Ingredients | Amount Per Serving |
---|---|
Calories
|
20 Calorie(s) |
Total Carbohydrates
|
4 Gram(s) |
Total Sugars
|
3 Gram(s) |
Added Sugars
|
3 Gram(s) |
(seed)
|
25 mg |
25 mg | |
(Pine Bark Extract)
|
25 mg |
25 mg | |
25 mg |
Cane Syrup, Dried, Rice Syrup, Natural Flavors, Palm Oil, Soy Lecithin, Fruit Juice, Vegetable Juice, Citric Acid, Malic Acid, Glycerin, Rebaudioside A (Form: Stevia PlantPart: leaf Genus: Stevia), Rosemary Oleoresin
Below is general information about the effectiveness of the known ingredients contained in the product OPC-3 Fruit Flavored Chews. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product OPC-3 Fruit Flavored Chews. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when used orally and appropriately in amounts commonly found in foods. Bilberry has Generally Recognized As Safe status (GRAS) for use in foods in the US (4912).
POSSIBLY SAFE ...when used orally and appropriately for medicinal purposes. Bilberry fruit extracts have been used with apparent safety in clinical trials at a dose of up to 160 mg daily for up to 6 months (39,40,8139,9739,14280,35472,35510,35512,103190,104192,104195). A higher bilberry extract dose of 1.4 grams daily has been used with apparent safety for up to 4 weeks (104194). Whole bilberries or bilberry juice have also been consumed with apparent safety in quantities of 100-160 grams daily for up to 35 days (35463,91506).
POSSIBLY UNSAFE ...when the leaves are used orally in high doses or for a prolonged period. Death can occur with chronic use of 1.5 gram/kg daily (2).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in the amounts commonly found in foods.
However, there is insufficient reliable information available about the safety of bilberry when used in medicinal amounts during pregnancy and lactation; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Grapes and grape skin extracts have Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).
POSSIBLY SAFE ...when the whole fruit of the grape, or extracts of the fruit, seed, or leaf, are used orally and appropriately in medicinal amounts. Grape seed extracts have been used with apparent safety in doses up to 200 mg daily for up to 11 months (9182,53016) and in doses up to 2000 mg daily for up to 3 months (53149,53190). Specific grape fruit extracts (Stilvid, Actafarma; Cognigrape, Bionap srl) have been used with apparent safety in doses up to 250-350 mg daily for 3-12 months or 700 mg daily for 6 months (53254,53256,96198). A specific grape leaf extract (AS 195, Antistax, Boehringer Ingelheim) has been used with apparent safety in doses up to 720 mg daily for up to 3 months (2538,52985,53005,53206). A preparation of dehydrated whole grapes, equivalent to 250 grams of fresh grapes daily, has also been used with apparent safety for up to 30 days (18228). A specific grape seed extract (Enovita; Indena SpA) 150 mg twice daily, standardized to provide at least 95% oligomeric proanthocyanins, has been used with apparent safety for up to 16 weeks (108091) ...when used topically and appropriately. Creams and ointments containing grape seed extract 2% or 5% have been used topically with apparent safety for up to 3 weeks (91539,100955). There is insufficient reliable information available about the safety of other grape plant parts when used topically.
CHILDREN: LIKELY SAFE
when used orally in amounts commonly found in foods.
Grapes and grape skin extracts have Generally Recognized As Safe (GRAS) status for use in foods in the US (4912). However, whole grapes should be eaten with caution in children aged 5 years and under. Whole grapes can be a choking hazard for young children (96193). To reduce the risk of choking, whole grapes should be cut in half or quartered before being given to children. There is insufficient reliable information available about the safety of grape when used in medicinal amounts in children.
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods.
There is insufficient reliable information available about the safety of medicinal amounts during pregnancy and breast-feeding; avoid using in amounts greater than what is commonly found in foods.
LIKELY SAFE ...when used in amounts commonly found in foods. Lemon has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when inhaled in amounts used for aromatherapy, short-term. Lemon essential oil has been used with apparent safety as aromatherapy for up to 2 weeks in clinical research (93475,98128,98129). There is insufficient reliable information available about the safety of lemon when used topically, or when used orally or intranasally in medicinal amounts.
PREGNANCY AND LACTATION:
Insufficient reliable information available.
Avoid using in amounts greater than those typically found in foods.
