Prilosec OTC Side Effects

Generic name: omeprazole

Medically reviewed by Drugs.com. Last updated on Feb 5, 2024.

Note: This document provides detailed information about Prilosec OTC Side Effects associated with omeprazole. Some dosage forms listed on this page may not apply specifically to the brand name Prilosec OTC.

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

Common side effects of Prilosec OTC

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
• diarrhea or loose stools
• difficulty with breathing
• dizziness
• ear congestion
• gas
• heartburn
• loss of voice
• muscle pain
• runny or stuffy nose
• sneezing
• unusual drowsiness

Incidence not known

• bloody nose
• continuing ringing or buzzing or other unexplained noise in the ears
• decreased interest in sexual intercourse
• dry mouth
• hearing loss
• inability to have or keep an erection
• increased sensitivity of the skin to sunlight
• increased sweating
• loss in sexual ability, desire, drive, or performance
• redness or other discoloration of the skin
• severe sunburn
• swelling of the breasts or breast soreness in both females and males
• trouble sleeping

Serious side effects of Prilosec OTC

Along with its needed effects, omeprazole (the active ingredient contained in Prilosec OTC) 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
• itching, skin rash
• joint pain
• loss of appetite
• muscle aches or cramps
• pain
• red or irritated eyes
• redness, tenderness, itching, burning, or peeling of the skin
• 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

• black, tarry stools
• bleeding gums
• blindness
• blistering, peeling, or loosening of the skin
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred or decreased vision
• chest pain or tightness
• confusion
• constipation
• cough
• dark urine
• decreased urine
• difficulty swallowing
• dizziness
• drowsiness
• eye pain
• fast, racing, or uneven heartbeat
• indigestion
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• lower back or side pain
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle spasms (tetany) or twitching seizures
• numbness and tingling around the mouth , fingertips, or feet
• nausea
• pain or swelling in the arms or legs without any injury
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• stomach pain
• swollen glands
• trembling
• unpleasant breath odor
• vomiting
• vomiting of blood
• yellow eyes or skin

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

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, oral tablet disintegrating delayed release.

General

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

Other

• Very common (10% or more): Fever (up to 33%), otitis media (up to 22%)
• Common (1% to 10%): Accidental injury, asthenia
• Uncommon (0.1% to 1%): Malaise
• Very rare (less than 0.01%): Elevated body temperature
• Postmarketing reports: Pain, fatigue, tinnitus^[Ref]

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]

Respiratory

• Very common (10% or more): Respiratory system reactions (up to 75%)
• Common (1% to 10%): Cough, pharyngitis/pharyngeal pain, rhinitis, upper respiratory infection
• 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]

Nervous system

• Very common (10% or more): Taste perversion (up to 15%)
• Common (1% to 10%): Dizziness, drowsiness, headache, somnolence
• Uncommon (0.1% to 1%): Paresthesia, taste disturbances, vertigo
• Rare (0.01% to 0.1%): Hepatic encephalopathy, lightheadedness
• Postmarketing reports: Tremor^[Ref]

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]

Gastrointestinal

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

Dermatologic

• Common (1% to 10%): Rash
• Uncommon (0.1% to 1%): Alopecia, dermatitis, erythema multiforme, increased sweating, pruritus, photosensitivity, skin eruptions, urticaria
• Rare (0.01% to 0.1%): Allergic vasculitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal)
• Frequency not reported: Subacute cutaneous lupus erythematosus
• Postmarketing reports: Cutaneous lupus erythematosus, dry skin, hyperhidrosis, petechia, skin inflammation, severe generalized skin reactions, systemic lupus erythematosus^[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, joint pain, muscular weakness, myalgia
• Postmarketing reports: Bone fracture, leg pain, muscle cramps^[Ref]

Psychiatric

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

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

Immunologic

• Common (1% to 10%): Flu syndrome^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Increased liver enzymes (ALT, alkaline phosphatase, AST, bilirubin, gamma glutamyl transferase)
• Rare (0.01% to 0.1%): Hepatic failure, hepatitis with/without jaundice
• Postmarketing reports: Cholestatic disease, fatal hepatic failure, hepatocellular disease, jaundice, liver disease, liver necrosis (some fatal), mixed hepatitis^[Ref]

Cardiovascular

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

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

Hematologic

• Rare (0.01% to 0.1%): Agranulocytosis, hypochromic/microcytic anemia, leukopenia, pancytopenia, thrombocytopenia
• Postmarketing reports: Anemia, fatal agranulocytosis, hemolytic anemia, leukocytosis, neutropenia, purpura^[Ref]

Hypersensitivity

• Rare (0.01% to 0.1%): Anaphylactic reaction/shock, angioedema, hypersensitivity reactions
• Postmarketing reports: Anaphylaxis^[Ref]

Metabolic

• Rare (0.01% to 0.1%): Hyponatremia
• Very rare (less than 0.01%): Hypocalcemia, hypokalemia, hypomagnesemia with/without hypocalcemia and/or hypokalemia, weight increase
• Postmarketing reports: Anorexia, cyanocobalamin (vitamin B12) deficiency, hypoglycemia^[Ref]

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

Hypokalemia was reported in pediatric patients.^[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]

Ocular

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

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]

Endocrine

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

Genitourinary

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

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

Frequently asked questions

• Is famotidine safer than omeprazole for heartburn?
• Pantoprazole vs. omeprazole: What's the difference between them?
• What foods should I avoid when taking omeprazole?
• Can you take an antacid with omeprazole?
• Can I take omeprazole in the morning and famotidine at night?
• Is omeprazole (Prilosec) bad for your kidneys?
• Does omeprazole cause cancer?
• How soon after taking levothyroxine can I take omeprazole?

Further information

Prilosec OTC side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer