Galactogil by Iprad Group

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Diabetes. It is unclear if oral cumin is beneficial in patients with diabetes. Details: Two small clinical studies in adults with type 2 diabetes show that taking cumin essential oil 25-100 mg by mouth daily for 8-12 weeks reduces fasting blood glucose, glycated hemoglobin (HbA1c), serum insulin, and diabetes-associated inflammatory markers when compared with placebo (111368,111370). However, meta-analyses of studies in patients with and without type 2 diabetes show conflicting results. One analysis of seven clinical trials shows that taking cumin essential oil 25-300 mg daily for up to 24 weeks does not improve fasting plasma glucose, HbA1c, or other markers of glycemic control when compared with a control group (106516). Another meta-analysis evaluating eight clinical trials, including all seven assessed in the previous analysis, shows that cumin essential oil has a large effect on both fasting plasma glucose and HbA1c when compared with control (106517). These discrepant findings may be due to the inclusion of an additional trial in the second analysis or different methods for pooling study results.
• Dyslipidemia. It is unclear if oral cumin is beneficial in patients with dyslipidemia. Details: A meta-analysis of six clinical trials including 376 individuals with or without hyperlipidemia shows that taking cumin reduces levels of total cholesterol by around 11 mg/dL and low-density lipoprotein (LDL) cholesterol by around 7 mg/dL when compared with control or placebo. Cumin also increases high-density lipoprotein (HDL) cholesterol levels by around 3 mg/dL, but does not affect triglyceride levels. A sub-analysis of dosages and dosage forms shows that cumin essential oil 25-100 mg daily or cumin powder 3 grams daily were beneficial, while lower doses of the powder or essential oil and all doses of cumin extract did not affect lipid levels. Patients included in the available research were either overweight or obese or had been diagnosed with type 2 diabetes or non-alcoholic steatohepatitis (NASH) (100162). It is not clear what effect, if any, cumin has in patients with diagnosed dyslipidemia.
• Hypertriglyceridemia. Small clinical studies suggest that oral cumin extract or essential oil does not seem to reduce triglyceride levels in patients with hypertriglyceridemia, although it may improve other lipid parameters. Details: A meta-analysis of two small clinical trials in adults with either type 2 diabetes or non-alcoholic steatohepatitis (NASH) who also have hypertriglyceridemia shows that taking cumin extract 225 mg daily for 6 months or cumin essential oil 25 mg daily for 3 months modestly reduces levels of total cholesterol and low-density lipoprotein (LDL) cholesterol and modestly increases levels of high-density lipoprotein (HDL) cholesterol when compared with placebo. However, taking cumin does not improve triglyceride levels (100162).
• Impaired glucose tolerance (prediabetes). It is unclear if oral cumin is beneficial in patients with prediabetes. Details: A small clinical trial in adults with prediabetes shows that taking cumin essential oil 75 mg daily for 10 weeks does not improve fasting blood glucose, glycated hemoglobin (HbA1c), or measures of insulin resistance but does seem to reduce body weight, body mass index (BMI), and low-density lipoprotein (LDL) cholesterol and increase high-density lipoprotein (HDL) cholesterol when compared with placebo (111369).
• Irritable bowel syndrome (IBS). Although there has been interest in using oral cumin for IBS, there is insufficient reliable information about the clinical effects of cumin for this purpose.
• Metabolic syndrome. It is unclear if oral cumin essential oil is beneficial in patients with metabolic syndrome. Details: A small clinical trial in adults with metabolic syndrome shows that taking cumin essential oil 75 mg three times daily for 8 weeks does not improve body weight, blood pressure, glycemic control, or lipid levels when compared with placebo (104143).
• Nonalcoholic steatohepatitis (NASH). Although there has been interest in using oral cumin for NASH, there is insufficient reliable information about the clinical effects of cumin for this purpose.
• Obesity. Small clinical studies suggest that oral cumin essential oil or powder may reduce body weight and body mass index (BMI) in overweight or obese individuals. Details: One small clinical study in overweight and obese individuals maintaining their usual diet and physical activity shows that taking cumin essential oil 100 mg three times daily for 8 weeks reduces weight by 1.3 kg and BMI by 0.5 kg/m2 when compared with placebo. The effect of cumin was similar to that of orlistat 120 mg three times daily. Cumin, but not orlistat, improved plasma insulin levels and insulin sensitivity; however, it did not affect insulin resistance, thyroid function, or plasma glucose or lipid levels (100160). Another small clinical study in overweight or obese females shows that taking cumin powder 1.5 grams in 150 mL of low-fat yogurt twice daily with meals as part of a calorie-restrictive diet for 3 months increases weight loss by an additional 2 kg when compared with yogurt and a calorie-restrictive diet alone. Intake of cumin also improved BMI, fat mass, waist circumference, and blood lipid levels, but did not affect fasting blood glucose levels (100161). More evidence is needed to rate cumin for these uses.