POSSIBLY SAFE ...when used orally and appropriately. A standardized extract of maritime pine bark (Pycnogenol, Horphag Research) has been safely used in doses of 50-450 mg daily for up to one year (2435,2451,2462,2554,2556,7693,10214,10416,12012,14899) (15424,15521,15522,15523,15524,100359,105782). The same extract has also been used with apparent safety in a dose of 800 mg daily for 16 days (103617). A different standardized extract of maritime pine bark (Oligopin, DRT Group) has been used with apparent safety in doses of up to 150 mg daily for up to 12 weeks (105781,105783). ...when applied topically as a cream or powder. A standardized extract of maritime pine bark (Pycnogenol, Horphag Research) 0.5% cream has been used for up to 7 days (50912). Powder from a standardized extract of maritime pine bark (Pycnogenol, Horphag Research) 100 mg has been applied to the skin daily for up to 6 weeks (50887,50896).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
A standardized extract of maritime pine bark (Pycnogenol, Horphag Research), administered in a dose of 1 mg/lb body weight daily, has been safely used in a clinical study of children aged 6-18 years for up to 3 months (13120).
PREGNANCY: POSSIBLY SAFE
when used orally during the third trimester of pregnancy.
In one small clinical study, a standardized extract of maritime pine bark (Pycnogenol, Horphag Research) has been used at a dose of 30 mg daily with apparent safety during the third trimester of pregnancy (15423). However, more evidence is needed; use cautiously or avoid using.
LACTATION:
There is insufficient reliable information available regarding the safety of maritime pine when used during lactation; avoid using.
LIKELY SAFE ...when used orally, responsibly, and in moderation (11880,97061).
POSSIBLY UNSAFE ...when used orally in excess of 1 to 2 five-oz glasses of wine daily. Larger amounts can cause significant adverse effects (11880). There is insufficient reliable information available about the safety of wine when used topically.
PREGNANCY: LIKELY UNSAFE
when used orally; alcohol is a teratogen.
Use during pregnancy is associated with significant risk of spontaneous abortion, fetal alcohol syndrome, and developmental and behavioral dysfunction in infants and children exposed to alcohol in utero (8100); avoid using.
LACTATION: LIKELY UNSAFE
when used orally.
Alcohol is secreted in breast milk. Chronic use can cause abnormal psychomotor development and disrupt the infant's sleep-wake pattern. Alcohol also seems to reduce milk production (11878); avoid using.
Below is general information about the interactions of the known ingredients contained in the product OPC-3 Fruit Flavored Chews. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, bilberry fruit extract might increase the risk of bleeding when taken with anticoagulant or antiplatelet drugs.
Details
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Theoretically, bilberry leaf or fruit extract may increase the risk of hypoglycemia when taken with antidiabetes drugs.
Details
Animal research suggests that bilberry leaf extract might have blood glucose-lowering activity (1264). Also, one small clinical trial in patients with type 2 diabetes shows that taking bilberry fruit extract 470 mg as a single dose prior to an oral glucose tolerance test lowers plasma glucose levels when compared with placebo (91507).
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Theoretically, bilberry fruit extract might decrease levels of drugs metabolized by CYP2E1.
Details
Animal research shows that exposure to small concentrations of bilberry extract in drinking water for around one month increased CYP2E1 activity by 31%. However, exposure over a 2-month period did not increase CYP2E1 activity (103191). This effect has not been reported in humans.
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Theoretically, bilberry fruit extract might reduce the efficacy of erlotinib.
Details
In vitro research suggests that bilberry fruit extract and its constituents, delphinidin and delphinidin-3-O-glucoside, inhibit the activity of erlotinib (97031). This interaction has not been reported in humans.
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Theoretically, grape extracts may have antiplatelet effects and may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
Details
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Ingesting grape juice with cyclosporine can reduce cyclosporine absorption.
Details
A small pharmacokinetic study in healthy young adults shows that intake of purple grape juice 200 mL along with cyclosporine can decrease the absorption of cyclosporine by up to 30% when compared with water (53177). Separate doses of grape juice and cyclosporine by at least 2 hours to avoid this interaction.
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Theoretically, grape juice might reduce the levels of CYP1A2 substrates.
Details
A small pharmacokinetic study in healthy adults shows that ingestion of 200 mL of grape juice decreases phenacetin plasma levels. This is thought to be due to induction of CYP1A2 (2539).
