Home Ingredients Troxerutin (Oxerutins)

Troxerutin (Oxerutins)

Evidence Level
Moderate
8 Clinical Trials
4 Documented Benefits
3/5 Evidence Score

Troxerutin and oxerutins are mixtures of O-(beta-hydroxyethyl)-rutosides, made by chemically modifying rutin, a flavonoid found in apples, citrus fruits and cranberries. Oxerutins are the standardized mixture sold as Venoruton, Paroven and Relvène; troxerutin is a related mixture with a different make-up. In the UK, oxerutin capsules are a prescription-only medicine. In 2000, FDA answered a notification to sell troxerutin as a new dietary ingredient by saying the safety information was inadequate. Almost all trials enrolled people with leg vein problems, and several key ones were written by staff of the maker. Pooled analyses found less leg heaviness, cramps and swelling than with placebo, on top of a large placebo response, while some trials found no effect. Two studies in healthy people measured less leg swelling after standing still or long flights. Leg swelling from heart, kidney or liver disease needs medical care.

Studied Dose Most trials used 1,000 mg/day of oxerutins (500 mg twice daily), the UK licensed dose; others used 900 to 1,200 mg/day for up to 6 months, or 2 g/day for 3 days around a long flight. A head-to-head trial used 900 mg/day of troxerutin.
Active Compound O-(beta-hydroxyethyl)-rutosides, semi-synthetic hydroxyethyl derivatives of rutin. Oxerutins are a standardized mixture whose main constituent is tri-hydroxyethylrutoside; troxerutin is a related hydroxyethylrutoside mixture.

Benefits

Leg heaviness, cramps and swelling sensations in vein studies

Two pooled analyses of placebo-controlled trials in adults with leg vein problems, mostly at 1,000 mg a day, found less pain, heaviness and cramps with hydroxyethylrutosides. In one, placebo alone cleared symptoms in 22 to 35% of patients and the drug added 11 to 24 points. The other judged every trial to be of limited quality, and a 28-day Danish trial found no difference from placebo.

Supported by Trial 1, Trial 4

Lower-leg volume alongside compression stockings

In 133 women with leg vein problems who all wore compression stockings, adding oxerutins 500 mg twice daily for 12 weeks reduced lower-leg volume by about 64 ml versus 33 ml with placebo, and the gap held for 6 weeks after stopping. The trial was run by staff of the maker.

Supported by Trial 2, Trial 8

Leg swelling after standing or long flights in healthy people

In 12 healthy young men, 1,000 mg a day reduced the leg-volume rise from an hour of standing still, and 500 mg a day held the effect, compared with placebo. In 151 healthy travelers, 1 g twice daily for 3 days around an 8 to 9 hour flight gave lower composite swelling scores than placebo. Both studies were small; the first was run by the maker.

Supported by Trial 5, Trial 6

Leg comfort scores in adults over 65

In a 6-month placebo-controlled trial of people over 65 with leg vein complaints (86 analyzed), 900 to 1,200 mg a day lowered total symptom scores more than placebo. Leg cramps, heaviness and restless legs improved, while aching pain and pins-and-needles did not, and ankle and calf size fell only slightly.

Supported by Trial 3

Mechanism of action

1

Acts on the lining of small blood vessels

According to the UK product information, the main effect of hydroxyethylrutosides is on the inner lining of small blood vessels, where they reduce capillary leakiness, which fits with less swelling. After absorption they distribute to tissues, especially vessel lining, and are released slowly. The label bases this on laboratory and in vivo studies it does not detail.

2

Absorption and how long it stays in the body

In 16 healthy volunteers given single doses of 0.5 to 4 g, blood levels of two hydroxyethyl-quercetin markers rose roughly in proportion to dose. The UK label reports peak levels 2 to 9 hours after a dose and a half-life of about 18 hours for the main constituent, which is processed in the liver and cleared in bile and urine.

3

Different hydroxyethylrutoside mixtures are not interchangeable

Rutin can carry different numbers of hydroxyethyl groups. In laboratory tests the di- and mono-hydroxyethyl forms scavenged free radicals more than the tri- form, and in 12 women oxerutins at 900 mg a day reduced leg volume more than the same dose of troxerutin. That trial had no placebo and was run by the oxerutins maker.

Clinical trials

1
Hydroxyethylrutosides for Leg Vein Symptoms: Meta-Analysis of 15 Trials
PubMed

Meta-analysis of 15 randomized trials of O-(beta-hydroxyethyl)-rutosides given for at least 4 weeks (average 1,000 mg/day), selected from 21 evaluated; authors at a French research company, funding not stated in the abstract. (Poynard et al. 1994, Vasa)

1,973 patients with chronic venous insufficiency.

Placebo alone cleared symptoms in 22 to 35% of patients. Hydroxyethylrutosides added 11 percentage points for pain, 12 for cramps, 12 for restless legs, 14 for swelling and 24 for tired legs (all p < 0.01). The large placebo response means the extra effect of the drug is smaller than the raw improvement patients felt.

2
Oxerutins Added to Compression Stockings: 12-Week Placebo-Controlled Trial (maker-run)
PubMed

Double-blind, randomized, multicenter, placebo-controlled trial of oxerutins (Venoruton) 500 mg twice daily for 12 weeks plus 6 weeks of follow-up off treatment; first author affiliated with the maker, Zyma GmbH. (Unkauf et al. 1996, Arzneimittelforschung)

133 women with grade II chronic venous insufficiency, all wearing standard compression stockings fitted after a first week of standard diuretics.

After 12 weeks, lower-leg volume fell by 63.9 ml with oxerutins plus stockings versus 32.9 ml with placebo plus stockings (p < 0.05), and the primary area-under-curve measure also favored oxerutins (p = 0.012). The gap held during the 6 weeks off treatment. Measured by water displacement.

3
Hydroxyethylrutosides in Adults Over 65: 6-Month Placebo-Controlled Trial
PubMed

Multicenter, double-blind, randomized, placebo-controlled trial; 900, 1,000 or 1,200 mg/day depending on the registered dose in each country, for 6 months. (MacLennan et al. 1994, Gerontology)

104 people over 65 with chronic venous insufficiency or varicose veins in the UK, Germany, Belgium and the Netherlands; 86 analyzed for efficacy.

Total symptom score fell from 5.7 to 2.3 on the drug versus 4.4 to 3.0 on placebo (p < 0.01). Leg cramps, heavy legs and restless legs improved more than with placebo; aching pain and pins-and-needles did not. Ankle and calf circumference fell slightly, reaching significance only at the end.

4
Venoruton for Leg Vein Symptoms in General Practice: 28-Day Trial With No Effect
PubMed

Randomized, double-blind, placebo-controlled trial of Venoruton 300 mg three times daily for 28 days; published in Danish with an English abstract. (Pedersen et al. 1992, Ugeskr Laeger)

Patients from general practice with leg vein symptoms and no other vein treatment (43 reported; the abstract also lists 28 on Venoruton and 19 on placebo).

No differences from placebo in swelling, pain, heaviness, restlessness, itching, cramps, overall discomfort or leg circumference. The authors concluded that Venoruton did not appear to have an effect.

5
Standing Leg Swelling in Healthy Men: Dose Comparison (maker-run)
PubMed

Randomized trial: 1-week placebo run-in, 3 weeks at 1,000 mg/day, then randomization to 1,000 mg/day, 500 mg/day or placebo for up to 7 more weeks; first author affiliated with the maker, Zyma GmbH. (Rehn et al. 1993, Arzneimittelforschung)

12 healthy young men.

The leg-volume rise from an hour of standing still kept falling on 1,000 mg/day, held steady on 500 mg/day and drifted back to baseline on placebo within 5 to 6 weeks. Both doses beat placebo (p = 0.0001 and p = 0.0328). A very small study measuring one lab-style swelling test.

6
Venoruton and Ankle Swelling on Long-Haul Flights in Healthy Travelers
PubMed

Randomized, placebo-controlled trial (LONFLIT4) of Venoruton 1 g twice daily for 3 days, starting 2 days before an 8 to 9 hour economy flight; funding not stated in the abstract. (Belcaro et al. 2003, Clin Appl Thromb Hemost)

164 healthy travelers randomized; 151 completed.

After the flight the composite swelling score averaged 3.0 with Venoruton versus 6.7 with placebo (p < 0.05). Visible swelling with discomfort occurred in 77% on placebo and mild swelling in 8% on Venoruton. The score was partly built from self-rated swelling and discomfort.

7
Hydroxyethylrutosides During Pregnancy: Placebo-Controlled Trial
PubMed

Double-blind, randomized, placebo-controlled trial of 500 mg O-(beta-hydroxyethyl)-rutosides twice daily at a hospital in Bandung, Indonesia. (Wijayanegara et al. 1992, J Int Med Res)

97 pregnant women with first-, second- or third-degree hemorrhoids.

Self-rated pain, bleeding, discharge and itching and clinician-rated signs improved more than with placebo at 2 and 4 weeks (p < 0.001). Three mild, short-lived side effects occurred on the drug. A later Cochrane review said the drug could not be recommended in pregnancy until safety is better established.

8
Rutosides After a Deep Vein Clot: Cochrane Review (no benefit found)
PubMed

Cochrane systematic review (second update) of rutosides versus placebo, no treatment, compression stockings or other treatment. (Morling et al. 2018, Cochrane Database Syst Rev)

3 small trials with 233 participants who had post-thrombotic syndrome after deep vein thrombosis.

No clear difference in symptom improvement versus placebo or no treatment (OR 1.29, 95% CI 0.69 to 2.41) or versus compression stockings, and one small trial favored another vein drug over rutosides. Evidence was low quality, mainly from lack of blinding. The authors found no evidence that rutosides beat placebo or stockings.

Side effects and drug interactions

Common Potential side effects

The UK product information lists digestive upset (wind, diarrhea, stomach pain, indigestion), rash and itching as rare, and allergic reactions, dizziness, headache, flushing, tiredness, joint pain, hair loss and sensitivity to sunlight as very rare.
In a review of 15 trials, no serious adverse effects were reported. In a Cochrane review of vein-support drugs as a class (28 of the 56 trials tested rutosides), adverse events were slightly more common than with placebo, mostly digestive, and only short-term safety data exist.
Leg swelling caused by heart, kidney or liver disease needs its own treatment and is not what this product is for. See a doctor if leg pain or swelling does not improve or gets worse.
Pregnancy: the UK label advises against use in the first three months, and a Cochrane review said use in pregnancy could not be recommended until safety is better established.
Safety and effectiveness in people under 18 have not been established.

Important Drug interactions

The UK product information reports no known interactions and states that oxerutins were shown not to interact with warfarin.
Interaction data come from the licensed product; if you take prescription medicines, check with a pharmacist before using other troxerutin or oxerutin products.

Frequently asked questions about Troxerutin (Oxerutins)

Are troxerutin and oxerutins the same thing?

Both are mixtures of hydroxyethylrutosides made from rutin, but they differ in make-up. Oxerutins (Venoruton, Paroven) are the standardized mixture used in most trials. In a small head-to-head trial in 12 women, oxerutins reduced leg volume more than the same dose of troxerutin, so results for one may not apply to the other.

Is troxerutin a medicine or a supplement?

In the UK, oxerutin capsules (Paroven) are a prescription-only medicine for relief of swelling linked to chronic venous insufficiency, at 500 mg twice daily. In the US, FDA replied to a 2000 notification to sell troxerutin as a new dietary ingredient that the safety information was inadequate, so a supplement containing it may be adulterated; the outcomes of later notifications are not posted publicly. The trials on this page tested licensed, standardized products, and other products sold as troxerutin may not match them.

