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Itching (83)
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Anxiety (53)
No Sex Drive (46)
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Omeprazole Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 4716 

Partial Seizures, Hypertension, Loss Of Consciousness, Tongue Biting, Syncope, Hyporeflexia (8477454-7)
on Jun 22, 2012 Male from FRANCE , 52 years of age, was treated with Omeprazole. Directly after, patient experienced the unwanted or unexpected Omeprazole side effects: partial seizures, hypertension, loss of consciousness, tongue biting, syncope, hyporeflexia. Omeprazole dosage: 1 Df, Daily.
Associated medications used:
  • Neupogen
  • Vinblastine Sulfate
  • Valsartan (80 Mg, Daily)
Patient was hospitalized.

Fatigue, Pulmonary Embolism, Aphasia, Tremor, Pain In Extremity, Muscular Weakness, Purpura, Vomiting, Diarrhoea (8476247-4)
Patient was taking Omeprazole. Patient felt the following Omeprazole side effects: fatigue, pulmonary embolism, aphasia, tremor, pain in extremity, muscular weakness, purpura, vomiting, diarrhoea on Jun 15, 2012 from UNITED KINGDOM Additional patient health information: Male , 61 years of age, . Omeprazole dosage: N/A.
Multiple prescriptions taken:
  • Gliclazide
  • Clobazam
  • Temozolomide (200 Mg;po 200 Mg/m2;po)
  • Levetiracetam
  • Ima950 (vaccines) (, 4.96 Mg;id, , 4.96 Mg;id)
  • Ima950 (vaccines) (, 4.96 Mg;id, , 4.96 Mg;id)
  • Leukine (75 Mcg;id, 75 Mcg;id)
  • Leukine (75 Mcg;id, 75 Mcg;id)
Patient was hospitalized.

Gastrooesophageal Reflux Disease, Nausea, Blister, Vomiting, Dysphagia, Throat Irritation, Gastric Disorder (8475822-0)
Adverse event was reported on Jun 19, 2012 by a Female taking Omeprazole (Dosage: N/A) . Location: UNITED STATES , 51 years of age, After Omeprazole was administered, patient encountered several Omeprazole side effects: gastrooesophageal reflux disease, nausea, blister, vomiting, dysphagia, throat irritation, gastric disorder.
Multiple concurrent drugs taken:
  • Prilosec Otc (Twicea Day)
Patient was hospitalized.

Thrombocytopenia, Abdominal Pain, Diarrhoea, Full Blood Count Abnormal, Contusion, Haematemesis (8475757-3)
on Jun 14, 2012 Female from UNITED KINGDOM , 42 years of age, was treated with Omeprazole. Directly after, patient experienced the unwanted or unexpected Omeprazole side effects: thrombocytopenia, abdominal pain, diarrhoea, full blood count abnormal, contusion, haematemesis. Omeprazole dosage: N/A.
Associated medications used:
  • Miconazole
  • Methotrexate
  • Flucloxacillin
  • Sulfasalazine
  • Venlafaxine
  • Methotrexate
  • Benzydamine
  • Metronidazole
Patient was hospitalized.


Haematemesis, Diarrhoea, Thrombocytopenia, Blood Disorder, Full Blood Count Abnormal, Contusion, Abdominal Pain (8475640-3)
on Jun 14, 2012 Female from UNITED KINGDOM , 42 years of age, was treated with Omeprazole. Patient felt the following Omeprazole side effects: haematemesis, diarrhoea, thrombocytopenia, blood disorder, full blood count abnormal, contusion, abdominal pain. Omeprazole dosage: 20 Mg, Bid.
Multiple prescriptions taken:
  • Nystatin
  • Flucloxacillin
  • Metronidazole
  • Benzydamine
  • Miconazole
  • Venlafaxine Hydrochloride (75 Mg, Bid)
  • Sulfasalazine
  • Scheriproct /00212301/
Patient was hospitalized.

Erectile Dysfunction (8475635-X)
Patient was taking Omeprazole. After Omeprazole was administered, patient encountered several Omeprazole side effects: erectile dysfunction on Jun 14, 2012 from GERMANY Additional patient health information: Male , 50 years of age, was diagnosed with
  • gastrooesophageal reflux disease
and. Omeprazole dosage: Unk.

Hepatic Function Abnormal (8475568-9)
Adverse event was reported on Jun 21, 2012 by a Male taking Omeprazole (Dosage: N/A) was diagnosed with
  • gastric disorder
and. Location: PORTUGAL , weighting 211.6 lb, Directly after, patient experienced the unwanted or unexpected Omeprazole side effects: hepatic function abnormal.
Associated medications used:
  • Alprazolem


Skin Reaction (8475104-7)
on Jun 14, 2012 Female from NETHERLANDS , 61 years of age, weighting 176.4 lb, was treated with Omeprazole. Patient felt the following Omeprazole side effects: skin reaction. Omeprazole dosage: 1d1c.
Multiple prescriptions taken:
  • Alendronate Sodium (1w1t)
  • Prednisolone (1d4t)
  • Spiriva (1d1inh)
  • Sucralfate (4d1sa)
  • Calci Chew D3 (1d1t)
  • Propranolol (2d2t)
  • Ursochol (2d1t)
  • Fenprocoumon (Tr)
Patient was hospitalized.

