Last reviewed 2026-04-20 · How we verify

Folic Acid (FOLIC ACID)

Folic acid is a small molecule drug that targets thymidylate synthase, originally developed by Lederle and currently owned by Wyeth Pharmaceuticals. It was FDA-approved in 1946 for various indications, including folic acid deficiency, iron deficiency anemia, and pregnancy. Folic acid is now off-patent with 36 generic manufacturers. It has a bioavailability of 75% and a half-life of 2.6 hours. Key safety considerations include monitoring for adverse effects such as gastrointestinal symptoms and allergic reactions.

At a glance

Approved indications

• Breastfeeding (mother)
• Folic acid deficiency
• Iron deficiency anemia
• Megaloblastic anemia due to folate deficiency
• Mineral Deficiency Prevention
• Mineral deficiency
• Pregnancy, function
• Prevention of Vitamin B12 Deficiency
• Vitamin Deficiency Prevention
• Vitamin deficiency

Common side effects

• Anorexia
• Nausea
• Abdominal distention
• Flatulence
• Bitter or bad taste
• Erythema
• Skin rash
• Itching
• General malaise
• Respiratory difficulty due to bronchospasm
• Anaphylaxis
• Altered sleep patterns

Key clinical trials

• Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
• A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
• A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer (PHASE2)
• Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44) (PHASE2)
• Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial (PHASE2)
• Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations (PHASE3)
• Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study (PHASE3)
• Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial) (PHASE2)

Primary sources

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