FDA label 6865c320-501a-47ec-8284-742030bdf928

WARNINGS Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient.

ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parental administration of folic acid. Folic acid is relatively nontoxic in man. Rare instances of allergic responses to folic acid preparations have been reported and have included erythema, skin rash, itching, general malaise, and respiratory difficulty due to bronchospasm. One patient experienced symproms suggesting anaphylaxis following injection of the drug. Gastrointestinal side effects, including anorexia, nausea, abdominal distention, flatullence, and a bitter or bad taste, have been reported in patients receiving 15 mg of folic acid daily for 1 month. Other side effects reported in patients receiving 15 mg daily include altered sleep patterns, difficulty in concentrating, irritability, over-activity, excitement, mental depression, confusion, and impaired judgment. Decreased vitamin B 12 serum levels may occur in patients receiving prolonged folic acid therapy In an uncontrolled study, orally administered folic acid was reported to increase the incidence of seizures in some epileptic patients receiving phenobarbital, primidone, or diphenythdantoin. Another investigator reported decreased diphenythydantoin serum levels in folate-deficient patients receiving diphenythydantoin who were treated with 5mg or 15mg of folic acid daily. To report SUSPECTED ADVERSE REACTIONS, contact Blu Pharmaceuticals at 1-877-264-0258, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .