Ingredients | Amount Per Serving |
---|---|
(Senna alexandrina )
(leaf)
|
840 mg |
(Rheum palmatum )
(root)
|
195 mg |
(Pimpinella anisum )
(seed)
|
165 mg |
(Trigonella foenum-graceum )
(seed)
|
165 mg |
(Frangula purshiana )
(bark)
|
67.5 mg |
Cellulose, Hypromellose, Silica, Hyprolose, Magnesium Stearate
Below is general information about the effectiveness of the known ingredients contained in the product Herbolax. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Herbolax. 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 food. Anise and anise oil have Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when anise powder is used orally and appropriately in medicinal amounts. Anise powder has been used with apparent safety in clinical research at doses of up to 9 grams daily for up to 4 weeks (94944,94945). ...when anise oil is used orally and appropriately in medicinal amounts. Anise oil has been used with apparent safety in clinical research at doses of up to 600 mg daily for up to 4 weeks (94946,94947).
CHILDREN: LIKELY SAFE
when used orally in amounts commonly found in food.
Anise and anise oil have Generally Recognized as Safe (GRAS) status in the US (4912). There is insufficient reliable information available about the safety of anise when used by children in medicinal amounts.
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in food.
Anise and anise oil have Generally Recognized as Safe (GRAS) status in the US (4912). There is insufficient reliable information available about the safety of anise when taken orally in medicinal amounts during pregnancy or breast-feeding.
POSSIBLY SAFE ...when used orally and appropriately, short-term. Cascara sagrada seems to be safe when used for less than one week (272,25023,40087). Cascara sagrada was formerly approved by the US Food and Drug Administration (FDA) as a safe and effective over-the-counter (OTC) laxative, but this designation was removed in 2002 due to a lack of supporting evidence (8229).
POSSIBLY UNSAFE ...when used orally, long-term. Using cascara sagrada for more than 1-2 weeks can lead to dependence, electrolyte loss, and hypokalemia (272).
CHILDREN: POSSIBLY UNSAFE
when used orally in children.
Cascara sagrada should be used cautiously in children due to the risk of electrolyte loss and hypokalemia (272).
PREGNANCY:
Insufficient reliable information available; avoid using.
LACTATION: POSSIBLY UNSAFE
when used orally.
Cascara sagrada is excreted into breast milk and might cause diarrhea (272).
LIKELY SAFE ...when used orally in amounts commonly found in foods. Fenugreek has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when the seed is used orally in medicinal amounts. Fenugreek seed powder 5-10 grams daily has been used with apparent safety for up to 3 years. Fenugreek seed extract 1 gram daily has been used with apparent safety for up to 3 months (7389,9783,18359,18362,49868,90112,90113,90117,93419,93420)(93421,93422,93423,96065,103285,108704).
CHILDREN: LIKELY SAFE
when used orally in amounts commonly found in foods (4912).
There is insufficient reliable information available about the safety of fenugreek when used in larger amounts. Unusual body and urine odor has been reported after consumption of fenugreek tea. Although the odor appears to be harmless, it may be misdiagnosed as maple syrup urine disease (9782,96068).
PREGNANCY: LIKELY UNSAFE
when used orally in amounts greater than those found in food.
Fenugreek has potential oxytoxic and uterine stimulant activity (12531). There are case reports of congenital malformations, including hydrocephalus, anencephaly, cleft palate, and spina bifida, after consumption of fenugreek seeds during pregnancy (96068). Consumption of fenugreek immediately prior to delivery may cause the neonate to have unusual body odor. Although this does not appear to cause long-term sequelae, it may be misdiagnosed as maple syrup urine disease (9781,96068).
LACTATION: POSSIBLY SAFE
when used orally to stimulate lactation, short-term.
Although most available clinical studies lack safety testing in the lactating parent or infant (12535,22569,22570), some evidence suggests that taking fenugreek 1725 mg three times daily orally for 21 days does not cause negative side effects in the infant (90115).
LIKELY SAFE ...when the stalk is used in amounts commonly found in foods and when the root is used as a food flavoring. Rhubarb has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when the root or rhizome is used orally and appropriately in medicinal amounts for up to 2 years (92294,92295,92297). ...when the stalk is used orally and appropriately in medicinal amounts for up to 4 weeks (71351,71363,97920). ...when used topically and appropriately (10437,97919).
POSSIBLY UNSAFE ...when the leaf is used orally. Rhubarb leaf contains oxalic acid and soluble oxalate, which can cause abdominal pain, burning of the mouth and throat, diarrhea, nausea, vomiting, seizures, and death (17).
PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used in medicinal amounts, rhubarb root is a stimulant laxative; avoid using (12).
LIKELY SAFE ...when used orally and appropriately, short-term. Senna is an FDA-approved nonprescription drug (8424,15429,15431,15442,40086,40088,74535,74545,74548,74562)(74567,74570,74583,74585,74586,74587,74593,74603,74606,74607)(74609,74613,74615,74624,74636,74639,74644,74650,74653,92711)(92712).
POSSIBLY UNSAFE ...when used orally long-term or in high doses. Long-term, frequent use, or use of high doses has been linked to serious side effects including laxative dependence and liver toxicity (13057,13095).
CHILDREN: LIKELY SAFE
when used orally and appropriately, short-term.
Senna is an FDA-approved nonprescription drug for use in children 2 years and older. (15429,15434,15435).
CHILDREN: POSSIBLY UNSAFE
when used orally long-term or in high doses.
Long-term, frequent use, or use of high doses has been linked to serious side effects including laxative dependence and liver toxicity (13057,13095,105956).
PREGNANCY: POSSIBLY SAFE
when used orally and appropriately, short-term (15429,24480).
POSSIBLY UNSAFE...when used orally long-term or in high doses. Long-term, frequent use, or use of high doses has been linked to serious side effects including laxative dependence and liver toxicity (13057,13095).
LACTATION: POSSIBLY SAFE
when used orally and appropriately, short term.
Although small amounts of constituents of senna cross into breast milk, senna has been taken while breast-feeding with apparent safety. Senna does not cause changes in the frequency or consistency of infants' stools. (6026,15429,15436,15437,24482,24484,24485,24486,24487,74545).
Below is general information about the interactions of the known ingredients contained in the product Herbolax. 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, anise oil might decrease the levels and clinical effects of acetaminophen.
Details
Animal research shows that taking anise oil with acetaminophen decreases peak plasma levels of acetaminophen but does not reduce overall bioavailability (94951). Whether this interaction will occur in humans is unclear.
|
Theoretically, anise seed might increase the risk of hypoglycemia when taken with antidiabetes drugs.
Details
A small clinical study shows that anise seed powder decreases fasting blood glucose levels by 36% when compared to baseline (94953).
|
Theoretically, anise oil might decrease the efficacy of caffeine.
Details
Animal research shows that taking anise oil with caffeine decreases the bioavailability of caffeine (94951). Whether this interaction will occur in humans is unclear.
|
Theoretically, anise oil might increase the effects and adverse effects of codeine.
Details
Animal research shows that anise oil increases the analgesic effects of codeine, possibly by inducing its phase I metabolism and increasing conversion to morphine (94950). Whether this interaction occurs in humans is unclear.
|
Theoretically, anise might interfere with contraceptive drug therapy.
Details
|
Theoretically, anise oil might increase the effects and adverse effects of diazepam.
Details
Animal research shows that taking anise oil with diazepam increases the motor impairment associated with diazepam, possibly by inhibiting its breakdown by cytochrome P450 3A4 (94950). Whether this interaction occurs in humans is unclear.
|
Theoretically, anise might interfere with estrogen-based hormone replacement therapy.
Details
|
Theoretically, anise oil might decrease the efficacy of fluoxetine.
Details
Animal research shows that taking anise oil with fluoxetine reduces the antidepressant effects of fluoxetine, possibly by promoting its breakdown by cytochrome P450 2D6 (94950). Whether this interaction occurs in humans is unclear.
|
Theoretically, anise oil might decrease the efficacy of imipramine.
Details
Animal research shows that taking anise oil with imipramine reduces the antidepressant effects of imipramine, possibly by promoting its breakdown by cytochrome P450 2D6 (94950). Whether this interaction occurs in humans is unclear.
|
Theoretically, anise oil might increase the effects and adverse effects of midazolam.
Details
Animal research shows that taking anise oil with midazolam increases the motor impairment associated with midazolam, possibly by inhibiting its breakdown by cytochrome P450 3A4 (94950). Whether this interaction occurs in humans is unclear.
|
Theoretically, anise might interfere with tamoxifen therapy.
Details
|
Theoretically, cascara sagrada might increase the risk of hypokalemia when taken with corticosteroids.
Details
|
Theoretically, cascara sagrada might decrease the effects of CYP3A4 substrates.