Does it help with leg swelling on long flights?

In a trial of 151 healthy travelers, 1 g twice daily for 3 days, starting 2 days before an 8 to 9 hour flight, gave lower composite swelling scores than placebo. The score partly relied on self-rating, and this is a single trial. The trial measured swelling, not blood clots.

Have any trials of oxerutins found no benefit?

Yes. A 28-day Danish trial in general practice found no difference from placebo in leg symptoms or leg size. A trial in 138 people with healed leg ulcers found no fewer ulcer recurrences over 18 months, and a Cochrane review found no evidence that rutosides beat placebo or compression stockings for symptoms after a deep vein clot.

Can it be taken during pregnancy?

The UK label says limited data show no harmful effects but advises against use in the first three months. One placebo-controlled trial in 97 pregnant women found no drug-related pregnancy or delivery problems, yet a Cochrane review concluded it could not be recommended in pregnancy until safety is better established. Ask your doctor or midwife.

What is Troxerutin?

Troxerutin and oxerutins are mixtures of O-(beta-hydroxyethyl)-rutosides, made by chemically modifying rutin, a flavonoid found in apples, citrus fruits and cranberries. Oxerutins are the standardized mixture sold as Venoruton, Paroven and Relvène; troxerutin is a related mixture with a different make-up.

What is Troxerutin used for?

NutraSmarts does not list Troxerutin under a health category. What the research covers: Two pooled analyses of placebo-controlled trials in adults with leg vein problems, mostly at 1,000 mg a day, found less pain, heaviness and cramps with hydroxyethylrutosides.

What doses of Troxerutin have been studied?

Troxerutin is a drug or research chemical, not a dietary supplement: it is a prescription medicine in some countries, is not approved for sale as a supplement in the US, or has a regulatory warning against it. Doses used in studies: Most trials used 1,000 mg/day of oxerutins (500 mg twice daily), the UK licensed dose; others used 900 to 1,200 mg/day for up to 6 months, or 2 g/day for 3 days around a long flight. A head-to-head trial used 900 mg/day of troxerutin. This is not dosing advice.

Is Troxerutin safe, and does it have side effects?

Troxerutin is a drug or research chemical, not a dietary supplement: it is a prescription medicine in some countries, is not approved for sale as a supplement in the US, or has a regulatory warning against it. Side effects and cautions reported for Troxerutin include: The UK product information lists digestive upset (wind, diarrhea, stomach pain, indigestion), rash and itching as rare, and allergic reactions, dizziness, headache, flushing, tiredness, joint pain, hair loss and sensitivity to sunlight as very rare. It may also interact with some medications. Troxerutin is not right for everyone, so check with a healthcare provider first if you are pregnant or breastfeeding, have a medical condition, or take prescription medication.

Does Troxerutin interact with any medications?

Possible interactions include: The UK product information reports no known interactions and states that oxerutins were shown not to interact with warfarin. Interaction data come from the licensed product; if you take prescription medicines, check with a pharmacist before using other troxerutin or oxerutin prod… If you take prescription medication, check with a pharmacist or doctor before using it.

How strong is the scientific evidence for Troxerutin?

NutraSmarts rates the evidence for Troxerutin as Moderate (3 out of 5). It is backed by 8 study summaries and 16 cited references summarized on this page. A higher rating reflects more, larger, and better-designed human studies. For a drug or research chemical, this rating does not mean it is suitable for self-use.

References(16 citations)

Evidence ratings on NutraSmarts are based on the totality of human clinical research, with emphasis on randomized controlled trials, meta-analyses, and systematic reviews. The references below directly support claims made throughout this page.

