Ingredients | Amount Per Serving |
---|---|
300 mg | |
(CoQ10)
|
105 mg |
(Ostarine)
|
60 mg |
N-Methyl-D-Aspartic Acid
|
30 mg |
Brown Rice Flour, Magnesium Stearate, Titanium Dioxide, Gelatin, FD&C Yellow #6, FD&C Green #3
Below is general information about the effectiveness of the known ingredients contained in the product Osta 2.0. 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
Below is general information about the safety of the known ingredients contained in the product Osta 2.0. 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. Coenzyme Q10 has been used safely in studies lasting up to 5 years (2134,6037,6038,6407,8163,8938,8939,8940,15395,17413,17716,96538)(109391). ...when used topically on the gums (2107,2108,8916,8917,8918).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately.
Coenzyme Q10 in doses of 1-10 mg/kg/day has been used safely for up to 9 months under medical supervision (12199,13223,15256,44005,107449).
PREGNANCY: POSSIBLY SAFE
when used orally and appropriately.
Coenzyme Q10 100 mg twice daily has been used with apparent safety during pregnancy, starting at 20 weeks gestation until term (17201).
LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY UNSAFE ...when used orally. Ostarine 1-3 mg daily has been used with apparent safety under medical supervision for up to 12-16 weeks by most patients in clinical studies (98832,98833). However, there are concerns about the potential of ostarine and other selective androgen receptor modulators (SARMs) to cause serious adverse reactions, including hepatotoxicity, myocardial infarction, and stroke (98840,106197). No long-term safety studies have been conducted (98840).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally and appropriately. Saw palmetto has been safely used in clinical studies lasting up to 3 years (2735,6750,6752,6764,6772,6773,11354,14274,15550,17202,17306,17684,73315,73383,73384,73385,73389,89441,96410,96412,110540).
POSSIBLY SAFE ...when used rectally and appropriately. Saw palmetto has been used safely in clinical research at a dose of 640 mg once daily for 30 days (73387). However, the long-term safety of saw palmetto administered rectally is not known.
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally.
Saw palmetto has hormonal activity (6766); avoid using.
Below is general information about the interactions of the known ingredients contained in the product Osta 2.0. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Coenzyme Q10 has antioxidant effects. Theoretically, this may reduce the activity of chemotherapy drugs that generate free radicals.
Details
|
Theoretically, coenzyme Q10 might have additive effects with antihypertensive drugs.
Details
|
Coenzyme Q10 is chemically similar to menaquinone and might have vitamin K-like procoagulant effects, which could decrease the effects of warfarin.
Details
Concomitant use of coenzyme Q10 and warfarin might reduce the anticoagulant effects of warfarin (2128,6048,6199). Four cases of decreased warfarin efficacy thought to be due to coenzyme Q10 have been reported (2128,6048,11048). However, there is some preliminary clinical research that suggests coenzyme Q10 might not significantly decrease the effects of warfarin in patients who have a stable INR (11905).
|
Theoretically, ostarine might increase levels of drugs metabolized by CYP2C9, although clinical research suggests this is not clinically relevant.
Details
Although in vitro research suggests that ostarine inhibits CYP2C9, more robust clinical research shows that ostarine does not significantly affect CYP2C9 (98834).
|
Theoretically, concomitant use of ostarine with CYP3A4 inducers could decrease the clinical effects of ostarine.
Details
Ostarine is partially metabolized by CYP3A4. Clinical research shows that taking rifampin, a potent inducer of CYP3A4, reduces the maximum plasma concentration of ostarine by 23% and the area under the curve by 43% (98834).
|
Theoretically, concomitant use of ostarine with CYP3A4 inhibitors could increase the effects and adverse effects of ostarine, although this is unlikely to be clinically significant.
Details
Ostarine is partially metabolized by CYP3A4. However, clinical research shows that taking itraconazole, a potent inhibitor of CYP3A4, had minimal effects on the levels of ostarine in the body (98834).
|
Theoretically, concomitant use with hepatotoxic drugs might increase the risk of adverse hepatotoxic effects.
