Black Tea Congou leaves • POMx brand Pomegranate juice (from concentrate) Other Ingredients: Fructose, Natural Flavors, Citric Acid.
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Below is general information about the effectiveness of the known ingredients contained in the product POM Wonderful Pomegranate Black Tea. 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
Below is general information about the safety of the known ingredients contained in the product POM Wonderful Pomegranate Black Tea. 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 consumed orally in moderate amounts (1452,9222,9223,9224,9228,9233,9234,9235,9236,36376)(36426,36434,36436,36581). Black tea contains caffeine. According to a review by Health Canada, and a subsequent large meta-analysis conducted in the US, drinking up to 4 cups of black tea daily, or approximately 400 mg of caffeine, is not associated with significant adverse cardiovascular, bone, behavioral, or reproductive effects in healthy adults (11733,98806). The US Dietary Guidelines Advisory Committee states that there is strong and consistent evidence that consumption of caffeine 400 mg daily is not associated with increased risk of major chronic diseases, such as cardiovascular disease or cancer, in healthy adults (98806).
POSSIBLY UNSAFE ...when consumed orally long term or in high amounts. Black tea contains a significant amount of caffeine. Chronic use, especially in large amounts, can produce tolerance, habituation, psychological dependence, and other significant adverse effects. Doses of caffeine greater than 600 mg per day, or approximately 6 cups of black tea, have been associated with significant adverse effects such as tachyarrhythmias and sleep disturbances (11832). These effects would not be expected to occur with the consumption of decaffeinated black tea. Keep in mind that only the amount of ADDED caffeine must be stated on product labels. The amount of caffeine found in ingredients such as black tea, which naturally contains caffeine, does not need to be provided. This can make it difficult to determine the total amount of caffeine in a given product.
LIKELY UNSAFE ...when consumed orally in very high amounts. The fatal acute oral dose of caffeine is estimated to be 10-14 grams (150-200 mg per kilogram). Serious toxicity can occur at lower doses depending on variables in caffeine sensitivity such as smoking, age, prior caffeine use, etc. (11832).
CHILDREN: POSSIBLY SAFE
when used in food and beverage amounts (4912,11833).
PREGNANCY: POSSIBLY SAFE
when used orally in moderate amounts.
Due to the caffeine content of black tea, mothers should closely monitor their intake to ensure moderate consumption. Caffeine crosses the human placenta but is not considered a teratogen. Fetal blood concentrations of caffeine approximate maternal concentrations (4260). The use of caffeine during pregnancy is controversial; however, moderate consumption has not been associated with clinically important adverse fetal effects (2708,2709,2710,2711,9606,11733,16014,16015,37802,37584). In some studies, consuming amounts over 200 mg daily is associated with a significantly increased risk of miscarriage (16014). This increased risk may be most likely to occur in females with genotypes that confer a slow rate of caffeine metabolism (98806). According to a review by Health Canada, and a subsequent large meta-analysis conducted in the US, most healthy patients can safely consume doses up to 300 mg daily during pregnancy without an increased risk of spontaneous abortion, stillbirth, preterm birth, fetal growth retardation, or congenital malformations (11733,98806). Advise keeping caffeine consumption below 300 mg daily. This is similar to the amount of caffeine in about 3 cups of black tea. Keep in mind that only the amount of ADDED caffeine must be stated on product labels. The amount of caffeine found in ingredients such as black tea, which naturally contains caffeine, does not need to be provided. This can make it difficult to determine the total amount of caffeine in a given product.
PREGNANCY: POSSIBLY UNSAFE
when used orally in large amounts.