  1. Poynard T, Valterio C. Meta-analysis of hydroxyethylrutosides in the treatment of chronic venous insufficiency. Vasa. 1994;23(3):244-50..PubMedUsed to support: Meta-analysis of 15 randomized trials (1,973 patients with chronic venous insufficiency, average dose 1,000 mg/day for at least 4 weeks): placebo alone cleared symptoms in 22 to 35% of patients, and hydroxyethylrutosides added 11 to 24 percentage points for pain, cramps, restless legs, swelling and tired legs (all p < 0.01). The authors were at Quanta Medical, a French research company; funding is not stated in the abstract.
  2. Aziz Z, Tang WL, Chong NJ, Tho LY. A systematic review of the efficacy and tolerability of hydroxyethylrutosides for improvement of the signs and symptoms of chronic venous insufficiency. J Clin Pharm Ther. 2015;40(2):177-85. doi: 10.1111/jcpt.12247.PubMedUsed to support: Systematic review of 15 randomized trials (1,643 participants with chronic venous insufficiency): in pooled placebo comparisons, hydroxyethylrutosides reduced pain, heavy legs and cramps, with no serious adverse effects reported. The authors called the gains modest, judged every included trial to be of limited quality, and said better-quality trials are needed to draw firm conclusions.
  3. Martinez-Zapata MJ, Vernooij RW, Simancas-Racines D, Uriona Tuma SM, Stein AT, Moreno Carriles RMM, Vargas E, Bonfill Cosp X. Phlebotonics for venous insufficiency. Cochrane Database Syst Rev. 2020;11(11):CD003229. doi: 10.1002/14651858.CD003229.pub4.PubMedUsed to support: Cochrane review of oral vein-support drugs (phlebotonics) as a class: 56 placebo-controlled trials with usable data (7,690 participants), 28 of them on rutosides. Pooled across all drugs, they probably reduce lower-leg swelling slightly (RR 0.70) and ankle circumference (about 4 mm), make little or no difference to quality of life, and slightly increase adverse events (RR 1.14), mostly digestive. Only short-term safety data were available; results are not split out for rutosides in the abstract.
  4. Unkauf M, Rehn D, Klinger J, de la Motte S, Grossmann K. Investigation of the efficacy of oxerutins compared to placebo in patients with chronic venous insufficiency treated with compression stockings. Arzneimittelforschung. 1996;46(5):478-82..PubMedUsed to support: Double-blind randomized trial in 133 women with chronic venous insufficiency, all wearing compression stockings: oxerutins 500 mg twice daily for 12 weeks reduced lower-leg volume by 63.9 ml versus 32.9 ml with placebo (p < 0.05), and the difference held during 6 weeks off treatment. The first author's listed affiliation is Zyma GmbH, the maker of Venoruton.
  5. MacLennan WJ, Wilson J, Rattenhuber V, Dikland WJ, Vanderdonckt J, Moriau M. Hydroxyethylrutosides in elderly patients with chronic venous insufficiency: its efficacy and tolerability. Gerontology. 1994;40(1):45-52. doi: 10.1159/000213574.PubMedUsed to support: Double-blind placebo-controlled trial in 104 people over 65 with chronic venous insufficiency or varicose veins (86 analyzed for efficacy), 900 to 1,200 mg/day for 6 months: total symptom score fell from 5.7 to 2.3 with hydroxyethylrutosides versus 4.4 to 3.0 with placebo (p < 0.01). Cramps, heavy legs and restless legs improved; aching pain and pins-and-needles did not differ. Doses differed by country because the registered dose differed.
  6. Pedersen FM, Hamberg O, Sørensen MD, Neland K. [Effect of 0-(beta-hydroxyethyl)-rutoside (Venoruton) on symptomatic venous insufficiency in the lower limbs]. Ugeskr Laeger. 1992;154(38):2561-3..PubMedUsed to support: Danish double-blind randomized trial in patients from general practice with leg vein symptoms: Venoruton 300 mg three times daily for 28 days did not differ from placebo for swelling, pain, heaviness, restlessness, itching, cramps or leg circumference. The abstract reports 43 participants and also lists 28 on Venoruton and 19 on placebo.
