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warnings and cautions
5 WARNINGS AND PRECAUTIONS Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurologic manifestations remain progressive. This may result in severe nervous system damage before the correct diagnosis is made. ( 5.1 ) 5.1 Risk of Obscuring Diagnosis of Pernicious Anemia The use of single-agent FOLIC ACID oral solution (without the use of vitamin B12) is not recommended for the treatment of pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurologic manifestations remain progressive. There is a potential danger in administering folic acid to patients with undiagnosed anemia, since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B 12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Risk of Obscuring Diagnosis of Pernicious Anemia [see Warnings and Precautions (5.1) ] The following adverse reactions associated with the use of folic acid were identified in clinical studies or post marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse Reactions: Hypersensitivity reactions including rash, itching, malaise, and bronchospasm. Gastrointestinal reactions (nausea, anorexia, abdominal distension, flatulence, dysgeusia) Neurological reactions (altered sleep patterns, difficulty concentrating, irritability, overactivity, excitement, depression, confusion, impaired judgement) Decreased vitamin B 12 serum levels (with prolonged folic acid therapy). Increased seizures in patients with epilepsy receiving phenobarbital, primidone, or diphenylhydantoin The most common adverse reactions are nausea, anorexia, and bloating. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Ayurax, LLC at 1-844-551-9911 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.