Caffeine from black tea crosses the placenta, producing fetal blood concentrations similar to maternal levels (4260). Consumption of caffeine in amounts over 300 mg daily is associated with a significantly increased risk of miscarriage (16014,98806). Advise keeping caffeine consumption from all sources below 300 mg daily. This is similar to the amount of caffeine in about 3 cups of black tea. High doses of caffeine throughout pregnancy have resulted in symptoms of caffeine withdrawal in newborn infants (9891). High doses of caffeine have also been associated with spontaneous abortion, premature delivery, and low birth weight (2709,2711,24995,24998,37561,37898,38012,38186,38199,38212)(38285,38290). Keep in mind that only the amount of ADDED caffeine must be stated on product labels. The amount of caffeine found in ingredients such as black tea, which naturally contains caffeine, does not need to be provided. This can make it difficult to determine the total amount of caffeine in a given product.
Preliminary evidence from a population study also suggests that increasing consumption of black tea might increase the risk of spina bifida (15112); however, this finding needs to be verified with additional research. More evidence is needed to determine the safety of using black tea during pregnancy. For now, advise avoidance of large quantities of black tea during pregnancy.
LACTATION: POSSIBLY SAFE
when used orally in moderate amounts.
Due to the caffeine content of black tea, caffeine intake should be closely monitored. Breast milk concentrations of caffeine are thought to be approximately 50% of maternal serum concentrations. Minimal consumption would likely result in limited exposure to a nursing infant (9892).
LACTATION: POSSIBLY UNSAFE
when used orally in large amounts.
Consumption of black tea might cause irritability and increased bowel activity in nursing infants (6026). Black tea might also interfere with iron metabolism and folic acid bioavailability in nursing infants (631,53782). Large doses or excessive intake of black tea should be avoided during lactation.
LIKELY SAFE ...when pomegranate fruit or fruit juice is used orally and appropriately. Pomegranate juice has been safely used in studies lasting up to 3 years (4912,8310,13022,13023,13690,14137,14388,17329,91693).
POSSIBLY SAFE ...when pomegranate extract is taken orally and appropriately. A specific pomegranate ellagitannin-enriched polyphenol extract (POMx, POM Wonderful) 1-3 grams daily has been safely used for up to 18 months (17729,69261,91686,91695,91697,99100,105269). ...when pomegranate seed oil is used orally and appropriately. Pomegranate seed oil 60 mg daily has been used with apparent safety for up to 12 weeks (91685). ...when a hot water extract of pomegranate seed powder is used orally and appropriately. Pomegranate seed powder 5 grams daily has been used with apparent safety for up to 8 weeks (105270). ...when pomegranate extract is used topically on oral mucosa (13689).
POSSIBLY UNSAFE ...when the pomegranate root, stem, and peel are used orally in large amounts. Bark of the pomegranate root and stem contains the piperidine alkaloids pelletierine, pseudopelletierine, isopelletierine, and methyl isopelletierine. These alkaloids have muscle relaxant properties that have been associated with paralysis and death in animals (13687,13694,13695). Dried pomegranate peel may contain aflatoxin, which is a potent hepatocarcinogen and toxin (92018).
PREGNANCY AND LACTATION: POSSIBLY SAFE
when the fruit or fruit juice is consumed orally and appropriately (13686,105267).
There is insufficient reliable information available regarding the safety of using other forms of pomegranate or other parts of the plant during pregnancy or lactation; avoid using.
Below is general information about the interactions of the known ingredients contained in the product POM Wonderful Pomegranate Black Tea. 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, black tea might decrease the vasodilatory effects of adenosine and interfere with its use prior to stress testing.
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Black tea contains caffeine. Caffeine is a competitive inhibitor of adenosine at the cellular level (38172). However, caffeine does not seem to affect supplemental adenosine because high interstitial levels of adenosine overcome the antagonistic effects of caffeine (11771). It is recommended that methylxanthines such as caffeine, as well as methylxanthine-containing products, be stopped 24 hours prior to pharmacological stress tests (11770). However, methylxanthines appear more likely to interfere with dipyridamole (Persantine) than adenosine-induced stress testing (11771).
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Theoretically, alcohol might increase the levels and adverse effects of caffeine.
