Side Effects > Prilosec

Prilosec Side Effects

Generic Name: omeprazole

Please note - some side effects for Prilosec may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Prilosec - for the Consumer

Prilosec Delayed-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Prilosec Delayed-Release Capsules:

Diarrhea; headache.

Seek medical attention right away if any of these SEVERE side effects occur when using Prilosec Delayed-Release Capsules:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; dark urine; fast or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; swelling of the hands, ankles, or feet; unusual bruising or bleeding; unusual tiredness; vision changes; yellowing of the eyes or skin.

Prilosec OTC Delayed-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Prilosec OTC Delayed-Release Tablets:

Diarrhea; headache.

Seek medical attention right away if any of these SEVERE side effects occur when using Prilosec OTC Delayed-Release Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; dark urine; fast or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; swelling of the hands, ankles, or feet; unusual bruising or bleeding; unusual tiredness; vision changes; yellowing of the eyes or skin.

Prilosec Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Prilosec Suspension:

Diarrhea; gas; headache; nausea; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Prilosec Suspension:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; dark urine; fast, slow, or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; severe stomach pain; swelling of the hands, ankles, or feet; unusual bruising or bleeding; unusual tiredness; vision changes; yellowing of the eyes or skin.

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Prilosec Side Effects - for the Professional

Prilosec

6.1 Clinical Trials Experience with Prilosec Monotherapy

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below reflects exposure to Prilosec Delayed-Release Capsules in 3096 patients from worldwide clinical trials (465 patients from US studies and 2,631 patients from international studies). Indications clinically studied in US trials included duodenal ulcer, resistant ulcer, and Zollinger-Ellison syndrome. The international clinical trials were double blind and open-label in design. The most common adverse reactions reported (i.e., with an incidence rate ≥ 2%) from Prilosec-treated patients enrolled in these studies included headache (6.9%), abdominal pain (5.2%), nausea (4.0%), diarrhea (3.7%), vomiting (3.2%), and flatulence (2.7%).

Additional adverse reactions that were reported with an incidence ≥1% included acid regurgitation (1.9%), upper respiratory infection (1.9%), constipation (1.5%), dizziness (1.5%), rash (1.5%), asthenia (1.3%), back pain (1.1%), and cough (1.1%).

The clinical trial safety profile in patients greater than 65 years of age was similar to that in patients 65 years of age or less.

The clinical trial safety profile in pediatric patients who received Prilosec Delayed-Release Capsules was similar to that in adult patients. Unique to the pediatric population, however, adverse reactions of the respiratory system were most frequently reported in both the 1 to <2 and 2 to 16 year age groups (75.0% and 18.5%, respectively). Similarly, fever was frequently reported in the 1 to 2 year age group (33.0%) and accidental injuries were reported frequently in the 2 to 16 year age group (3.8%). [See Use in Specific Populations (8.4) ]

6.2 Clinical Trials Experience with Prilosec in 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 reactions unique to these drug combinations were observed. Adverse reactions observed were limited to those previously reported with omeprazole, clarithromycin, or amoxicillin alone.

Dual Therapy (Prilosec/clarithromycin)

Adverse reactions observed in controlled clinical trials using combination therapy with Prilosec and clarithromycin (n = 346) that differed from those previously described for Prilosec 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 prescribing information, Adverse Reactions section).

Triple Therapy (Prilosec/clarithromycin/amoxicillin)

The most frequent adverse reactions 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 antimicrobial agents alone. (For more information on clarithromycin or amoxicillin, refer to the respective prescribing information, Adverse Reactions sections).

6.3 Post-marketing Experience

The following adverse reactions have been identified during post-approval use of Prilosec Delayed-Release Capsules. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their actual frequency or establish a causal relationship to drug exposure.

Body As a Whole: Hypersensitivity reactions including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, urticaria,; fever; pain; fatigue; malaise;

Cardiovascular: Chest pain or angina, tachycardia, bradycardia, palpitations, elevated blood pressure, peripheral edema

Endocrine: Gynecomastia

Gastrointestinal: Pancreatitis (some fatal), anorexia, irritable colon, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, stomatitis, abdominal swelling, 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. Gastroduodenal 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: Liver disease including hepatic failure (some fatal), liver necrosis (some fatal), hepatic encephalopathy hepatocellular disease, cholestatic disease, mixed hepatitis, jaundice, and elevations of liver function tests [ALT, AST, GGT, alkaline phosphatase, and bilirubin]

