pharmacopeia
GET
/api/v1/drug/ascorbic-acid

Mechanism of action

Sourced from openFDA

The exact mechanism of action of ascorbic acid for the treatment of symptoms and signs of scurvy (a disorder caused by severe deficiency in vitamin C) is unknown; however, administration of ascorbic acid in patients with scurvy is thought to restore the body pool of ascorbic acid.

Indications

Sourced from openFDA
  • Ascorbic acid injection is indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients, age 5 months and older, for whom oral administration is not possible, insufficient or contraindicated. Limitations of Use Ascorbic acid injection is not indicated for the treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy.

Contraindications

Sourced from openFDA
  • None. None.contraindicated

Dosage & administration

Sourced from openFDA

• Supplied in a Pharmacy Bulk Package (PBP). Dispense single doses to multiple patients in a pharmacy admixture program; use within 4 hours of puncture. ( 2.1 ) • Must be diluted prior to use ( 2.1 ) • Administer as a slow intravenous infusion ( 2.1 ) • See Full Prescribing Information for important administration instructions ( 2.1 ) • Maximum recommended duration is one week ( 2.2 ) Population ( 2.2 ) Recommended Doses Pediatric patients age 5 months to less than 12 months 50 mg once daily Pediatric patients age 1 year to less than 11 years 100 mg once daily Adults and pediatric patients age 11 years and older 200 mg once daily Specific Populations ( 2.3, 8.1, 8.2 ) Pregnant women, lactating women, patients with glucose-6-phosphate dehydrogenase deficiency Should not exceed the U.S. Recommended Dietary Allowance (RDA) 2.1 Important Preparation and Administration Instructions • Ascorbic acid injection vials contain 25,000 mg of ascorbic acid and the largest recommended single dose is 200 mg. Do not give the entire contents of the vial to a single patient. • Do not administer ascorbic acid injection as an undiluted intravenous injection. • Minimize exposure to light because ascorbic acid injection is light sensitive. • Ascorbic acid injection is supplied as a Pharmacy Bulk Package (PBP) which is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion: a. Use only in a suitable ISO Class 5 work area such as a laminar flow hood (or an equivalent clean air compounding area).

Warnings & precautions

Sourced from openFDA

• Oxalate nephropathy and Nephrolithiasis : Ascorbic acid has been associated with development of acute or chronic oxalate nephropathy following prolonged use of high doses of ascorbic acid infusion. Patients with renal disease including renal impairment, history of oxalate kidney stones, geriatric patients, and pediatric patients less than 2 years old may be at increased risk ( 5.1 ). • Hemolysis : Patients with glucose-6-phosphate dehydrogenase deficiency are at risk of severe hemolysis; a reduced dose is recommended ( 5.2 ). • Laboratory Test Interference: Ascorbic acid may interfere with laboratory tests based on oxidation-reduction reactions, including blood and urine glucose testing ( 5.3 ). 5.1 Oxalate Nephropathy and Nephrolithiasis Acute and chronic oxalate nephropathy have been reported with prolonged administration of high doses of ascorbic acid. Acidification of the urine by ascorbic acid may cause precipitation of cysteine, urate or oxalate stones. Patients with renal disease including renal impairment, history of oxalate kidney stones, and geriatric patients may be at increased risk for oxalate nephropathy while receiving treatment with ascorbic acid. Pediatric patients less than 2 years of age may be at increased risk for oxalate nephropathy during treatment with ascorbic acid because their kidneys are immature [see Use in Specific Populations (8.4, 8.5, 8.6) ] . Monitor renal function in patients at increased risk receiving ascorbic Acid Injection.

Adverse reactions

Sourced from openFDA

The following adverse reactions are discussed in greater detail in other sections of the labeling: • Oxalate nephropathy and Nephrolithiasis [see Warnings and Precautions (5.1) ]. • Hemolysis in patients with glucose-6-phosphate dehydrogenase deficiency [see Warnings and Precautions (5.2) ]. The following adverse reactions associated with the use of ascorbic acid were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure: Administration site reactions: pain and swelling. Ascorbic acid injection should not be rapidly administered. Rapid intravenous administration (>250 mg/minute) of ascorbic acid injection may cause temporary faintness or nausea, lethargy, flushing, dizziness, and headache (the recommended infusion rates of diluted ascorbic acid injection solution are 1.3 mg/minute (Pediatric Patients age 5 months to less than 12 months), 3.3 mg/minute (Pediatric Patients age 1 year to less than 11 years) and 33 mg/minute (Adults and Pediatric Patients 11 years and older) [see Dosage and Administration (2.2) ]). Acute and chronic oxalate nephropathy have occurred with prolonged administration of high doses of ascorbic acid [see Warnings and Precautions (5.1) ]. In patients with glucose-6-phosphate dehydrogenase deficiency, severe hemolysis has occurred [see Warnings and Precautions (5.2) ].

