Formula Inf Drops by Weleda (Canada)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Alopecia areata. Although there has been interest in using oral aconite for alopecia areata, there is insufficient reliable information about the clinical effects of aconite for this purpose.
• Amenorrhea. Although there has been interest in using oral aconite for amenorrhea, there is insufficient reliable information about the clinical effects of aconite for this purpose.
• Asthma. Although there has been interest in using oral aconite for asthma, there is insufficient reliable information about the clinical effects of aconite for this purpose.
• Coronavirus disease 2019 (COVID-19). Although there has been interest in using injectable aconite for COVID-19, there is insufficient reliable information about the clinical effects of aconite for this purpose.
• Diarrhea. Although there has been interest in using oral aconite for diarrhea, there is insufficient reliable information about the clinical effects of aconite for this purpose.
• Heart failure. It is unclear if oral aconite is beneficial in patients with left ventricular failure. Details: Preliminary clinical research in patients with left ventricular failure shows that taking heat processed aconite tuber 1000 mg daily for up to 7 months modestly improves heart and kidney function when compared with placebo (30314).
• Pneumonia. Injectable aconite has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Oral aconite has not been evaluated for this use. Details: A meta-analysis of 20 small, low-quality randomized and non-randomized studies in older Chinese adults with severe pneumonia shows that 77% of patients receiving an injection containing aconite extract 0.1 mg/mL and panax ginseng extract 0.8 mg/mL had improvement in symptoms such as fever, cough, and chest tightness when compared with 61% of those who received standard treatment. This combination injection may also modestly reduce disease severity and the risk of mortality when compared with standard treatment. However, these outcomes were not evaluated in all studies, and dosing regimens were heterogenous, with doses ranging from 60-100 mL daily or twice daily for 7-14 days (110472).
• Raynaud syndrome. Although there has been interest in using oral aconite for Raynaud syndrome, there is insufficient reliable information about the clinical effects of aconite for this purpose. More evidence is needed to rate aconite for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Common Cold. Preliminary clinical research shows that taking a specific homeopathic product (Eupatorium perfoliatum D2) derived from boneset has a similar effect to aspirin on symptoms of the common cold (36793). More evidence is needed to rate boneset for this use.

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There is insufficient reliable information available about the effectiveness of bryonia.

