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Clinical Trials Experience: 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 clinical practice.
Worldwide, over 10,000 patients have been treated with PREVACID in Phase 2 or Phase 3 clinical trials involving various dosages and durations of treatment. In general, PREVACID treatment has been well-tolerated in both short-term and long-term trials.
The following adverse reactions were reported by the treating physician to have a possible or probable relationship to drug in 1% or more of PREVACID-treated patients and occurred at a greater rate in PREVACID-treated patients than placebo-treated patients in Table 5 (see Table 5).
Click on icon to see table/diagram/imageHeadache was also seen at greater than 1% incidence but was more common on placebo. The incidence of diarrhea was similar between patients who received placebo and patients who received 15 and 30 mg of PREVACID, but higher in the patients who received 60 mg of PREVACID (2.9, 1.4, 4.2, and 7.4%, respectively).
The most commonly reported possibly or probably treatment-related adverse event during maintenance therapy was diarrhea.
In the risk reduction study of PREVACID for NSAID-associated gastric ulcers, the incidence of diarrhea for patients treated with PREVACID, misoprostol, and placebo was 5, 22, and 3%, respectively.
Another study for the same indication, where patients took either a COX-2 inhibitor or lansoprazole and naproxen, demonstrated that the safety profile was similar to the prior study. Additional reactions from this study not previously observed in other clinical trials with PREVACID included contusion, duodenitis, epigastric discomfort, esophageal disorder, fatigue, hunger, hiatal hernia, hoarseness, impaired gastric emptying, metaplasia, and renal impairment.
Combination Therapy with Amoxicillin and Clarithromycin: In clinical trials using combination therapy with PREVACID plus amoxicillin and clarithromycin, and PREVACID plus amoxicillin, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with PREVACID, amoxicillin, or clarithromycin.
Triple Therapy: PREVACID/amoxicillin/clarithromycin: The most frequently reported adverse reactions for patients who received triple therapy for 14 days were diarrhea (7%), headache (6%), and taste perversion (5%). There were no statistically significant differences in the frequency of reported adverse reactions between the 10- and 14-day triple therapy regimens. No treatment-emergent adverse reactions were observed at significantly higher rates with triple therapy than with any dual therapy regimen.
For information about adverse reactions with antibacterial agents (amoxicillin and clarithromycin) indicated in combination with PREVACID, refer to the Undesirable Effects section of their prescribing information.
Laboratory Values: The following changes in laboratory parameters in patients who received PREVACID were reported as adverse reactions: Abnormal liver function tests, increased SGOT (AST), increased SGPT (ALT), increased creatinine, increased alkaline phosphatase, increased globulins, increased GGTP, increased/decreased/abnormal WBC, abnormal AG ratio, abnormal RBC, bilirubinemia, blood potassium increased, blood urea increased, crystal urine present, eosinophilia, hemoglobin decreased, hyperlipemia, increased/decreased electrolytes, increased/decreased cholesterol, increased glucocorticoids, increased LDH, increased/decreased/abnormal platelets, increased gastrin levels and positive fecal occult blood. Urine abnormalities such as albuminuria, glycosuria, and hematuria were also reported. Additional isolated laboratory abnormalities were reported.
In the placebo controlled studies, when SGOT (AST) and SGPT (ALT) were evaluated, 0.4% (4/978) and 0.4% (11/2677) patients, who received placebo and PREVACID, respectively, had enzyme elevations greater than three times the upper limit of normal range at the final treatment visit. None of these patients who received PREVACID reported jaundice at any time during the study.
In clinical trials using combination therapy with PREVACID plus amoxicillin and clarithromycin, and PREVACID plus amoxicillin, no increased laboratory abnormalities particular to these drug combinations were observed.
For information about laboratory value changes with antibacterial agents (amoxicillin and clarithromycin) indicated in combination with PREVACID, refer to the Undesirable Effects section of their prescribing information.
IV: Adverse reactions, including abnormalities in laboratory data, were observed in 31 (14.0%) of 221 patients given lansoprazole at a dose of 30 mg twice a day in clinical trials before approval. Main adverse reactions included abnormal changes in laboratory data such as increased ALT (GPT) (6.2%), AST (GOT) (5.7%), LDH (2.0%), and γ-GTP (1.5%). (At the time of approval).
Adverse reactions, including abnormalities in laboratory data, were observed in 35 (3.1%) of 1,142 patients in the postmarketing investigations. The major adverse reactions were diarrhea, hepatic dysfunction, hepatic disorder, fever and leukocyte count decreased (0.3% each). (As of the end of the reexamination).
Clinically significant adverse reactions (All frequencies unknown): Anaphylactic reactions (generalized rash, facial edema, dyspnea, etc.) may occur, and shock has consequently occurred in certain cases. Therefore, close observation should be made, and if any abnormality is observed, PREVACID I.V. should be discontinued and appropriate measures taken.
Pancytopenia, agranulocytosis or hemolytic anemia may occur. Granulocytopenia, thrombocytopenia or anemia may occur. Therefore, close observation should be made, and if any abnormality is observed, such appropriate measures as discontinuation of PREVACID I.V. should be taken.
Severe hepatic dysfunction with jaundice, increased AST(GOT), ALT(GPT), etc., may occur. Therefore, close observation should be made. If any abnormality is observed, PREVACID I.V. should be discontinued and appropriate measures taken.
Toxic epidermal necrolysis: TEN and oculomucocutaneous syndrome (Stevens-Johnson syndrome) may occur. Therefore, close observation should be made. If any abnormality is observed, PREVACID I.V. should be discontinued and appropriate measures taken.
Interstitial pneumonia may occur. Therefore, if fever, coughing, dyspnea, abnormal lung sound (crepitation), etc., are observed, such examinations as chest X-ray should immediately be performed, and PREVACID I.V. should be discontinued. Appropriate measures, such as treatment with a corticosteroid preparation, should be taken.
Interstitial nephritis may occur, resulting in acute renal failure in some cases. Therefore, pay attention to renal function test values (increases in BUN, creatinine, etc), and if any abnormality is observed, PREVACID I.V. should be discontinued and appropriate measures taken.
Clinically significant adverse reactions (similar drug): The following adverse reactions are reported in a similar drug (Omeprazole).
Visual disturbance may occur. Therefore, if any abnormality is observed, PREVACID I.V. should be discontinued and appropriate measures taken.
Other adverse reactions: See Table 6.
Click on icon to see table/diagram/imagePostmarketing Experience: Tablet: Additional adverse experiences have been reported since PREVACID has been marketed. The majority of these cases are foreign-sourced and a relationship to PREVACID has not been established. Because these reactions were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events are listed as follows by COSTART body system.
Body as a Whole: anaphylactic/anaphylactoid reactions, systemic lupus erythematosus.
Digestive System: hepatotoxicity, pancreatitis, vomiting.
Hemic and Lymphatic System: agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura.
Infections and Infestations: Clostridium difficile associated diarrhea.
Metabolism and Nutritional Disorders: hypomagnesemia.
Musculoskeletal System: bone fracture, myositis.
Skin and Appendages: severe dermatologic reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal), cutaneous lupus erythematosus.
Special Senses: speech disorder.
Urogenital System: interstitial nephritis, urinary retention.
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