Interactions between Erdafitinib and Thaissept
1 drug interaction and 29 additional warnings found for the following 2 drugs:
- erdafitinib
- Thaissept (estradiol)
Drug interactions
Moderate drug interactions
Moderate:
estradiol erdafitinib
Applies to: Thaissept (estradiol) and erdafitinib
Additional contraception recommended
Coadministration with erdafitinib may decrease the plasma concentrations and effectiveness of estrogen- and/or progestin-containing hormonal therapies, including hormonal contraceptives. The proposed mechanism is erdafitinib mediated induction of CYP450 3A4, the isoenzyme primarily responsible for the metabolic clearance of various contraceptive hormones. When midazolam, a sensitive CYP450 3A4 substrate, was administered with erdafitinib, midazolam mean ratio peak plasma concentration (Cmax) and systemic exposure (AUC) were 86.3% and 82.1%, respectively. A reduction in the efficacy of hormonal contraceptives during treatment with erdafitinib cannot be excluded. Erdafitnib can cause embryo-fetal harm when administered to a pregnant women.
Management
Hormonal contraceptives, including oral, injectable, transdermal, and implantable forms, may not be reliable during concomitant therapy with erdafitinib. Since the use of erdafitinib is likely associated with embryo-fetal harm, it is particularly important that patients not become pregnant during treatment. Therefore, hormonal contraceptives should not be used as the sole method of birth control in women of childbearing potential treated with erdafitinib. Women of childbearing potential should use a highly effective, non-hormonal method of contraception during treatment with erdafitinib and for 1 month after the last dose. Male patients with female partners of reproductive potential should use effective contraception during treatment with erdafitinib and for 1 month after the last dose.
References (4)
- "Product Information. BALVERSA (erdafitinib)." JANSSEN-CILAG INTERNATIONAL N.V
- (2025) "Product Information. Balversa (erdafitinib)." Janssen-Cilag Ltd
- (2025) "Product Information. Balversa (erdafitinib)." Janssen Products, LP
- (2025) "Product Information. Balversa (erdafitinib)." Janssen Inc
Food/lifestyle interactions
Moderate food/lifestyle interactions
Moderate:
erdafitinib Food/Lifestyle
Applies to: erdafitinib
Generally avoid
Grapefruit or grapefruit juice may increase the plasma concentrations of erdafitinib. The proposed mechanism for the interaction is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruit. Inhibition of hepatic CYP450 3A4 may also contribute. The interaction has not been studied with grapefruit juice but has been reported for other CYP450 3A4 inhibitors. When coadministered with itraconazole, a strong CYP450 3A4 inhibitor, erdafitinib mean ratios for the peak plasma concentration (Cmax) and systemic exposure (AUC) were 105% and 134%, respectively, relative to erdafitinib alone. Increased exposure of erdafitinib may heighten the risk of hyperphosphatemia and gastrointestinal, dermatologic, and ocular toxicities. In general, the effects of grapefruit products are concentration-, dose- and preparation-dependent, and can vary widely among brands. Certain preparations of grapefruit (e.g., high dose, double strength) have sometimes demonstrated potent inhibition of CYP450 3A4, while other preparations (e.g., low dose, single strength) have typically demonstrated moderate inhibition.
Management
Until further information is available, it may be advisable for patients to limit or avoid consumption of grapefruit, grapefruit juice, or Seville oranges during treatment with erdafitinib.
References (4)
- "Product Information. BALVERSA (erdafitinib)." JANSSEN-CILAG INTERNATIONAL N.V
- (2025) "Product Information. Balversa (erdafitinib)." Janssen-Cilag Ltd
- (2025) "Product Information. Balversa (erdafitinib)." Janssen Products, LP
- (2025) "Product Information. Balversa (erdafitinib)." Janssen Inc
Minor food/lifestyle interactions
Minor:
estradiol Food/Lifestyle
Applies to: Thaissept (estradiol)
Coadministration with grapefruit juice may increase the bioavailability of oral estrogens. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall induced by certain compounds present in grapefruits. In a small, randomized, crossover study, the administration of ethinyl estradiol with grapefruit juice (compared to herbal tea) increased peak plasma drug concentration (Cmax) by 37% and area under the concentration-time curve (AUC) by 28%. Based on these findings, grapefruit juice is unlikely to affect the overall safety profile of ethinyl estradiol. However, as with other drug interactions involving grapefruit juice, the pharmacokinetic alterations are subject to a high degree of interpatient variability. Also, the effect on other estrogens has not been studied.
