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
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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
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