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary There are no available data on use of ascorbic acid injection in pregnant women to inform a drug-associated risk of adverse developmental outcomes; however, use of ascorbic acid (vitamin C) has been used during pregnancy for several decades and no adverse developmental outcomes are reported in the published literature [see Data]. There are dose adjustments for ascorbic acid (vitamin C) use during pregnancy [see Clinical Considerations]. Animal reproduction studies have not been conducted with ascorbic acid injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Dose Adjustments During Pregnancy and Post-Partum Period Follow the U.S. Recommended Dietary Allowances (RDA) for pregnant women when considering use of Ascorbic acid injection for treatment of scurvy [see Dosage and Administration (2.3)]. Data Human Data There are no available data on use of ascorbic acid injection or another ascorbic acid injection in pregnant women.

Pharmacokinetics

Sourced from openFDA
Metabolism
In a single pharmacokinetic study, healthy male and female adults (n=8) were given a single intravenous dose of 1000 mg ascorbic acid (5 times the largest recommended single dose) infused over a 30 minute period. The mean peak exposure to ascorbic acid was 436.2 μM and occurred at the end of the 30 minute infusion.

Overdosage

Sourced from openFDA

Overdose with ascorbic acid may cause nausea, vomiting, diarrhea, facial flushing, rash, headache, fatigue or disturbed sleep. If overdose of ascorbic acid injection occurs, immediately discontinue administration and treat symptoms and signs of overdose, avoiding additional intake of ascorbic acid.

Approval history

Sourced from openFDA
  • Feb 21, 2001NDANDA021265Sandoz Canada Inc
  • Aug 2, 2006NDANDA021881Salix Pharms
  • Jan 25, 2012ANDAANDA090145Novel Labs Inc
  • Oct 2, 2017NDANDA209112Mcguff
  • May 4, 2018NDANDA209381Salix
  • Aug 7, 2025ANDAANDA217131Fresenius Kabi Usa
  • Apr 9, 2026ANDAANDA210273Apotex
  • Apr 9, 2026ANDAANDA210672Apotex

FAERS reports

View JSON
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.
28,307 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. 1Nausea2,5729.1%
  2. 2Fatigue2,5479.0%
  3. 3Pain2,3288.2%
  4. 4Vomiting2,2197.8%
  5. 5Diarrhoea2,1827.7%
  6. 6Drug Ineffective2,0747.3%
  7. 7Headache2,0357.2%
  8. 8Dyspnoea1,8976.7%
  9. 9Asthenia1,6825.9%
  10. 10Off Label Use1,6445.8%
  11. 11Dizziness1,5635.5%
  12. 12Rash1,5045.3%
  13. 13Arthralgia1,3824.9%
  14. 14Pyrexia1,3064.6%
  15. 15Pruritus1,2754.5%

Literature

View JSON

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

Clinical trials

View JSON

The 10 most recently updated of 1,211 ClinicalTrials.gov registrations naming Ascorbic Acid as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

View JSON

CPIC-curated drug–gene pairs for Ascorbic Acid. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Frequently asked questions

How does Ascorbic Acid work?
The exact mechanism of action of ascorbic acid for the treatment of symptoms and signs of scurvy (a disorder caused by severe deficiency in vitamin C) is unknown; however, administration of ascorbic acid in patients with scurvy is thought to restore the body pool of ascorbic acid.
What is Ascorbic Acid used for?
According to FDA labeling, Ascorbic Acid carries indications including: Ascorbic acid injection is indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients, age 5 months and older, for whom oral administration is not possible, insufficient or contraindicated. Limitations of Use Ascorbic acid injection is not indicated for the treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Ascorbic Acid?
Ascorbic Acid is classified as Ascorbic acid (vitamin C), plain, Organic acids, Other ophthalmologicals, Vitamin C, Enzyme Interactions, Free Radical Scavenging Activity, Cellular Activity Alteration.
What are the brand names for Ascorbic Acid?
Ascorbic Acid is marketed under brand names including Ascor, C-Time, Cemill 1000, Concept OB, Dialyvite 800, Dialyvite 800 with Iron, Dialyvite 800 with Zinc, Ferocon.
What are the contraindications for Ascorbic Acid?
Ascorbic Acid labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.
Note. Data for ascorbic-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.

Search pharmacopeia

Search drugs, classes, and ingredients