References (2)
- Weber A, Jager R, Borner A, et al. (1996) "Can grapefruit juice influence ethinyl estradiol bioavailability?" Contraception, 53, p. 41-7
- Schubert W, Eriksson U, Edgar B, Cullberg G, Hedner T (1995) "Flavonoids in grapefruit juice inhibit the in vitro hepatic metabolism of 17B-estradiol." Eur J Drug Metab Pharmacokinet, 20, p. 219-24
Disease interactions
27 potential interactions Applies to: 24 conditions, including High Blood Pressure, High Cholesterol, Migraine, Heart Failure, and Asthma.
Abnormal Uterine Bleeding
Major:
Thaissept
The estradiol in Thaissept has a major potential interaction with Abnormal Uterine Bleeding.
The use of estrogens is contraindicated in patients with undiagnosed, abnormal vaginal bleeding. Prolonged (greater than 1 year), unopposed estrogen use (i.e. estrogen without concomitant progestin therapy) has been associated with a significant, dose-related risk of endometrial carcinoma. The risk may be offset substantially by the addition of a progestin but may not be completely abolished. Prior to initiating estrogen therapy, appropriate diagnostic tests should be performed in patients with abnormal vaginal bleeding to rule out endometrial malignancy. The same applies if recurrent or persistent bleeding develops during estrogen therapy.
Angioedema
Moderate:
Thaissept
The estradiol in Thaissept has a moderate potential interaction with Angioedema.
The use of exogenous estrogens may induce or exacerbate symptoms of angioedema, particularly in women with hereditary angioedema. Consider the risk versus benefits of estrogen therapy. Close monitoring is recommended when prescribing these agents to patients predisposed to angioedema.
Asthma
Moderate:
Thaissept
The estradiol in Thaissept has a moderate potential interaction with Asthma.
Estrogens and progestogens may cause fluid retention, particularly when given in high dosages or for prolonged periods. Therapy with these agents should be administered cautiously in patients who have preexisting problems with excess fluid. In addition, patients with conditions that may be adversely affected by fluid accumulation, such as asthma, epilepsy, migraine, and cardiovascular or renal dysfunction, should be observed for exacerbation of their condition during estrogen and/or progestogen therapy.
Breast Cancer
Major:
Thaissept
The estradiol in Thaissept has a major potential interaction with Breast Cancer.
When treated with an estrogen, patients with breast cancer and bone metastases may develop severe hypercalcemia, in which case the drug should be stopped and measures be taken to reduce serum calcium levels.
Cerebral Vascular Disorder
Major:
Thaissept
The estradiol in Thaissept has a major potential interaction with Cerebral Vascular Disorder.
The use of estrogens is considered by manufacturers and some authorities to be contraindicated in patients with active thrombotic, thromboembolic, or thrombophilic disorders. The use of estrogen-containing oral contraceptives is additionally deemed contraindicated in patients with a history of such disorders and/or current cerebrovascular or coronary artery disease. Females with a history of migraines with aura are at an increased risk for stroke and this stroke risk may be further increased in females who have migraines with aura with use of combination oral contraceptives. Hypercoagulability and changes in various clotting factors and blood components have been observed in women receiving estrogen therapy. Known preexisting risk factors for increased thromboembolic or cardiovascular events include smoking, especially over age of 35; hypertension; hyperlipidemia; obesity; diabetes; age over 40; and lupus. Therapy with estrogens should be administered cautiously in the lowest effective dosage and only after careful consideration of risks and benefits. Estrogens should be avoided in patients with a history of thrombotic and thromboembolic disorders associated with estrogen use, except when used in the treatment of metastatic breast or prostatic malignancy.
Diabetes Mellitus
Moderate:
Thaissept
The estradiol in Thaissept has a moderate potential interaction with Diabetes Mellitus.
Impaired glucose tolerance has been observed in some patients administered oral contraceptives and appears to be related primarily to the estrogen dose. However, progestogens can increase insulin secretion and produce insulin resistance to varying degrees, depending on the agent. Caution and close monitoring are recommended in patients with diabetes mellitus during therapy with estrogens and/or progestogens, and adjustments made accordingly in their antidiabetic regimen.
Fluid Retention
Moderate:
Thaissept
The estradiol in Thaissept has a moderate potential interaction with Fluid Retention.
Estrogens and progestogens may cause fluid retention, particularly when given in high dosages or for prolonged periods. Therapy with these agents should be administered cautiously in patients who have preexisting problems with excess fluid. In addition, patients with conditions that may be adversely affected by fluid accumulation, such as asthma, epilepsy, migraine, and cardiovascular or renal dysfunction, should be observed for exacerbation of their condition during estrogen and/or progestogen therapy.