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Theoretically, black tea may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
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Theoretically, taking black tea with antidiabetes drugs might interfere with blood glucose control.
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Theoretically, concomitant use of large amounts of black tea might increase cardiac inotropic effects of beta-agonists.
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Black tea contains caffeine. Caffeine can increase cardiac inotropic effects of beta-agonists (15).
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Theoretically, black tea might reduce the effects of carbamazepine and increase the risk for convulsion.
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Black tea contains caffeine. Animal research suggests that caffeine can lower the anticonvulsant effects of carbamazepine and can induce seizures when taken in doses above 400 mg/kg (23559,23561). Human research has shown that taking caffeine 300 mg in three divided doses along with carbamazepine 200 mg reduces the bioavailability of carbamazepine by 32% and prolongs the plasma half-life of carbamazepine 2-fold in healthy individuals (23562).
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Theoretically, concomitant use might increase the effects and adverse effects of caffeine in black tea.
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Theoretically, black tea might increase the levels and adverse effects of clozapine and acutely exacerbate psychotic symptoms.
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Concomitant administration of black tea and clozapine might theoretically cause acute exacerbation of psychotic symptoms due to the caffeine in black tea. Caffeine can increase the effects and toxicity of clozapine. Caffeine doses of 400-1000 mg daily inhibit clozapine metabolism (5051). Clozapine is metabolized by cytochrome P450 1A2 (CYP1A2). Researchers speculate that caffeine might inhibit CYP1A2. However, there is no reliable evidence that caffeine affects CYP1A2. There is also speculation that genetic factors might make some patients be more sensitive to the interaction between clozapine and caffeine (13741).
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Theoretically, concomitant use might increase the effects and adverse effects of caffeine found in black tea.
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Theoretically, concomitant use might increase the levels and adverse effects of caffeine.
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Black tea contains caffeine. Caffeine is metabolized by CYP1A2 (3941,5051,11741,23557,23573,23580,24958,24959,24960,24962), (24964,24965,24967,24968,24969,24971,38081,48603). Theoretically, drugs that inhibit CYP1A2 may decrease the clearance rate of caffeine from black tea and increase caffeine levels.
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Theoretically, black tea might decrease the vasodilatory effects of dipyridamole and interfere with its use prior to stress testing.
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Black tea contains caffeine. Caffeine is a methylxanthine that may inhibit dipyridamole-induced vasodilation (11770,11772,24974,37985,53795). It is recommended that methylxanthines such as caffeine, as well as methylxanthine-containing products such as black tea, be stopped 24 hours prior to pharmacological stress tests (11770). Methylxanthines appear more likely to interfere with dipyridamole (Persantine) than adenosine-induced stress testing (11771).
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Theoretically, disulfiram might increase the risk of adverse effects from caffeine.
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Black tea contains caffeine. In human research, disulfiram decreases the clearance and increases the half-life of caffeine (11840).
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Theoretically, using black tea with diuretic drugs might increase the risk of hypokalemia.
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Theoretically, concomitant use might increase the risk for simulant adverse effects.
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Black tea contains caffeine. There is evidence that using ephedrine with caffeine might increase the risk of serious life-threatening or debilitating adverse effects such as hypertension, myocardial infarction, stroke, seizures, and death (6486,9740,10307). Tell patients to avoid taking caffeine with ephedrine and other stimulants.
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Theoretically, estrogens might increase the levels and adverse effects of caffeine.
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Black tea contains caffeine. Estrogen inhibits caffeine metabolism (2714).
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Theoretically, black tea might reduce the effects of ethosuximide and increase the risk for convulsions.
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Black tea contains caffeine. Animal research suggests that caffeine 92.4 mg/kg can decrease the anticonvulsant activity of ethosuximide (23560). However, this effect has not been observed in humans.
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Theoretically, black tea might reduce the effects of felbamate and increase the risk for convulsions.
