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Omeprazol Side Effects

Common Omeprazol Side Effects


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

Hypomagnesaemia (425)
Diarrhoea (308)
Hypocalcaemia (297)
Nausea (283)
Renal Failure Acute (243)
Vomiting (239)
Dyspnoea (225)
Dizziness (202)
Gastrooesophageal Reflux Disease (189)
Fatigue (167)
Abdominal Pain (162)
Pain (160)
Headache (158)
Malaise (156)
Dyspepsia (150)
Asthenia (145)
Rash (145)
Fall (137)
Abdominal Pain Upper (133)
Hypokalaemia (129)

➢ 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.

Omeprazol Side Effects Reported to FDA

The following Omeprazol 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 Omeprazol 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
This is a report of a 79-year-old male patient (weight: NA) from GB, suffering from the following symptoms/conditions: dyspepsia, who was treated with Omeprazole (dosage: NA, start time: Jul 23, 2010), combined with:
  • Aspirin
  • Bendroflumethiazide
  • Losartan
  • Movicol
  • Paracetamol
  • Sertraline
and developed a serious reaction and side effect(s). The consumer presented with:
  • Nightmare
  • Soft Tissue Injury
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Omeprazole treatment in male patients, resulting in nightmare side effect.

Renal Failure Acute
This report suggests a potential Omeprazole Renal Failure Acute side effect(s) that can have serious consequences. A 70-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Omeprazole (dosage: NA) starting Oct 15, 2013. Soon after starting Omeprazole the patient began experiencing various side effects, including:
  • Renal Failure Acute
Drugs used concurrently:
  • Aveeno
  • Metoclopramide
Although Omeprazole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as renal failure acute, may still occur.

Product Label Issue, Arthralgia, Gait Disturbance
This Product Label Issue, Arthralgia, Gait Disturbance problem was reported by a consumer or non-health professional from US. A 27-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: gastrooesophageal reflux disease. On NS this consumer started treatment with Omeprazole (dosage: NA). The following drugs were being taken at the same time: NA. When commencing Omeprazole, the patient experienced the following unwanted symptoms/side effects:
  • Product Label Issue
  • Arthralgia
  • Gait Disturbance
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as product label issue, may become evident only after a product is in use by the general population.

Oesophageal Candidiasis
This is a report of a 40-year-old female patient (weight: NA) from ES. The patient developed the following symptoms/conditions: dyspepsia and was treated with Omeprazole (dosage: 20 Mg, Interval: 1 Day) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Oesophageal Candidiasis
This opens a possibility that Omeprazole treatment could cause the above reactions, including oesophageal candidiasis, and some female subjects may be more susceptible.


Abdominal Pain Upper, Gastritis, Disease Recurrence
A 55-year-old female patient (weight: NA) from US with the following symptoms/conditions: erosive oesophagitis,gastric ulcer started Omeprazole treatment (dosage: NA) on 201105. Soon after starting Omeprazole treatment, the subject experienced various side effects, including:
  • Abdominal Pain Upper
  • Gastritis
  • Disease Recurrence
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Omeprazole.

Stevens-johnson Syndrome
A 10-year-old male patient from SG (weight: NA) experienced symptoms, such as: NA and was treated with Omeprazole(dosage: NA). The treatment was initiated on Jan 04, 2013. After that a consumer reported the following side effect(s):
  • Stevens-johnson Syndrome
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Omeprazole efficacy:
  • Ceftazidime Sodium
  • Cloxacillin Sodium


Dizziness, Nausea, Musculoskeletal Stiffness, Malaise
In this report, Omeprazole was administered for the following condition: gastrooesophageal reflux disease.A 68-year-old female consumer from CA (weight: NA) started Omeprazole treatment (dosage: NA) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Dizziness
  • Nausea
  • Musculoskeletal Stiffness
  • Malaise
A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Omeprazole treatment could be related to the listed above side effect(s).