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POSSIBLY EFFECTIVE

• Dysmenorrhea. Taking fennel oil or extract by mouth may reduce pain in patients with primary dysmenorrhea. This benefit may be similar to ibuprofen or mefenamic acid. Details: Two separate meta-analyses in patients with primary dysmenorrhea show that taking fennel oil or fennel extract for 1-6 menstrual cycles reduces dysmenorrhea pain when compared with placebo. Improvement in pain was similar when compared with ibuprofen or mefenamic acid. In the included studies, doses of fennel oil ranged from 3-30 drops every 4-8 hours, and doses of fennel extract ranged from 30-230 mg daily (104196,108972). However, most studies included in these meta-analyses were small and low-quality, and all studies were conducted in Iran. Higher quality studies in other geographic locations are needed to confirm these findings.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Anxiety. Although there has been interest in using oral fennel for anxiety, there is insufficient reliable information about the clinical effects of fennel for this purpose.
• Bronchitis. Although there has been interest in using oral fennel for bronchitis, there is insufficient reliable information about the clinical effects of fennel for this purpose.
• Cancer. Although there has been interest in using oral fennel for cancer prevention, there is insufficient reliable information about the clinical effects of fennel for this purpose.
• Cholera. Although there has been interest in using oral fennel for cholera, there is insufficient reliable information about the clinical effects of fennel for this purpose.
• Colic. Small clinical studies suggest that oral fennel may reduce crying time in infants with colic. However, most research to date has evaluated fennel in combination with other ingredients. Details: A meta-analysis of three small clinical studies shows that giving fennel to infants with colic can reduce crying time by about 72 minutes daily when compared with placebo (97497). However, the studies included in this meta-analysis were at medium to high risk of bias, and the placebo response rate was high in all of the included studies. Additionally, two of the three studies evaluated combination products (16735,19715,49428). In the one study that used fennel alone, administering 5-20 mL of fennel seed oil 0.1% emulsion daily for one week led to colic relief in 65% of infants, compared with 24% of infants receiving placebo (49428). The other studies evaluated fennel in combination with lemon balm and German chamomile (ColiMil) or in combination with chamomile, vervain, licorice, and lemon balm (Calma-Bebi, Bonomelli). These combination products produced a response in 57% to 85% of infants, compared with 26% to 49% of infants receiving placebo (16735,19715).
• Constipation. Oral fennel has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small crossover trial in patients with constipation shows that drinking an herbal tea containing 3 grams of a combination of fennel, anise, elderberry, and senna daily for 5 days can decrease colonic transit time, increase the number of daily evacuations, and improve the perception of bowel function when compared with placebo (49494). Another small clinical study in elderly patients with constipation shows that drinking a specific tea (Smooth Move, Traditional Medicinals) containing fennel, senna, licorice, orange peel, cassia cinnamon, coriander, and ginger for 28 days can increase the number of bowel movements when compared to baseline (46196). The validity of this finding is limited by the lack of a comparator group. Additionally, a small clinical study in patients aged 60-65 years with functional constipation shows that taking a traditional Iranian combination product containing 5 grams each of fennel seed and rose flower, dissolved in water twice daily before meals for 4 weeks, improves constipation severity and stool consistency when compared with polyethylene glycol 10 grams. Improvements in constipation severity persisted in both groups 4 weeks after treatment completion (108973). However, polyethylene glycol is usually taken at a higher dose of 17 grams daily, limiting the validity of these findings.