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Black tea contains caffeine. Animal research suggests that a high dose of caffeine 161.7 mg/kg can decrease the anticonvulsant activity of felbamate (23563). However, this effect has not been observed in humans.
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Theoretically, fluconazole might increase the levels and adverse effects of caffeine.
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Theoretically, black tea might decrease the metabolism of flurbiprofen.
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In vitro research shows that black tea decreases the metabolism of flurbiprofen, a cytochrome P450 2C9 (CYP2C9) substrate, by about 10%. However, clinical research suggests that drinking black tea does not significantly affect flurbiprofen plasma levels, metabolism, or elimination (11094).
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Theoretically, black tea might increase the levels and adverse effects of flutamide.
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Black tea contains caffeine. In vitro evidence suggests that caffeine can inhibit the metabolism of flutamide (23553). Theoretically, concomitant use of caffeine and flutamide might increase serum concentrations of flutamide and increase the risk of adverse effects.
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Theoretically, fluvoxamine might increase the levels and adverse effects of caffeine.
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Theoretically, abrupt black tea withdrawal might increase the levels and adverse effects of lithium.
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Theoretically, metformin might increase the levels and adverse effects of caffeine.
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Black tea contains caffeine. Animal research suggests that metformin can reduce caffeine metabolism (23571). Theoretically, concomitant use can increase caffeine serum concentrations and the risk of caffeine adverse effects.
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Theoretically, methoxsalen might increase the levels and adverse effects of caffeine.
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Black tea contains caffeine. Methoxsalen can reduce caffeine metabolism (23572). Concomitant use can increase caffeine serum concentrations and the risk of caffeine adverse effects.
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Theoretically, mexiletine might increase the levels and adverse effects of caffeine.
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Theoretically, concomitant use might increase the risk of a hypertensive crisis.
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Black tea contains caffeine. Caffeine has been shown to inhibit monoamine oxidase (MAO) A and B in laboratory studies (37724,37877,37912,38108). Concomitant intake of large amounts of caffeine with MAOIs might precipitate a hypertensive crisis (15). In a case report, a patient that consumed 10-12 cups of caffeinate coffee and took the MAOI tranylcypromine presented with severe hypertension (91086). Hypertension was resolved after the patients switched to drinking decaffeinated coffee.
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Theoretically, concomitant use might increase the risk of hypertension.
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Black tea contains caffeine. Concomitant use of caffeine and nicotine has been shown to have additive cardiovascular effects, including increased heart rate and blood pressure. Blood pressure was increased by 10.8/12.4 mmHg when the agents were used concomitantly (36549).
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Theoretically, black tea might reduce the absorption of organic anion-transporting polypeptide (OATP) substrates.
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In vitro, black tea extract inhibits organic anion-transporting polypeptide (OATP)2B1. OATP2B1 is expressed in the small intestine and liver and is responsible for the uptake of drugs and other compounds. In an animal model, black tea extract was found to inhibit the absorption of rosuvastatin, a substrate of OATP2B1 (104584). However, this effect has not been reported in humans.
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Theoretically, black tea might decrease the effects of pentobarbital.
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Black tea contains caffeine. Theoretically, caffeine might negate the hypnotic effects of pentobarbital (13742).
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Theoretically, black tea might reduce the effects of phenobarbital and increase the risk for convulsions.
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Theoretically, phenothiazines might increase the levels and adverse effects of caffeine. Also, black tea may bind to phenothiazines and reduce their absorption.
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Theoretically, phenylpropanolamine might increase the risk of hypertension, as well as the levels and adverse effects of caffeine.
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Theoretically, black tea might reduce the effects of phenytoin and increase the risk for convulsions.
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Theoretically, black tea might increase the levels and clinical effects of pioglitazone.
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Theoretically, quinolone antibiotics might increase the levels and adverse effects of caffeine.
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Theoretically, concomitant use might increase the levels and adverse effects of both caffeine and riluzole.