Details
In vitro research suggests that cascara sagrada can induce CYP3A4 enzymes, albeit to a much lower degree than rifampin, a known CYP3A4 inducer (110704).
|
Theoretically, cascara sagrada might cause hypokalemia, potentially increasing the risk of digoxin toxicity.
Details
|
Theoretically, cascara sagrada might increase the risk of hypokalemia when taken with diuretic drugs.
Details
|
Theoretically, cascara sagrada might have additive adverse effects when taken with stimulant laxatives.
Details
Cascara sagrada has stimulant laxative effects and might compound fluid and electrolyte losses when taken with stimulant laxatives (19).
|
Theoretically, cascara sagrada might increase the risk of bleeding when taken with warfarin.
Details
Cascara sagrada has stimulant laxative effects (19). In some people, cascara sagrada can cause diarrhea. Diarrhea can increase the effects of warfarin, increase international normalized ratio (INR), and increase the risk of bleeding.
|
Theoretically, fenugreek might have additive effects when used with anticoagulant or antiplatelet drugs.
Details
Some of the constituents in fenugreek have antiplatelet effects in animal and in vitro research. However, common fenugreek products might not contain sufficient concentrations of these constituents for clinical effects. A clinical study in patients with coronary artery disease or diabetes shows that taking fenugreek seed powder 2.5 grams twice daily for 3 months does not affect platelet aggregation, fibrinolytic activity, or fibrinogen levels (5191,7389,49643).
|
Theoretically, fenugreek seed might have additive hypoglycemic effects when used with antidiabetes drugs.
Details
|
Theoretically, fenugreek seed might alter the clinical effects of clopidogrel by inhibiting its conversion to the active form.
Details
Animal research shows that fenugreek seed 200 mg/kg daily for 14 days increases the maximum serum concentration of clopidogrel by 21%. It is unclear how this affects the pharmacokinetics of the active metabolite of clopidogrel; however, this study found that concomitant use of fenugreek seed and clopidogrel prolonged bleeding time by an additional 11% (108701).
|
Theoretically, fenugreek seed might have additive hypotensive effects when used with metoprolol.
Details
Animal research shows that fenugreek seed 300 mg/kg daily for 2 weeks decreases systolic and diastolic blood pressure by 9% and 11%, respectively, when administered alone, and by 15% and 22%, respectively, when given with metoprolol 10 mg/kg (108703).
|
Theoretically, fenugreek might decrease plasma levels of phenytoin.
Details
Animal research shows that taking fenugreek seeds for 1 week decreases maximum concentrations and the area under the curve of a single dose of phenytoin by 44% and 72%, respectively. This seems to be related to increased clearance (110905). So far, this interaction has not been reported in humans.
|
Theoretically, concurrent use of sildenafil and fenugreek might reduce levels and therapeutic effects of sildenafil.
Details
Animal research shows that taking fenugreek seeds for 1 week reduces maximum concentrations and the area under the curve of a single dose of sildenafil by 27% and 48%, respectively (110898). So far, this interaction has not been reported in humans.
|
Theoretically, fenugreek may reduce the levels and clinical effects of theophylline.
Details
Animal research shows that fenugreek 50 grams daily for 7 days reduces the maximum serum concentration (Cmax) of theophylline by 28% and the area under the plasma drug concentration-time curve (AUC) by 22% (90118).
|
Theoretically, fenugreek might have additive effects with warfarin and increase the international normalized ratio (INR).
Details
|
Theoretically, frequent and high doses of rhubarb might increase the risk of hypokalemia when taken with corticosteroids.
Details
|
Theoretically, taking rhubarb with cyclosporine might reduce cyclosporine levels.
Details
Animal research shows that co-administration of rhubarb decoction 0.25 or 1 gram/kg with cyclosporine 2.5 mg/kg, decreases cyclosporine maximum plasma concentration and overall exposure levels when compared with taking cyclosporine alone. The authors theorize that rhubarb might reduce cyclosporine bioavailability by inducing of P-glycoprotein and/or cytochrome P450 3A4 (92304). However, since rhubarb was administered as a single oral dose and enzyme induction usually occurs after multiple doses, it is possible that cyclosporine absorption was actually reduced via rhubarb's stimulant laxative effects (12). Also, the composition of the rhubarb decoction was not described.
|
Theoretically, overuse of rhubarb might increase the risk of adverse effects when taken with digoxin.
Details
|
Theoretically, frequent and high doses of rhubarb might increase the risk of hypokalemia.
Details
|
Theoretically, concomitant use of rhubarb with potentially hepatotoxic drugs might increase the risk of developing liver damage.
