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Omeprazole Side Effects

For the Consumer

Applies to omeprazole: oral capsule delayed release, oral packet, oral powder for suspension, oral tablet delayed release

Along with its needed effects, omeprazole may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking omeprazole:

Rare
  • 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
Incidence not known
  • Drowsiness
  • fast, racing, or uneven heartbeat
  • mood or mental changes
  • muscle spasms (tetany) or twitching seizures
  • nausea or vomiting
  • trembling

Get emergency help immediately if any of the following symptoms of overdose occur while taking omeprazole:

Symptoms of overdose
  • Blurred vision
  • confusion
  • dryness of the mouth
  • flushing
  • headache
  • increased sweating

Some side effects of omeprazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Body aches or pain
  • chest pain
  • constipation
  • cough
  • diarrhea or loose stools
  • difficulty with breathing
  • dizziness
  • ear congestion
  • gas
  • heartburn
  • loss of voice
  • muscle pain
  • nasal congestion
  • runny nose
  • sneezing
  • unusual drowsiness

For Healthcare Professionals

Applies to omeprazole: compounding powder, oral delayed release capsule, oral delayed release tablet, oral powder for reconstitution, oral powder for reconstitution delayed release, oral suspension

General

The most commonly reported side effects included headache, abdominal pain, nausea, and diarrhea.[Ref]

Nervous system

Lightheadedness occurred predominantly in severely ill or elderly patients.

Taste disturbance usually resolved when treatment was stopped.

Taste perversion most commonly occurred in patients given concomitant treatment with clarithromycin.

Hepatic encephalopathy occurred in patients with preexisting liver disease.[Ref]

Very common (10% or more): Taste perversion (Up to 15%)
Common (1% to 10%): Headache, drowsiness, somnolence, dizziness
Uncommon (0.1% to 1%): Paresthesia, vertigo, taste disturbances
Rare (0.01% to 0.1%): Lightheadedness, hepatic encephalopathy
Postmarketing reports: Tremor[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (Up to 14%)
Common (1% to 10%): Abdominal pain, constipation, flatulence, nausea/vomiting, acid regurgitation, tongue discoloration, benign fundic gland polyps
Rare (0.01% to 0.1%): Dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis
Very rare (less than 0.01%): Dyspepsia, hemorrhagic necrotic gastritis
Postmarketing reports: Pancreatitis (sometimes fatal), irritable colon, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, Clostridium difficile associated diarrhea, abdominal swelling[Ref]

Hemorrhagic necrotic gastritis has been reported in pediatric patients.

Diarrhea most commonly occurred in patients given concomitant treatment with clarithromycin and amoxicillin.

Benign gastric fundic gland polyps appeared to be reversible when omeprazole was discontinued.[Ref]

Respiratory

Common (1% to 10%): Upper respiratory infection, cough, rhinitis, pharyngitis/pharyngeal pain
Rare (0.01% to 0.1%): Bronchospasm
Very rare (less than 0.01%): Dyspnea
Postmarketing reports: Epistaxis[Ref]

Patients 1 to less than 2 years of age had the highest frequency of adverse reactions of the respiratory system, followed by patients 1 month to less than 1 year and patients 2 to 16 years of age.[Ref]

Other

Otitis media occurred most frequently in patients 1 month to less than 1 year of age.

Fever most commonly occurred in patients 1 to less than 2 years of age.

Accidental injury most commonly occurred in patients 2 to 16 years of age.[Ref]

Common (1% to 10%): Asthenia, flu-syndrome, fever
Uncommon (0.1% to 1%): Malaise
Very rare (less than 0.01%): Elevated body temperature
Frequency not reported: Otitis media, accidental injury
Postmarketing reports: Pain, fatigue, tinnitus[Ref]

Dermatologic

Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Dermatitis, alopecia, skin eruptions, erythema multiforme, urticaria and/or pruritus, photosensitivity
Rare (0.01% to 0.1%): Increased sweating/hyperhidrosis, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal)
Frequency not reported: Subacute cutaneous lupus erythematosus
Postmarketing reports: Severe generalized skin reactions, skin inflammation, petechia, dry skin, systemic lupus erythematosus[Ref]