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EFFECTIVE

• Bowel preparation. Oral sodium phosphate is effective for cleansing the colon in preparation for colonoscopy; however, it is unclear whether sodium phosphate is as effective as polyethylene glycol (PEG) solution. Some products are approved by the US Food and Drug Administration (FDA) for this use. However, due to the potential for kidney damage, sodium phosphate is not recommended as first-line therapy. Details: Sodium phosphate tablets (OsmoPrep, Salix Pharmaceuticals; Visicol, Salix Pharmaceuticals) are FDA-approved for cleansing the colon in preparation for colonoscopy. Clinical research shows that using the OsmoPrep formulation can achieve an "excellent" or "good" response rate, which is defined as having 90% of the mucosa visible with only some or little suctioning needed, in 94% to 97% of patients (88133). Similarly, using the specific product Visicol has been shown to achieve an excellent or good response rate in 82% to 86% of patients (94674). Non-FDA-approved sodium phosphate products have also been investigated. One such product (Fleet Phospho-soda, C. B. Fleet Co.) has been shown to achieve adequate bowel cleansing in 23% to 89% of patients (93846,94673). Another sodium phosphate tablet preparation (Clicolon tablets, Korea Pharma Co.) has been shown to achieve adequate bowel cleansing in 63% to 93% of patients (93848,93850,93853). Excellent or good bowel cleansing was found in 98.6% of patients using a 32-tablet regimen of other sodium phosphate tablets (Quiklean, Universal Integrated Corporation) (107008). Reasons for the differences in the percentage of patients who achieve adequate bowel cleansing with the same sodium phosphate product may relate to the method used to analyze bowel cleansing, differences in diet followed during bowel cleansing, and demographic factors (93846,93848,93850,93853). Various preparations (OsmoPrep, Salix Pharmaceuticals; Visicol, Salix Pharmaceuticals; Clicolon tablets, Korea Pharma Co.; Quiklean, Universal Integrated Corporation) have been used which contain 1.102 grams of sodium phosphate monobasic monohydrate and 0.398 grams of sodium phosphate dibasic anhydrous. These products have been taken as 3-4 tablets with 8 ounces of water every 15 minutes for a total of 20 tablets the evening before colonoscopy, and 3-4 tablets with 8 ounces of water every 15 minutes for a total of 12-20 tablets the morning of a colonoscopy (88133,93848,93850,94674,107008). Also, sodium phosphate solution (Fleet Phospho-soda, C. B. Fleet Co.) containing sodium hydrogen phosphate 24.4 grams and disodium phosphate dodecahydrate 10.8 grams has also been used the morning and evening before the procedure (93846). Numerous publications have compared the bowel cleansing activity of sodium phosphate with PEG solution. When given as a split-overnight dosage, sodium phosphate is about as effective as PEG solutions in achieving adequate bowel cleansing. However, when day-before dosage is used, PEG is more effective for bowel cleansing than sodium phosphate (93861,93862,107008). Sodium phosphate and PEG may have different effectiveness depending on the colonic site assessed. When only trials assessing descending colon cleansing are considered, sodium phosphate is found to work similarly to PEG solutions. When only studies assessing ascending colon cleansing are considered, PEG is more effective for bowel cleansing than sodium phosphate (93861). Also, a large clinical trial in outpatients scheduled for non-sedated colonoscopy shows that receiving PEG resulted in an easier insertion and a less painful colonoscopy when compared with receiving sodium phosphate (104473). However, in patients with chronic constipation, sodium phosphate seems to be preferable. A meta-analysis of three small clinical studies in adults with chronic constipation shows that using sodium phosphate has an 87% greater chance of a successful bowel preparation when compared with using PEG (104472). Sodium phosphate is not recommended as first-line therapy for bowel preparation prior to colonoscopy due to the potential for kidney damage (93863,94672). In fact, one sodium phosphate preparation (Fleet Phospho-soda, C. B. Fleet Co.) that was previously approved as an over-the-counter supplement for bowel preparation in the US was withdrawn from the market for this indication in December 2008 due to concerns for phosphate-induced kidney disease (94672). Of the sodium phosphate products that are still approved by the FDA, current guidelines recommend that these products not be used for bowel cleansing in patients with kidney disease, pre-existing electrolyte disturbances, congestive heart failure, cirrhosis, ascites, or inflammatory bowel disease. Guidelines also recommend that caution should be used if these products are prescribed for patients who are elderly, hypertensive, or taking certain classes of drugs (94672). For small bowel preparation for endoscopy, a meta-analysis suggests that sodium phosphate is no more effective than fasting alone (93860).
• Hypophosphatemia. Oral or intravenous phosphate salts are effective for the prevention or treatment of hypophosphatemia. Some products are approved by the US Food and Drug Administration (FDA) for this use. Details: Taking sodium or potassium phosphate orally is effective for preventing and treating hypophosphatemia (15). Treating hypophosphatemia with oral phosphates requires monitoring of serum electrolyte levels to determine appropriate dosing (15). The FDA-approved intravenous (IV) product is also used for the correction of hypophosphatemia (8302,8303,88135). FDA-approved intravenous (IV) sodium phosphate or potassium phosphate 15-30 mmol is typically given over 2-12 hours. Higher doses have been used if needed to increase efficacy (8302,8303,88135).

LIKELY EFFECTIVE

• Constipation. Oral or rectal sodium phosphate is approved by the US Food and Drug Administration (FDA) as an ingredient in over-the-counter (OTC) products to treat constipation. Details: Sodium phosphate is an FDA-permitted ingredient of oral and rectal OTC products intended for the treatment of constipation (88107).
• Dyspepsia. Oral aluminum phosphate and calcium phosphate are approved by the US Food and Drug Administration (FDA) as ingredients in over-the-counter (OTC) antacids. Details: Aluminum phosphate and calcium phosphate are FDA-permitted ingredients of oral OTC products intended for use as antacids (88107).
• Hypercalcemia. Although other treatments are preferred, oral non-calcium phosphate salts are beneficial for treatment of mild to moderate hypercalcemia. Details: Taking phosphate salts (except calcium phosphate) orally is effective for treating mild to moderate hypercalcemia (88144,88145). Treating hypercalcemia with oral phosphates requires monitoring of serum electrolyte levels to determine appropriate dosing (15); other agents are now preferred (6479). Intravenous phosphates should be avoided due to the risk of calcium precipitation in vital organs (metastatic calcification) (15,88144,88145).

