Omeprazole side effects
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
List of side effects
side effects#Occurrence in ≥ 1% of patients|Occurrence in ≥ 1% of patients]
- side effects#U.S. clinical trial|U.S. clinical trial]
- side effects#International clinical trial|International clinical trial]
side effects#Occurrence in < 1% of patients|Occurrence in < 1% of patients]
side effects#Combination therapy for H. pylori eradication|Combination therapy for H. pylori eradication]
- side effects#Triple therapy (omeprazole/clarithromycin/amoxicillin)|Triple therapy (omeprazole/clarithromycin/amoxicillin)]
- side effects#Dual therapy (omeprazole/clarithromycin)|Dual therapy (omeprazole/clarithromycin)]
Occurrence in ≥ 1% of patients
Omeprazole was generally well tolerated during domestic and international clinical trials in 3096 patients. The incidence of clinical adverse experiences in patients greater than 65 years of age was similar to that in patients 65 years of age or less. side effects#List of side effects|Return to top]
U.S. clinical trial
In the U.S. clinical trial population of 465 patients (including duodenal ulcer, Zollinger-Ellison syndrome and resistant ulcer patients), the following adverse experiences were reported to occur in 1% or more of patients on therapy with Omeprazole: headache, diarrhea, abdominal pain, nausea, URI, dizziness, vomiting, rash, constipation, cough, asthenia, back pain. side effects#List of side effects|Return to top]
International clinical trial
The following adverse reactions which occurred in 1% or more of Omeprazole-treated patients have been reported in international double-blind, and open-label, clinical trials in which 2,631 patients and subjects received Omeprazole: abdominal pain, asthenia, constipation, diarrhea, flatulence, nausea, vomiting, acid regurgitation, headache. side effects#List of side effects|Return to top]
Occurrence in < 1% of patients
Additional adverse experiences occurring in < 1% of patients or subjects in domestic and/or international trials, or occurring since the drug was marketed, are shown below within each body system. In many instances, the relationship to Omeprazole was unclear.
- Body As a Whole: Allergic reactions, including, rarely, anaphylaxis (see also Skin below), fever, pain, fatigue, malaise, abdominal swelling
- Cardiovascular: Chest pain or angina, tachycardia, bradycardia, palpitation, elevated blood pressure, peripheral edema
- Gastrointestinal: Pancreatitis (some fatal), anorexia, irritable colon, flatulence, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, dry mouth, stomatitis. During treatment with Omeprazole, gastric fundic gland polyps have been noted rarely. These polyps are benign and appear to be reversible when treatment is discontinued.
- Gastro-duodenal carcinoids have been reported in patients with ZE syndrome on long-term treatment with Omeprazole. This finding is believed to be a manifestation of the underlying condition, which is known to be associated with such tumors.
- Hepatic: Mild and, rarely, marked elevations of liver function tests (SGPT), AST (SGOT), γ-glutamyl transpeptidase, alkaline phosphatase, and bilirubin (jaundice). In rare instances, overt liver disease has occurred, including hepatocellular, cholestatic, or mixed hepatitis, liver necrosis (some fatal), hepatic failure (some fatal), and hepatic encephalopathy.
- Metabolic/Nutritional: Hyponatremia, hypoglycemia, weight gain
- Musculoskeletal: Muscle cramps, myalgia, muscle weakness, joint pain, leg pain
- Nervous System/Psychiatric: Psychic disturbances including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, tremors, apathy, somnolence, anxiety, dream abnormalities; vertigo; paresthesia; hemifacial dysesthesia
- Respiratory: Epistaxis, pharyngeal pain
- Skin: Rash and, rarely, cases of severe generalized skin reactions including toxic epidermal necrolysis (TEN; some fatal), Stevens-Johnson syndrome, and erythema multiforme (some severe); purpura and/or petechiae (some with rechallenge); skin inflammation, urticaria, angioedema, pruritus, photosensitivity, alopecia, dry skin, hyperhidrosis
- Special Senses: Tinnitus, taste perversion
- Ocular: Blurred vision, ocular irritation, dry eye syndrome, optic atrophy, anterior ischemic optic neuropathy, optic neuritis, double vision
- Urogenital: Interstitial nephritis (some with positive rechallenge), urinary tract infection, microscopic pyuria, urinary frequency, elevated serum creatinine, proteinuria, hematuria, glycosuria, testicular pain, gynecomastia
- Hematologic: Rare instances of pancytopenia, agranulocytosis (some fatal), thrombocytopenia, neutropenia, leukopenia, anemia, leucocytosis, and hemolytic anemia have been reported.
side effects#List of side effects|Return to top]
Combination therapy for H. pylori eradication
In clinical trials using either dual therapy with Omeprazole and clarithromycin, or triple therapy with Omeprazole, clarithromycin, and amoxicillin, no adverse experiences peculiar to these drug combinations have been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with Omeprazole, clarithromycin, or amoxicillin. side effects#List of side effects|Return to top]
Triple therapy (omeprazole/clarithromycin/amoxicillin)
The most frequent adverse experiences observed in clinical trials using combination therapy with Omeprazole, clarithromycin, and amoxicillin (n = 274) were diarrhea (14%), taste perversion (10%), and headache (7%). None of these occurred at a higher frequency than that reported by patients taking the antimicrobial drugs alone. side effects#List of side effects|Return to top]
Dual therapy (omeprazole/clarithromycin)
Adverse experiences observed in controlled clinical trials using combination therapy with Omeprazole and clarithromycin (n = 346) which differed from those previously described for Omeprazole alone were: Taste perversion (15%), tongue discoloration (2%), rhinitis (2%), pharyngitis (1%) and flu syndrome (1%). side effects#List of side effects|Return to top]
Adapted from the FDA Package Insert.