Gallbladder Disease
Moderate:
Thaissept
The estradiol in Thaissept has a moderate potential interaction with Gallbladder Disease.
A two- to four-fold increase in risk of gallbladder disease has been noted in women receiving postmenopausal estrogen therapy. The risk for gallbladder disease may be less for premenopausal women using oral contraceptives containing low-dose estrogens and/or progestins. Therapy with estrogens should be administered cautiously in patients with preexisting gallbladder disease or a history of pregnancy-related cholestasis.
Heart Failure
Moderate:
Thaissept
The estradiol in Thaissept has a moderate potential interaction with Heart Failure.
Estrogens and progestogens may cause fluid retention, particularly when given in high dosages or for prolonged periods. Therapy with these agents should be administered cautiously in patients who have preexisting problems with excess fluid. In addition, patients with conditions that may be adversely affected by fluid accumulation, such as asthma, epilepsy, migraine, and cardiovascular or renal dysfunction, should be observed for exacerbation of their condition during estrogen and/or progestogen therapy.
High Blood Pressure
Major:
Thaissept
The estradiol in Thaissept has a major potential interaction with High Blood Pressure.
The risk of myocardial infarction and strokes, including those associated with oral contraceptive use and some estrogen use, is increased in patients with hypertension. Moreover, estrogens (and progestogens) may elevate blood pressure and worsen the hypertension, thus compounding the risk. Clinically significant blood pressure increases have been reported during estrogen therapy, particularly in patients receiving high dosages or treated with oral contraceptive combinations having high progestational activity. These effects also increase with duration of therapy and patient age. Therapy with estrogens should be administered cautiously in patients with preexisting hypertension. Some estrogen-based therapies, such as combined hormonal contraceptives, may be contraindicated in patients with uncontrolled hypertension or hypertension with vascular disease. Patients should be monitored for changes in cardiovascular status, and their antihypertensive regimen adjusted or estrogen therapy withdrawn as necessary. In patients requiring contraception, alternative methods should be considered for those who are hypertensive, over age 35, and smoke.
High Cholesterol
Moderate:
Thaissept
The estradiol in Thaissept has a moderate potential interaction with High Cholesterol.
Estrogens may cause adverse lipid changes. Use of estrogens has been associated with elevations in triglyceride levels, particularly in women with pre-existing hypertriglyceridemia. Discontinue therapy if elevated triglycerides lead to pancreatitis. Manage hypercholesterolemia appropriately as indicated.
History, Thrombotic/Thromboembolic Disorder
Major:
Thaissept
The estradiol in Thaissept has a major potential interaction with History, Thrombotic/Thromboembolic Disorder.
The use of estrogens is considered by manufacturers and some authorities to be contraindicated in patients with active thrombotic, thromboembolic, or thrombophilic disorders. The use of estrogen-containing oral contraceptives is additionally deemed contraindicated in patients with a history of such disorders and/or current cerebrovascular or coronary artery disease. Females with a history of migraines with aura are at an increased risk for stroke and this stroke risk may be further increased in females who have migraines with aura with use of combination oral contraceptives. Hypercoagulability and changes in various clotting factors and blood components have been observed in women receiving estrogen therapy. Known preexisting risk factors for increased thromboembolic or cardiovascular events include smoking, especially over age of 35; hypertension; hyperlipidemia; obesity; diabetes; age over 40; and lupus. Therapy with estrogens should be administered cautiously in the lowest effective dosage and only after careful consideration of risks and benefits. Estrogens should be avoided in patients with a history of thrombotic and thromboembolic disorders associated with estrogen use, except when used in the treatment of metastatic breast or prostatic malignancy.
Hypoparathyroidism
Moderate:
Thaissept
The estradiol in Thaissept has a moderate potential interaction with Hypoparathyroidism.
Estrogens should be used with caution in individuals with severe hypocalcemia or hypoparathyroidism. Estrogen-induced hypocalcemia may occur in patients with hypoparathyroidism; consider whether the benefits of estrogen therapy outweigh the risks.
Ischemic Heart Disease
Major:
Thaissept
The estradiol in Thaissept has a major potential interaction with Ischemic Heart Disease.