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Black tea contains caffeine. Caffeine and riluzole are both metabolized by cytochrome P450 1A2 (CYP1A2), and concomitant use might reduce metabolism of one or both agents (11739).
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Theoretically, concomitant use might decrease the levels and clinical effects of rosuvastatin.
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In animals, taking black tea extract along with rosuvastatin reduces plasma levels of rosuvastatin by approximately 48%. In vitro, black tea extract was found to inhibit organic anion-transporting polypeptide (OATP)2B1, a protein expressed in the small intestine that is responsible for the uptake of rosuvastatin and other compounds (104584). This effect has not been reported in humans.
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Theoretically, concomitant use might increase stimulant adverse effects.
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Black tea contains caffeine. Due to the central nervous system (CNS) stimulant effects of caffeine, concomitant use with stimulant drugs can increase the risk of adverse effects (11832).
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Theoretically, terbinafine might increase the levels and adverse effects of caffeine.
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Black tea contains caffeine. Terbinafine decreases the clearance of intravenous caffeine by 19% (11740).
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Theoretically, black tea might increase the levels and adverse effects of theophylline.
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Theoretically, black tea might increase the levels and adverse effects of tiagabine.
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Black tea contains caffeine. Animal research suggests that chronic caffeine administration can increase the serum concentrations of tiagabine. However, concomitant use does not seem to reduce the antiepileptic effects of tiagabine (23561).
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Theoretically, ticlopidine might increase the levels and adverse effects of caffeine.
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Black tea contains caffeine. In vitro evidence suggests that ticlopidine can inhibit caffeine metabolism (23557). However, this effect has not been reported in humans.
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Theoretically, TCAs might bind with black tea constituents when taken at the same time.
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Theoretically, black tea might reduce the effects of valproate and increase the risk for convulsions.
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Theoretically, concomitant use might increase the levels and adverse effects of caffeine.
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Black tea contains caffeine. Verapamil increases plasma caffeine concentrations by 25% (11741).
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Consuming large amounts of black tea might decrease the effects of warfarin.
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In one case, a 67-year-old female who took warfarin and who regularly consumed large amounts of black tea had a stable international normalized ratio (INR) of 1.7 to 2.7. However, the INR increased to 5 when tea consumption was discontinued. It is thought that the vitamin K content of black tea may have reduced the effects of warfarin (16902). Monitor patients carefully who start or discontinue drinking black tea while taking warfarin.
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Theoretically, taking pomegranate with ACEIs might increase the risk of adverse effects.
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Pomegranate juice is thought to have ACE inhibitor-like effects (8310).
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Theoretically, taking pomegranate with antihypertensive drugs might increase the risk of hypotension.
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Theoretically, taking pomegranate with carbamazepine might increase the risk of adverse effects, although research suggests this interaction is unlikely to be clinically significant.
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Animal research shows that pomegranate juice may inhibit cytochrome P450 3A4 (CYP3A4) metabolism of carbamazepine and increase levels of carbamazepine by 1.5 times without prolonging the elimination half-life. This suggests that pomegranate juice inhibits intestinal CYP3A4, but might not inhibit hepatic CYP3A4 (13188). However, some human research suggests that pomegranate does not significantly inhibit CYP3A4 drug metabolism in humans (16711,16712,17326).
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Theoretically, pomegranate might increase levels of drugs metabolized by CYP2C9.
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Theoretically, pomegranate might increase levels of drugs metabolized by CYP2D6.
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In vitro, pomegranate juice inhibits CYP2D6 (13703). However, the clinical significance of this potential interaction in humans is not known.
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Theoretically, pomegranate might increase levels of drugs metabolized by CYP3A4, but most research suggests this interaction is unlikely to be clinically significant.