Psychiatric

Common (1% to 10%): Insomnia
Rare (0.01% to 0.1%): Agitation, confusion/reversible mental confusion, depression, aggression, hallucinations
Postmarketing reports: Anxiety, apathy, nervousness, dream abnormalities, psychiatric and sleep disturbances[Ref]

Confusion, agitation, aggression, depression, and hallucinations occurred predominantly in severely ill or elderly patients.[Ref]

Musculoskeletal

Common (1% to 10%): Back pain
Uncommon (0.1% to 1%): Fracture of the hip/wrist/spine
Rare (0.01% to 0.1%): Arthralgia, myalgia, muscular weakness, joint pain
Postmarketing reports: Muscle cramps, leg pain, bone fracture[Ref]

Hepatic

Uncommon (0.1% to 1%): Increased liver enzymes (ALT, AST, GGT, alkaline phosphatase, bilirubin)
Rare (0.01% to 0.1%): Hepatitis with/without jaundice, hepatic failure/encephalopathy
Postmarketing reports: Liver disease, fatal hepatic failure, liver necrosis (some fatal), hepatocellular disease, cholestatic disease, mixed hepatitis, jaundice[Ref]

Cardiovascular

Peripheral edema usually resolved when treatment was stopped.[Ref]

Uncommon (0.1% to 1%): Peripheral edema
Postmarketing reports: Chest pain/angina, tachycardia, bradycardia, palpitations, elevated blood pressure/hypertension[Ref]

Hematologic

Rare (0.01% to 0.1%): Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypochromic/microcytic anemia
Postmarketing reports: Purpura, fatal agranulocytosis, hemolytic anemia, neutropenia, anemia, leukocytosis[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Hypersensitivity reactions, angioedema, anaphylactic reaction/shock, allergic vasculitis[Ref]

Metabolic

Rare (0.01% to 0.1%): Hyponatremia
Very rare (less than 0.01%): Weight increase, hypomagnesemia with/without hypocalcemia and/or hypokalemia, hypokalemia
Frequency not reported: Hypocalcemia
Postmarketing reports: Anorexia, hypoglycemia[Ref]

Severe hypomagnesemia may result in hypocalcemia, and may be associated with hypokalemia.

Hypokalemia was reported in pediatric patients.[Ref]

Ocular

Irreversible visual impairment has been reported in critically ill patients who generally received high doses of the IV formulation as a bolus; however, no causal relationship has been established.[Ref]

Rare (0.01% to 0.1%): Blurred vision
Frequency not reported: Irreversible visual impairment
Postmarketing reports: Optic atrophy, anterior ischemic optic neuropathy, optic neuritis, dry eye syndrome, ocular irritation, double vision[Ref]

Renal

Rare (0.01% to 0.1%): Interstitial nephritis
Very rare (less than 0.01%): Impaired renal function, nephrosis
Postmarketing reports: Elevated serum creatinine, glycosuria[Ref]

Genitourinary

A causal relationship between this drug and impotence has not been established.[Ref]

Very rare (less than 0.01%): Impotence
Postmarketing reports: Hematuria, proteinuria, microscopic pyuria, urinary tract infection, urinary frequency, testicular pain[Ref]

Endocrine

Rare (0.01% to 0.1%): Gynecomastia[Ref]

Oncologic

Postmarketing reports: Gastroduodenal carcinoids[Ref]

Gastroduodenal carcinoids have been reported in patients with Zollinger-Ellison syndrome on long-term therapy. This condition may be a manifestation of the underlying condition, which is known to be associated with tumors.[Ref]

References

1. "Product Information. Zegerid (omeprazole)." Santarus Inc, San Diego, CA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. "Product Information. Prilosec (omeprazole)." Merck & Co, Inc, West Point, PA.

5. "Product Information. Omeprazole (omeprazole)." Mylan Pharmaceuticals Inc, Morgantown, WV.

Some side effects of omeprazole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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