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It is unclear if grape juice or grape seed extract inhibits CYP2C9; research is conflicting.
Details
In vitro evidence shows that grape seed extract or grape juice might inhibit CYP2C9 enzymes (11094,53011,53089). However, a small pharmacokinetic study in healthy adults shows that drinking 8 ounces of grape juice once does not affect the clearance of flurbiprofen, a probe-drug for CYP2C9 metabolism (11094). The effects of continued grape juice consumption are unclear.
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Theoretically, grape seed extract may increase the levels of CYP2D6 substrates.
Details
In vitro evidence suggests that grape seed extract might inhibit CYP2D6 enzymes (53011). However, this interaction has not been reported in humans.
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Theoretically, grape seed extract might increase the levels of CYP2E1 substrates.
Details
In vitro and animal research suggests that grape seed proanthocyanidin extract inhibits CYP2E1 enzymes (52949). However, this interaction has not been reported in humans.
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It is unclear if grape seed extract inhibits or induces CYP3A4; research is conflicting.
Details
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Theoretically, long-term intake of grape seed extract might decrease the effects of midazolam.
Details
Animal research shows that subchronic ingestions of grape seed extract can increase the elimination of intravenous midazolam by increasing hepatic CYP3A4 activity. Single doses of grape seed extract do not appear to affect midazolam elimination (53011).
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Grape juice might decrease phenacetin absorption.
Details
A small pharmacokinetic study in healthy adults shows that ingestion of 200 mL of grape juice decreases phenacetin plasma levels. This is thought to be due to induction of cytochrome P450 1A2 (CYP1A2) (2539).
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Theoretically, taking itraconazole capsules or tablets with a beverage containing lemon might increase the levels and clinical effects of itraconazole.
Details
In one case report, dissolving itraconazole tablets in a small amount of specific beverages containing lemon prior to administration increased the level of itraconazole in a lung transplant patient. In this case, the increased bioavailability was desirable and was likely due to improved tablet dissolution in the acidic beverage (110781).
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Theoretically, maritime pine bark extract might increase the risk of bleeding when used with antiplatelet or anticoagulant drugs.
Details
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Theoretically, maritime pine bark extract might increase the risk of hypoglycemia when used with antidiabetes drugs.
Details
One clinical study shows that maritime pine bark extract decreases blood sugar in patients with diabetes being treated with antidiabetes agents (15522). Monitor blood glucose levels closely. Dose adjustments might be necessary.
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Theoretically, maritime pine bark extract might decrease the effectiveness of immunosuppressant therapy.
Details
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Concomitant use increases the risk of long-term teratogenic effects.
Details
Alcohol increases the transesterification of acitretin to etretinate, which is a teratogen that can remain in the body for years after discontinuation of acitretin. Patients of reproductive potential should avoid alcohol completely while taking acitretin and at least 2 months after discontinuation (108003).
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Concomitant use may interfere with blood glucose control.
Details
Alcohol can impair gluconeogenesis and may increase the risk of acute hypoglycemia when used concomitantly with antidiabetes drugs (2262). However, the carbohydrates in wine may also worsen glycemic control in patients with diabetes.
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Theoretically, concomitant use may interfere with blood pressure control.
Details
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Concomitant use may increase the risk of gastrointestinal (GI) bleeding.
Details
Concomitant use of aspirin with alcohol may increase the risk of GI bleeding (2262).
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Theoretically, concomitant use may increase the risk of adverse effects from alcohol.
Details
In patients taking bupropion, there have been rare reports of adverse psychiatric events or reduced alcohol tolerance. Additionally, in chronic alcohol users, abrupt discontinuation of alcohol while taking bupropion may increase the risk of seizure (108023).
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Concomitant use may cause a disulfiram-like reaction.
Details
Cefamandole can cause a disulfiram-like reaction when taken with alcohol (2262).
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Concomitant use may cause a disulfiram-like reaction.
Details
Cefoperazone can cause a disulfiram-like reaction when taken with alcohol (2262).
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Theoretically, concomitant use might increase the risk of CNS impairment.
Details
Cetirizine may cause somnolence in some patients. There is some concern that taking cetirizine in conjunction with alcohol might reduce alertness and impair CNS performance (108022).
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Concomitant use may cause a disulfiram-like reaction.
Details
Chlorpropamide can cause a disulfiram-like reaction when taken with alcohol (506).