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Pomegranate contains several polyphenols that have individually been shown to inhibit CYP3A4. However, there is contradictory evidence about the effect of whole pomegranate juice on CYP3A4 activity. In vitro, pomegranate juice significantly inhibits the CYP3A4 enzyme, with comparable inhibition to grapefruit juice (13188,16711,17326). In an animal model, pomegranate juice inhibits CYP3A4 metabolism of carbamazepine and increases levels of carbamazepine by 1.5 times (13188); however, in human volunteers, drinking a single glass of pomegranate juice 240 mL or taking 200 mL daily for 2 weeks does not significantly affect levels of the CYP3A4 substrate midazolam after oral or intravenous administration (16711,17730). Another study in healthy volunteers shows that consuming pomegranate juice 300 mL three times daily for three days also does not significantly affect levels of simvastatin, a CYP3A4 substrate (16712,91696) This suggests that pomegranate is unlikely to significantly affect levels of CYP3A4 substrates in humans (17326).
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Theoretically, taking pomegranate with rosuvastatin might increase the risk of adverse effects.
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In one case, a patient taking rosuvastatin 5 mg every other day in combination with ezetimibe 10 mg daily developed rhabdomyolysis after drinking pomegranate juice 200 mL twice weekly for 3 weeks. This patient had a history of elevated creatine kinase levels while not receiving any statin treatment. This suggests a possible underlying myopathy and predisposition to rhabdomyolysis (14465).
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Theoretically, pomegranate might increase levels of tolbutamide, although research suggests this interaction is unlikely to be clinically significant.
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Animal research shows that pomegranate juice inhibits the cytochrome P450 2C9 (CYP2C9) metabolism of tolbutamide. Pomegranate juice increased tolbutamide levels by 1.2 times without prolonging the elimination half-life. This suggests that pomegranate juice inhibits intestinal CYP2C9, but might not inhibit hepatic CYP2C9 (17327). Despite this evidence, clinical research shows that neither pomegranate juice nor pomegranate extract have a significant effect on CYP2C9 activity in humans (91694). This interaction does not appear to be clinically significant in humans.
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Theoretically, pomegranate might increase warfarin levels and increase the risk of bleeding. Also, discontinuing regular consumption of pomegranate juice might decrease warfarin levels.
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In one case report, a patient had a stable, therapeutic bleeding time, as measured by international normalized ratio (INR), while taking warfarin in combination with pomegranate juice 2-3 times per week. The patient became subtherapeutic within about 10 days after discontinuing pomegranate juice, which required a warfarin dose increase (17328). In another case report, a patient with a stable INR for over one year presented with an INR of 14. The patient noted no changes to medications or diet but did report consuming around 3 liters of pomegranate juice over the previous week. The patient's INR stabilized upon moderation of pomegranate juice consumption (24273). The mechanism of this potential interaction is unclear.
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Below is general information about the adverse effects of the known ingredients contained in the product POM Wonderful Pomegranate Black Tea. 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, black tea is well tolerated when consumed as a beverage in moderate amounts.
Most Common Adverse Effects:
Orally: Many of the adverse effects of black tea can be attributed to its caffeine content, such as diuresis, gastric irritation, insomnia, nausea, nervousness, restlessness, tachycardia, tachypnea, tremors, and vomiting.
Serious Adverse Effects (Rare):
Orally: Many of the adverse effects of black tea can be attributed to its caffeine content, such as arrhythmia, chest pain, convulsions, delirium, premature heartbeat, and respiratory alkalosis. Large doses of caffeine can cause massive catecholamine release and subsequent sinus tachycardia, metabolic acidosis, hyperglycemia, and ketosis.
Cardiovascular
...Orally, black tea can cause some cardiovascular-related adverse events.
Some of these effects may be due to the caffeine content of black tea. Acute administration of black tea can cause increased blood pressure. However, regular consumption does not seem to increase blood pressure or pulse, even in patients with mild hypertension (1451,1452,2722). Also, epidemiological research suggests that there is no association of caffeine consumption with incidence of hypertension (13739).
