OMEPRAZOLE (omeprazole)

There are 0 contraindications.

There are 4 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Clostridioides difficile infection
Interstitial nephritis
Subacute cutaneous lupus erythematosus
Systemic lupus erythematosus

There are 6 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
CYp2c19 poor metabolizer
Disease of liver
Fracture
Hypomagnesemia
Osteoporosis
Vitamin b12 deficiency

There are 42 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare

Abnormal hepatic function tests Acute generalized exanthematous pustulosis Agranulocytosis Anaphylaxis Anemia Angioedema Anterior ischemic optic neuropathy Atrophic gastritis Bradycardia Bronchospastic pulmonary disease Cardiac arrhythmia Cholestatic hepatitis Clostridioides difficile infection DRESS syndrome Erythema multiforme Esophageal candidiasis Fracture Hematuria Hepatic failure Hepatitis Hyperbilirubinemia Hypertension Hypocalcemia Hypoglycemic disorder Hypokalemia Hyponatremia Increased alanine transaminase Increased aspartate transaminase Interstitial nephritis Leukocytosis Leukopenia Neutropenic disorder Optic neuritis Pancreatitis Pancytopenia Proteinuria Stevens-johnson syndrome Subacute cutaneous lupus erythematosus Systemic lupus erythematosus Thrombocytopenic disorder Toxic epidermal necrolysis Urticaria

There are 61 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Diarrhea Flatulence Headache disorder Vomiting	Back pain Chest pain Constipation Cough Dizziness Fever General weakness Nausea Pruritus of skin Sore throat Upper respiratory infection

Rare/Very Rare

Abdominal distension Alopecia Anorexia Arthralgia Benign fundic gland polyposis of stomach Blurred vision Cramps Diplopia Discolored feces Dry eye Dry skin Dysgeusia Epistaxis Erectile dysfunction Fatigue Glycosuria Gynecomastia Hyperhidrosis Hypomagnesemia Irritable bowel syndrome Leg pain Malaise Muscle weakness Myalgia Ocular irritation Pain Palpitations Paresthesia Peripheral edema Petechiae Purpura Skin inflammation Skin photosensitivity Skin rash Sleep disorder Stomatitis Tachycardia Testicular pain Tinnitus Tremor Urinary tract infection Vertigo Vitamin b12 deficiency Weight gain Xerostomia

Reproductive studies in rats and rabbits using omeprazole dosages during organogenesis of up to 138 and 69.1 mg/kg daily (about 34 times the human dosage of 40 mg daily based on body surface area (BSA)), respectively, have not revealed evidence of teratogenicity. However, in rabbits given omeprazole dosages of 6.9-69.1

mg/kg daily during organogenesis (about 3.4-34 times the human dosage of 40 mg daily based on BSA), dose-related increases in embryolethality, fetal resorptions, and pregnancy loss occurred. In rats, dose-related embryo/fetal toxicity and postnatal developmental toxicity were observed in offspring resulting from administration of omeprazole in dosages of 13.8-138 mg/kg daily (about 3.4-34 times the human dosage of 40 mg daily based on BSA) prior to mating through the lactation period.

Reproductive studies of oral esomeprazole (an enantiomer of omeprazole) in rats and rabbits during organogenesis using dosages approximately 68 and 42 times the usual human dosage of 40 mg daily based on BSA, did not reveal evidence of embryo/fetal toxicity. When administered through most of pregnancy and lactation, effects on bone morphology were observed in rat offspring at dosages approximately 34 times the human dosage of 40 mg daily based on BSA of esomeprazole; however, when confined to administration during the gestational period only, no effects on bone morphology were observed in another study. There are no adequate and well controlled studies using omeprazole in pregnant women.

Available epidemiologic data have not demonstrated an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester exposure to omeprazole. Reproductive studies in rats and rabbits using omeprazole dosages approximately 3.4-34 times the human dosage of 40 mg daily (based on BSA) resulted in dose-dependent increases in embryolethality.

A population-based retrospective cohort epidemiologic study using data from the Swedish Medical Birth Registry reported on outcomes in infants whose mothers used omeprazole during pregnancy; most (about 86%) were exposed to omeprazole during the first trimester, 5% during and beyond the first trimester, and about 14% were exposed only after the first trimester of pregnancy. The number of infants exposed to omeprazole in utero with any malformation, low birth weight, low Apgar score, or hospitalization was similar to the number in this population. The number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the omeprazole-exposed infants than the expected number in this population.

In a population-based retrospective cohort study in Denmark reporting on 1800 live births whose mothers received omeprazole during the first trimester and 837,317 live births whose mothers did not receive a PPI, the overall rate of birth defects was 2.9% in infants whose mothers received omeprazole during the first trimester and 2.6% in infants born to mothers not exposed to any PPI during the first trimester.

In a retrospective cohort study, the incidence of congenital malformations in 689 women who received omeprazole or histamine H2-antagonists in the first trimester of pregnancy was compared with a control group of women who were not exposed to acid-suppressant drugs. The malformation rate associated with histamine H2-antagonists exposure was 5.5%, the malformation rate for nonexposed women was 4.1%,

and the malformation rate associated with omeprazole exposure was 3.6%. A small prospective cohort study followed women exposed to omeprazole (89% during the first trimester) during pregnancy; major congenital malformations occurred in 4% of live births in omeprazole-exposed women, 2.8%

of disease-paired controls, and 2% exposed to non-teratogenic agents. Rates of spontaneous and elective abortions, preterm deliveries, gestational age at delivery, and mean birth weight were similar among the groups. The manufacturers state that several studies reported that adverse short-term effects were not observed in infants when a single oral or IV dose of omeprazole was administered to pregnant women as premedication for cesarean section under general anesthesia. Available data on sodium bicarbonate administration during pregnancy have not identified a drug-associated risk of major fetal malformations or miscarriage.

Limited data suggest omeprazole is distributed into human milk. The effects of omeprazole on milk production and on the breast-fed infant are unknown. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for the drug and any potential adverse effects on the breast-fed infant from omeprazole or from the underlying maternal condition.

In US and European clinical trials, more than 2000 patients treated with omeprazole were >=65 years of age. Although no overall differences in efficacy or safety were observed between geriatric and younger patients, and other clinical experience revealed no evidence of age-related differences, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.