Details
|
Theoretically, long-term use of anthraquinones from rhubarb might increase the risk of nephrotoxicity when used with nephrotoxic drugs.
Details
The anthraquinone constituents of rhubarb have been shown to induce nephrotoxicity in animal research (71322). Additionally, in a case report, a 23-year old female presented with kidney failure after taking 6 tablets of a proprietary slimming agent (found to contain the anthraquinones emodin and aloe-emodin from rhubarb) daily for 6 weeks and then adding diclofenac 25 mg 4 times daily for 2 days. The authors postulate that the anthraquinone constituents of rhubarb contributed to the renal dysfunction, and the addition of diclofenac, a nephrotoxic drug, led to renal failure (15257). Until more is known, advise patients to avoid taking rhubarb if they are taking other potentially nephrotoxic drugs.
|
Theoretically, rhubarb might increase the risk for fluid and electrolyte loss when taken with other stimulant laxatives.
Details
|
Theoretically, excessive use of rhubarb might increase the risk of bleeding when taken with warfarin.
Details
|
Theoretically, senna might increase the risk of adverse effects when taken with digoxin.
Details
Overuse/abuse of senna increases the risk of adverse effects from cardiac glycosides, such as digoxin, due to potassium depletion (15425).
|
Theoretically, senna might increase the risk of hypokalemia when taken with diuretic drugs.
Details
Overuse of senna might compound diuretic-induced potassium loss and increase the risk for hypokalemia (15425).
|
Theoretically, taking senna may interfere with the absorption of exogenous estrogens.
Details
|
Theoretically, senna might increase the risk for fluid and electrolyte loss when taken with other stimulant laxatives.
Details
|
Theoretically, excessive use of senna might increase the effects of warfarin.
Details
Senna has stimulant laxative effects and can cause diarrhea. Diarrhea can increase the effects of warfarin, increase international normalized ratio (INR), and increase the risk of bleeding. In one case report, excessive use of senna for 3 weeks resulted in diarrhea, bloody stools, and an elevated INR of 11.9 (16530).
|
Below is general information about the adverse effects of the known ingredients contained in the product Herbolax. 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, anise seems to be well tolerated.
Most Common Adverse Effects:
Topically: Contact dermatitis in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis in sensitive individuals.
Dermatologic ...Topically, anise, in combination with other herbs, has been reported to cause localized pruritus (13483).
Immunologic ...Anise can cause allergic reactions in sensitive individuals. Orally or by inhalation, anise can cause rhinoconjunctivitis, occupational asthma, and anaphylaxis (13484). Topically, anise can cause contact dermatitis, rhinitis, and asthma (31319,31341). Contact dermatitis and cheilitis have also been reported following the use of toothpaste containing anethole, a constituent of anise (31403,31528).
General
...Orally, cascara sagrada seem to be well tolerated when used appropriately, short-term.
Most Common Adverse Effects:
Orally: Mild abdominal discomfort and cramps.
Serious Adverse Effects (Rare):
Orally: Hepatotoxicity. Fresh or improperly aged cascara sagrada bark can cause severe vomiting.
Endocrine ...Orally, long-term use of cascara sagrada can lead to potassium depletion (4).
Gastrointestinal
...Orally, cascara sagrada can commonly cause mild abdominal discomfort, colic, and cramps (4).
In some cases, chronic use can cause pseudomelanosis coli. Pseudomelanosis coli (pigment spots in intestinal mucosa) is believed to be harmless, usually reverses with discontinuation, and is not directly associated with an increased risk of developing colorectal adenoma or carcinoma (6138).
Fresh or improperly aged cascara sagrada bark can cause severe vomiting due to the presence of free anthrone constituents (2,92307).
Genitourinary ...Orally, long-term use of cascara sagrada can lead to albuminuria and hematuria (4).
Hepatic ...There is some concern about potential liver problems with cascara sagrada. In some cases, cascara sagrada bark 750-1275 mg (containing approximately 21 mg cascaroside) daily in divided doses for three days resulted in cholestatic hepatitis, ascites, and portal hypertension. Symptoms resolved following discontinuation of cascara sagrada (6895,92306).
Musculoskeletal ...Orally, long-term use of cascara sagrada can lead to muscle weakness and finger clubbing (4).
Other ...Orally, long-term use of cascara sagrada can lead to cachexia (4).
General
...Orally, fenugreek seed is generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, bloating, diarrhea, dyspepsia, flatulence, hypoglycemia, and nausea.