Intestinal Obstruction, Pneumonia, Pulmonary Embolism, Malaise, Product Solubility Abnormal, Product Quality Issue
This is a report of the following Omeprazole Magnesium Delayed Release Otc side effect(s):
  • Intestinal Obstruction
  • Pneumonia
  • Pulmonary Embolism
  • Malaise
  • Product Solubility Abnormal
  • Product Quality Issue
A 54-year-old male patient from US (weight: NA) presented with the following condition: dyspepsia and received a treatment with Omeprazole Magnesium Delayed Release Otc (dosage: NA) starting: Jan 01, 2013.The following concurrently used drugs could have generated interactions: NA.The patient was hospitalized.This report suggests that a Omeprazole Magnesium Delayed Release Otc treatment could be associated with the listed above side effect(s).

Subacute Cutaneous Lupus Erythematosus
This Omeprazole (omeprazole) report was submitted by a 60-year-old female consumer from GB (weight: NA). The patient was diagnosed with: gastrooesophageal reflux disease and Omeprazole (omeprazole) was administered (dosage: Df) starting: NS. The consumer developed a set of symptoms:
  • Subacute Cutaneous Lupus Erythematosus
Other drugs used simultaneously:
  • Dompreridone (domperidone) (Df)
Those unexpected symptoms could be linked to a Omeprazole (omeprazole) treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Constipation, Pollakiuria, Weight Decreased, Achlorhydria, Malabsorption, Visual Acuity Reduced, Alopecia, Anxiety, Nail Disorder
This is a report of a possible correlation between Omeprazole Delayed-release use and the following symptoms/side effect(s):
  • Constipation
  • Pollakiuria
  • Weight Decreased
  • Achlorhydria
  • Malabsorption
  • Visual Acuity Reduced
  • Alopecia
  • Anxiety
  • Nail Disorder
which could contribute to an assessment of Omeprazole Delayed-release risk profile.A 68-year-old female consumer from US (weight: NA) was suffering from gastritis erosive and was treated with Omeprazole Delayed-release (dosage: NA) starting Oct 14, 2012.Other concurrent medications:
  • Prilosec


Angina Pectoris, Anxiety, Confusional State, Depression, Paranoia, Erectile Dysfunction
A 56-year-old male patient from GB (weight: NA) presented with the following symptoms: NA and after a treatment with Omeprazole (dosage: NA) experienced the following side effect(s):
  • Angina Pectoris
  • Anxiety
  • Confusional State
  • Depression
  • Paranoia
  • Erectile Dysfunction
The treatment was started on 201008. Omeprazole was used in combination with the following drugs:
  • Cialis
  • Co-diovan
  • Diltiazem Hydrochloride
  • Rosuvastatin
  • Warfarin
The patient was hospitalized.This report could alert potential Omeprazole consumers.

Malaise, Weight Decreased, Transaminases Increased
In this report, a 83-year-old male patient from GB (weight: NA) was affected by a possible Omeprazole side effect.The patient was diagnosed with hiatus hernia. After a treatment with Omeprazole (dosage: NA, start date: Nov 28, 2013), the patient experienced the following side effect(s):
  • Malaise
  • Weight Decreased
  • Transaminases Increased
The following simultaneously used drugs could have led to this reaction:
  • Adizem-xl
  • Amoxicillin
  • Aspirin
  • Bendroflumethiazide
  • Clarithromycin
  • Finasteride
  • Isosorbide
  • Perindopril Erbumine
The findings here stress that side effects should be taken into consideration when evaluating a Omeprazole treatment.

Erythema, Pruritus
This is a report of a 25-year-old male patient from IT (weight: NA), who used Omeprazole (dosage: 40 Mg Total) for a treatment of gastroenteritis. After starting a treatment on Feb 16, 2014, the patient experienced the following side effect(s):
  • Erythema
  • Pruritus
The following drugs could possibly have interacted with the Omeprazole treatment
  • Metoclopramide Hydrochloride (1 Df Total)
Taken together, these observations suggest that a Omeprazole treatment could be related to side effect(s), such as Erythema, Pruritus.

Circulatory Collapse, Unresponsive To Stimuli, Liver Function Test Abnormal, Hyponatraemia
This circulatory collapse side effect was reported by a pharmacist from GB. A 69-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Omeprazole (dosage: NA), which was started on NS. Concurrently used drugs:
  • Indapamide
  • Atenolol
  • Enalapril
  • Lactulose
  • Senna
  • Statin
When starting to take Omeprazole the consumer reported the following symptoms:
  • Circulatory Collapse
  • Unresponsive To Stimuli
  • Liver Function Test Abnormal
  • Hyponatraemia
The patient was hospitalized. These side effects may potentially be related to Omeprazole.