The use of estrogens is considered by manufacturers and some authorities to be contraindicated in patients with active thrombotic, thromboembolic, or thrombophilic disorders. The use of estrogen-containing oral contraceptives is additionally deemed contraindicated in patients with a history of such disorders and/or current cerebrovascular or coronary artery disease. Females with a history of migraines with aura are at an increased risk for stroke and this stroke risk may be further increased in females who have migraines with aura with use of combination oral contraceptives. Hypercoagulability and changes in various clotting factors and blood components have been observed in women receiving estrogen therapy. Known preexisting risk factors for increased thromboembolic or cardiovascular events include smoking, especially over age of 35; hypertension; hyperlipidemia; obesity; diabetes; age over 40; and lupus. Therapy with estrogens should be administered cautiously in the lowest effective dosage and only after careful consideration of risks and benefits. Estrogens should be avoided in patients with a history of thrombotic and thromboembolic disorders associated with estrogen use, except when used in the treatment of metastatic breast or prostatic malignancy.
Liver Disease
Moderate:
erdafitinib
Erdafitinib has a moderate potential interaction with Liver Disease.
There are limited pharmacokinetic (PK) data on the use of erdafitinib in patients with severe renal impairment or severe hepatic impairment (Child-Pugh C). The PKs of erdafitinib in patients with renal impairment requiring dialysis are unknown.
Moderate:
Thaissept
The estradiol in Thaissept has a moderate potential interaction with Liver Disease.
Estrogens are primarily metabolized by the liver. Use of estrogen therapy is contraindicated in patients with liver dysfunction or disease. Patients with impaired hepatic function may be at increased risk for adverse effects associated with estrogen administration due to decreased drug clearance. Patients with hepatic hemangiomas are at increased risk of exacerbation with use of estrogens. Therapy with estrogens should be administered cautiously in patients with cholestatic jaundice associated with past estrogen use or with pregnancy. In addition, clinicians should be aware that estrogen therapy may affect liver function tests.
Migraine
Major:
Thaissept
The estradiol in Thaissept has a major potential interaction with Migraine.
The use of estrogens is considered by manufacturers and some authorities to be contraindicated in patients with active thrombotic, thromboembolic, or thrombophilic disorders. The use of estrogen-containing oral contraceptives is additionally deemed contraindicated in patients with a history of such disorders and/or current cerebrovascular or coronary artery disease. Females with a history of migraines with aura are at an increased risk for stroke and this stroke risk may be further increased in females who have migraines with aura with use of combination oral contraceptives. Hypercoagulability and changes in various clotting factors and blood components have been observed in women receiving estrogen therapy. Known preexisting risk factors for increased thromboembolic or cardiovascular events include smoking, especially over age of 35; hypertension; hyperlipidemia; obesity; diabetes; age over 40; and lupus. Therapy with estrogens should be administered cautiously in the lowest effective dosage and only after careful consideration of risks and benefits. Estrogens should be avoided in patients with a history of thrombotic and thromboembolic disorders associated with estrogen use, except when used in the treatment of metastatic breast or prostatic malignancy.
Moderate:
Thaissept
The estradiol in Thaissept has a moderate potential interaction with Migraine.
Estrogens and progestogens may cause fluid retention, particularly when given in high dosages or for prolonged periods. Therapy with these agents should be administered cautiously in patients who have preexisting problems with excess fluid. In addition, patients with conditions that may be adversely affected by fluid accumulation, such as asthma, epilepsy, migraine, and cardiovascular or renal dysfunction, should be observed for exacerbation of their condition during estrogen and/or progestogen therapy.
Neoplasia, Estrogen Dependent
Major:
Thaissept
The estradiol in Thaissept has a major potential interaction with Neoplasia, Estrogen Dependent.
The use of estrogens is generally contraindicated in patients with known or suspected estrogen-dependent neoplasia such as breast and endometrial cancer, since it may stimulate tumor proliferation. High dosages of estrogens may be used for the palliative treatment of inoperable, metastatic breast cancer, but only in appropriately selected men and postmenopausal women.
Pancreatitis
Moderate:
Thaissept
The estradiol in Thaissept has a moderate potential interaction with Pancreatitis.
Estrogens may cause adverse lipid changes. Use of estrogens has been associated with elevations in triglyceride levels, particularly in women with pre-existing hypertriglyceridemia. Discontinue therapy if elevated triglycerides lead to pancreatitis. Manage hypercholesterolemia appropriately as indicated.
Phosphate Imbalance
Moderate:
erdafitinib
Erdafitinib has a moderate potential interaction with Phosphate Imbalance.
Increases in phosphate levels are a pharmacodynamic effect of erdafitinib. Hyperphosphatemia was reported as adverse reaction in 76% of patients after initiating treatment, with 32% requiring phosphate binders during treatment. Caution and monitoring of phosphate levels is advised in all patients. Follow the manufacturer's dose modification guidelines if required.