Serious Adverse Effects (Rare):
All ROA: Severe allergic reactions including angioedema, bronchospasm, and shock.
Endocrine ...Orally, large doses of fenugreek seed, 100 grams daily of defatted powder, have caused hypoglycemia (164,96068).
Gastrointestinal ...Orally, fenugreek seed can cause mild gastrointestinal symptoms, such as diarrhea, dyspepsia, abdominal distention and pain, nausea, and flatulence, especially when taken on an empty stomach (622,12534,18349,93421,96065,96068,105016).
Immunologic ...Fenugreek can cause allergic reactions when used orally and topically, and when the powder is inhaled (719,96068). Orally, fenugreek has caused bronchospasm, diarrhea, and itching, and skin reactions severe enough to require intravenous human immunoglobulin (96068). Topically, fenugreek paste has resulted in facial swelling, wheezing, and numbness around the head (719,96068). When used both orally and topically by a single individual, asthma and rhinitis occurred (96068). Inhalation of fenugreek powder has resulted in fainting, sneezing, runny nose, and eye tearing (719,96068).
Neurologic/CNS ...Orally, loss of consciousness has occurred in a 5 week-old infant drinking tea made from fenugreek (9782). Dizziness and headaches have been reported in clinical research of fenugreek extract (49551,93419). However, these events are rare.
Renal ...Orally, fenugreek aqueous see extract may increase the frequency of micturition, although this even appears to be rare (49551).
Other
...Consumption of fenugreek during pregnancy, immediately prior to delivery, may cause the neonate to have an unusual body odor, which may be confused with maple syrup urine disease.
It does not appear to cause long-term sequelae (9781). This unusual body odor may also occur in children drinking fenugreek tea. A case of a specific urine and sweat smell following oral fenugreek extract use has been reported for a patient in one clinical trial (18349).
In 2011, outbreaks of enteroaggregative hemorrhagic Escherichia coli (EATEC) O104:H4 infection occurred in Germany and Spain. Epidemiological studies linked the outbreaks to fenugreek seeds that had been imported from Africa. However, laboratory analyses were unable to isolate the causative strain of bacteria from fenugreek seed samples (49776,49777,49781,90114).
General
...Orally, rhubarb root and stalk are well tolerated when used in food amounts and seem to be well tolerated when used in medicinal amounts.
Rhubarb leaf contains oxalic acid and can be toxic. Topically, rhubarb seems to be well tolerated.
Most Common Adverse Effects:
Orally: Cramps, diarrhea, gastrointestinal discomfort, nausea, vomiting.
Topically: Rash.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis.
Cardiovascular ...Orally, chronic use or abuse of rhubarb can cause arrhythmias (12).
Dermatologic ...Orally, rhubarb taken alone or in combination with other ingredients has been reported to cause rash (71315,71342). Topically, short term application of a specific product (Pyralvex) containing rhubarb, salicylic acid, and ethanol to the gums has been reported to cause slight burning and dark discoloration of the gums in approximately 1% of patients (71369). It is unclear if this effect is due to rhubarb, other ingredients, or the combination.
Endocrine ...Orally, chronic use or abuse of rhubarb can cause electrolyte loss (especially potassium), hyperaldosteronism, albuminuria, and edema (12).
Gastrointestinal
...Orally, rhubarb can cause cramp-like or spasmodic gastrointestinal discomfort, watery diarrhea, and uterine contractions (18).
Rhubarb, alone or in combination with other ingredients, has also been reported to cause bloating, nausea, diarrhea, vomiting, and stomach upset or pain in clinical studies. Diarrhea is more common with a starting dose of at least 3 grams of extract (71315,71329,71339,71340,71341,71342,71373,92300). Chronic use or abuse of rhubarb can cause inhibition of gastric motility and pseudomelanosis coli (pigment spots in the intestinal mucosa) (12,6138).
Although some research suggests that rhubarb and other anthranoid laxatives might increase the risk of colorectal cancer due to pseudomelanosis coli (30743), more recent research suggests that this condition is harmless, typically reversed with rhubarb discontinuation, and not associated with an increased risk for colorectal adenoma or carcinoma (6138).
Hematologic ...Orally, chronic use or abuse of rhubarb can cause hematuria (12).
