Pantoprazole: The most frequently occurring adverse reactions, occuring at a rate of > 2%, in
patients on oral pantoprazole (20 mg or 40 mg) were headache, diarrhea, nausea, abdominal pain,
vomiting, flatulence, dizziness and arthralgia.
Additional adverse reactions that were reported for pantoprazole with a frequency of ≤ 2% were
allergic reaction, pyrexia, photosensitivity reaction, facial edema, constipation, dry mouth, hepatitis,
leukopenia, thrombocytopenia, elevated CK (creatine kinase), generalized edema, elevated
triglycerides, elevated liver enzymes, myalgia, depression, vertigo, urticaria, rash, pruritus and
blurred vision.
In patients ages 1 year through 16 years, the most commonly reported (> 4%) adverse reactions
included URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain.
Additional adverse reactions reported for pantoprazole in pediatric patients with a frequency of ≤ 4%
were allergic reaction, facial edema, constipation, flatulence, nausea, elevated triglycerides, elevated
liver enzymes, elevated CK (creatine kinase), arthralgia, myalgia, dizziness, vertigo and urticaria.
Adverse reactions not reported in pediatric patients but are considered relevant to pediatric patients
are photosensitivity reaction, dry mouth, hepatitis, thrombocytopenia, generalized edema,
depression, pruritus, leukopenia, and blurred vision.
Adverse reactions identified during postapproval use of pantoprazole were asthenia, fatigue, malaise,
pancytopenia, agranulocytosis, anaphylaxis (including anaphylactic shock), Clostridium difficile
associated diarrhea, weight changes, hyponatremia, hypomagnesemia, severe dermatologic
reactions (some fatal), including erythema multiforme, Stevens-Johnson syndrome, and toxic
epidermal necrolysis (TEN, some fatal), and angioedema (Quincke’s edema), rhabdomyolysis, bone
fracture, ageusia, dysgeusia, interstitial nephritis, hepatocellular damage leading to jaundice and
hepatic failure, hallucination and confusion, insomnia, and somnolence.
Although no significant drug-drug interactions have been observed in clinical studies, the potential for
significant drug-drug interactions with more than once-daily dosing with high doses of pantoprazole
has not been studied in poor metabolizers or individuals who are hepatically impaired
Levosulpiride: With prolonged administration of levosulpiride, disturbances such as amenorrhea,
gynecomastia, galactorrhea, hyperprolactinemia and changes in libido are observed; in particular
cases, reversible effects of levosulpiride on functioning of hypothalamic pituitary gonadal axis are
observed.