Black tea, which contains caffeine, may cause other adverse cardiovascular effects when used orally. These effects include tachycardia, tachypnea, chest pain, premature heartbeat, arrhythmia, and hypertension (2729,11832,11838,13735). Large doses of caffeine can also cause massive catecholamine release and subsequent sinus tachycardia (13734).
There is evidence that daily consumption of strong black tea (2 liters) or black tea solids (4 grams) can raise plasma homocysteine levels. It is unclear if lower doses have this effect (8035). Some epidemiological research has linked tea consumption with ischemic heart disease and total mortality (220,36339). Combining caffeinated beverages such as black tea with ephedra may theoretically increase the risk of adverse cardiovascular events. There is a report of ischemic stroke in an athlete who consumed ephedra 40-60 mg, creatine monohydrate 6 grams, caffeine 400-600 mg, and a variety of other supplements daily for 6 weeks (1275).
Dental ...Orally, black tea may cause tooth surface loss and teeth staining (36370).
Endocrine
...Black tea contains caffeine.
Large doses of caffeine can cause massive catecholamine release and subsequent metabolic acidosis, hyperglycemia, and ketosis (13734).
Some evidence shows caffeine is associated with fibrocystic breast disease, breast cancer, and endometriosis. However, other research has not supported this finding (8043). Restricting caffeine in females with fibrocystic breast conditions doesn't seem to affect breast nodularity, swelling, or pain (8996). A population analysis of the Women's Health Initiative observational study found no association between consumption of caffeine-containing beverages such as black tea and the incidence of invasive breast cancer in models adjusted for demographic, lifestyle, and reproductive factors (108806). Also, a dose-response analysis of two low-quality observational studies found that high consumption of caffeine is not associated with an increased risk of breast cancer (108807).
Gastrointestinal ...Orally, caffeine in black tea can cause gastric irritation, nausea, and vomiting (11832,11838,13735). Some believe that long-term use of caffeine can cause withdrawal symptoms following discontinuation of use. However, the existence of caffeine withdrawal is controversial. Some researchers think that if it exists, it appears to be of little clinical significance (11839). Gastrointestinal withdrawal symptoms such as nausea and vomiting have been described. However, these symptoms may be from nonpharmacological factors related to knowledge and expectation of effects. Clinically significant gastrointestinal symptoms caused by caffeine withdrawal may be uncommon (2723,11839).
Hematologic ...Orally, caffeine in black tea can cause hypokalemia (11832,11838,13735). In infants, black tea can cause microcytic anemia (631).
Immunologic ...Orally, caffeine in black tea can cause anaphylaxis in sensitive individuals, although true IgE-mediated caffeine allergy seems to be relatively rare (11315).
Musculoskeletal
...Some epidemiological research suggests that caffeine, which is found in black tea, may be associated with an increased risk of osteoporosis, but conflicting evidence exists.
Caffeine can increase urinary excretion of calcium (2669,10202,11317). Females identified with a genetic variant of the vitamin D receptor appear to be at an increased risk for the detrimental effect of caffeine on bone mass (2669). However, moderate caffeine intake, less than 300 mg per day, does not seem to significantly increase osteoporosis risk in most postmenopausal adults with normal calcium intake (2669,6025,10202,11317).
Some researchers believe that stopping regular use of caffeine may cause withdrawal symptoms such as muscle tension and muscle pains. However, these symptoms may be from nonpharmacological factors related to knowledge and expectation of effects (2723,11839).
Neurologic/CNS
...Orally, caffeine in black tea can cause insomnia, nervousness, headache, anxiety, agitation, jitteriness, restlessness, ringing in the ears, tremors, delirium, and convulsions (11832,11838,13735).
Caffeine may also exacerbate sleep disturbances in patients with acquired immunodeficiency syndrome (AIDS) (10204).
