pharmacopeia
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/api/v1/drug/beta-carotene

Boxed warning

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately.

Indications

Sourced from openFDA
  • USAGE: Vitafol ® Fe + prenatal supplement provides vitamin, mineral and omega-3 fatty acid supplementation throughout pregnancy, including individuals with known allergies to fish.* Vitafol ® Fe + does not contain fish oils, fish proteins, or fish by-products.

Contraindications

Sourced from openFDA
  • Vitafol ® Fe + prenatal supplement is contraindicated in patients with hypersensitivity to any of its components or color additives. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid.contraindicated

Dosage & administration

Sourced from openFDA

Take one softgel capsule by mouth daily during pregnancy, or as directed by a physician.

Warnings & precautions

Sourced from openFDA

WARNINGS/PRECAUTIONS: This product is intended for use as directed by your healthcare provider. Do not share with others. Vitafol ® Fe + must be used with caution in patients with known sensitivity or allergy to soy. Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur. Iodine should be used with caution in patients with an overactive thyroid. Prolonged use of iron salts may produce iron storage disease. Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency. Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding. Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended. Avoid Overdosage. Keep out of the reach of children. DRUG INTERACTIONS Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism.

Adverse reactions

Sourced from openFDA

Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol ® Fe + . However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems. You should call your doctor for medical advice about adverse or unexpected reactions. To report to the company an adverse event or obtain product information, call 1-877-324-9349.

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.
0 total reports matchedShare = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Premature Delivery20—
  2. 2Maternal Exposure During Pregnancy11—
  3. 3Foetal Exposure During Pregnancy8—
  4. 4Abortion Spontaneous7—
  5. 5Congenital Anomaly7—
  6. 6Exposure During Pregnancy7—
  7. 7Fatigue7—
  8. 8Inappropriate Schedule Of Product Administration7—
  9. 9Pain7—
  10. 10Drug Exposure During Pregnancy6—
  11. 11Nausea6—
  12. 12Nasopharyngitis5—
  13. 13Anxiety4—
  14. 14Atrial Septal Defect4—
  15. 15Diarrhoea4—

Literature

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Recent PubMed references pinned to Beta Carotene 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 115 ClinicalTrials.gov registrations naming Beta Carotene as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

What is Beta Carotene used for?
According to FDA labeling, Beta Carotene carries indications including: USAGE: Vitafol ® Fe + prenatal supplement provides vitamin, mineral and omega-3 fatty acid supplementation throughout pregnancy, including individuals with known allergies to fish.* Vitafol ® Fe + does not contain fish oils, fish proteins, or fish by-products.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Beta Carotene?
Beta Carotene is classified as Protectives against UV-radiation for systemic use, Vitamin A, plain.
What are the brand names for Beta Carotene?
Beta Carotene is marketed under brand names including B-Caro-T, Macuvite with Lutein, Ocuvite, PreserVision.
What are the contraindications for Beta Carotene?
Beta Carotene labeling lists contraindications including: Vitafol ® Fe + prenatal supplement is contraindicated in patients with hypersensitivity to any of its components or color additives. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid.. Always consult the full prescribing information and a clinician.
Note. Data for beta-carotene 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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