• Cough. Although there has been interest in using oral fennel for cough, there is insufficient reliable information about the clinical effects of fennel for this purpose.
• Dementia. Although there has been interest in using oral fennel for dementia, there is insufficient reliable information about the clinical effects of fennel for this purpose.
• Diabetes. Although there has been interest in using oral fennel for diabetes, there is insufficient reliable information about the clinical effects of fennel for this purpose.
• Dyspepsia. Although there has been interest in using oral fennel for dyspepsia, there is insufficient reliable information about the clinical effects of fennel for this purpose.
• Flatulence. Although there has been interest in using oral fennel for flatulence, there is insufficient reliable information about the clinical effects of fennel for this purpose.
• Hirsutism. It is unclear if topical fennel is beneficial in patients with hirsutism. Details: A small clinical study in females with male pattern body hair due to unknown causes shows that applying a fennel 2% cream twice daily for 12 weeks can reduce hair diameter by approximately 19% when compared with placebo (49429).
• Insomnia. Although there has been interest in using oral fennel for insomnia, there is insufficient reliable information about the clinical effects of fennel for this purpose.
• Irritable bowel syndrome (IBS). Oral fennel has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in adults with either diarrhea- or constipation-predominant IBS shows that taking two capsules containing fennel essential oil 25 mg and curcumin 42 mg per capsule (CU-FEO, Alfa Wassermann S.p.A.) twice daily for 30 days improves overall ratings of abdominal pain, abdominal distention, and quality of life by 24% when compared with placebo (97422).
• Lactation. Although there has been interest in using oral fennel to stimulate breastmilk production, there is insufficient reliable information about the clinical effects of fennel for this purpose.
• Menopausal symptoms. Small clinical studies suggest that oral fennel oil or fennel seed powder may modestly improve menopausal symptoms. Details: One small clinical trial in adults with medium severity menopausal symptoms shows that taking fennel essential oil 60 mg daily for 8 weeks improves scores on the Menopause Rating Scale when compared with a sunflower oil placebo (97498). Another small clinical study in postmenopausal adults shows that taking fennel seed powder 2 grams daily for 8 weeks improves scores on the Kupperman Menopausal Index when compared with placebo (104198). Fennel has also been evaluated in combination with other ingredients. One small clinical study shows that taking a combination of fennel 120 mg, chamomile 1000 mg, and saffron 60 mg daily for 12 weeks reduces physical, psychological, and urogenital symptom scores on the Menopause Rating Scale when compared with placebo or lower doses of the combination (103628). Additionally, a moderate-sized clinical study in postmenopausal women conducted in Iran shows that taking combined fennel and valerian extract 500 mg twice daily for 8 weeks modestly improves self-reported scores for frequency and severity of hot flashes but does not improve sleep quality or duration of hot flashes when compared with placebo (112369). However, it is unclear if these benefits are due to fennel, other ingredients, or the combination.
• Nausea and vomiting. Although there has been interest in using oral fennel for nausea and vomiting, there is insufficient reliable information about the clinical effects of fennel for this purpose.
• Nocturnal enuresis. Although there has been interest in using oral fennel for nocturnal enuresis, there is insufficient reliable information about the clinical effects of fennel for this purpose.
• Osteoarthritis. It is unclear if oral fennel extract is beneficial in patients with knee osteoarthritis. Details: A small clinical trial in females with osteoarthritis of the knee shows that taking powdered fennel extract 800 mg daily for 2 weeks reduces pain and disability scores, but not stiffness, when compared with placebo (104199).
