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Prilosec (Omeprazole) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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) ]

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).

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, (see also Skin below); 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



REPORTS OF SUSPECTED PRILOSEC SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Prilosec. The information is not vetted and should not be considered as verified clinical evidence.

Possible Prilosec side effects / adverse reactions in 50 year old female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 50 year old female

Reactions: Back Pain, Glaucoma, Respiratory Disorder, Diabetes Mellitus, Pain in Extremity, Pain, Wrong Drug Administered, Impaired Work Ability, Menopause, Blood Glucose Decreased, Road Traffic Accident, Insomnia, Gastrooesophageal Reflux Disease, DRY Eye, Sleep Apnoea Syndrome

Suspect drug(s):
Nexium
    Administration route: Oral

Prilosec
    Administration route: Oral

Other drugs received by patient: 20 Medications



Possible Prilosec side effects / adverse reactions in 35 year old male

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 35 year old male

Reactions: Drug Dose Omission, Dyspepsia, Drug Ineffective, Accident AT Work, Rotator Cuff Syndrome

Suspect drug(s):
Nexium
    Administration route: Oral

Prilosec OTC
    Administration route: Oral

Prilosec
    Administration route: Oral

Protonix



Possible Prilosec side effects / adverse reactions in 92 year old male

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 92 year old male

Reactions: Inappropriate Schedule of Drug Administration, Syncope, Dizziness

Suspect drug(s):
Aspirin
    Indication: Product Used FOR Unknown Indication

Lipitor
    Indication: Product Used FOR Unknown Indication

Avodart
    Dosage: (1 dosage forms, 1 wk), oral
    Administration route: Oral
    Indication: Benign Prostatic Hyperplasia

Prilosec
    Dosage: oral
    Indication: Product Used FOR Unknown Indication

Hydrochlorothiazide
    Dosage: (12.5 mg), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lisinopril
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Coreg
    Indication: Product Used FOR Unknown Indication

Flomax
    Indication: Product Used FOR Unknown Indication

Acetaminophen
    Indication: Product Used FOR Unknown Indication



See index of all Prilosec side effect reports >>

Drug label data at the top of this Page last updated: 2008-03-27

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