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Concomitant use may increase blood alcohol levels and adverse effects.
Details
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Theoretically, concomitant use might increase the risk of adverse effects from alcohol.
Details
Some case reports suggest that citalopram may reduce alcohol tolerance and increase the risk of adverse effects from alcohol (108024).
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Concomitant use may increase sedative and other adverse effects.
Details
Concomitant use of alcohol with CNS depressants can increase sedative and other adverse effects, potentially through inhibition of the metabolism of certain CNS depressants (2262).
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Red wine can reduce the levels and clinical effects of cyclosporine.
Details
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Concomitant use may cause a disulfiram reaction.
Details
Disulfiram can cause a disulfiram reaction when taken with alcohol (2262). Patients taking disulfiram should not consume any alcohol.
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Chronic alcohol use might reduce the levels and clinical effects of doxycycline.
Details
Although acute alcohol ingestion does not seem to significantly impact the pharmacokinetics of doxycycline, chronic alcohol ingestion has been shown to significantly reduce the half-life and serum concentration of doxycycline (107998).
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Chronic or excessive alcohol use might increase the risk of pancreatitis from eluxadoline.
Details
In clinical studies, the risk of pancreatitis with eluxadoline was increased in chronic alcohol users and in those with acute intake of 3 or more alcoholic beverages daily (108004).
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Concomitant use may increase blood alcohol levels and adverse effects.
Details
Concomitant use of erythromycin with alcohol can increase blood alcohol levels and adverse effects (2262).
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Consumption of red wine can rapidly increase felodipine levels and adverse effects.
Details
Red wine taken on an empty stomach can cause "dose dumping" of extended-release felodipine, possibly by changing absorption or metabolism. Red wine can delay the appearance of felodipine in plasma until 4 hours after dosing and can rapidly increase its plasma concentration, producing peak serum levels 3 to 4 times higher than when felodipine is given with water. This can cause an increase in adverse effects 5 hours after dosing (11976).
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Concomitant use increases the risk of severe hypotension and syncope.
Details
Alcohol use is contraindicated in patients taking flibanserin due to the risk of severe hypotension and syncope (108002).
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Concomitant use may cause a disulfiram-like reaction.
Details
Griseofulvin can cause a disulfiram-like reaction, including tachycardia and facial flushing, when taken with alcohol (2262).
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Concomitant use might increase blood alcohol levels and adverse effects.
Details
Concomitant use of the H2-blockers cimetidine and ranitidine with low doses of alcohol (0.15 grams/kg) might increase blood alcohol levels and adverse effects. Effects with higher doses of alcohol (0.3-1.5 grams/kg) are variable (2262).
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Concomitant use of alcohol with hepatotoxic drugs may increase the risk of hepatotoxicity.
Details
Concomitant use of excessive amounts of alcohol with potentially hepatotoxic drugs can increase the risk of liver damage (2262).
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Theoretically, concomitant use might increase the risk of CNS impairment.
Details
Levocetirizine may cause somnolence in some patients. There is some concern that taking levocetirizine in conjunction with alcohol might reduce alertness and impair CNS performance (108026).
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Theoretically, concomitant use may increase the absorption and elimination of levomilnacipran.
Details
In vitro research shows that alcohol increases the release of levomilnacipran from extended-release capsules, resulting in complete drug release in 4 hours (108024). This effect has not been evaluated in humans.
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Concomitant use may increase the risk of lactic acidosis.
Details
Concomitant consumption of large amounts of alcohol can increase the risk of lactic acidosis with metformin (107995).
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Concomitant use may cause a disulfiram-like reaction.
Details
Although there is some disagreement over the likelihood of a disulfiram-like reaction with concomitant use of alcohol and metronidazole (108000), prescribing materials recommend discontinuing alcohol intake during the use of metronidazole. In the US, it is recommended to discontinue alcohol during and for at least three days after therapy with metronidazole (107999); in Canada, it is recommended to discontinue alcohol during and for at least 1 day after therapy with metronidazole (108001).
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Concomitant use may cause hypertensive crisis.
Details
Wine contains tyramine (105702), which is metabolized by monoamine oxidase. Concurrent use of MAOIs with tyramine-containing beverages can lead to elevated levels of tyramine in the body. This can increase the effects of tyramine, which has been reported to cause hypertension, headache, and hypertensive crisis in numerous cases (100189,100192,101010). Sensitivity to tyramine can increase up to 10-fold to 100-fold in people using an MAOI (100189,101010).