  7. Rehn D, Nocker W, Diebschlag W, Golden G. Time course of the anti-oedematous effect of different dose regimens of O-(beta-hydroxyethyl) rutosides in healthy volunteers. Arzneimittelforschung. 1993;43(3):335-8..PubMedUsed to support: Randomized study in 12 healthy young men: after 3 weeks at 1,000 mg/day, the leg-volume rise caused by an hour of standing still kept falling on 1,000 mg/day, held steady on 500 mg/day and returned to baseline on placebo within 5 to 6 weeks; both doses beat placebo. The first author's listed affiliation is Zyma GmbH, the maker of Venoruton.
  8. Belcaro G, Cesarone MR, Nicolaides AN, Geroulakos G, Acerbi G, Candiani C, Griffin M, Bavera P, Dugall M, Brandolini R, Di Renzo A, Ricci A, Ippolito E, Winford M, Golden G; LONFLIT4-VENORUTON Study. The LONFLIT4-VENORUTON study: a randomized trial prophylaxis of flight-edema in normal subjects. Clin Appl Thromb Hemost. 2003;9(1):19-23. doi: 10.1177/107602960300900102.PubMedUsed to support: Randomized placebo-controlled trial in healthy travelers on 8 to 9 hour economy flights (164 randomized, 151 completed): Venoruton 1 g twice daily for 3 days, starting 2 days before the flight, gave a lower composite swelling score after the flight than placebo (3.0 vs 6.7), a score partly built from self-rated swelling and discomfort. Funding is not stated in the abstract.
  9. Wijayanegara H, Mose JC, Achmad L, Sobarna R, Permadi W. A clinical trial of hydroxyethylrutosides in the treatment of haemorrhoids of pregnancy. J Int Med Res. 1992;20(1):54-60. doi: 10.1177/030006059202000107.PubMedUsed to support: Double-blind placebo-controlled trial in 97 pregnant women with first- to third-degree hemorrhoids: 500 mg hydroxyethylrutosides twice daily improved self-rated pain, bleeding, discharge and itching and clinician-rated signs at 2 and 4 weeks (p < 0.001). Three mild, short-lived side effects occurred on the drug, and no drug-related pregnancy or delivery problems were seen.
  10. Quijano CE, Abalos E. Conservative management of symptomatic and/or complicated haemorrhoids in pregnancy and the puerperium. Cochrane Database Syst Rev. 2005;2005(3):CD004077. doi: 10.1002/14651858.CD004077.pub2.PubMedUsed to support: Cochrane review of conservative care for hemorrhoids in pregnancy and after birth: the two included trials (150 women) both tested oral rutosides against placebo and found fewer non-responders (RR 0.07). One fetal death (placebo group) and one birth defect (rutoside group, possibly unrelated) were reported. The authors concluded the drug could not be recommended until new evidence reassures women and clinicians about its safety.
  11. Morling JR, Broderick C, Yeoh SE, Kolbach DN. Rutosides for treatment of post-thrombotic syndrome. Cochrane Database Syst Rev. 2018;11(11):CD005625. doi: 10.1002/14651858.CD005625.pub4.PubMedUsed to support: Cochrane review of rutosides for symptoms that follow a deep vein clot (post-thrombotic syndrome): 3 small trials (233 participants), low-quality evidence. No clear difference from placebo or no treatment (OR 1.29) or from compression stockings, and one small trial favored another vein drug. The authors found no evidence that rutosides beat placebo or stockings.
  12. Wright DD, Franks PJ, Blair SD, Backhouse CM, Moffatt C, McCollum CN. Oxerutins in the prevention of recurrence in chronic venous ulceration: randomized controlled trial. Br J Surg. 1991;78(10):1269-70. doi: 10.1002/bjs.1800781039.PubMedUsed to support: Double-blind randomized trial in 138 patients with recently healed leg ulcers, all given compression stockings: Paroven 500 mg twice daily did not reduce ulcer recurrence (23% vs 22% at 12 months and 34% vs 32% at 18 months, oxerutins vs placebo; P = 0.93).