POSSIBLY EFFECTIVE

• Kidney stones (nephrolithiasis). Oral potassium phosphate seems to be beneficial for prevention of kidney stones in individuals with hypercalciuria. Details: Taking potassium phosphate orally may help prevent calcium oxalate kidney stones in patients with hypercalciuria (6470). Clinical research in adults with absorptive hypercalciuria and at high risk for stone formation shows that taking a specific slow-release potassium phosphate product (Uro-Phos-K, Mission Pharmacal), providing phosphate 620 mg orally twice daily for 4 days, reduces urinary calcium excretion by 35% to 40% (2208,2209). Potassium and sodium phosphate salts providing 1200-1500 mg of elemental phosphate daily have been used (2209,6470).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Athletic performance. The evidence is mixed as to whether oral sodium phosphate improves cycling or running performance. Most research suggests that oral calcium phosphate and potassium phosphate are not beneficial. Details: Clinical research shows that taking calcium phosphate or potassium phosphate orally does not improve running or cycling performance (2499,9300,8301). Evidence for the use of sodium phosphate to improve cycling performance is mixed. One very small clinical study shows that taking sodium phosphate as tribasic sodium phosphate dodecahydrate for 6 days before a 10-mile cycling trial increases mean power output by about 10% and decreases the time needed to complete the trial by 3% in trained male cyclists (88150). Other small clinical trials in trained cyclists show that taking the same form of sodium phosphate as 50 mg/kg of fat-free mass in four divided doses daily for 6 days modestly improves work, power output, and peak oxygen uptake and reduces heart rate during high-intensity cycling exercise when compared to baseline (93857,93858,93859,107007). However, conflicting research shows that taking a similar dosage of this form of sodium phosphate does not improve time trial performance, work accomplished relative to energy expenditure, power output, or oxygen uptake in trained cyclists (93855,93856,107007). Sodium phosphate has also been evaluated for improving running performance, with mixed findings. Two small clinical trials in female athletes show that tribasic sodium phosphate dodecahydrate 50 mg/kg of fat-free mass taken in four divided doses daily for 6 days moderately improves repeated sprint times when compared with placebo (93843,93844). However, taking the same dosage does not significantly improve sprint times in male athletes (93849). Also, sodium phosphate does not seem to improve endurance or aerobic capacity in treadmill tests (8301,93854). Reasons for the discrepancies regarding the effects of sodium phosphate on athletic performance are not entirely clear, but likely relate to the very small number of participants in the included trials.
• Diabetic ketoacidosis. Potassium phosphate infusion is not recommended as first-line therapy for adults with diabetic ketoacidosis. Details: Clinical research shows that intravenous infusion of potassium phosphate 8.5 mmol/hour (approximately 6 grams of phosphate over 24 hours) along with potassium chloride 12.5 mEq/hour provides no benefit over potassium chloride alone in adults with diabetic ketoacidosis (88149). Guidelines for the treatment of diabetic ketoacidosis in the both the US and UK do not recommend phosphate replacement for most patients. However, it may be considered in specific cases, such as cardiac dysfunction, anemia, respiratory depression, and serum phosphate concentrations below 1 mg/dL (107349,107350A).
• Osteoporosis. Calcium phosphate seems to be beneficial for bone density improvement; however, it does not seem to be more beneficial than calcium carbonate. Details: In postmenopausal adults with osteoporosis and low phosphate intakes, taking calcium 1800 mg daily as tricalcium phosphate for 12 months improves lumbar spine and hip densities. However, it is no more effective than taking the same amount of calcium as calcium carbonate (93847). The calcium products were used in combination subcutaneous teriparatide and oral vitamin D (cholecalciferol) 1000 IU daily.
• Refeeding syndrome. It is unclear if intravenous potassium phosphate or sodium phosphate is beneficial for prevention of refeeding syndrome. Details: Preliminary clinical research shows that giving intravenous sodium and potassium phosphates, 50 mmol (1.56 grams) phosphate over 24 hours, prevents the refeeding syndrome seen when restarting adequate nutrition after severe malnutrition or starvation when compared with historical controls (88148). More evidence is needed to rate phosphate salts for these uses.

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UNSAFE ...when used orally or topically. Aconite root contains toxic alkaloids that are strong, fast-acting poisons that affect the heart and central nervous system, causing severe arrhythmias, reduced consciousness, and death (15499,19669,30294,30300,30301,30303,30309,30334,30335,30336,92276,104514,106706). All species of this plant are dangerous. Severe poisoning has been reported after ingestion of 0.2-2 mg of aconitine, 1 gram of the raw plant, or 6 grams of processed and cured aconite (3490,104514). Even when a processed product is used, aconite can cause toxicity including nausea, vomiting, dizziness, muscle spasms, hypothermia, paralysis of the respiratory system, and heart rhythm disorders (15499). Aconite can also be absorbed through the skin and cause significant toxicity (12).

