pharmacopeia
GET
/api/v1/drug/folic-acid
2D structure
(2S)-2-[[4-[(2-amino-4-oxo-3H-pteridin-6-yl)methylamino]benzoyl]amino]pentanedioic acid
SMILES C1=CC(=CC=C1C(=O)N[C@@H](CCC(=O)O)C(=O)O)NCC2=CN=C3C(=N2)C(=O)NC(=N3)N
InChIKey OVBPIULPVIDEAO-LBPRGKRZSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Enzyme Interactions.

Indications

Sourced from openFDA
  • Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.

Contraindications

Sourced from openFDA
  • Folic acid is contraindicated in patients who have shown previous intolerance to the drug.contraindicated

Dosage & administration

Sourced from openFDA

Oral administration is preferred. Although most patients with malabsorption cannot absorb food folates, they are able to absorb folic acid given orally. Parenteral administration is not advocated but may be necessary in some individuals (e.g., patients receiving parenteral or enteral alimentation). Doses greater than 0.1 mg should not be used unless anemia due to vitamin B 12 deficiency has been ruled out or is being adequately treated with a cobalamin. Daily doses greater than 1 mg do not enhance the hematologic effect, and most of the excess is excreted unchanged in the urine. The usual therapeutic dosage in adults and children (regard less of age) is up to 1 mg daily. Resistant cases may require larger doses. When clinical symptoms have subsided and the blood picture has become normal, a daily maintenance level should be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under 4 years of age, 0.4 mg for adults and children 4 or more years of age, and 0.8 mg for pregnant and lactating women, but never less than 0.1 mg/day. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent. In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased.

Warnings & precautions

Sourced from openFDA

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

Adverse reactions

Sourced from openFDA

Allergic sensitization has been reported following both oral and parenteral 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 symptoms suggesting anaphylaxis following injection of the drug. Gastrointestinal side effects, including anorexia, nausea, abdominal distention, flatulence, and a bitter or bad taste, have been reported in patients receiving 15 mg folic acid daily for 1 month. Other side effects reported in patients receiving 15 mg daily include altered sleep patterns, difficulty in concentrating, irritability, overactivity, 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 diphenylhydantoin. Another investigator reported decreased diphenylhydantoin serum levels in folate-deficient patients receiving diphenylhydantoin who were treated with 5 mg or 15 mg of folic acid daily.

Overdosage

Sourced from openFDA

Except during pregnancy and lactation, folic acid should not be given in therapeutic doses greater than 0.4 mg daily until pernicious anemia has been ruled out. Patients with pernicious anemia receiving more than 0.4 mg of folic acid daily who are inadequately treated with vitamin B 12 may show reversion of the hematologic parameters to normal, but neurologic manifestations due to vitamin B 12 deficiency will progress. Doses of folic acid exceeding the Recommended Dietary Allowance (RDA) should not be included in multivitamin preparations; if therapeutic amounts are necessary, folic acid should be given separately.

Approval history

Sourced from openFDA
  • Feb 18, 1986ANDAANDA089202Fresenius Kabi Usa
  • Feb 21, 2001NDANDA021265Sandoz Canada Inc
  • Jul 21, 2005ANDAANDA040625Amneal Pharm
  • Jan 12, 2009ANDAANDA040796Leading
  • Jun 9, 2009ANDAANDA090035Chartwell Molecular
  • Jul 12, 2013ANDAANDA091145Aiping Pharm Inc
  • Jan 27, 2014ANDAANDA202437Cadila Pharms Ltd
  • Jan 26, 2026NDANDA216395Solubiomix

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
246,867 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective25,05310%
  2. 2Fatigue23,7589.6%
  3. 3Pain23,4619.5%
  4. 4Arthralgia19,7978.0%
  5. 5Off Label Use17,7407.2%
  6. 6Rheumatoid Arthritis17,7177.2%
  7. 7Nausea15,9456.5%
  8. 8Diarrhoea14,5055.9%
  9. 9Headache14,4755.9%
  10. 10Rash13,8305.6%
  11. 11Dyspnoea13,5095.5%
  12. 12Abdominal Discomfort11,8424.8%
  13. 13Alopecia11,8194.8%
  14. 14Joint Swelling11,6864.7%
  15. 15Condition Aggravated11,3324.6%

Literature

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Recent PubMed references pinned to Folic Acid as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 2,663 ClinicalTrials.gov registrations naming Folic Acid as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Folic Acid work?
Mechanism-of-action class: Enzyme Interactions.
What is Folic Acid used for?
According to FDA labeling, Folic Acid carries indications including: Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Folic Acid?
Folic Acid is classified as Folic acid and derivatives, Other diagnostic agents, Enzyme Interactions, Cellular Activity Alteration.
What are the brand names for Folic Acid?
Folic Acid is marketed under brand names including Animi-3 with Vitamin D, Concept OB, Dialyvite 800, Dialyvite 800 with Iron, Dialyvite 800 with Zinc, Encora AM Tablet, Encora PM Tablet, Ferocon.
What are the contraindications for Folic Acid?
Folic Acid labeling lists contraindications including: Folic acid is contraindicated in patients who have shown previous intolerance to the drug.. Always consult the full prescribing information and a clinician.
Note. Data for folic-acid is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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