Off Label Use, Bronchiolitis (8474885-6)
on Jun 19, 2012 Male from BRAZIL , weighting 15.43 lb, was diagnosed with
  • gastrooesophageal reflux disease
  • bronchiolitis
and was treated with Omeprazole Magnesium. After Omeprazole was administered, patient encountered several Omeprazole side effects: off label use, bronchiolitis. Omeprazole Magnesium dosage: N/A.
Multiple concurrent drugs taken:
  • Glucocorticosteroid
Patient was hospitalized.

Vomiting, Diarrhoea, Muscular Weakness, Hypomagnesaemia, Tremor, Gait Disturbance, Hypocalcaemia, Malaise (8474848-0)
Patient was taking Omeprazole. Directly after, patient experienced the unwanted or unexpected Omeprazole side effects: vomiting, diarrhoea, muscular weakness, hypomagnesaemia, tremor, gait disturbance, hypocalcaemia, malaise on Jun 05, 2012 from SPAIN Additional patient health information: Male , 54 years of age, . Omeprazole dosage: N/A.

Granulocytopenia (8474040-X)
Adverse event was reported on Apr 19, 2012 by a Female taking Omeprazole (Dosage: N/A) . Location: UNITED STATES , 16 years of age, Patient felt the following Omeprazole side effects: granulocytopenia.
Multiple prescriptions taken:
  • Septra Ds (For 10 Days)
  • Miralax /00754501/
  • Clozapine (25mg Qam, 50mg Hs)
  • Vyvanse
  • Ranitidine
  • Depakote Er
  • Prazosin


Pain, Dysphonia, Nausea, Chest Discomfort, Malaise, Fatigue, Abdominal Pain Upper (8473496-6)
on Jun 25, 2012 Female from UNITED STATES , 51 years of age, weighting 148.0 lb, was diagnosed with
  • gastritis
and was treated with Omeprazole. After Omeprazole was administered, patient encountered several Omeprazole side effects: pain, dysphonia, nausea, chest discomfort, malaise, fatigue, abdominal pain upper. Omeprazole dosage: 1 Daily Po.

Wound, Suture Rupture, Musculoskeletal Disorder, Rash, Appetite Disorder, Disease Progression, Hypoaesthesia, Hypersensitivity, Osteomyelitis (8473198-6)
on Jun 19, 2012 Female from BRAZIL , weighting 174.2 lb, was treated with Omeprazole. Directly after, patient experienced the unwanted or unexpected Omeprazole side effects: wound, suture rupture, musculoskeletal disorder, rash, appetite disorder, disease progression, hypoaesthesia, hypersensitivity, osteomyelitis. Omeprazole dosage: N/A.
Associated medications used:
  • Lyrica
  • Mabthera
  • Mabthera (2 Cycle)
  • Maxsulid
  • Hydroxychloroquine Sulfate
  • Fluxene (Dosing Freq: Reported As 60 Mg In The Morning)
  • Simvastatin
  • Os-cal +d
Patient was hospitalized.

Gingival Pain, Sensitivity Of Teeth, Oral Discomfort (8472880-4)
Patient was taking Omeprazole. Patient felt the following Omeprazole side effects: gingival pain, sensitivity of teeth, oral discomfort on Apr 27, 2012 from UNITED STATES Additional patient health information: Male , 83 years of age, . Omeprazole dosage: N/A.

Rhinorrhoea, Productive Cough (8472878-6)
Adverse event was reported on Mar 16, 2012 by a Female taking Omeprazole (Dosage: N/A) was diagnosed with
  • gastrooesophageal reflux disease
  • blood pressure increased
and. Location: UNITED STATES , 88 years of age, After Omeprazole was administered, patient encountered several Omeprazole side effects: rhinorrhoea, productive cough.
Multiple concurrent drugs taken:
  • Avapro


Increased Appetite (8472873-7)
on Jan 27, 2012 Female from UNITED STATES , 80 years of age, was diagnosed with
  • gastrooesophageal reflux disease
  • hypothyroidism
and was treated with Omeprazole. Directly after, patient experienced the unwanted or unexpected Omeprazole side effects: increased appetite. Omeprazole dosage: N/A.
Associated medications used:
  • Synthroid


Oral Mucosal Blistering (8472868-3)
on Jul 13, 2011 Female from UNITED STATES , 56 years of age, was diagnosed with
  • gastrooesophageal reflux disease
and was treated with Omeprazole. Patient felt the following Omeprazole side effects: oral mucosal blistering. Omeprazole dosage: N/A.