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Concomitant use of large amounts of alcohol may decrease the metabolism of narcotic drugs.
Details
Concomitant consumption of large amounts of alcohol can decrease the metabolism of narcotic drugs (2262).
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Concomitant use may increase the risk of gastrointestinal (GI) bleeding.
Details
Concomitant use of NSAIDs with alcohol may increase the risk of GI bleeding (2262).
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Concomitant use may decrease the effectiveness of phenytoin.
Details
Chronic, heavy alcohol use can induce the metabolism, reducing therapeutic effectiveness of phenytoin (2262).
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Concomitant use may cause a disulfiram-like reaction.
Details
Although high quality evidence is lacking, there is concern that secnidazole can cause a disulfiram-like reaction when taken with alcohol. Prescribing materials in the US recommend discontinuation of alcohol during and for at least two days after therapy with secnidazole (107996).
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Concomitant use may cause a disulfiram-like reaction.
Details
Sulfonamide antibiotics can cause a disulfiram-like reaction when taken with alcohol (2262).
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Concomitant use may cause a disulfiram-like reaction.
Details
Although high quality evidence is lacking, there is concern that tinidazole can cause a disulfiram-like reaction when taken with alcohol. Prescribing materials in the US recommend discontinuation of alcohol during and for at least three days after therapy with tinidazole (107997).
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Theoretically, concomitant use may cause a disulfiram-like reaction.
Details
Tolbutamide can cause a disulfiram-like reaction when taken with alcohol (2262).
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Theoretically, concomitant use may increase the risk of adverse effects from alcohol.
Details
There have been reports of patients experiencing increased effects from alcohol while taking varenicline. Some cases involved unusual and sometimes aggressive behavior and were accompanied by amnesia (108021). Caution patients to use alcohol with caution when taking varenicline, as it may alter alcohol tolerance.
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Concomitant use may increase the risk of acute hypotension.
Details
Acute alcohol intoxication can increase the risk of hypotension and additive effects with vasodilators (2262).
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Alcohol can alter the effects of warfarin, although the exact effect depends on the nature of alcohol consumption.
Details
Acute alcohol intoxication can decrease metabolism and increase the effects of warfarin. In contrast, chronic, heavy alcohol use can induce metabolism of warfarin, reducing therapeutic effectiveness (2262).
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Below is general information about the adverse effects of the known ingredients contained in the product OPC-3 Fruit Flavored Chews. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Orally, bilberry fruit, juice, and extracts seem to be well tolerated.
Most Common Adverse Effects:
Orally: Dark-colored stools, flatulence, and gastrointestinal discomfort.
Gastrointestinal
...In one small clinical trial, mild-to-moderate flatulence was reported in 33% of patients taking sieved bilberries and concentrated bilberry juice (91506).
However, the patients in this study had ulcerative colitis, and the study lacked a control group, limiting the validity of this finding. In another small clinical study of males with age-related cognitive impairment, temporary adverse gastrointestinal (GI) effects were reported in 13% of patients drinking a combination of bilberry and grape juice. However, the adverse GI effect rate was identical in patients drinking a placebo juice (110641). A post-marketing surveillance report of 2295 patients using bilberry extract (Tegens) found that 1% of patients complained of GI discomfort and less than 1% experienced nausea or heartburn (35500).
Theoretically, fresh bilberry fruit may have laxative effects. One clinical trial noted an increased frequency of bowel movements following the administration of a combination formulation containing aerial agrimony parts, cinnamon quills, powdered bilberry fruit, and slippery elm bark (35462). It is unclear if these effects were due to bilberry, other ingredients, or the combination.
Other ...Orally, bilberry may cause discoloration of feces and the tongue. In one study, a dark-bluish to black discoloration of both the feces and the tongue was observed following consumption of sieved bilberries and concentrated bilberry juice. In one patient, a slight discoloration of the teeth has also been observed (91506). In another study, 50% of patients reported dark green stools after taking bilberry extract 700 mg twice daily for 4 weeks (104194).
General
...Orally, the whole fruit, as well as the seed, fruit, and leaf extracts, seem to be well tolerated.
Topically, grape seed extracts seem to be well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, diarrhea, dry mouth, dyspepsia, headache, joint pain, and nausea.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis to grape skin has been reported.
