xl
  • Amoxicillin
  • Aspirin
  • Bendroflumethiazide
  • Clarithromycin
  • Finasteride
  • Isosorbide
  • Perindopril Erbumine


Erythema, Pruritus
on Mar 10, 2014 Male from IT , 25 years of age, was diagnosed with and was treated with Omeprazole. Directly after, patient experienced the unwanted or unexpected Omeprazole side effects: erythema, pruritus. Omeprazole dosage: 40 Mg Total.
Associated medications used:
  • Metoclopramide Hydrochloride (1 Df Total)


Circulatory Collapse, Unresponsive To Stimuli, Liver Function Test Abnormal, Hyponatraemia
Patient was taking Omeprazole. Patient felt the following Omeprazole side effects: circulatory collapse, unresponsive to stimuli, liver function test abnormal, hyponatraemia on Mar 21, 2014 from GB Additional patient health information: Female , 69 years of age, . Omeprazole dosage: N/A.
Multiple prescriptions taken:
  • Indapamide
  • Atenolol
  • Enalapril
  • Lactulose
  • Senna
  • Statin
Patient was hospitalized.

Nightmare
Adverse event was reported on Mar 07, 2014 by a Male taking Omeprazole (Dosage: N/A) was diagnosed with and. Location: GB , 79 years of age, After Omeprazole was administered, patient encountered several Omeprazole side effects: nightmare.
Multiple concurrent drugs taken:
  • Movicol
  • Sertraline
  • Bendroflumethiazide
  • Paracetamol
  • Losartan
  • Aspirin


Hypomagnesaemia
on Mar 07, 2014 Female from DE , 63 years of age, was diagnosed with and was treated with Omeprazole. Directly after, patient experienced the unwanted or unexpected Omeprazole side effects: hypomagnesaemia. Omeprazole dosage: N/A.
Associated medications used:
  • Methotrexate
  • Amlodipine
  • Calcichew D3
  • Folic Acid
Patient was hospitalized and became disabled.

Cardiac Arrest
on Mar 06, 2014 Male from COUNTRY NOT SPECIFIED , 79 years of age, was treated with Omeprazole. Patient felt the following Omeprazole side effects: cardiac arrest. Omeprazole dosage: 20 Mg, Unk.
Multiple prescriptions taken:
  • Aclasta (5 Mg, Unk)
  • Burinex (5 Mg, Unk)
  • Diovan (80 Mg, Unk)
  • Zyloric (300 Mg, Unk)
  • Aspicore (1 Df, Unk)


Gynaecomastia
Patient was taking Omeprazole. After Omeprazole was administered, patient encountered several Omeprazole side effects: gynaecomastia on Mar 04, 2014 from GB Additional patient health information: Male , 97 years of age, . Omeprazole dosage: N/A.
Multiple concurrent drugs taken:
  • Aspirin
  • Bisoprolol
  • Ibuprofen
  • Levocetirizine
  • Mometasone
  • Paracetamol
  • Ranitidine


Renal Failure Acute
Adverse event was reported on Mar 06, 2014 by a Female taking Omeprazole (Dosage: N/A) . Location: GB , 70 years of age, weighting 141.0 lb, Directly after, patient experienced the unwanted or unexpected Omeprazole side effects: renal failure acute.
Associated medications used:
  • Aveeno
  • Metoclopramide


Systemic Lupus Erythematosus, Bicytopenia, Evans Syndrome, Lupus Vasculitis, Cutaneous Lupus Erythematosus
on Feb 28, 2014 Female from FR , 57 years of age, was treated with Omeprazole. Patient felt the following Omeprazole side effects: systemic lupus erythematosus, bicytopenia, evans syndrome, lupus vasculitis, cutaneous lupus erythematosus. Omeprazole dosage: (df).