Nightmare
This is a Omeprazole side effect report of a 79-year-old male patient (weight:NA) from GB, suffering from the following symptoms/conditions: dyspepsia, who was treated with Omeprazole (dosage:NA, start time: Jun 23, 2010), combined with:
  • Movicol
  • Sertraline
  • Bendroflumethiazide
  • Paracetamol
  • Losartan
  • Aspirin
, and developed a serious reaction and a nightmare side effect. The patient presented with:
  • Nightmare
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Omeprazole treatment in male patients suffering from dyspepsia, resulting in nightmare.

Hypomagnesaemia
This report suggests a potential Omeprazole hypomagnesaemia side effect(s) that can have serious consequences. A 63-year-old female patient from DE (weight:NA) was diagnosed with the following health condition(s): gastrooesophageal reflux disease,rheumatoid arthritis and used Omeprazole (dosage: NA) starting Aug 16, 2013. Soon after starting Omeprazole the patient began experiencing various side effects, including:
  • Hypomagnesaemia
Drugs used concurrently:
  • Methotrexate
  • Amlodipine
  • Calcichew D3
  • Folic Acid
The patient was hospitalized and became disabled. Although Omeprazole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as hypomagnesaemia, may still occur.

Cardiac Arrest
This death problem was reported by a consumer or non-health professional from COUNTRY NOT SPECIFIED. A 79-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): NA.On Feb 18, 2013 a consumer started treatment with Omeprazole (dosage: 20 Mg, Unk). The following drugs/medications were being taken at the same time:
  • Aclasta (5 Mg, Unk)
  • Burinex (5 Mg, Unk)
  • Diovan (80 Mg, Unk)
  • Zyloric (300 Mg, Unk)
  • Aspicore (1 Df, Unk)
When commencing Omeprazole, the patient experienced the following unwanted symptoms /side effects:
  • Cardiac Arrest
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as death, may become evident only after a product is in use by the general population.

Gynaecomastia
This is a Omeprazole side effect report of a 97-year-old male patient (weight: NA) from GB. The patient developed the following symptoms/conditions: NA and was treated with Omeprazole (dosage: NA) starting May 07, 2012. Concurrently used drugs:
  • Aspirin
  • Bisoprolol
  • Ibuprofen
  • Levocetirizine
  • Mometasone
  • Paracetamol
  • Ranitidine
Soon after that, the consumer experienced the following of symptoms:
  • Gynaecomastia
This opens a possibility that Omeprazole could cause gynaecomastia and that some male patients may be more susceptible.

Renal Failure Acute
A 70-year-old female patient (weight: NA) from GB with the following symptoms: NA started Omeprazole treatment (dosage: NA) on Jan 06, 2014. Soon after starting Omeprazole treatment, the consumer experienced several side effects, including:
  • Renal Failure Acute
. Concurrently used drugs:
  • Aveeno
  • Metoclopramide
This finding indicates that some patients can be more vulnerable to developing Omeprazole side effects, such as renal failure acute.

Grand Mal Convulsion, Cognitive Disorder, Electrocardiogram Qt Prolonged, Electrocardiogram St Segment Depression, Hypocalcaemia, Hypokalaemia, Hypomagnesaemia
This grand mal convulsion side effect was reported by a physician from CH. A 78-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Omeprazol (dosage: NA), which was started on NS. Concurrently used drugs:
  • Metoprolol
  • Zolpidem
  • Calcium/vitamin D3 (500 Mg/440 Iu/day)
  • Ibuprofen (400 Mg/day As Needed)
  • Lercanidipin
  • Perindopril
  • Vitamin D3 (Monthly)
.When starting to take Omeprazol the consumer reported symptoms, such as:
  • Grand Mal Convulsion
  • Cognitive Disorder
  • Electrocardiogram Qt Prolonged
  • Electrocardiogram St Segment Depression
  • Hypocalcaemia
  • Hypokalaemia
  • Hypomagnesaemia
These side effects may potentially be related to Omeprazol. The patient was hospitalized.

