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Vitamin B2 (riboflavin): Drug information

Vitamin B2 (riboflavin): Drug information
(For additional information see "Vitamin B2 (riboflavin): Patient drug information" and see "Vitamin B2 (riboflavin): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • B-2-400 [OTC]
Pharmacologic Category
  • Vitamin, Water Soluble
Dosing: Adult
Dietary supplement

Dietary supplement: Oral: 100 mg once or twice daily.

Migraine, prevention

Migraine, prevention (alternative agent) (off-label use):

Note: An adequate trial for assessment of effect is considered to be at least 2 to 3 months at a therapeutic dose (EHF [Steiner 2019]).

Oral: 400 mg once daily (Rahimdel 2015; Schoenen 1998).

Dosing: Pediatric

(For additional information see "Vitamin B2 (riboflavin): Pediatric drug information")

Dietary supplement

Dietary supplement: Infants, Children, and Adolescents: A multivitamin preparation is most commonly used for the provision of riboflavin supplementation in pediatric patients; the use of a single-ingredient riboflavin product as a daily supplement for the prevention of deficiency in pediatric patients is very rare. If single-ingredient riboflavin supplement is necessary, consult product labeling for appropriateness of product in infants and young children in particular.

Migraine headache, prevention

Migraine headache, prevention: Limited data available, efficacy results variable: Children ≥ 8 years and Adolescents: Oral: 200 to 400 mg once daily; dosing based on a retrospective study of 41 patients (ages 8 to 18 years) who received 200 mg/day (n=21) or 400 mg/day (n=20) as prophylaxis for migraine and migraine-type headaches; results showed significant reduction in primary endpoint of frequency of headache attack; 68.4% of patients had a ≥50% decrease in headache frequency during treatment (Condò 2009). However, in a prospective, placebo-controlled study of 48 patients (ages 5 to 15 years), patients received 200 mg/day (n=27) or placebo (n=21) and in the treatment group (riboflavin) no benefit compared to placebo for migraine frequency or intensity was observed; a high placebo responder rate was also reported (MacLennan 2008).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

B-2-400: 400 mg

Generic: 50 mg [DSC]

Tablet, Oral:

Generic: 25 mg, 50 mg, 100 mg

Generic Equivalent Available: US

Yes

Administration: Adult

Oral: Administer with food.

Administration: Pediatric

Oral: Administer with food

Use: Labeled Indications

Dietary supplement

Use: Off-Label: Adult

Migraine, prevention

Medication Safety Issues
Sound-alike/look-alike issues:

Riboflavin may be confused with ribavirin

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not defined: Genitourinary: Urine discoloration (yellow-orange)

Warnings/Precautions

Other warnings/precautions:

• Vitamin deficiency: Single vitamin deficiency is rare; evaluate for other deficiencies.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Water-soluble vitamins cross the placenta. Riboflavin requirements may be increased in patients who are pregnant (IOM 1998).

Breastfeeding Considerations

Riboflavin is found in breast milk. Concentrations may be influenced by supplements or maternal deficiency. Riboflavin requirements may be increased in patients who are breastfeeding (IOM 1998).

Dietary Considerations

Dietary sources of riboflavin include liver, kidney, dairy products, green vegetables, eggs, whole grain cereals, yeast, and mushroom.

Dietary reference intake (IOM 1998):

1 to 6 months: Adequate intake: 0.3 mg/day

7 to 12 months: Adequate intake: 0.4 mg/day

1 to 3 years: RDA: 0.5 mg

4 to 8 years: RDA: 0.6 mg

9 to 13 years: RDA: 0.9 mg

14 to 18 years: RDA: Females: 1 mg; Males: 1.3 mg

≥19 years: RDA: Females: 1.1 mg; Males: 1.3 mg

Pregnancy: RDA: 1.4 mg

Lactation: RDA: 1.6 mg

Mechanism of Action

Component of flavoprotein enzymes that work together, which are necessary for normal tissue respiration; also needed for activation of pyridoxine and conversion of tryptophan to niacin

Pharmacokinetics

Absorption: Readily via GI tract; increased with food

Metabolism: Hepatic

Half-life, biologic: 66 to 84 minutes

Excretion: 9% eliminated unchanged in urine

Pricing: US

Capsules (B-2-400 Oral)

400 mg (per each): $0.16

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Arcavit-B2 (AT);
  • B2-ASmedic (DE);
  • Beflavine (FR);
  • Berivine (LU);
  • Bi-Love-G (JP);
  • Bisanorin (JP);
  • Bisulase (JP);
  • Bituvitan (JP);
  • Bonabon B!2 (JP);
  • Butirid (JP);
  • Dalivit (BR);
  • Eyekas (JP);
  • Flavitol (AT);
  • Hibon (JP);
  • Lacflavin (JP);
  • Liperox (AR);
  • Multiscleran (DE);
  • Ribobis (JP);
  • Ribobutin (JP);
  • Ribon (LU);
  • Riboract (JP);
  • Vita-B2 (FI, PL);
  • Vitamin B2 (PE);
  • Vitamin B2 Jenapharm (DE);
  • Vitamin B2 Jenapharm[inj.] (DE);
  • Vitamin B2 Streuli[Ampullen] (CH);
  • Vitamin B2 Streuli[Tab.] (CH);
  • Vitamin B2-Injektopas (DE);
  • Vitaminum B2 (PL);
  • Wakaflavin-L (JP);
  • Werdo (DE)


For country code abbreviations (show table)
  1. Condò M, Posar A, Arbizzani A, Parmeggiani A. Riboflavin prophylaxis in pediatric and adolescent migraine. J Headache Pain. 2009;10(5):361-365. [PubMed 19649688]
  2. Holland S, Silberstein SD, Freitag F, et al. Evidence-based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012;78(17):1346-1353. [PubMed 22529203]
  3. IOM (Institute of Medicine), "Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline," Washington, DC: The National Academies Press, 1998.
  4. MacLennan SC, Wade FM, Forrest KM, Ratanayake PD, Fagan E, Antony J. High-dose riboflavin for migraine prophylaxis in children: a double-blind, randomized, placebo-controlled trial. J Child Neurol. 2008;23(11):1300-1304. [PubMed 18984840]
  5. Powers HJ, "Riboflavin (Vitamin B-2) and Health," Am J Clin Nutr, 2003, 77(6):1352-60. [PubMed 12791609]
  6. Pringsheim T, Davenport W, Mackie G, et al. Canadian Headache Society guideline for migraine prophylaxis. Can J Neurol Sci. 2012;39(2 Suppl 2):S1-S59. [PubMed 22683887]
  7. Rahimdel A, Zeinali A, Yazdian-Anari P, Hajizadeh R, Arefnia E. Effectiveness of Vitamin B2 versus Sodium Valproate in Migraine Prophylaxis: a randomized clinical trial. Electron Physician. 2015;7(6):1344-1348. [PubMed 26516440]
  8. Riboflavin vitamin B-2 tablets [prescribing information]. Vandalia, OH: Basic Drugs, Inc.
  9. Schoenen J, Jacquy J, Lenaerts M. Effectiveness of high-dose riboflavin in migraine prophylaxis. A randomized controlled trial. Neurology. 1998;50(2):466-470. [PubMed 9484373]
  10. Steiner TJ, Jensen R, Katsarava Z, et al. Aids to management of headache disorders in primary care (2nd edition): on behalf of the European Headache Federation and Lifting The Burden: the Global Campaign Against Headache. J Headache Pain. 2019;20(1):57. doi:10.1186/s10194-018-0899-2 [PubMed 31113373]
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