• Polycystic ovary syndrome (PCOS). It is unclear if oral fennel is beneficial in patients with PCOS. Details: A small clinical study in patients with PCOS shows that taking two fennel capsules, containing anethole 21-27 mg per capsule, daily along with a hypocaloric standard diet or a hypocaloric high-protein diet for 3 months does not reduce body weight or improve androgenic parameters such as testosterone levels, sex hormone-binding globulin levels, or free androgen index, when compared with these diets plus placebo (104197). Fennel has also been evaluated in combination with other ingredients. A clinical study in patients with oligomenorrhea due to PCOS shows that taking a traditional combination product (Aslagh) containing equivalent amounts of essential oils of fennel, wild carrot seeds, and Vitex agnus-castus fruit for 3 months, either alone or in combination with metformin, improves rates of menstrual bleeding and menstrual cyclicity similarly to metformin alone. All three groups experienced a significant improvement from baseline. Aslagh was taken as two, 500-mg capsules twice daily, except during menses; metformin was titrated over one week to a dose of 500 mg three times daily (108974). Additionally, a moderate-sized clinical study in patients with PCOS shows that taking fennel 60 mg and Elwendia persica 25 mg twice daily for 4 months modestly improves number of ovarian follicles and body mass index when compared with placebo; however, when compared to baseline, the combination also improves hirsutism scores and menstrual cycle duration and interval (112370). It is unclear if these effects are due to fennel, other ingredients, or the combination.
• Rheumatoid arthritis (RA). Although there has been interest in using oral fennel for RA, there is insufficient reliable information about the clinical effects of fennel for this purpose.
• Sexual desire. It is unclear if oral fennel is beneficial for improving sexual desire. Details: A small clinical study in postmenopausal adults shows that taking fennel seed powder 2 grams daily for 8 weeks does not improve scores on the Hurlbert Index of Sexual Desire when compared with placebo (104198).
• Sunburn. It is unclear if topical fennel emulsion is beneficial for preventing sunburn. Details: A small clinical study shows that applying a fennel 5% emulsion topically prior to ultraviolet (UV) exposure can reduce sunburn by 65% when compared with a control (49518).
• Upper respiratory tract infection (URTI). Although there has been interest in using oral fennel for upper respiratory tract infections, there is insufficient reliable information about the clinical effects of fennel for this purpose.
• Vaginal atrophy. It is unclear if intravaginal application of fennel cream is beneficial in patients with vaginal atrophy. Details: A small clinical study in postmenopausal adults shows that applying 5 grams of a fennel 5% cream to the vagina once daily for 8 weeks seems to reverse vaginal thinning, improve vaginal pH, and reduce symptoms of vaginal atrophy such as itching, dryness, and pain with intercourse when compared with placebo (92509). Patients in the fennel group also rated their sexual function to be improved when compared with those receiving placebo (97496). More evidence is needed to rate fennel for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Lactation. A survey of mothers using a specific goat's rue product (Lactogal Plus;Schabe Pharma Italia Srl), which also contained vitamins and magnesium, shows that 77% of those surveyed self-reported sufficient changes in milk production. Most mothers reported taking the product for at least 2 weeks, but information on the dose used was not provided. The validity of this study is limited by the lack of a comparator group and unclear dosing regimens. It is also unclear if this potential effect is due to goat's rue, additional vitamins and magnesium, or the combination (104533). More evidence is needed to rate goat's rue for this use.