Details
Some clinical research shows that ostarine can increase alanine aminotransferase, a marker of liver damage, in some patients (98832,98833). Additionally, the U.S. Food and Drug Administration warns that supplements containing SARMs, such as ostarine, have been associated with reports of liver toxicity (94879,94880,94881) and there are at least two reports of drug-induced liver injury attributed to the use of ostarine (106197,111385).
|
Theoretically, concomitant use of ostarine with probenecid could increase the effects and adverse effects of ostarine.
Details
Clinical research shows that probenecid increases ostarine levels and slows the clearance of ostarine, likely via inhibition of UDP-glucuronosyltransferase (UGT). Ostarine is partially metabolized by UGT (98834).
|
Theoretically, concomitant use of ostarine with rifampin could decrease the clinical effects of ostarine.
Details
Clinical research shows that taking rifampin with ostarine reduces the maximum plasma concentration of ostarine by 23% and the area under the curve by 43% (98834). Ostarine is partially metabolized by cytochrome P450 3A4 (CYP3A4), and rifampin is a potent CYP3A4 inducer.
|
Saw palmetto might increase the risk of bleeding with anticoagulant or antiplatelet drugs.
Details
Saw palmetto is reported to prolong bleeding time (8659). Theoretically, it might increase the risk of bleeding when used concomitantly with anticoagulant or antiplatelet drugs.
|
Saw palmetto might reduce the effectiveness of contraceptive drugs.
Details
Saw palmetto might have antiestrogenic effects (6766). Theoretically, it might interfere with contraceptive drugs taken concomitantly.
|
Saw palmetto might reduce the effectiveness of estrogens.
Details
Saw palmetto might have antiestrogenic effects (6766). Theoretically, it might interfere with estrogens taken concomitantly.
|
Below is general information about the adverse effects of the known ingredients contained in the product Osta 2.0. 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, coenzyme Q10 is generally well tolerated.
In clinical studies, no serious adverse effects have been reported.
Most Common Adverse Effects:
Orally: Gastrointestinal side effects such as appetite suppression, diarrhea, epigastric discomfort, heartburn, nausea, and vomiting. These generally occur in less than 1% of patients. Some of these adverse effects can be minimized if daily doses above 100 mg are divided.
Cardiovascular ...Palpitations have been reported as being possibly associated with coenzyme Q10 treatment (89421). Death due to myocardial infarction occurred in one Parkinson disease patient taking coenzyme Q10; causality is unclear (15395).
Dermatologic ...Two of 143 participants in a case series reported skin itching after starting treatment with oral coenzyme Q10 (6047). Allergic rash has also been reported (6409,11872). An itching exanthema was seen in two heart failure patients treated with intravenous coenzyme Q10 (44284).
Gastrointestinal ...Gastrointestinal side effects of coenzyme Q10 have included nausea (3365,6409,8907,10152,43982,44172,44179,44330,89421,109392), vomiting (3365,10152,44330,89421), epigastric discomfort (3365,44179,44330,89421), constipation (109392), diarrhea (44179,92904,89421,109392), stomach upset (8940,12170,109387,109388,109392), loss of appetite (2121), heartburn (2121,44179,109392), and flatulence (43982), although this occurs in less than 1% of patients. In one clinical study, gastrointestinal bleeding in association with angiodysplasia has been reported to be possibly related to coenzyme Q10 treatment (89421).
Genitourinary ...An uncomplicated urinary infection was reported in a patient taking oral coenzyme Q10 (nanoQuinon, MSE Pharmazeutika) (44020).
Hematologic ...Thrombocytopenia was noted in one patient treated with oral coenzyme Q10 (44296); however, other factors (viral infection, other medications) may have been responsible for this adverse effect.
Musculoskeletal ...Increased plasma creatine kinase with high-intensity exercise has been reported in patients taking coenzyme Q10 (44303). Muscle pain has been reported rarely in one clinical trial (109392).
