Each capsule contains Proprietary Blend: Caryophylli Flos • Curculiginis Rhizoma • Semen Allii Tuberosi • Herba Epimedii • Rhizoma Polygonati .
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
Below is general information about the effectiveness of the known ingredients contained in the product Hard Times for Men. 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 Hard Times for Men. 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 in amounts commonly found in foods. Clove, clove oil, and eugenol have Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).
POSSIBLY SAFE ...when clove oil is applied topically (272). A clove oil 1% cream has been applied to the anus with apparent safety for up to 6 weeks (43487). A liposome-based product containing clove oil 45% has been applied to the palms with apparent safety for up to 2 weeks (100596).
LIKELY UNSAFE ...when clove smoke is inhaled. Smoking clove cigarettes can cause respiratory injury (17,43599). ...when clove oil is injected intravenously. This can cause pulmonary edema, hypoxemia, and acute dyspnea (16384). There is insufficient reliable information available about the safety of using clove orally in medicinal amounts.
CHILDREN: LIKELY UNSAFE
when clove oil is taken orally.
Ingesting 5-10 mL of undiluted clove oil has been linked to reports of coagulopathy, liver damage, and other serious side effects in infants and children up to 3 years of age (6,17,43385,43395,43419,43457,43652).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts found in foods (4912).
Clove, clove oil, and eugenol have Generally Recognized As Safe (GRAS) status for use in foods in the US (4912). There is insufficient reliable information available about the safety of using clove in medicinal amounts during pregnancy and lactation; avoid using.
POSSIBLY SAFE ...when horny goat weed extract is used orally and appropriately, short-term. A specific extract of horny goat weed containing 60 mg icariin, 15 mg daidzein, and 3 mg genistein (Xianling Gubao; Tong Ji Tang Pharmacal Company) has been used daily with apparent safety for up to 24 months (14900,97268). Another aqueous extract of horny goat weed containing up to 25.36% icariin has been used in a dose of 300 mL daily with apparent safety for up to 6 months (55452). Another horny goat weed extract has been used with apparent safety at doses up to 1000 mg daily (providing 200 mg icariin) for up to 30 days (108311).
POSSIBLY UNSAFE ...when used orally long-term or in high doses. Long-term use, or taking high doses of some species of horny goat weed, has been linked to serious adverse effects including respiratory arrest (10346).
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Horny goat weed might have androgenic activity (10346). Theoretically, it might harm a developing fetus; avoid using.
LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Hard Times for Men. 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, clove oil may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
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Theoretically, concomitant use of clove extracts with antidiabetes drugs might increase the risk of hypoglycemia.
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Clinical and laboratory research suggest that polyphenol extracts from clove flower buds might lower blood glucose levels (100595). Dosing adjustments for insulin or oral hypoglycemic agents may be necessary when taken with clove. Monitor blood glucose levels closely.
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Theoretically, topical application of clove oil with ibuprofen might increase the absorption and side effects of topical ibuprofen.
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Laboratory research shows that topical application of clove oil increases the absorption of topical ibuprofen (98854). This interaction has not been reported in humans.
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Theoretically, horny goat weed might increase the risk of bleeding.
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In vitro research and animal research shows that horny goat weed can inhibit platelet aggregation and thrombus formation (105832). This effect has not been reported in humans.
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Theoretically, horny goat weed might increase the risk of hypotension.
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Laboratory research suggests that horny goat weed might have hypotensive effects (10346). This effect has not been reported in humans.
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Theoretically, horny goat weed might increase the effects and side effects of CYP1A2 substrates.
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In vitro, horny goat weed leaf extract inhibits CYP1A2 (97267). This effect has not been reported in humans.
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Theoretically, horny goat weed might increase the effects and side effects of CYP2B6 substrates.
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In vitro, horny goat weed leaf extract inhibits CYP2B6 (97267). This effect has not been reported in humans.
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Theoretically, horny goat weed might increase the effects and side effects of CYP3A4 substrates.
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In vitro, horny goat weed extract inhibits CYP3A4 and suppresses CYP3A4 mRNA expression (112708). This effect has not been reported in humans.
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Theoretically, concomitant use of horny goat weed with estrogens might increase their therapeutic and adverse effects.
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Below is general information about the adverse effects of the known ingredients contained in the product Hard Times for Men. 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, clove is well tolerated when consumed as a spice; however, clove oil in doses of only 5-10 mL can be toxic in children.
Topically, clove is generally well tolerated. When inhaled or used intravenously, clove may be unsafe.
Most Common Adverse Effects:
Topically: Burning, contact dermatitis, dental decay, itching, mucous membrane irritation, tingling, ulcers.
Inhaled: Dental decay, hypertension, itching, tachycardia.
Serious Adverse Effects (Rare):
Orally: Liver failure, respiratory distress.
Inhaled: Pneumonitis, pulmonary edema, respiratory distress.
Cardiovascular ...Smoking clove cigarettes increases heart rate and systolic blood pressure (12892).
Dental ...Population research has found that the risk of dental decay is increased in clove cigarette smokers (43332). Repeated topical application of clove in the mouth can cause gingival damage and skin and mucous membrane irritation (4,272,512). Eugenol, a constituent of clove and a material commonly found in dentistry, has been associated with side effects including gum inflammation and irritation (43365,43373,43522).