PREGNANCY AND LACTATION: UNSAFE
when used orally or topically (15499).

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POSSIBLY UNSAFE ...when used orally. Boneset can cause severe diarrhea and vomiting. Hepatotoxic pyrrolizidine alkaloids (PAs) are common in this genus of plants; however, the alkaloids in boneset have not been adequately characterized to determine their toxic potential (12842,102557).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally. Hepatotoxic PAs are common in this genus of plants; however, the alkaloids in boneset have not been adequately characterized to determine their toxic potential (12842,102557). Hepatotoxic PAs might be teratogenic; avoid using.

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LIKELY UNSAFE ...when the root or berries are used orally (2,18). Consuming 40 berries might be fatal (18).

CHILDREN: LIKELY UNSAFE
when the root or berries are used orally (2,18). Consuming as few as 15 berries can be fatal in children (18).

PREGNANCY: UNSAFE
when the root is used orally. Bryonia root might have abortifacient effects (2). ...when the berries are used orally (2).

LACTATION: LIKELY UNSAFE
when the root or berries are used orally (2).

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LIKELY SAFE ...when used orally and appropriately short-term (15). ...when sodium phosphate is used rectally and appropriately, no more than once every 24 hours, short-term (104471). Long-term use or high doses used orally or rectally require monitoring of serum electrolytes (2494,2495,2496,2497,2498,3092,112922). ...when used intravenously. Potassium phosphate is an FDA-approved prescription drug (15).

POSSIBLY UNSAFE ...when phosphate (expressed as phosphorus) intake exceeds the tolerable upper intake level (UL) of 4 grams daily for adults under 70 years and 3 grams daily for adults older than 70. Hyperphosphatemia, resulting in electrolyte disturbances, alterations in calcium homeostasis, and calcification of nonskeletal tissues, may occur (7555). ...when used rectally more frequently than once every 24 hours, in excessive doses, with longer retention enema time, or in older patients with comorbidity or renal impairment (112922). The US Food and Drug Administration (FDA) warns that this may increase the risk of hyperphosphatemia, dehydration, and electrolyte imbalances leading to kidney and heart damage (104471).

CHILDREN: LIKELY SAFE
when used orally and appropriately at recommended dietary allowances (RDAs). The daily RDAs are: children 1-3 years, 460 mg; children 4-8 years, 500 mg; males and females 9-18 years, 1250 mg (7555). ...when sodium phosphate is used rectally and appropriately, no more than once every 24 hours, short-term in children 2 years and older (104471). ...when used intravenously. Intravenous potassium phosphate is an FDA-approved prescription drug (15).

CHILDREN: POSSIBLY UNSAFE
when phosphate (expressed as phosphorus) intake exceeds the tolerable upper intake level (UL) of 3 grams daily for children 1-8 years of age and 4 grams daily for children 9 years and older. Hyperphosphatemia, resulting in electrolyte disturbances, alterations in calcium homeostasis, and calcification of nonskeletal tissues, may occur (7555). ...when sodium phosphate is used rectally more frequently than once every 24 hours, or in children under 2 years of age or with Hirchsprung disease (112922). The US Food and Drug Administration (FDA) warns that these uses may increase the risk of hyperphosphatemia, dehydration, and electrolyte imbalances leading to kidney and heart damage (104471).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately at the recommended dietary allowance (RDA) of 1250 mg daily for individuals 14-18 years of age and 700 mg daily for those over 18 years of age (7555). ...when sodium phosphate is used rectally and appropriately short-term (15). ...when used intravenously. Intravenous potassium phosphate is an FDA-approved prescription drug (15).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when phosphate (expressed as phosphorus) intake exceeds the tolerable upper intake level (UL). Hyperphosphatemia, resulting in electrolyte disturbances, alterations in calcium homeostasis, and calcification of nonskeletal tissues, may occur. The UL during pregnancy is 3.5 grams daily. During lactation, the UL is 4 grams daily (7555).

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, combining aconite with other antiplatelet or anticoagulant drugs might increase the risk of bruising and bleeding.  Details Higenamine, a constituent of aconite, is thought to have antiplatelet and antithrombotic effects. In an animal model of thrombosis, higenamine inhibited platelet aggregation and reduced the size of thrombus formation (92282).