Neurologic/CNS ...Headache and dizziness have been reported in human research (3365,11872,43982,44330,109392). Insomnia has been reported as being possibly associated with coenzyme Q10 treatment (89421). Cognitive decline, depression, and sudden falls were reported rarely in a clinical trial of patients with Huntington disease (8940). Increased lethargy was reported for one patient treated with oral coenzyme Q10 (44042). Feeling of internal trembling has been reported in a clinical trial for one patient treated with coenzyme Q10 (44020).
Ocular/Otic
...Visual sensitivity to light has been reported for a patient treated with coenzyme Q10.
However, the association of this effect with coenzyme Q10 treatment was not clear (6409).
A burning sensation has been reported for 10% of patients treated with a topical eye solution containing coenzyme Q10 and alpha-tocopheryl polyethylene glycol 1000 succinate following cataract surgery (44228).
Psychiatric ...Worsening depression has been reported as being possibly associated with oral coenzyme Q10 treatment (89421).
Pulmonary/Respiratory ...Drug-induced pneumonitis was diagnosed in a 61 year-old woman who had been taking coenzyme Q10 and perilla leaf extract for two months (43978). Symptoms improved after she stopped taking the supplements and began taking oral prednisone. Causation from coenzyme Q10 was unclear.
Other ...In a case report, a naval aviator using a supplement containing coenzyme Q10 and niacin had reduced G tolerance (44186). G tolerance was regained with cessation of the supplement.
General
...Orally, ostarine is possibly unsafe.
Most Common Adverse Effects:
Orally: Abdominal pain, anorexia, constipation, diarrhea, nausea, and transient increases in alanine aminotransferase (ALT) levels.
Serious Adverse Effects (Rare):
Orally: Hepatotoxicity.
Cardiovascular ...Orally, in a 12-week study of healthy elderly patients taking ostarine daily, high-density lipoprotein (HDL) cholesterol levels decreased by 9 mg/dL and 15 mg/dL with ostarine 1 mg and 3 mg, respectively, when compared with placebo (98833). Theoretically, reductions in HDL reported with ostarine could potentially increase the risk for adverse cardiovascular effects. In fact, the U.S. Food and Drug Administration also warns that supplements containing SARMs, such as ostarine, have been associated with increased risk of myocardial infarction and stroke (94879,94880,94881,98840).
Gastrointestinal ...Orally, ostarine has been commonly reported to cause gastrointestinal adverse effects (98832,98833). In a 16-week study of cancer patients taking ostarine 1-3 mg daily, nausea, diarrhea, constipation, abdominal pain, and anorexia occurred in 10% or more of patients, which was more common than with placebo. Vomiting was also commonly reported, although the incidence was slightly lower than placebo (98832). In a 12-week study of healthy elderly patients taking ostarine 1-3 mg by mouth daily, diarrhea occurred more frequently with ostarine than with placebo. Nausea was also reported, but at the same rate as placebo (98833).
Hematologic ...Orally, in a 16-week study of cancer patients taking ostarine 1-3 mg daily, anemia and thrombocytopenia were reported more frequently with ostarine than with placebo, although the rate of occurrence in both groups was similar (98832).
Hepatic
...Orally, in a 16-week study of cancer patients taking ostarine 1-3 mg daily, a transient increase in alanine aminotransferase (ALT) of 2- to 4-times the upper limit of normal occurred in 7.
4% of patients taking ostarine 3 mg (98832). In a 12-week study of healthy elderly patients taking ostarine by mouth daily, an increase in ALT was reported in 4.2% of patients taking ostarine 1 mg and 20.8% of patients taking ostarine 3 mg. ALT levels did not change in the placebo group. In most cases, ALT levels resolved over the course of the study without the need to discontinue treatment. However, one patient's ALT increased to over 4-times the upper limit of normal, which required discontinuation of ostarine. The patient's ALT returned to normal after treatment discontinuation (98833).