Dermatologic ...Orally, mild hair thinning has been reported in a patient taking a specific grape leaf extract AS195 KG) (2538). Urticaria (hives) has also been reported with this same extract (53206). Cases of contact dermatitis have been reported in grape workers, including those working in California vineyards (53270,53272,53275).
Gastrointestinal ...Orally, abdominal pain and nausea have been reported with use of grape seed extract, but these effects typically occur at rates similar to placebo (9182,13162). In a case report of a 57-year-old man, intermittent nausea, vomiting, and diarrhea occurred over a 10-day period and improved once grape seed extract was stopped (96764). Gastrointestinal adverse effects have also been reported with use of a different grape seed extract (Entelon, Hanlim Pharm). However, the specific types of gastrointestinal effects were not described (100954). A specific grape leaf extract AS195 (Antistax, Boehringer Ingelheim Pharma GmbH & Co. KG) has reportedly caused flatulence, mild constipation, gastrointestinal discomfort, diarrhea, dyspepsia, dry mouth, and retching (2538,52985,53206). Diarrhea, gastrointestinal distress, indigestion, and aversion to taste have been reported with use of Concord grape juice (52972,53166,53175,53181,53199). Loose stools have been reported in a clinical trial of grape pomace (99270). Bowel obstruction caused by intact grapes and grape seeds has been described in case reports (53241,53284,53278). Excessive consumption of grapes, dried grapes, raisins, or sultanas might cause diarrhea due to laxative effects (4201).
Hematologic ...Orally, one case of leg hematoma following a minor trauma was reported in a person using grape leaf extract (2538). Also, one case of bruising was reported in a person drinking Concord grape juice daily for 2 weeks (52972).
Immunologic ...Orally, there is one report of an anaphylactic reaction to oral grape skin extract, which included urticaria and angioedema (4073).
Musculoskeletal ...Orally, musculoskeletal disorders, including back pain, have been reported with use of a specific grape leaf extract AS195 KG) (2538,53206). Joint pain and lumbago have been reported with use of grape seed extract, but these effects occur at rates similar to placebo (91541).
Neurologic/CNS ...Orally, headache has been reported with use of grape seed extract, but this effect occurs at rates similar to placebo (9182,91541). A specific grape leaf extract AS195 (Antistax, Boehringer Ingelheim Pharma GmbH & Co. KG) has reportedly caused dizziness, tiredness, headache, and sleep problems (2538,53206). As a class, nervous system adverse effects have been reported with use of a specific grape seed extract (Entelon, Hanlim Pharm). However, the specific types of adverse neurologic effects were not described (100954).
Ocular/Otic ...Orally, ocular adverse effects have been reported with use of a specific grape seed extract (Entelon, Hanlim Pharm). However, the specific types of ocular adverse effects were not described (100954).
Pulmonary/Respiratory ...Orally, nasopharyngitis and oropharyngeal pain have been reported with use of a specific grape leaf extract AS195 KG) (53206). Sore throat, cough, allergic rhinitis, and nasopharyngitis have been reported with use of grape seed extract, but these effects occur at rates similar to placebo (9182,91541). One case report describes a 16-year-old female who developed increased levels of immunoglobulin E (IgE) following skin-prick exposure to grape vine pollen, as well as positive test responses following bronchial and conjunctival provocation (53301). Reduced forced vital capacity has been described in California grape workers (53080,53081). Occupational eosinophilic lung was diagnosed in a grape grower with a history of asthma. Respiratory exposure to sulfites in grape was implicated as the cause of the adverse reaction (53285).
Other
...Orally, grape products can cause adverse effects due to contamination with pesticides or mycotoxins.
Some evidence has shown that pesticides used in vineyards may remain on grape surfaces post-harvesting. For example, the fungicide folpet sprayed on grapevines has been shown to remain on the grape surface. Although there was minimal penetration of the epicuticular wax, it showed high resistance to washing (52935). Carbaryl has been identified in over 58% of juice samples collected in Canada. This pesticide reportedly occurred more frequently in grape than in other juices. However, estimates of short-term intake were below proposed acute reference doses (53003).