Mouth Ulceration, Glossodynia (8472867-1)
Patient was taking Omeprazole. After Omeprazole was administered, patient encountered several Omeprazole side effects: mouth ulceration, glossodynia on Jun 20, 2011 from UNITED STATES Additional patient health information: Female , 77 years of age, was diagnosed with
  • gastrooesophageal reflux disease
and. Omeprazole dosage: N/A.
Multiple concurrent drugs taken:
  • Vitamin D
  • Levothyroxine
  • Citracal /01606701/
  • Magnesium Sulfate


Decreased Appetite, Diarrhoea, Trismus, Vomiting, Aggression (8472866-X)
Adverse event was reported on May 04, 2011 by a Male taking Omeprazole (Dosage: N/A) was diagnosed with
  • gastrooesophageal reflux disease
and. Location: UNITED STATES , weighting 30.00 lb, Directly after, patient experienced the unwanted or unexpected Omeprazole side effects: decreased appetite, diarrhoea, trismus, vomiting, aggression.

Visual Impairment, Diplopia, Appendicitis (8472862-2)
on Jun 19, 2012 Male from UNITED STATES , weighting 165.1 lb, was diagnosed with
  • adverse event
  • vitamin supplementation
and was treated with Omeprazole. Patient felt the following Omeprazole side effects: visual impairment, diplopia, appendicitis. Omeprazole dosage: N/A.
Multiple prescriptions taken:
  • Vitamin Tab
  • Folic Acid
  • Wellbutrin
  • Humira


Pneumonia Bacterial, Dyspnoea (8472718-5)
on Oct 25, 2011 Female from UNITED STATES , 69 years of age, was treated with Omeprazole. After Omeprazole was administered, patient encountered several Omeprazole side effects: pneumonia bacterial, dyspnoea. Omeprazole dosage: N/A.
Multiple concurrent drugs taken:
  • Revlimid (25 Mg, Daily X 21 Days, Po)
  • Lipitor
Patient was hospitalized.

Ascites, Oedema, Asthenia, Anaemia, Staphylococcal Sepsis (8472283-2)
Patient was taking Omeprazole. Directly after, patient experienced the unwanted or unexpected Omeprazole side effects: ascites, oedema, asthenia, anaemia, staphylococcal sepsis on Jun 19, 2012 from FRANCE Additional patient health information: Female , weighting 138.9 lb, was diagnosed with
  • dyspepsia
  • thrombocytopenia
  • hypertension
  • anaemia
  • pruritus
  • cough
  • hepatitis c
  • vomiting
  • oesophagitis
and. Omeprazole dosage: N/A.
Associated medications used:
  • Promacta
  • Aldactone
  • Neorecormon
  • Dexeryl
  • Pulmicort
  • Vx-950
  • Vogalene
Patient was hospitalized.

Erectile Dysfunction (8471926-7)
Adverse event was reported on Jun 18, 2012 by a Male taking Omeprazole (Dosage: N/A) was diagnosed with
  • gastrooesophageal reflux disease
and. Location: GERMANY , 50 years of age, Patient felt the following Omeprazole side effects: erectile dysfunction.

Thrombocytopenia (8471406-9)
on Nov 02, 2011 Male from UNITED STATES , 69 years of age, was treated with Omeprazole. After Omeprazole was administered, patient encountered several Omeprazole side effects: thrombocytopenia. Omeprazole dosage: N/A.
Multiple concurrent drugs taken:
  • Zolpidem
  • Senna (senna)
  • Revlimid (10 Mg, 1 In 1 D, Po)
  • Lyrica


Diffuse Alveolar Damage, Pulmonary Toxicity, Infection, Pneumonitis (8470864-3)
on Jun 19, 2012 Male from UNITED KINGDOM , weighting 156.5 lb, was treated with Omeprazole. Directly after, patient experienced the unwanted or unexpected Omeprazole side effects: diffuse alveolar damage, pulmonary toxicity, infection, pneumonitis. Omeprazole dosage: N/A.
Associated medications used:
  • Diazepam
  • Gabapentin
  • Senna /00142201/
  • Domperidone
  • Erlotinib Hydrochloride (150 Mg, Uid/qd)
  • Oxycodone Hcl
  • Docusate Sodium
  • Folic Acid
Patient was hospitalized.

Showing 1-25 of 4716 

Omeprazole Health Episodes

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Omeprazole Information

Alternative OMEPRAZOLE Names:OMEPRAZOL

Active Ingredient: OMEPRAZOL

More About Omeprazole

Side Effects reported to FDA: 4716. View Omeprazole Adverse Reports

Omeprazole safety alerts: 2009 2007

Reported deaths: 342

Reported hospitalizations: 1974

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 

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