(Read more about GOAT'S RUE)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Wrinkled skin. Preliminary clinical research in adult women with sagging facial skin shows that application of a topical serum containing 1% vanilla extract and 1.5% bakuchiol extract to the face and neck twice daily for 56 days improves skin firmness and jowl ptosis when compared with baseline. It is unclear if this effect is due to vanilla extract, bakuchiol extract, or the combination. Also, the validity of this study is limited by the lack of a comparator group (104752). More evidence is needed to rate vanilla for this use.

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LIKELY SAFE ...when used orally in amounts commonly found in foods. Cumin and cumin oil have Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when the powder or essential oil is used orally and appropriately in medicinal amounts, short-term (12). Cumin essential oil has been used with apparent safety in doses up to 225 mg daily for up to 8 weeks or 100 mg daily for up to 6 months (100160,100162,104143). Cumin powder has been used with apparent safety in doses up to 3 grams daily for up to 6 months (100161,100162). There is insufficient reliable information available about the safety of cumin powder or essential oil when used orally, long-term.

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using in excess of food amounts.

(Read more about CUMIN)

LIKELY SAFE ...when used orally in amounts commonly found in foods. Fennel has Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when fennel essential oil or extract is used orally and appropriately, short-term. Twenty-five drops (about 1.25 mL) of fennel fruit extract standardized to fennel 2% essential oil has been safely used four times daily for 5 days (49422). Also, two 100 mg capsules each containing fennel 30% essential oil standardized to 71-90 mg of anethole has been safely used daily for 8 weeks (97498). Powdered fennel extract has been used with apparent safety at a dose of 800 mg daily for 2 weeks (104199). ...when creams containing fennel 2% to 5% are applied topically (49429,92509).

CHILDREN: POSSIBLY SAFE
when combination products containing fennel are used to treat colic in infants for up to one week. Studied products include up to 20 mL of a fennel seed oil emulsion; a specific product (ColiMil) containing fennel 164 mg, lemon balm 97 mg, and German chamomile 178 mg; and up to 450 mL of a specific tea (Calma-Bebi, Bonomelli) containing fennel, chamomile, vervain, licorice, and lemon balm (16735,19715,49428).

PREGNANCY: POSSIBLY UNSAFE
when used orally. Observational research has found that regular use of fennel during pregnancy is associated with shortened gestation (100513).

LACTATION: POSSIBLY UNSAFE
when used orally. Case reports have linked consumption of an herbal tea containing extracts of fennel, licorice, anise, and goat's rue to neurotoxicity in two breast-feeding infants. The adverse effect was attributed to anethole, a constituent of fennel and anise (16744). However, levels of anethole were not measured in breastmilk, and the herbal tea was not tested for contaminants. Furthermore, other adverse effects related to use of fennel during lactation have not been reported. However, until more is known, avoid using.

(Read more about FENNEL)

There is insufficient reliable information available about the safety of goat's rue.

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

(Read more about GOAT'S RUE)

LIKELY SAFE ...when used orally in amounts commonly found in foods. Vanilla has Generally Recognized Safe (GRAS) status in the US (4912). There is insufficient reliable information available about the safety of vanilla when used orally or topically in medicinal amounts.

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods (4912). There is insufficient reliable information available about the safety of vanilla when used in amounts in excess of that found in foods; avoid using.

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, cumin might increase the risk of bleeding when used with antiplatelet or anticoagulant drugs.  Details In vitro evidence suggests that cumin can inhibit platelet aggregation (46897). Theoretically, cumin might increase the risk of bleeding when used with antiplatelet or anticoagulant drugs.

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, cumin might increase the risk of hypoglycemia when taken with antidiabetes drugs.  Details Animal research suggests that cumin can lower blood sugar in diabetic animals (19,46857,46895). However, research in humans with and without diabetes has found conflicting results (106516,106517).

RIFAMPIN (Rifadin) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, cumin might increase the effects and adverse effects of rifampin.  Details Animal research suggests that an aqueous extract of cumin containing a specific flavonoid glycoside can increase the bioavailability and plasma levels of rifampin (46876).

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, fennel might increase the risk of bleeding when used with antiplatelet or anticoagulant drugs.  Details Animal research suggests that fennel oil has antithrombotic and antiplatelet effects (31415,49445).

CIPROFLOXACIN (Cipro) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, fennel might decrease the levels and clinical effects of ciprofloxacin.  Details Animal research shows that fennel reduces ciprofloxacin bioavailability by nearly 50%, possibly due to the metal cations such as calcium, iron, and magnesium contained in fennel. This study also found that fennel increased tissue distribution and slowed elimination of ciprofloxacin (6135).

CONTRACEPTIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking large amounts of fennel might decrease the effects of contraceptive drugs due to competition for estrogen receptors.  Details Some constituents of fennel have estrogenic activity (11).