  13. Kienzler JL, Sallin D, Schifflers MH, Ghika A. Pharmacokinetics of mono-3'- and mono-4'-0-(beta-hydroxyethyl)-rutoside derivatives, after single doses of Venoruton powder in healthy volunteers. Eur J Clin Pharmacol. 2002;58(6):395-402. doi: 10.1007/s00228-002-0472-3.PubMedUsed to support: Open randomized four-way crossover in 16 healthy volunteers given single oral doses of Venoruton powder (0.5, 1, 2 or 4 g): blood levels of two hydroxyethyl-quercetin markers rose roughly in proportion to dose, time to peak and half-life did not change with dose, and all doses were well tolerated. The first author's listed affiliation is in Nyon, Switzerland, with a Novartis email address.
  14. Rehn D, Golden G, Nocker W, Diebschlag W, Lehmacher W. Comparison between the efficacy and tolerability of oxerutins and troxerutin in the treatment of patients with chronic venous insufficiency. Arzneimittelforschung. 1993;43(10):1060-3..PubMedUsed to support: Double-blind randomized comparison in 12 postmenopausal women with chronic venous insufficiency: oxerutins and troxerutin (both hydroxyethylrutoside mixtures) at 900 mg/day for 12 weeks both reduced leg volume and symptoms, with a larger volume reduction for oxerutins (about 261 vs 73 ml x week, p = 0.04). Notes lab findings that di- and mono-hydroxyethylrutosides scavenge free radicals more than the tri- form. No placebo arm; first author affiliated with Zyma GmbH.
  15. Thornton & Ross Ltd (STADA); electronic Medicines Compendium (accessed 2026). Paroven capsules 250 mg: Summary of Product Characteristics. electronic Medicines Compendium (emc), UK. 2021;Marketing authorisation PL 00240/0550; text revised 22/10/2021 (page updated 16 May 2024)..SourceUsed to support: Not PubMed-indexed. UK product information for oxerutins, listed on the emc as a prescription-only medicine: indicated for relief of symptoms of swelling (oedema) linked to chronic venous insufficiency; adult dose 500 mg twice daily; not for leg swelling caused by heart, kidney or liver disease; no reported interactions and shown not to interact with warfarin; limited pregnancy data show no adverse effects but not for use in the first three months; rare digestive effects and very rare allergic reactions, headache, dizziness and flushing; peak blood levels 2 to 9 hours after a dose and a half-life of about 18 hours for the main constituent, tri-hydroxyethylrutoside.
  16. Wilkening VL; US Food and Drug Administration, Center for Food Safety and Applied Nutrition. Letter to Nutratech, Inc. responding to its new dietary ingredient notification for troxerutin. US Food and Drug Administration, new dietary ingredient notifications (docket FDA-1995-S-0039). 2000;NDI report 67; notification dated March 27, 2000; FDA response dated June 9, 2000 per FDA's list of submitted 75-day premarket notifications..SourceUsed to support: Not PubMed-indexed. FDA letter (read from the archived copy in the govdocs1 corpus, file 934370.pdf) answering Nutratech's notification to market troxerutin, proposed at 100 to 1,000 mg/day, as a new dietary ingredient. FDA found that only 4 of the 27 submitted studies examined troxerutin itself and that none included adequate clinical chemistry, urinalysis or other measures of the effects of chronic use in healthy people, so a supplement containing it may be adulterated under 21 U.S.C. 342(f)(1)(B). FDA's list shows later troxerutin notifications (Nutratech, August 2000; Girex, December 2007 and May 2008) whose response letters are not publicly viewable.