Lansoprazole (Prevacid) Adverse Reactions
- abdominal pain
- agranulocytosis
- alopecia
- anaphylactoid reactions
- anemia
- aplastic anemia
- cholelithiasis
- constipation
- diarrhea
- elevated hepatic enzymes
- erythema multiforme
- gynecomastia
- headache
- hemolysis
- hemolytic anemia
- hepatitis
- hyperbilirubinemia
- jaundice
- leukopenia
- nausea/vomiting
- neutropenia
- pancreatitis
- pancytopenia
- pernicious anemia
- pruritus
- rash (unspecified)
- Stevens-Johnson syndrome
- thrombocytopenia
- thrombotic thrombocytopenic purpura (TTP)
- toxic epidermal necrolysis
- urticaria
- vitamin B12 deficiency
Lansoprazole (Prevacid) Adverse Reactions
The safety profile of lansoprazole is similar in adults and children 1 - 11 years old. Adverse reactions reported during lansoprazole clinical trials were mild and primarily related to the GI tract. The most frequent adverse reactions (> 1%) in adults which occurred at a greater frequency than placebo included: diarrhea (3.6% vs 2.6%), abdominal pain (1.8% vs 1.3%), and nausea/vomiting (1.5% vs 1.3%). The incidence of diarrhea was dose-related. At a daily dose of 60 mg of lansoprazole, 7.4% of patients experienced diarrhea compared with 1.4% at 15 mg/day and 4.2% at 15 mg/day (2.9% incidence in the placebo group). In children 1 - 11 years old, the most frequent side effect was constipation (5%). Other GI adverse events occurring infrequently (< 1%) in lansoprazole-treated patients during clinical trials or post-marketing experience and included: melena, anorexia, bezoar, constipation, xerostomia, dyspepsia, dysphagia, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundic gland polyps, gastroenteritis, gastrointestinal hemorrhage, hematemesis, increased appetite, increased salivation, rectal hemorrhage, stomatitis, tenesmus, and ulcerative colitis.
Headache was reported in > 1% of patients taking lansoprazole, but a higher percentage of patients taking placebo reported headache. During GERD trials with lansoprazole in pediatric patients, the frequency of headache in children 1 - 11 years old was 3%.
Hepatitis and/or jaundice have been associated with PPIs. Specifically, cholelithiasis (<1%), hepatoxicity (post-marketing data), hyperbilirubinemia, and elevated hepatic enzymes (increased AST and ALT) have been reported during lansoprazole therapy. In controlled clinical trials, 0.4% (1/250) placebo patients and 0.3% (2/795) lansoprazole patients had hepatic enzyme elevations > 3 times the upper limit of the normal range at the end of the study, but without evidence of jaundice. Pancreatitis has been reported post-marketing, but causal association and frequency are unknown.
Infrequent hematological reactions have been associated with lansoprazole therapy (<1%). These reactions have included agranulocytosis, anemia, aplastic anemia, hemolysis, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura (TTP). Generally, long-term (e.g., > 3 years) treatment with acid-suppressing agents can lead to malabsorption of vitamin B12 (cyanocobalamin). In a study of healthy volunteers, it was shown that omeprazole caused a significant reduction in cyanocobalamin absorption (vitamin B12 deficiency). Although clinical data in lansoprazole is lacking, it may be prudent to monitor patients for signs of pernicious anemia. Neurological manifestations of pernicious anemia can occur in the absence of hematologic changes.
Allergic reactions, including rash (unspecified) and anaphylactoid reactions, have been reported infrequently with PPI therapy including lansoprazole (<1%). Specific dermatological reactions reported in < 1% of lansoprazole-treated patients included: acne, alopecia, pruritus, rash, and urticaria. Severe dermatological reactions reported during post-marketing experience include: erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (some fatal).
Gynecomastia was reported in < 1% of patients receiving lansoprazole.
Significant elevations in serum gastrin have been reported with lansoprazole and is consistent with the effects of other PPIs; this effect may be dose-related. Although not specifically studied in patients receiving lansoprazole, the risk of carcinoid tumors during therapy with proton pump inhibitors is low based on cumulative safety experience. Monitoring of serum gastrin levels during PPI therapy is generally not necessary.
Other infrequent (< 1%) or rare adverse experiences reported without regard to causality are detailed in the prescribing information for lansoprazole.
[ Last revised: 3/12/2004 4:52:00 PM ]
References
. Marcuard SP, Albernaz L, Khazanie PG. Omeprazole therapy causes malabsorption of cyanocobalamin (vitamin B12). Ann Intern Med 1994;120:211 - 5.
. Reilly JP. Safety profile of the proton-pump inhibitors. Am J Health-Syst Pharm 1999;56(Suppl 4):S11 - 7.
Related entries
Monthly Archives
Syndicate
Allergies