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, fennel might increase levels of drugs metabolized by CYP3A4.  Details In vitro research suggests that fennel inhibits CYP3A4 enzyme activity (38375,49468). This effect has not been reported in humans.

ESTROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking large amounts of fennel might interfere with hormone replacement therapy due to competition for estrogen receptors.  Details Some constituents of fennel have estrogenic activity (11).

TAMOXIFEN (Nolvadex) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking large amounts of fennel might decrease the antiestrogenic effect of tamoxifen.  Details Some constituents of fennel have estrogenic activity (11), which may interfere with the antiestrogenic activity of tamoxifen.

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General ...Orally, cumin powder and essential oil seem to be well tolerated, short-term.
Most Common Adverse Effects:
Orally: Gastrointestinal upset.
Topically: Contact dermatitis in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis in sensitive individuals.

Dermatologic ...Topically, undiluted cumin oil has been reported to cause phototoxic effects (6).

Gastrointestinal ...Orally, gastrointestinal upset has been reported in some patients taking cumin essential oil (104143).

Immunologic ...Orally, cumin may cause allergic reactions, including anaphylaxis, in sensitive individuals. One case report of anaphylaxis associated with cumin consumption has been reported (46905).
Topically, cumin may cause allergic contact dermatitis in sensitive individuals (31341,46902,46905).

(Read more about CUMIN)

General ...Orally and topically, fennel seems to be well tolerated.
Most Common Adverse Effects:
Orally: Gastrointestinal discomfort, photosensitivity, and allergic reactions in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Seizures.

Dermatologic ...Advise patients to avoid excessive sunlight or ultraviolet light exposure while using fennel (19). Allergic reactions affecting the skin such as atopic dermatitis and photosensitivity may occur in patients who consume fennel (6178,49507).

Gastrointestinal ...Orally, fennel may cause gastrointestinal complaints, including nausea and vomiting (19146,104196).

Hematologic ...Methemoglobinemia has been reported in four infants following intoxication related to ingestion of a homemade fennel puree that may have been made from improperly stored fennel (49444).

Immunologic ...A case report describes an 11-year-old male who developed an allergy to fennel-containing toothpaste. Immediately after using the toothpaste, the patient experienced sneezing, coughing, itchy mouth, rhinorrhea, nasal congestion, wheezing, difficulty breathing, and palpitations, which resolved within 10 minutes of spitting out the toothpaste and rinsing the mouth. In challenge tests, the patient reacted to chewing fresh fennel root, but not ground fennel seeds (103822).

Neurologic/CNS ...Orally, fennel oil has been associated with tonic clonic and generalized seizures (12868). New-onset cluster headaches are reported in a 24-year-old female while using a toothpaste containing fennel and camphor for 3 months. The headaches resolved upon stopping the toothpaste (112368). It is unclear if this adverse effect can be attributed to fennel, camphor, or the combination.

Pulmonary/Respiratory ...Orally, fennel and fennel seed have been reported to cause bronchial asthma (49478).

(Read more about FENNEL)

General ...No adverse effects have been reported; however, a thorough evaluation of safety outcomes has not been conducted.

(Read more about GOAT'S RUE)

General ...Orally, vanilla is well tolerated when used in amounts commonly found in foods (4912). Orally and topically, vanilla has been associated with allergic responses including contact dermatitis. Workers preparing vanilla have reported headache, dermatitis, and insomnia, which is historically characterized as "occupational vanillism" (100502).

Dermatologic ...Workers preparing vanilla have reported dermatitis, associated with what is historically characterized as "occupational vanillism" (100502).

Immunologic ...Orally, vanilla resulted in eczematous reactions in children that had been diagnosed with atopic dermatitis (81981). Topically, vanilla has been shown to cause contact dermatitis when used as a lip salve (81988).

Neurologic/CNS ...Workers preparing vanilla have reported headache and insomnia, associated with what is historically characterized as "occupational vanillism" (100502).

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