Gynaecomastia
on Jan 24, 2014 Male from US , 29 years of age, was treated with Omeprazole Delayed-release Capsules, Usp. After Omeprazole was administered, patient encountered several Omeprazole side effects: gynaecomastia. Omeprazole Delayed-release Capsules, Usp dosage: N/A. Patient was hospitalized.

Tubulointerstitial Nephritis
Patient was taking Omeprazole Delayed-release Capsules, Usp. Directly after, patient experienced the unwanted or unexpected Omeprazole side effects: tubulointerstitial nephritis on Jan 24, 2014 from US Additional patient health information: Female , 73 years of age, was diagnosed with and. Omeprazole Delayed-release Capsules, Usp dosage: N/A.
Associated medications used:
  • Levothyroxine
  • Paracetamol W/caffeine
Patient was hospitalized.

Liver Injury
Adverse event was reported on Jan 24, 2014 by a Male taking Omeprazole Delayed-release Capsules, Usp (Dosage: N/A) was diagnosed with and. Location: US , 52 years of age, Patient felt the following Omeprazole side effects: liver injury.
Multiple prescriptions taken:
  • Acetylsalicylic Acid
  • Valsartan
  • Hydrochlorothiazide
  • Atorvastatin
  • Esomeprazole
Patient was hospitalized.

Pain In Extremity
on Mar 03, 2014 Female from COUNTRY NOT SPECIFIED , 53 years of age, was diagnosed with and was treated with Omeprazole. After Omeprazole was administered, patient encountered several Omeprazole side effects: pain in extremity. Omeprazole dosage: Daily.
Multiple concurrent drugs taken:
  • Over The Counter Probiotic
  • Triam Hctz (37.5/25mg Daily)
  • Torsemide
  • Mucinex
  • Aspirin (Daily)
  • Methotrexate (8 Pills Every Wed)
  • Move Free Over The Counter (Daily)
  • Proair Hfa


Renal Failure Acute
on Mar 01, 2014 Female from GB , 70 years of age, weighting 141.0 lb, was treated with Omeprazole. Directly after, patient experienced the unwanted or unexpected Omeprazole side effects: renal failure acute. Omeprazole dosage: N/A.
Associated medications used:
  • Aveeno
  • Metoclopramide


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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


    Track Online

  • User Sign In
  • Register to track your side effects

  • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Discuss Omeprazole Side Effects

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    Safety Alerts, Active Ingredients, Usage Information

    Alternative OMEPRAZOLE Names:OMEPRAZOL

    Active Ingredient: OMEPRAZOL

    More About Omeprazole

    Side Effects reported to FDA: 5861

    Omeprazole safety alerts: 2009 2007

    Reported deaths: 416

    Reported hospitalizations: 2383

    Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) - Drug Interaction

    Audience: Cardiovascular healthcare professionals, pharmacists

    [Posted 11/17/2009] FDA notified healthcare professionals of new safety information concerning an interaction between clopidogrel (Plavix), an anti-clotting medication, and omeprazole (Prilosec/Prilosec OTC), a proton pump inhibitor (PPI) used to reduce stomach acid.  New data show that when clopidogrel and omeprazole are taken together, the effectiveness of clopidogrel is reduced. Patients at risk for heart attacks or strokes who use clopidogrel to prevent blood clots will not get the full effect of this medicine if they are also taking omeprazole. Separating the dose of clopidogrel and omeprazole in time will not reduce this drug interaction.

    Other drugs that are expected to have a similar effect and should be avoided in combination with clopidogrel include: cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, felbamate, fluoxetine, fluvoxamine, and ticlopidine. 

    Recommendations for healthcare professionals are provided in the "Information for Healthcare Professionals" sheet.

    [11/17/2009 - Information for Healthcare Professionals - FDA]
    [11/17/2009 - Public Health Advisory - FDA]
    [11/17/2009 - Follow-Up to January 2009 Early Communication - FDA]

    Previous MedWatch Alert:

    [01/26/2009] Clopidogrel bisulfate (marketed as Plavix) Early Communication 

    Latest Omeprazole clinical trials