Metabolic/Nutritional: Hypoglycemia, hyponatremia, weight gain

Musculoskeletal: Muscle weakness, myalgia, muscle cramps, joint pain, leg pain

Nervous System/Psychiatric: Psychiatric and sleep disturbances including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, apathy, somnolence, anxiety, and dream abnormalities; tremors, paresthesia; vertigo

Respiratory: Epistaxis, pharyngeal pain

Skin: Severe generalized skin reactions including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, and erythema multiforme; photosensitivity; urticaria; rash; skin inflammation; pruritus; petechiae; purpura; alopecia; dry skin; hyperhidrosis

Special Senses: Tinnitus, taste perversion

Ocular: Optic atrophy, anterior ischemic optic neuropathy, optic neuritis, dry eye syndrome, ocular irritation, blurred vision, double vision

Urogenital: Interstitial nephritis, hematuria, proteinuria, elevated serum creatinine, microscopic pyuria, urinary tract infection, glycosuria, urinary frequency, testicular pain

Hematologic: Agranulocytosis (some fatal), hemolytic anemia, pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia, leucocytosis

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Side Effects by Body System

General

Omeprazole is generally well tolerated. Any drug which increases gastric pH would be anticipated to stimulate release of gastrin. Animal studies have demonstrated an increase in plasma gastrin concentrations following the administration of omeprazole. In addition, long term animal studies have revealed a dose-related increase in the incidence of gastric enterochromaffin-like (ECL) cell carcinoids. This has given rise to concern regarding the safety of long-term administration of omeprazole in humans. However, to date, long-term human studies of up to six years duration have not found any suggestion of gastric carcinoid formation due to omeprazole use.

In humans, plasma gastrin levels rise within days of initial treatment, generally peaking by 2 to 4 months. The usual increase is 2 to 4 fold over baseline, although some patients experience gastrin levels greater than 10 times normal. Hyperplasia of gastric enterochromaffin-like cells has been observed with long-term use, but no evidence of dysplasia, carcinoid tumors, or other neoplastic changes have been noted in humans.

Gastrointestinal

Gastric polyposis have been reported in three of eleven patients treated with long-term omeprazole therapy (20 to 40 mg daily). Hyperplastic and fundic gland polyps developed in the stomach of these patients. Neither dysplasia nor malignancy was present. The significance of these findings from a small case series is unknown. Controlled studies are needed to fully evaluate this effect.

Ninety-one patients receiving long-term maintenance therapy for gastroesophageal reflux disease were followed for 5 years. Hyperplasia of gastric enterochromaffin-like cells was noted in 20% of patients and atrophic gastritis in 25%. Effects were more pronounced in patients with very high serum gastrin levels. The significance of these observed changes is unknown. No evidence of dysplasia, carcinoid, or other forms of neoplasia were noted.

Gastrointestinal side effects have included diarrhea (3.0% to 3.7%), abdominal pain (2.4%), nausea (2.2% to 4%), vomiting (1.5% to 3.2%), constipation (1.1%), anorexia, irritable colon, flatulence, dry mouth, esophageal candidiasis, and persistent achlorhydria in a Zollinger-Ellison patient. Gastric polyps, hyperplasia of gastric enterochromaffin-like cells, and atrophic gastritis have been reported after long-term therapy. Campylobacter gastroenteritis has been identified in one case-control study.

Rare cases of pancreatitis, some fatal, have been reported during the post marketing period.

Endocrine

Endocrine side effects have included gynecomastia, breast enlargement in females, and breast tenderness.

Hepatic

A 62-year-old man with erosive esophagitis developed signs and symptoms of hepatic disease 17 days after the start of therapy with omeprazole 20 mg per day. Five days after presentation, the patient died from complications associated with fulminant hepatic failure. Autopsy findings included massive central zone necrosis and hemorrhage with proliferation of bile ducts.

Hepatic side effects have included elevations in serum transaminases, alkaline phosphatase, bilirubin, and rare cases of hepatitis and hepatic encephalopathy. Fatal fulminant hepatic failure attributed to omeprazole has also been reported.

Renal

Renal side effects have included elevations in serum creatinine, rare reports of interstitial nephritis, and renal failure.

Hematologic

Hematologic side effects have included rare reports of hemolytic anemia, pancytopenia, thrombocytopenia, neutropenia, anemia, agranulocytosis and leukocytosis.