Ochratoxin A is a mycotoxin that is suspected to be nephrotoxic, teratogenic, hepatotoxic and carcinogenic and has been identified in grape juice, frozen grape pulps, and red and white wine sold in Rio de Janeiro, Brazil. However, the highest levels identified in grape products were lower than the established virtually safe dose of 5 ng/kg of body weight daily (53010,53004). Ochratoxin A has also been identified in red, but not white, grape juice marketed in Switzerland, Canada, and the U.S. (53292,53020).
General
...Orally, lemon is well tolerated in amounts commonly found in foods.
A thorough evaluation of safety outcomes has not been conducted on the use of larger amounts.
Most Common Adverse Effects:
Orally: Epigastralgia and heartburn with the regular consumption of fresh lemon juice.
Dermatologic ...Topically, the application of lemon oil might cause photosensitivity, due to furocoumarin derivative content. This occurs most often in fair-skinned people (11019).
Gastrointestinal ...Orally, fresh lemon juice, taken as 60 mL twice daily, has been reported to cause gastrointestinal disturbances in 37% of patients in one clinical trial, compared with 8% of patients in the placebo group. Specifically, of the patients consuming lemon juice, 21% experienced heartburn and 8% experienced epigastralgia, compared to 1% and 3%, respectively, in the placebo group (107489).
General
...Orally and topically, maritime pine bark extract seems to be well tolerated.
Most Common Adverse Effects:
Orally: Gastrointestinal complaints, dizziness, and vertigo.
Cardiovascular ...A single case of chest pain has been reported for a patient treated with a standardized extract of maritime pine bark (Pycnogenol, Horphag Research). However, the patient had a history of myocardial infarction (50905). Another patient taking the same maritime pine bark extract experienced acute decompensation of heart failure. The patient previously has stable coronary artery disease (50929). It is not clear if either of these adverse effects were directly related to maritime pine bark extract.
Gastrointestinal ...Orally, a standardized extract of maritime pine bark (Pycnogenol, Horphag Research) may cause gastrointestinal problems (15521,15522,17300,50891,50942). Also, mouth ulcer and bad breath have been reported in a single trial (15521).
Neurologic/CNS ...Orally, a standardized extract of maritime pine bark (Pycnogenol, Horphag Research) may cause dizziness and severe vertigo (15521,15522,17300,50904,50933). Also, headache has been reported in a single trial (15521).
General
...Orally, the side effects of wine depend on the amount of alcohol ingested and can vary among individuals.
Most Common Adverse Effects:
Orally: Most adverse effects are associated with alcohol content and include abdominal pain, aggression, blackouts, central nervous system (CNS) depression, confusion, diarrhea, drowsiness, emotional lability, flushing, hypoglycemia, hypothermia, indigestion, lack of coordination and trouble walking, migraines, nausea, neuropathies, perceptual and sensational disturbances, and vomiting.
Serious Adverse Effects (Rare):
Orally: Chronic heavy alcohol ingestion (three or more drinks daily) can lead to amnesia, cardiac myopathy, cirrhosis, dementia, hepatotoxicity, malnutrition, myocardial infarction (MI), physical dependence, and somnolence. Other effects of chronic use are chronic cerebellar syndrome, hypomagnesemia, Korsakoff's psychosis, pancreatitis, skeletal myopathies, various types of cancer, and Wernicke's encephalopathy.
Chronic ingestion of three or more alcoholic beverages daily is associated with an increased risk of all-cause mortality, ischemic stroke, and hypertension. Consumption of any amount of alcohol can increase the risk of hemorrhagic stroke.
Cardiovascular ...Orally, chronic heavy alcohol ingestion of three or more drinks daily is associated with an increased risk of all-cause mortality, atrial fibrillation, cardiac myopathy, hypertension, ischemic stroke, and myocardial infarction (MI) (2261,6843,6892,8102,9004,33984,34028,34054,34058,34059). Consumption of any amount of alcohol can increase the risk of hemorrhagic stroke (841,2271).
Gastrointestinal ...Orally, wine can cause a variety of side effects which depend on the amount of alcohol ingested and can vary among individuals. Some common side effects include abdominal pain, diarrhea, indigestion, nausea, and vomiting. (6843,8972,9004,34013,34031). Chronic alcohol use is also associated with pancreatitis (6843,9004).
Hepatic ...Orally, chronic heavy alcohol ingestion (three or more drinks daily) can lead to cirrhosis and hepatotoxicity (6843,9004).