STIMULANT DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, combining aconite with other stimulant drugs might alter the effects of the stimulant drug or increase the risk of cardiovascular toxicity.  Details Aconite and its constituents have stimulant effects due to agonist activity at beta-2-adrenoreceptors. In cardiac muscle, aconite appears to have a positive inotropic effect and increases heart rate and blood pressure (2634,15499,30296,92282). However, some constituents of aconite can reduce heart rate and blood pressure (15499,30343).

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BISPHOSPHONATES Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking phosphate salts with bisphosphonates might increase the risk of hypocalcemia.  Details Combining bisphosphonates and phosphate can cause hypocalcemia. In one report, hypocalcemic tetany developed in a patient taking alendronate (Fosamax) who received a large dose of phosphate salts as a pre-operative laxative (14589).

ERDAFITINIB (Balversa) Interaction Rating = Major Do not take this combination. Severity = High •  Occurrence = Probable •  Level of Evidence = A Taking erdafitinib with phosphate salts increases the risk of hyperphosphatemia.  Details Erdafitinib increases phosphate levels. It is recommended that patients taking erdafitinib restrict phosphate intake to no more than 600-800 mg daily (104470).

FUTIBATINIB (Lytgobi) Interaction Rating = Major Do not take this combination. Severity = High •  Occurrence = Likely •  Level of Evidence = A Taking futibatinib with phosphate salts increases the risk of hyperphosphatemia.  Details Futibatinib can cause hyperphosphatemia, as reported in 88% of patients in clinical studies. In addition, 77% of patients in clinical studies required use of a phosphate binder to manage hyperphosphatemia. Phosphate salts should generally be avoided by people taking this medication (112912).

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General ...Orally and topically, aconite is generally regarded as unsafe for use. Any benefits of therapy might not outweigh the risk of toxicity.
Most Common Adverse Effects:
All routes of administration: Serious neurologic, cardiovascular, gastrointestinal, and respiratory adverse effects have been reported.

Cardiovascular ...Orally and topically, aconite can cause hypotension, palpitations, chest tightness, pulmonary edema, arrhythmia, bradycardia, tachycardia, sustained or bidirectional ventricular tachycardia, ventricular fibrillation, and Torsade de pointes (558,559,561,562,563,3490,15499,15650,30294,30295)(30300,30305,30323,30336,92276,92277,92278,104514,106706,110473)(112901). Cardioversion has been reported to be ineffective for the reversal of aconite-induced dysrhythmia, but the use of agents such as amiodarone, lidocaine, and magnesium have been successful in some cases (2634,3490,106706,112901).

Gastrointestinal ...Orally, aconite can cause nausea, vomiting, diarrhea, and gastric pain (563,30297,30341,92277,92278). Topically, aconite can cause nausea and vomiting (92276).

Neurologic/CNS ...Orally, aconite can cause weakness, sweating, restlessness, dizziness, numbness, paresthesia, seizures, and reduced consciousness (558,559,561,562,563,3490,15499,15650,30335,30336,30341,92277,92278,104513). Topically, aconite can cause generalized paresthesia, fatigue, sweating, dizziness and tongue numbness (92276).

Ocular/Otic ...Orally, aconite has been reported to cause visual blurring and yellow-green vision with pupil dilation (30319).

Pulmonary/Respiratory ...Orally, aconite overdose can lead to respiratory failure (104513).

Renal ...Orally and topically, aconite can cause hypokalemia and metabolic and/or respiratory acidosis (558,559,561,562,563,3490,15499,15650).

Other ...Orally and topically, aconite has been reported to cause death in both adults and children (559,3490,3491,30301,30334,30341,92276,92278). In one case report, topical application of aconite to an infant led to cardiogenic shock with multi-organ failure and death (92276). Poisoning has been reported in 15 patients after consuming a homemade liquor containing aconite. Patients presented with tongue or extremity numbness, vomiting, dizziness, or heart palpitations, and 5 died (110471). Death has also been reported in individuals who cooked aconite tubers as vegetables or for health purposes (92278).
The first symptoms of aconite poisoning after oral ingestion of the leaves or root usually occur within 10-90 minutes, although toxicity may be delayed until a second or third dose (559,15499,104513,110471). Recovery time from aconite poisoning ranges from 1.5-2 days for mild intoxication to 7-9 days for patients with cardiovascular complications; fatalities in treated patients are about 5% (15499). Treatment of aconite toxicity is typically supportive, although charcoal hemoperfusion has aided in detoxification (15499,106706).

