Prilosec Side Effects
Generic Name: omeprazole
Note: This document contains side effect information about omeprazole. Some of the dosage forms listed on this page may not apply to the brand name Prilosec.
For the Consumer
Applies to omeprazole: oral capsule delayed release, oral packet, oral powder for suspension, oral tablet delayed release
Side effects requiring immediate medical attention
Along with its needed effects, omeprazole (the active ingredient contained in Prilosec) 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:
- Back, leg, or stomach pain
- bleeding or crusting sores on the lips
- bloody or cloudy urine
- continuing ulcers or sores in the mouth
- difficult, burning, or painful urination
- frequent urge to urinate
- general feeling of discomfort or illness
- itching, skin rash
- joint pain
- loss of appetite
- muscle aches or cramps
- 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
- Blistering, peeling, or loosening of the skin
- fast, racing, or uneven heartbeat
- mood or mental changes
- muscle spasms (tetany) or twitching seizures
- red skin lesions, often with a purple center
- red, irritated eyes
Get emergency help immediately if any of the following symptoms of overdose occur while taking omeprazole:
Symptoms of overdose
- Blurred vision
- dryness of the mouth
- increased sweating
Side effects not requiring immediate medical attention
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:
- Body aches or pain
- chest pain
- diarrhea or loose stools
- difficulty with breathing
- ear congestion
- loss of voice
- muscle pain
- nasal congestion
- runny nose
- 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
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]
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
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]
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]
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.
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]
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 (the active ingredient contained in Prilosec) was discontinued.[Ref]
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
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]
Common (1% to 10%): Rash
Frequency not reported: Subacute cutaneous lupus erythematosus
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
Common (1% to 10%): Insomnia
Rare (0.01% to 0.1%): Aggression, agitation, confusion/reversible mental confusion, depression, hallucinations
Common (1% to 10%): Flu syndrome[Ref]
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]
Uncommon (0.1% to 1%): Peripheral edema
Peripheral edema usually resolved when treatment was stopped.[Ref]
Rare (0.01% to 0.1%): Hyponatremia
Severe hypomagnesemia may result in hypocalcemia, and this condition may be associated with hypokalemia.
Hypokalemia was reported in pediatric patients.[Ref]
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]
Rare (0.01% to 0.1%): Blurred vision
Frequency not reported: Irreversible visual impairment
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%): Gynecomastia[Ref]
Very rare (less than 0.01%): Impotence
A causal relationship between this drug and impotence has not been established.[Ref]
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]
1. Cerner Multum, Inc. "Australian Product Information." O 0
2. "Product Information. Zegerid (omeprazole)." Santarus Inc, San Diego, CA.
3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
4. "Product Information. Prilosec (omeprazole)." Merck & Co, Inc, West Point, PA.
5. "Product Information. Omeprazole (omeprazole)." Mylan Pharmaceuticals Inc, Morgantown, WV.
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.
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