Omeprazole
PRILOSEC
Pronunciation: oe-ME-pra-zoel (PRYE-loe-sek)
“Ome pries Loose – Oh my!”
What it isIrreversible proton-pump inhibitor for GERD, peptic ulcer disease and H. pylori regimens.
Why this oneIt is the most interaction-prone common PPI; pantoprazole is preferred when clopidogrel must remain effective.
What limits itLong-term use can deplete magnesium and B12 and raise fracture or enteric-infection risk; reassess the indication.
FDA-approved for
- GERD/ulcers (1989)
Off-label
- functional dyspepsia
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Active duodenal ulcer (short-term) | Adults | 20 mg QD × 4 wk | 20 mg QD; some need an additional 4 wk | 20 mg QD |
| H. pylori eradication (duodenal ulcer, to reduce recurrence) — triple therapy | Adults | 20 mg BID + clarithromycin 500 mg BID + amoxicillin 1000 mg BID × 10 days | If ulcer present at start: then 20 mg QD × 18 days | 20 mg BID |
| H. pylori eradication (duodenal ulcer) — dual therapy | Adults | 40 mg QD + clarithromycin 500 mg TID × 14 days | If ulcer present at start: then 20 mg QD × 14 days | 40 mg QD |
| Active benign gastric ulcer (short-term) | Adults | 40 mg QD | 40 mg QD × 4–8 wk | 40 mg QD |
| Symptomatic GERD (no esophageal lesions) | Adults | 20 mg QD | 20 mg QD up to 4 wk | 20 mg QD |
| Erosive esophagitis due to GERD (endoscopically diagnosed) | Adults | 20 mg QD | 20 mg QD × 4–8 wk; +4 wk if no response at 8 wk; repeat 4–8 wk courses for recurrence | 20 mg QD |
| Maintenance of healing of erosive esophagitis | Adults | 20 mg QD | 20 mg QD | 20 mg QD |
| Pathological hypersecretory conditions (Zollinger-Ellison, multiple endocrine adenomas, systemic mastocytosis) | Adults | 60 mg QD | Individualized; continue as long as clinically indicated; >80 mg/day in divided doses | Up to 120 mg TID has been administered |
| Treatment of GERD / maintenance of healing of erosive esophagitis | Peds 1–16 yr, 5 to <10 kg | 5 mg QD | 5 mg QD | 5 mg QD |
| Treatment of GERD / maintenance of healing of erosive esophagitis | Peds 1–16 yr, 10 to <20 kg | 10 mg QD | 10 mg QD | 10 mg QD |
| Treatment of GERD / maintenance of healing of erosive esophagitis | Peds 1–16 yr, ≥20 kg | 20 mg QD | 20 mg QD | 20 mg QD |
Renal No dosage reduction necessary
Hepatic Consider dose reduction, particularly for maintenance of healing of erosive esophagitis (no specific dose given)
Peds <1 yr: safety/effectiveness not established. Asian patients: consider dose reduction (esp. maintenance of erosive esophagitis). Elderly: no dosage adjustment necessary.
Instructions
- Take before eating
- Swallow capsule whole
- Antacids may be used concomitantly
- If unable to swallow capsule: open and empty all pellets onto 1 tablespoon of soft, not-hot applesauce; swallow immediately with a glass of cool water
- Do not chew or crush pellets; do not store pellet/applesauce mixture
Available strengths
- DR cap 10, 20, 40 mg
Cautions
- Concomitant gastric malignancy — symptomatic response does not preclude it
- Atrophic gastritis with long-term use
- With amoxicillin: penicillin anaphylaxis; pseudomembranous (C. difficile) colitis
- With clarithromycin: avoid in pregnancy unless no alternative; ↑ omeprazole/clarithromycin levels; clarithromycin + cisapride or pimozide contraindicated
Adverse reactions
- Headache (6.9%)
- Abdominal pain (5.2%)
- Nausea (4.0%)
- Diarrhea (3.7%)
- Vomiting (3.2%)
- Flatulence (2.7%)
- Acid regurgitation (1.9%)
- Upper respiratory infection (1.9%)
- Constipation (1.5%)
- Dizziness (1.5%)
- Rash (1.5%)
- Asthenia (1.3%)
Pregnancy Category C; animal studies and first-trimester cohort data show no increased risk of congenital anomalies — use only if clearly needed.
Lactation Excreted in human milk (peak <7% of serum); decide whether to discontinue nursing or the drug.
Cost
Generic entry2009
NO BOXED WARNINGS
Principal riskLong-term use: B12 deficiency, hypomagnesemia, fracture
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilityLong-term infection, magnesium/B12 and bone risks; selected agents have clinically important CYP interactions.
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