Dermatologic ...The American Dental Association has accepted clove for professional use, but not nonprescription use, due to potential damage to soft tissue that may be induced by clove application. In clinical research, small aphthous-like ulcers appeared in the area of the mouth where clove gel was applied in four participants (43448). Skin irritation and stinging have been reported with clove oil application (43338,43626). In a 24-year-old, exposure to a clove oil spill resulted in permanent local anesthesia and anhidrosis, or lack of sweating, at the affected area (43626).
Endocrine ...A case of hypoglycemia and metabolic acidosis have been reported after administration of one teaspoon of clove oil to a seven-month-old infant (43457). A case of electrolyte imbalance following accidental ingestion by a seven-month-old has also been reported (6).
Hematologic ...A case of disseminated intravascular coagulation has been reported in a 2-year-old patient after consuming between 5-10 mL of clove oil. The patient was treated with heparin, fresh frozen plasma, protein C, factor VII, and antithrombin III. On the fifth day, the patient started to improve and made a full recovery (43652).
Hepatic ...There are three cases of hepatic failure occurring in children after ingestion of 5-10 mL of clove oil (43395,43419,43652). Liver injury also occurred in a 3-year-old male (96949). These patients were successfully treated with N-acetylcysteine. The course of liver injury seems to be milder and shorter with early N-acetylcysteine treatment (43395,43419,96949). Another patient, who also presented with disseminated intravascular coagulation, was successfully treated with heparin, fresh frozen plasma, protein C, factor VII, and antithrombin III (43652).
Immunologic ...Contact dermatitis and urticaria has been reported following topical exposure to clove oil or eugenol, a constituent of clove oil (12635,43339,43606,43346).
Neurologic/CNS ...CNS depression has been reported in a 7-month-old who was given one teaspoon of clove oil accidentally in place of mineral oil for diarrhea. The patient was successfully treated with supportive care and gastric lavage (43457). A case of confusion and inability to speak has been reported secondary to oral exposure to clove oil and alcohol. The patient required intubation and was successfully treated with thiamine and normal saline (43580). Seizure and coma have been reported in a two-year-old male after ingesting 5-10 mL of clove oil (43652).
Pulmonary/Respiratory
...Clove cigarettes have been associated with throat and chest tightness (43337), pulmonary edema (43618), and fatal aspiration pneumonitis (43599).
The causative factor may be clove alone or clove along with other substances found in cigarettes. Clove cigarettes contain significant amounts of nicotine, tar, and carbon monoxide and increase plasma levels of nicotine and exhaled carbon monoxide, which might cause long-term health effects similar to tobacco smoking (12892). According to the American Medical Association, inhaling clove cigarette smoke has been associated with severe lung injury in a few susceptible individuals with prodromal respiratory infection. Also, some individuals with normal respiratory tracts have apparently suffered aspiration pneumonitis as the result of a diminished gag reflex induced by a local anesthetic action of eugenol, which is volatilized into the smoke (43602).
Intravenous injection of clove oil in a 32-year-old female resulted in hypoxia, acute dyspnea, interstitial and alveolar infiltrates, and non-cardiogenic pulmonary edema. The patient was managed with supplemental oxygen and recovered over the next seven days (16384).
Occupational exposure to eugenol, a constituent of clove, has also been reported to cause asthma and rhinitis (43492).
Renal ...Proteinuria and other urinary abnormalities were observed in a seven-month-old infant given one teaspoon of clove oil accidentally in place of mineral oil for diarrhea. The patient was successfully treated with supportive care and gastric lavage (43457).
General
...Orally, horny goat weed seems to be well tolerated when used short-term.
Most Common Adverse Effects:
Orally: Dizziness, dry mouth, nosebleed, thirst, and vomiting.
Serious Adverse Effects (Rare):
Orally: Respiratory arrest.
Cardiovascular ...A 66-year-old male with a history of cardiovascular disease developed tachyarrhythmia after taking horny goat weed for 2 weeks (13006). It is not clear if this product contained only horny goat weed or a combination of ingredients; therefore, assigning causality is not possible.
Gastrointestinal ...Orally, long-term use of horny goat weed has been associated with reports of vomiting, dry mouth, thirst, and nosebleed (10346).
Hepatic ...A case of hepatotoxicity characterized by abdominal pain, nausea, vomiting, and fever has been reported in a 40-year-old male patient with hepatitis C, after a month of taking one tablet daily of a combination product containing horny goat weed and multiple other ingredients (Enzyte, Vianda). Symptoms improved following cessation of the product, but it is not clear if they were due to horny goat weed, another ingredients, or hepatitis C (91590). An observational study over 24 years found 26 cases of drug-induced hepatoxicity associated with horny goat weed (112707).
Musculoskeletal ...Orally, large doses of horny goat weed may cause exaggeration of tendon reflexes to the point of spasm (10346).
Neurologic/CNS ...Orally, long-term use of horny goat weed has been associated with reports of dizziness (10346).
Psychiatric ...There is a case report of hypomania in a 66-year-old male who took horny goat weed for 2 weeks (13006). It is not clear if this product contained only horny goat weed or a combination of ingredients; therefore, assigning causality is not possible.
Pulmonary/Respiratory ...Orally, large doses of horny goat weed may cause respiratory arrest (10346).