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General ...Orally, boneset is reported to cause nausea and severe diarrhea and vomiting (12842). Additionally, other plants in the Eupatorium genus contain the hepatotoxic pyrrolizidine alkaloids (PAs). However, the alkaloids in boneset have not been adequately characterized to determine their toxic potential (12842,102557). Liver toxicity and liver damage may be possible in high doses.

Gastrointestinal ...Orally, boneset has been reported to cause nausea and severe diarrhea and vomiting (12842).

Hepatic ...Other plants in the Eupatorium genus contain hepatotoxic pyrrolizidine alkaloids (PAs). However, the alkaloids in boneset have not been adequately characterized to determine their toxic potential (12842,102557). Liver toxicity and liver damage may be possible in high doses.

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General ...Orally, bryonia root can cause dizziness, vomiting, convulsions, colic, bloody diarrhea, abortion, nervous excitement, and kidney damage. Large doses of bryonia can cause anuria, collapse, paralysis, and death (2). Bryonia berries can be fatal when taken orally; 40 berries can be fatal in adults, and 15 berries can be fatal in children (18).
Topically, skin contact with fresh bryonia may cause irritation (19).

Dermatologic ...Topically, skin contact with fresh bryonia may cause irritation (19).

Gastrointestinal ...Orally, bryonia root can cause vomiting, colic, and bloody diarrhea (2).

Genitourinary ...Orally, bryonia root can cause abortion (2). Large doses of bryonia can cause anuria and death (2).

Musculoskeletal ...Orally, large doses of bryonia can cause paralysis and death (2).

Neurologic/CNS ...Orally, bryonia root can cause dizziness, convulsions, and nervous excitement (2). Large doses of bryonia can cause paralysis and death (2).

Renal ...Orally, bryonia root can cause kidney damage (2). Large doses of bryonia can cause anuria and death (2).

Other ...Orally, bryonia berries can be fatal. Consuming 40 berries can be fatal in adults and as few as 15 berries can be fatal in children (18).

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General ...Orally, intravenously, and rectally, phosphate salts are generally well tolerated when used appropriately and/or as prescribed.
Most Common Adverse Effects:
Orally: Abdominal pain, anal irritation, bloating, diarrhea, headache, gastrointestinal irritation, hyperphosphatemia, hypocalcemia, malaise, nausea, sleep disturbance, and vomiting.
Rectally: Hyperphosphatemia and hypocalcemia.
Serious Adverse Effects (Rare):
Orally: Extraskeletal calcification.

Cardiovascular ...Orally, a case of allergic acute coronary syndrome e., Kounis syndrome) is reported in a 43-year-old female after ingesting a specific sodium phosphate laxative product (Travad oral). She presented with maculopapular rash that progressed to anaphylaxis and a non-ST elevation acute coronary syndrome. The patient recovered after hospitalization for 3 days with medical management (112894).

Gastrointestinal ...Orally, phosphate salts can cause gastrointestinal irritation, nausea, abdominal pain, bloating, anal irritation, and vomiting (15,2494,2495,2496,2497,93846,93848,93850,93851,93853,107008). Sodium and potassium phosphates can cause diarrhea (15). Aluminum phosphate can cause constipation (15). A large comparative study shows that, when taken orally as a bowel preparation for colonoscopy, sodium phosphate is associated with gastric mucosal lesions in about 4% of patients (93868).

Neurologic/CNS ...Orally, phosphate salts can commonly cause malaise (93846). Headaches and sleep disturbance may also occur (93848,93851).

Renal ...Orally, use of sodium phosphate for bowel cleansing has been associated with an increased risk of acute kidney injury in some patients (93863). However, a pooled analysis of clinical research suggests that results are not consistent for all patients (93864). Some evidence suggests that female gender, probably due to lower body weight, iron-deficiency anemia, dehydration, and chronic kidney disease are all associated with an increased risk of sodium phosphate-induced kidney dysfunction (93865).

Other ...Orally, phosphate salts can cause fluid and electrolyte disturbances including hyperphosphatemia and hypocalcemia, and extraskeletal calcification. Potassium phosphates can cause hyperkalemia. Sodium phosphates can cause hypernatremia and hypokalemia (15,2494,2495,2496,2497,107008).
Rectally, phosphate salts can cause fluid and electrolyte disturbances including hyperphosphatemia and hypocalcemia (15,112922).
Deaths related to intake of oral or rectal phosphate salts are rare and most have occurred in infants and are related to overdose (93866). However, death has also been reported in elderly patients using sodium phosphate enemas, mainly at standard doses of 250 mL (93867).

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