Hepatic ...Orally, chronic use of anthraquinone-containing products, such as rhubarb, has been associated with hepatotoxicity (15257). Use of rhubarb specifically has been linked to at least 24 reports of liver injury, although details on the dose of rhubarb and duration of use in these cases are not clear (100963). In one clinical study, rhubarb, taken in combination with other ingredients, has been reported to cause mild to moderate elevations of serum alanine aminotransferase (71315).
Immunologic ...Orally, rhubarb has rarely been reported to cause anaphylaxis (18).
Musculoskeletal ...Orally, chronic use or abuse of rhubarb can cause accelerated bone deterioration and muscular weakness (12).
Renal ...Orally, chronic use or abuse of rhubarb can cause electrolyte loss (especially potassium), albuminuria, hematuria, dehydration, and nephropathies (12). There is one case report of renal failure in a patient who took a product containing rhubarb for six weeks. The patient presented with renal failure two days after starting diclofenac, which is known to have nephrotoxic effects. It is hypothesized that the combination of diclofenac with the anthraquinone constituents of rhubarb precipitated renal dysfunction (15257).
General
...Orally, senna is generally well-tolerated when used short-term in appropriate doses.
Most Common Adverse Effects:
Orally: Abdominal pain and discomfort, cramps, diarrhea, flatulence, nausea, fecal urgency, and urine discoloration.
Serious Adverse Effects (Rare):
Orally: Skin eruptions.
Cardiovascular ...Excessive use can cause potassium depletion and other electrolyte abnormalities (15425). In theory, this could cause potentially dangerous changes in heart rhythm. A small decrease in heart rate was seen in one clinical study (74587).
Dermatologic ...In adults, there are rare case reports of skin eruptions associated with senna, including erythema multiforme, fixed drug eruption, lichenoid reaction, toxic epidermal necrolysis, urticaria, photosensitivity, and contact dermatitis (96558). Infants and young children given senna products have experienced contact reactions on the buttocks due to prolonged exposure to stool while wearing a diaper overnight. These reactions range from erythema with small blisters, to large fluid-filled blisters with skin sloughing, as occurs with second degree burns (96559). In a case series of children treated with senna for chronic constipation, burn-like reactions occurred in 2.2%, typically with higher doses (mean 60 mg/day, range 35.2 to 150 mg/day) (96558,96559). These reactions can be avoided by giving senna early in the day, so that bowel movements occur at a time when diapers can be changed quickly (96559).
Gastrointestinal ...Orally, senna can cause abdominal pain and discomfort, cramps, bloating, flatulence, nausea, fecal urgency, and diarrhea (15427,15434,15435,15436,15439,15440,15441,105955). Chronic use has also been associated with "cathartic colon," radiographically diagnosed anatomical changes to the colon such as benign narrowing, colonic dilation, and loss of colonic folds (15428). The clinical relevance of these findings is unclear. Chronic use can also cause pseudomelanosis coli (pigment spots in intestinal mucosa) which is harmless, usually reverses with discontinuation, and is not associated with an increased risk of developing colorectal adenoma or carcinoma (6138). The cathartic properties of senna leaf are greater than the fruit (15430). Thus, the American Herbal Products Association only warns against long-term use of senna leaf (12).
Hepatic ...Chronic liver damage, portal vein thrombosis, and hepatitis have been reported following oral use of senna alkaloids, such as in tea made from senna leaves (13057,13095,41431,74560,74564,74584,105956). There is a case report of hepatitis in a female who consumed moderate amounts of senna tea. The patient was a poor metabolizer of cytochrome P450 2D6 (CYP2D6). It's thought that moderate doses of senna in this patient led to toxic hepatitis due to the patient's reduced ability to metabolize and eliminate the rhein anthrone metabolites of senna, which are thought to cause systemic toxicity (13057). There is also a case of liver failure, encephalopathy, and renal insufficiency in a female who consumed 1 liter/day of senna tea, prepared from 70 grams of dried senna fruit, over 3 years (13095). In another case report, a 3-year-old female presented with hepatitis that led to pancytopenia after drinking tea made from 2-3 grams dry senna leaves three times or more weekly for over one year (105956).
Immunologic ...In one case report, a 19-year-old male developed anaphylaxis with dyspnea, facial edema, and hives. This reaction was determined to be caused by the senna content in a specific combination product (Delgaxan Plus, Pompadour Ibérica) that the patient ingested (105957).
Musculoskeletal ...Hypertrophic osteoarthropathy, finger clubbing, cachexia, and tetany have been reported from excessive oral senna use in humans (15426,74580,74582,74620,74625).
Renal ...Nephrocalcinosis has been reported as a result of oral senna overuse (74582).