The U.S. Food and Drug Administration also warns that supplements containing SARMs, such as ostarine, have been associated with reports of liver toxicity (94879,94880,94881). There are at least two reports of drug-induced liver injury (DILI) attributed to ostarine. In one case, a 40-year-male developed DILI, characterized by anorexia, diarrhea, lethargy, weight loss, and jaundice, after taking ostarine to improve weight training and increase muscle mass for 2 months. The patient's symptoms and liver function tests improved gradually over several months after discontinuation of ostarine (106197). In another case, a 31-year-old male presented with a probable DILI characterized by pruritus, dark urine, and elevated transaminases for 1 week after using ostarine for 3 weeks. The DILI and associated signs and symptoms resolved within weeks after discontinuation of ostarine (111385).
In one case, a 43-year-old male taking ostarine and cardarine to increase muscle mass presented with several signs and symptoms associated with DILI, including epigastric pain, dark urine, and elevated liver function tests. The patient claims the supplements were used short-term for a few days before cycling a long distance. However, based on the pharmacokinetic properties of these products and the levels detected in the patient's blood, hair, and urine, researchers suggest that longer-term use was present. The patient's symptoms resolved within a few weeks after discontinuation of both supplements (111382). It is unclear if these adverse effects are due to ostarine, cardarine, or the combination.
Musculoskeletal
...Orally, in a 12-week study of healthy elderly patients taking ostarine 1-3 mg daily, back pain was reported in 25% of patients (98833).
However, in a 16-week study of cancer patients taking ostarine 1-3 mg daily, back pain occurred at a similar rate with ostarine and placebo (98832).
In one case, a 43-year-old male taking ostarine and cardarine to increase muscle mass presented with several symptoms, including myalgia and rhabdomyolysis with elevated creatine phosphokinase (CPK). The patient claims the supplements were used short-term for a few days before cycling a long distance. However, based on the pharmacokinetic properties of these products and the levels detected in the patient's blood, hair, and urine, researchers suggest that longer-term use was present. The patient's symptoms resolved within a few weeks after discontinuation of both supplements (111382). It is unclear if these adverse effects are due to ostarine, cardarine, or the combination.
Neurologic/CNS ...Orally, in a 16-week study of cancer patients taking ostarine 1-3 mg daily, headache occurred more frequently with ostarine than with placebo. Fatigue was also commonly reported, but at a rate similar to placebo (98832). In a 12-week study of healthy elderly patients taking ostarine 1-3 mg daily, headache occurred in 29% of patients, which was more common than with placebo. Fatigue was also reported, but at a lower rate than with placebo (98833). The U.S. Food and Drug Administration also warns that supplements containing SARMs, such as ostarine, have been associated with increased risk of stroke (94879,94880,94881).
Pulmonary/Respiratory ...Orally, in a 16-week study of cancer patients taking ostarine 1-3 mg daily, pneumonia occurred more frequently with ostarine than with placebo. Cough and dyspnea were also reported, but at rates slightly lower than placebo (98832). In a 12-week study of healthy elderly patients taking ostarine 1-3 mg daily, cough occurred more frequently with ostarine than with placebo (98833).
Other ...Orally, in a 16-week study of cancer patients taking ostarine 1-3 mg daily, pyrexia occurred more frequently with ostarine than with placebo (98832).
General
...Orally, saw palmetto is well tolerated and adverse effects are mild, infrequent, and reversible.
Most Common Adverse Effects:
Orally: Abdominal pain, constipation, decreased libido, diarrhea, dizziness, fatigue, headache, nausea, rhinitis, vomiting.
Cardiovascular ...Occasionally, cases of hypertension, postural hypotension, tachycardia, angina pectoris, arrhythmia, extrasystole, angiopathy, myocardial infarction, and congestive heart failure have been reported in patients using saw palmetto orally (6424,6484,6752,6772,17684,73388,89441). One case of severe bradycardia and second degree heart block was reported in a 64 year-old male taking an unknown amount of saw palmetto for a few weeks (96413).