There is some concern that stopping regular use of caffeine may cause withdrawal symptoms such as headache; tiredness and fatigue; decreased energy, alertness, and attentiveness; drowsiness; decreased contentedness; depressed mood; difficulty concentrating; irritability; and lack of clear-headedness are typical of caffeine withdrawal (13738). Other symptoms such as delirium, nervousness, restlessness, and anxiety have been described. However, these symptoms may be from nonpharmacological factors related to knowledge and expectation of effects (2723,11839).
Oncologic ...There is some evidence that consumption of black tea (greater than 1 cup per day) may increase the risk of colon and rectal cancers (8041,36482). Drinking 3 or more cups daily has been shown to increase the risk of pancreatic cancer (36507). In addition, drinking black tea more than once a day, drinking strong black tea, or using more than 300 grams of tea leaves per month is associated with an approximately 2-fold increased risk of esophageal cancer when compared with drinking black tea up to once daily, drinking mild to moderate black tea, or using up to 300 grams of tea leaves per month (102756). Some evidence also shows caffeine, which is found in black tea, is associated with breast cancer in females. However, this is controversial since findings are conflicting (8043).
Pulmonary/Respiratory ...Orally, caffeine in black tea may cause tachypnea-induced respiratory alkalosis (11832,11838,13735). Some researchers think that stopping regular use of caffeine may cause withdrawal symptoms such as runny nose. However, this symptom may be from nonpharmacological factors related to knowledge and expectation of effects (2723,11839).
Renal ...Orally, caffeine in black tea may cause diuresis (11832,11838,13735).
General
...Orally, pomegranate fruit juice is generally well tolerated.
Pomegranate fruit extract and seed oil seem to be well tolerated. Pomegranate root, stem, and peel should not be used orally in large amounts. Topically, pomegranate fruit extract seems to be well tolerated.
Most Common Adverse Effects:
Oral: Diarrhea, flatulence.
Cardiovascular ...In one clinical trial, 2% of patients experienced hyperlipidemia and hypertension after consumption of pomegranate juice (69175). However, most clinical research shows that pomegranate does not increase cholesterol or blood pressure and may actually improve these parameters in some patients (8310,13022,13023,69168,69373,69374).
Dermatologic ...Topically, pomegranate may cause urticaria (hives) in some patients (8445).
Gastrointestinal ...Orally, pomegranate may cause mild gastrointestinal adverse effects. In one clinical study, drinking pomegranate juice 8 ounces daily caused diarrhea and flatulence in 2% of patients (69175). In another clinical study, taking pomegranate extract (POMx, POM Wonderful LLC) 3000 mg daily caused diarrhea in 10% of patients. This dose of pomegranate extract also caused nausea, abdominal pain, constipation, gastrointestinal upset, and vomiting in a small number of patients (91695).
Immunologic
...Orally, pomegranate fruit or seeds may cause allergic reactions.
These allergic reactions occur more commonly in people who are allergic to other plants (7674). In rare cases, pomegranate fruit can cause angioedema. Angioedema seems to occur without warning and in people who have eaten pomegranate for many years. Patients should be told to stop eating pomegranate if swelling of the tongue or face develops (7673). In one report, a patient experienced pomegranate-dependent, exercise-induced anaphylaxis. The patient developed widespread urticaria (hives) and lip edema after eating pomegranate seeds and then exercising (17331). In another report, an atopic patient experienced an allergic reaction to pomegranate fruit. Symptoms included urticaria (hives), facial angioedema, and hypotension (91692).
Topically, pomegranate may cause contact hypersensitivity characterized by urticaria (hives), angioedema, rhinorrhea, red itchy eyes, and dyspnea arising within a few minutes of exposure (8445).
Pulmonary/Respiratory ...Orally, pomegranate juice may cause nasal congestion, but this event is rare. In one clinical study, pomegranate juice was associated with nasal congestion in 2% of patients (69175). There is also one case report of a 7-year-old asthmatic child who developed bronchospasm moments after ingesting several pomegranate seeds (69149).