Renal Dysfunction
Moderate:
erdafitinib
Erdafitinib has a moderate potential interaction with Renal Dysfunction.
There are limited pharmacokinetic (PK) data on the use of erdafitinib in patients with severe renal impairment or severe hepatic impairment (Child-Pugh C). The PKs of erdafitinib in patients with renal impairment requiring dialysis are unknown.
Moderate:
Thaissept
The estradiol in Thaissept has a moderate potential interaction with Renal Dysfunction.
Estrogens and progestogens may cause fluid retention, particularly when given in high dosages or for prolonged periods. Therapy with these agents should be administered cautiously in patients who have preexisting problems with excess fluid. In addition, patients with conditions that may be adversely affected by fluid accumulation, such as asthma, epilepsy, migraine, and cardiovascular or renal dysfunction, should be observed for exacerbation of their condition during estrogen and/or progestogen therapy.
Retinal Disorders
Moderate:
erdafitinib
Erdafitinib has a moderate potential interaction with Retinal Disorders.
Erdafitinib can cause ocular disorders, including central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED) resulting in visual field defect. Perform monthly ophthalmological examinations during the first 4 months of treatment and every 3 months afterwards, and urgently at any time for visual symptoms. Ophthalmological examination should include assessment of visual acuity, slit lamp examination, fundoscopy, and optical coherence tomography. Follow manufacturers dose modification guidelines in patients at risk or with ocular adverse reactions.
Seizures
Moderate:
Thaissept
The estradiol in Thaissept has a moderate potential interaction with Seizures.
Estrogens and progestogens may cause fluid retention, particularly when given in high dosages or for prolonged periods. Therapy with these agents should be administered cautiously in patients who have preexisting problems with excess fluid. In addition, patients with conditions that may be adversely affected by fluid accumulation, such as asthma, epilepsy, migraine, and cardiovascular or renal dysfunction, should be observed for exacerbation of their condition during estrogen and/or progestogen therapy.
Thrombotic/Thromboembolic Disorder
Major:
Thaissept
The estradiol in Thaissept has a major potential interaction with Thrombotic/Thromboembolic Disorder.
The use of estrogens is considered by manufacturers and some authorities to be contraindicated in patients with active thrombotic, thromboembolic, or thrombophilic disorders. The use of estrogen-containing oral contraceptives is additionally deemed contraindicated in patients with a history of such disorders and/or current cerebrovascular or coronary artery disease. Females with a history of migraines with aura are at an increased risk for stroke and this stroke risk may be further increased in females who have migraines with aura with use of combination oral contraceptives. Hypercoagulability and changes in various clotting factors and blood components have been observed in women receiving estrogen therapy. Known preexisting risk factors for increased thromboembolic or cardiovascular events include smoking, especially over age of 35; hypertension; hyperlipidemia; obesity; diabetes; age over 40; and lupus. Therapy with estrogens should be administered cautiously in the lowest effective dosage and only after careful consideration of risks and benefits. Estrogens should be avoided in patients with a history of thrombotic and thromboembolic disorders associated with estrogen use, except when used in the treatment of metastatic breast or prostatic malignancy.
Thyroid Disease
Moderate:
Thaissept
The estradiol in Thaissept has a moderate potential interaction with Thyroid Disease.
When administering estrogen and/or progestogen therapy in patients with thyroid disorders, clinicians should be aware that these hormones may affect thyroid function tests. Patients on thyroid replacement therapy may require higher doses of thyroid hormone and appropriate monitoring. Changes have mostly been reported with the use of combination oral contraceptives. Specifically, thyroid-binding globulin (TBG) may be increased, resulting in elevated circulating total thyroid hormone, as measured by PBI (protein-bound iodine), T4 by column or radioimmunoassay, or T3 by radioimmunoassay. Free T3 resin uptake may be decreased. On the contrary, a decrease in TBG and, consequently, thyroxine concentration, has been reported by the manufacturers of the progestin-only (norethindrone) oral contraceptives.
More resources
erdafitinib
A total of 483 drugs are known to interact with erdafitinib.
- Erdafitinib is in the drug class multikinase inhibitors.
- Erdafitinib is used to treat the following conditions:
Thaissept
A total of 446 drugs are known to interact with Thaissept.
- Thaissept is in the drug class estrogens.
- Thaissept is used to treat the following conditions:
Drug Interaction Classification
| Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit. | |
| Moderately clinically significant. Usually avoid combinations; use it only under special circumstances. | |
| Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan. | |
| No interaction information available. |
Further information
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