Immunologic ...People who are allergic to sulfites and/or yeast might react to wine. Wine is associated with triggering asthmatic reactions in people with a history of asthma, possibly due to salicylates and/or added sulfites contained in wines (6174). A case report describes a 33-year-old female who developed allergic reactions ranging from mild symptoms to anaphylaxis after consumption of beer or wine. The allergy was attributed to the yeast Saccharomyces cerevisiae, which is used in the fermentation of both beverages (107819).
Musculoskeletal ...Orally, wine can cause a variety of side effects which depend on the amount of alcohol ingested and can vary among individuals. Some common side effects include lack of coordination and trouble walking. Other effects of chronic use include skeletal myopathies (6843,8972,9004).
Neurologic/CNS
...Orally, wine can cause a variety of side effects which depend on the amount of alcohol ingested and can vary among individuals.
Some common side effects include blackouts, central nervous system (CNS) depression, drowsiness, lack of coordination and trouble walking, migraines, neuropathies, and perceptual and sensational disturbances. Chronic heavy alcohol ingestion (three or more drinks daily) can lead to amnesia, dementia, physical dependence, and somnolence. Other effects of chronic use are chronic cerebellar syndrome, Korsakoff's psychosis, and Wernicke's encephalopathy (6843,8972,9004,34055,34068).
Heavy alcohol consumption (fifteen or more drinks weekly) is also associated with a higher percentage of white matter changes and larger ventricular and sulcal size on magnetic resonance imaging (MRI) of the brain. This suggests that heavy alcohol consumption decreases cerebral blood flow and may contribute to brain atrophy (8651). Consumption of any amount of alcohol can increase the risk of hemorrhagic stroke (841,2271).
Oncologic
...There is evidence that heavy alcohol consumption is associated with the mutation of the p53 gene in individuals with esophageal carcinoma (9005).
There is also some evidence that heavy consumption of wine is associated with the highest risk of esophageal cancer when compared with heavy consumption of beer and spirits (8972,9004). Chronic heavy alcohol ingestion (three or more drinks daily) can lead to mouth cancer, esophageal cancer, pharyngeal cancer, laryngeal cancer, and liver cancer (6843,8972,9004,31557,33977,34010,34037,34045,34061,34065,34069,34085). Some research suggests an association between alcohol consumption and an increased risk of pancreatic cancer, but other studies do not support this association (8038). Daily consumption of one or more alcoholic drinks in females might increase the risk of breast cancer by 2% to 15% and increase mortality from breast cancer by as much as 30% (6843,8100,8974,9006,96686). There is also evidence suggesting that females who consume alcohol daily have an increased risk of developing breast cancer when the daily intake of folate is 300 mcg or less (8974,9006). However, the association of wine intake and breast cancer risk in females may vary depending on the type of wine. Red wine results in higher levels of free testosterone and luteinizing hormone (LH) and lower hormone binding globulin (SHBG) levels when compared with white wine. This suggests that red wine has similar activity to aromatase inhibitors and may not increase the risk of breast cancer unlike white wine (97992).
Observational research has found that wine consumption is associated with a higher risk of developing skin cancer in females and a higher risk of invasive melanoma in both males and females (97055,97991).
Psychiatric ...Orally, wine can cause a variety of side effects which depend on the amount of alcohol ingested and can vary among individuals. Some common side effects include aggression, confusion, and emotional lability (6843,9004,34040). Chronic heavy alcohol ingestion (three or more drinks daily) can lead to dementia, physical amnesia, and somnolence (6843,8972,9004).
Pulmonary/Respiratory ...Orally, wine can cause a variety of side effects due to the alcohol content. The side effects depend on the amount ingested and can vary among individuals. A common side effect includes respiratory depression (6843,8972,9004). Wine is also associated with triggering asthmatic reactions in people with a history of asthma, possibly due to salicylates and/or added sulfites contained in wines (6174).
Other
...Orally, chronic heavy alcohol ingestion (three or more drinks daily) can lead to malnutrition and poor glycemic control (6843,8972,9004).
There is some evidence consumption of more than six beers per week is associated with a larger waist-to-hip ratio than those consuming an equivalent amount of hard liquor or wine. However, an association between moderate alcohol intake equivalent to approximately three beers per week or less and waist-to-hip ratio does not seem to exist (10164,10165). It is also unclear whether waist-to-hip ratios associated with the intake of wine, beer, or other alcoholic beverages have any clinical significance (9007).