Dermatologic ...A case report describes a 61-year-old male who developed a fixed drug eruption with localized blisters and erosions three days after starting oral saw palmetto. The lesions resolved when saw palmetto was stopped, but recurred when it was reintroduced six months later. Topical corticosteroid treatment was necessary and the patient was left with some residual hyperpigmented patches (104805). A combination of saw palmetto and beta-sitosterol has been associated with a single report of worsening acne (15550).
Endocrine ...Two case reports involving one 11-year-old female undergoing treatment for telogen effluvium and another 10-year-old female undergoing treatment for hirsutism, describe hot flashes and the onset of menarche associated with use of saw palmetto. One of these patients was consuming saw palmetto in a food supplement; the other was taking a supplement containing saw palmetto 320 mg daily (73361,96414). In both cases, the hot flashes resolved following treatment discontinuation. In one case, a rechallenge with saw palmetto caused a recurrence of hot flashes.
Gastrointestinal ...Gastrointestinal complaints such as nausea, vomiting, constipation, diarrhea, gastralgia, and halitosis are the most frequently reported adverse effects associated with saw palmetto (6484,6752,60442,73315,73320,73348,73354,73383,73385,73388,89441). Less often, cases of duodenal ulcer, dyspepsia, or heartburn have been reported (6772,73329,73354). Meteorism (intestinal gas accumulation) has also been reported with saw palmetto, although causality was unclear (60442).
Genitourinary ...Some clinicians are concerned that saw palmetto might cause erectile dysfunction, ejaculatory disturbance, or altered libido because of its potential effects on 5-alpha-reductase. Some preliminary clinical studies have reported sexual dysfunction, particularly ejaculatory dysfunction, erectile dysfunction, and reduced libido, in patients taking saw palmetto (5093,17202,17684,73383,89441). However, most of these patients were previously diagnosed with prostate disorders, so causality is unclear. Additionally, several clinical studies indicate that the occurrence of impotence in males taking saw palmetto is similar to placebo and tamsulosin (Flomax), and significantly less than finasteride (Proscar) (2732,6424,17306,107481). Rarely, cases of testicular pain, vesical tenesmus, and urinary tract infections have been reported in patients using saw palmetto extract orally (73388).
Hematologic ...Saw palmetto might have antiplatelet effects and potentially increase the risk of bleeding in some patients. There is one report of excessive intraoperative bleeding in a patient who took saw palmetto prior to surgery. Bleeding time normalized when saw palmetto was discontinued (8659). Also, one case of cerebral hemorrhage has been reported, but details are not available to determine causality (6772,73348). A case of retroperitoneal hematoma after bilateral inguinal hernia repair is reported in a male patient taking saw palmetto. The patient was discharged after a 3-day hospitalization in stable condition (112177).
Hepatic ...A case report describes a patient who developed acute hepatitis and pancreatitis while taking saw palmetto. Symptoms resolved when saw palmetto was discontinued, and reemerged upon re-challenge (14457). Other cases of acute hepatitis and pancreatitis, with elevated alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin have been reported in patients using saw palmetto orally (14457,73350,73351).
Musculoskeletal ...Orally, saw palmetto may cause fatigue, weakness, muscle pain, and back pain, although these adverse events are rare (6424,73388,89441). A case of saw palmetto-related rhabdomyolysis was reported in an 82-year-old male presenting with kidney dysfunction, increased C-reactive protein levels, and elevated serum creatine kinase (73358).
Neurologic/CNS ...Orally, saw palmetto can cause headaches, dizziness, insomnia, and fatigue (6750,6752,6772,11354,60442,73348,73385,73388,89441).
Ocular/Otic ...A case of intraoperative floppy-iris syndrome (IFIS) has been reported in a patient using saw palmetto orally (73340). However, no statistically significant association between saw palmetto and IFIS was found in a case series of 660 patients undergoing cataract surgery (73347).
Pulmonary/Respiratory ...Rhinitis is one of the more commonly reported adverse effects of saw palmetto (73348). One patient taking saw palmetto extract 160 mg twice daily reported "breathlessness" (73388). Two cases of respiratory depression have been reported in patients using saw palmetto extract (Permixon) 320 mg (6772).