ADVERSE REACTIONS
PRILOSEC Delayed-Release Capsules were generally well tolerated during domestic and international
clinical trials in 3096 patients.
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 PRILOSEC. Numbers in parentheses indicate percentages of the
adverse experiences considered by investigators as possibly, probably or definitely related to the drug:
| |
Omeprazole (n = 465) |
Placebo (n = 64) |
Ranitidine (n = 195) |
| Headache |
6.9 (2.4) |
6.3 |
7.7 (2.6) |
| Diarrhea |
3.0 (1.9) |
3.1 (1.6) |
2.1 (0.5) |
| Abdominal Pain |
2.4 (0.4) |
3.1 |
2.1 |
| Nausea |
2.2 (0.9) |
3.1 |
4.1 (0.5) |
| URI |
1.9 |
1.6 |
2.6 |
| Dizziness |
1.5 (0.6) |
0 |
2.6 (1.0) |
| Vomiting |
1.5 (0.4) |
4.7 |
1.5 (0.5) |
| Rash |
1.5 (1.1) |
0 |
0 |
| Constipation |
1.1 (0.9) |
0 |
0 |
| Cough |
1.1 |
0 |
1.5 |
| Asthenia |
1.1 (0.2) |
1.6 (1.6) |
1.5 (1.0) |
| Back Pain |
1.1 |
0 |
0.5 |
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.
| Incidence of Adverse Experiences ≥ 1% Causal Relationship not Assessed |
| |
Omeprazole(n = 2631) |
Placebo(n = 120) |
| Body as a Whole, site unspecified |
| Abdominal pain |
5.2 |
3.3 |
| Asthenia |
1.3 |
0.8 |
| Digestive System |
| Constipation |
1.5 |
0.8 |
| Diarrhea |
3.7 |
2.5 |
| Flatulence |
2.7 |
5.8 |
| Nausea |
4 |
6.7 |
| Vomiting |
3.2 |
10 |
| Acid regurgitation |
1.9 |
3.3 |
| Nervous System/Psychiatric |
| Headache |
2.9 |
2.5 |
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 PRILOSEC 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. 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 PRILOSEC. 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 [ALT (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, 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, 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, microscopicpyuria, urinary frequency, elevated serum creatinine, proteinuria, hematuria, glycosuria, testicular pain, gynecomastia
Hematologic: Rare instances of pancytopenia, agranulocytosis (some fatal), thrombocytopenia,
neutropenia, anemia, leucocytosis, and hemolytic anemia have been reported.
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.
Combination Therapy for H. pylori Eradication
In clinical trials using either dual therapy with PRILOSEC and clarithromycin, or triple therapy with PRILOSEC, 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.
Triple Therapy (PRILOSEC/clarithromycin/amoxicillin) — The most frequent adverse experiences
observed in clinical trials using combination therapy with PRILOSEC, 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.
For more information on clarithromycin or amoxicillin, refer to the respective package inserts,
ADVERSE REACTIONS sections.
Dual Therapy (PRILOSEC/clarithromycin) — Adverse experiences observed in controlled clinical
trials using combination therapy with PRILOSEC 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%).
For more information on clarithromycin, refer to the clarithromycin package insert, ADVERSE
REACTIONS section.
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