The absorption of cyanocobalamin (vitamin B12) has been studied before and after administration of omeprazole 20 mg or 40 mg per day for 14 days in ten healthy subjects. Omeprazole produced a dose-dependent reduction in protein-bound cyanocobalamin absorption. Because the effects of long-term omeprazole therapy on cyanocobalamin disposition are unknown, it may be prudent to monitor cyanocobalamin levels in patients receiving long-term omeprazole therapy.

Respiratory

Respiratory side effects have included cough, and rare reports of epistaxis and pharyngeal pain.

A 42-year-old female with postoperative heartburn experienced chronic, persistent cough coincident with omeprazole therapy. The cough was permanent, dry, exhausting, and worsened at night. Omeprazole treatment was continued for 4 months because the persistent cough was thought to be related to gastroesophageal reflux disease. However, no cause of the chronic cough was identified. After omeprazole was discontinued, the cough resolved.

Nervous system

Nervous system side effects have included headache, dizziness, somnolence, vertigo, hemifacial dysesthesia and numbness, paresthesias of the extremities, and a report of reversible gait ataxia.

Cardiovascular

Cardiovascular side effects have been reported rarely. These have included angina, tachycardia, bradycardia, palpitations, hypertension, and peripheral edema.

Dermatologic

Cutaneous leukocytoclastic vasculitis has been reported to occur in a 71-year-old woman. Three weeks after the start of omeprazole 20 mg daily for epigastric pain, patient presented with palpable skin rash on both hands and legs and the abdomen, accompanied with pruritus. Histopathological studies of affected tissue confirmed small vessel vasculitis. Skin lesions completely resolved within a few days after discontinuation of omeprazole treatment.

An 81-year-old female with severe reflux esophagitis experienced dermatomyositis coincident with omeprazole therapy. She presented with a progressive pruritic erythematous eruption which began as a vesicular rash on her dorsal hands and then spread to her face and most of her lower limbs. Three days prior to the onset of skin eruption, she had started omeprazole 40 mg daily. She was diagnosed with dermatomyositis. Omeprazole was replaced with ranitidine and mometasone furoate ointment twice daily was administered for the rash. After 1 week, her rash had also settled significantly with less erythema and edema, particularly over her dorsal hands.

Dermatologic side effects have included rash and rare reports of pruritus, alopecia, dry skin, hyperhidrosis, and cases of disseminated epidermal necrosis, furunculosis, and exfoliative dermatitis. At least one case of vasculitis has been reported, in addition to a case of dermatomyositis.

Hypersensitivity

Hypersensitivity side effects have included urticaria and angioedema. One case report of anaphylaxis upon a second use of omeprazole is documented.

Metabolic

Metabolic side effects have included hypoglycemia, hyponatremia, weight gain, and increased uric acid levels. It has also been reported that omeprazole may cause hypomagnesemia, along with hypocalcemia and hypokalemia.

A case report of omeprazole associated with symptomatic hyponatremia, probably secondary to inappropriate ADH secretion, has been reported.

Two case reports have suggested that omeprazole may rarely cause increased uric acid levels and acute gout attacks.

Two cases of hospitalized patients with refractory chronic hypokalemia and hypocalcemia secondary to hypomagnesemia were resolved after withdrawal of omeprazole.

Psychiatric

Psychiatric side effects have been reported rarely. These have included depression, nervousness, hallucinations, insomnia, anxiety, dream disturbances, and apathy.

Genitourinary

Genitourinary side effects have included impotence and rare reports of urinary tract infection, pyuria, urinary frequency, proteinuria, hematuria, glycosuria, and testicular pain.

Musculoskeletal

Musculoskeletal side effects have included the development of a nonspecific polyarthritis, which appears to resolve after withdrawal of omeprazole. Hip fracture has been reported. At least one case of acute severe myopathy has also been reported.

The risk of hip fracture was significantly increased among patients prescribed long-term high dose PPIs.

A 71-year-old male was admitted to the emergency department complaining of severe epigastric pain. He was administered a single dose of omeprazole 40 mg. After 12 hours, the epigastric pain continued and the patient was hospitalized. Blood analysis at this time showed an increase in creatinine kinase, creatinine kinase isoenzymes, and myoglobin levels, without concomitant symptoms of muscle injury. Omeprazole-induced myopathy was suspected, the drug discontinued, and no other gastrointestinal drugs were given. After one week, he recovered from epigastralgia with a concomitant improvement in laboratory parameters.

Immunologic

Immunologic side effects have been reported rarely. These have included a single case report of an autoimmune disorder with the development of fever, arthralgias, Raynaud's phenomenon, and a positive ANA titer.

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