Systemic Lupus Erythematosus, Bicytopenia, Evans Syndrome, Lupus Vasculitis, Cutaneous Lupus Erythematosus
This is a report of a 57-year-old female patient (weight: NA) from FR, suffering from the following symptoms/conditions: NA, who was treated with Omeprazole (dosage: (df), start time: NS), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Systemic Lupus Erythematosus
  • Bicytopenia
  • Evans Syndrome
  • Lupus Vasculitis
  • Cutaneous Lupus Erythematosus
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Omeprazole treatment in female patients, resulting in systemic lupus erythematosus side effect.

Gynaecomastia
This report suggests a potential Omeprazole Delayed-release Capsules, Usp Gynaecomastia side effect(s) that can have serious consequences. A 29-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Omeprazole Delayed-release Capsules, Usp (dosage: NA) starting NS. Soon after starting Omeprazole Delayed-release Capsules, Usp the patient began experiencing various side effects, including:
  • Gynaecomastia
Drugs used concurrently: NA.The patient was hospitalized. Although Omeprazole Delayed-release Capsules, Usp demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as gynaecomastia, may still occur.

Tubulointerstitial Nephritis
This Tubulointerstitial Nephritis problem was reported by a health professional from US. A 73-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: peptic ulcer. On NS this consumer started treatment with Omeprazole Delayed-release Capsules, Usp (dosage: NA). The following drugs were being taken at the same time:
  • Levothyroxine
  • Paracetamol W/caffeine
When commencing Omeprazole Delayed-release Capsules, Usp, the patient experienced the following unwanted symptoms/side effects:
  • Tubulointerstitial Nephritis
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as tubulointerstitial nephritis, may become evident only after a product is in use by the general population.

Liver Injury
This is a report of a 52-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: abdominal pain upper and was treated with Omeprazole Delayed-release Capsules, Usp (dosage: NA) starting NS. Concurrently used drugs:
  • Acetylsalicylic Acid
  • Valsartan
  • Hydrochlorothiazide
  • Atorvastatin
  • Esomeprazole
Soon after that, the consumer experienced the following side effects:
  • Liver Injury
The patient was hospitalized. This opens a possibility that Omeprazole Delayed-release Capsules, Usp treatment could cause the above reactions, including liver injury, and some male subjects may be more susceptible.

Pain In Extremity
A 53-year-old female patient (weight: NA) from COUNTRY NOT SPECIFIED with the following symptoms/conditions: gastrooesophageal reflux disease started Omeprazole treatment (dosage: Daily) on Dec 05, 2012. Soon after starting Omeprazole treatment, the subject experienced various side effects, including:
  • Pain In Extremity
Concurrently used drugs:
  • 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
This finding indicates that some female patients could be more vulnerable to Omeprazole.

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Top 10 Omeprazol Side Effects for Women

Women Side EffectsReports
Hypomagnesaemia 246
Nausea 182
Diarrhoea 168
Hypocalcaemia 161
Vomiting 140
Dyspnoea 131
Pain 128
Dizziness 122
Abdominal Pain 112
Gastrooesophageal Reflux Disease 111

Top 10 Omeprazol Side Effects for Men

Men Side EffectsReports
Hypomagnesaemia 178
Renal Failure Acute 142
Diarrhoea 139
Hypocalcaemia 135
Nausea 101
Vomiting 99
Dyspnoea 92
Dizziness 79
Gastrooesophageal Reflux Disease 77
Confusional State 74

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

    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 Omeprazol Side Effects

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    How Effective is Omeprazol for You?

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    Omeprazol Safety Alerts, Active Ingredients, Usage Information

    NDC0093-6450
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameEsomeprazole Magnesium
    NameEsomeprazole Magnesium
    Dosage FormCAPSULE, DELAYED RELEASE
    RouteORAL
    On market since20150217
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)ESOMEPRAZOLE MAGNESIUM DIHYDRATE
    Strength(s)20
    Unit(s)mg/1
    Pharma ClassProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]

    More About Omeprazol

    Side Effects reported to FDA: 5913

    Omeprazol 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 Omeprazol clinical trials