tecovirimat will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
tetracyclinetetracycline will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Professional | 40mg | 90 + 2 Pills | 348.59€ 331.99€ | |
| Tadalista Super Active | 20mg | 10 Pills | 55.64€ 52.99€ | |
| Cialis Super Active | 20mg | 270 + 30 Pills | 661.49€ 629.99€ | |
| Cialis Generic | 10mg | 180 + 8 Pills | 236.88€ 225.60€ | |
| Kamagra Gold | 100 mg | 180 + 6 Pills | 436.79€ 415.99€ | |
| Levitra Original | 20mg | 8 Pills | 65.05€ 61.95€ | |
| Cialis Professional | 40mg | 270 + 6 Pills | 898.37€ 855.59€ | |
| Kamagra Polo | 100 mg | 272 + 12 Pills | 622.94€ 593.28€ | |
| Levitra Soft Tabs | 20mg | 90 + 6 Pills | 241.31€ 229.82€ | |
| Cialis Professional | 40mg | 30 Pills | 148.94€ 141.85€ | |
| Levitra Generic | 20mg | 120 + 10 Pills | 224.15€ 213.48€ | |
| Levitra Generic | 60mg | 180 + 10 Pills | 501.43€ 477.55€ | |
| Levitra Generic | 20mg | 360 + 10 Pills | 458.44€ 436.61€ | |
| Kamagra Soft Tabs | 100mg | 84 + 4 Pills | 233.05€ 221.95€ | |
| Levitra Soft Tabs | 20mg | 360 + 20 Pills | 682.21€ 649.72€ | |
| Cialis Black | 80mg | 180 + 10 Pills | 356.64€ 339.66€ |
Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors tetracycline will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors tobramycin inhaledtobramycin inhaled and vardenafil both increase nephrotoxicity and/or ototoxicity. Avoid concurrent or sequential use to decrease risk for ototoxicity tobramycin inhaled and vardenafil both increase nephrotoxicity and/or ototoxicity. Avoid concurrent or sequential use to decrease risk for ototoxicity topiramatetopiramate will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. topiramate will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
anastrozoleanastrozole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme increase libido in women CYP3A4 metabolism. anastrozole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. azithromycinazithromycin increases toxicity of vardenafil by QTc interval. azithromycin increases toxicity of vardenafil by QTc interval. carvedilolvardenafil increases effects of carvedilol by pharmacodynamic synergism.
vardenafil increases effects of carvedilol by pharmacodynamic synergism. chloroquinechloroquine increases toxicity of vardenafil by QTc interval. chloroquine increases toxicity of vardenafil by QTc interval. cyclophosphamidecyclophosphamide will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. cyclophosphamide will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. valbenazinevalbenazine and vardenafil both increase QTc interval. valbenazine and vardenafil both increase QTc interval.
Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors verapamil will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors Either increases effects of the other by QTc interval. voriconazolevoriconazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors voriconazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors vorinostatvorinostat and vardenafil both increase QTc interval.
vorinostat and vardenafil both increase QTc interval. zafirlukastzafirlukast will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. zafirlukast will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. acetazolamideacetazolamide will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. acetazolamide will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. verapamilverapamil will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors verapamil will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
| Measure | Result | Timeframe | Notes |
|---|---|---|---|
| Erection Success Rate | 70-80% in clinical trials | After 1 Dose | High efficacy reported |
| Patient Satisfaction | 75% reported improvement | After 4 weeks | Based on surveys |
| Onset Time | 30-60 minutes | Post-dose | Rapid onset for most patients |
| Duration of Effect | 4-5 hours | After intake | Provides window for activity |
Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors Either increases effects of the other by QTc interval. voriconazolevoriconazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors voriconazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors vorinostatvorinostat and vardenafil both increase QTc interval. vorinostat and vardenafil both increase QTc interval.
| Patient Type | Recommended Dose | Notes |
|---|---|---|
| Adult Men with ED | 10 mg | 1 hour before activity |
| Elderly Patients | 5-10 mg | Adjust based on tolerability |
| Patients with Liver Impairment | 5 mg | Lower dose recommended |
| Use with CYP3A4 inhibitors | 5 mg | To reduce adverse risk |
zafirlukastzafirlukast will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
zafirlukast will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
tecovirimat will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. tetracyclinetetracycline will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors tetracycline will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors tobramycin inhaledtobramycin inhaled and vardenafil both increase nephrotoxicity and/or ototoxicity. Avoid concurrent or sequential use to decrease risk for ototoxicity tobramycin inhaled and vardenafil both increase nephrotoxicity and/or ototoxicity.
Avoid concurrent or sequential use to decrease risk for ototoxicity topiramatetopiramate will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. topiramate will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. valbenazinevalbenazine and vardenafil both increase QTc interval. valbenazine and vardenafil both increase QTc interval. verapamilverapamil will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. acetazolamideacetazolamide will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. acetazolamide will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. anastrozoleanastrozole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme increase libido in women CYP3A4 metabolism.
anastrozole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. azithromycinazithromycin increases toxicity of vardenafil by QTc interval. azithromycin increases toxicity of vardenafil by QTc interval. carvedilolvardenafil increases effects of carvedilol by pharmacodynamic synergism. vardenafil increases effects of carvedilol by pharmacodynamic synergism. chloroquinechloroquine increases toxicity of vardenafil by QTc interval.
drospirenonedrospirenone will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. drospirenone will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. labetalolvardenafil increases effects of labetalol by pharmacodynamic synergism. vardenafil increases effects of labetalol by pharmacodynamic synergism. Possible additive vasorelaxation, leading to low blood pressure.
Soluble guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension Coadministration with nitrates (either regularly and/or intermittently) and nitric oxide donors Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates A suitable time interval following PDE5 dosing for the safe administration of nitrates or nitric oxide donors has not been determined Use with caution in anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease), cardiovascular disease, left ventricular outflow obstruction, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, multidrug antihypertensive regimens, retinitis pigmentosa, concomitant use of CYP3A4 inhibitors, patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia) There have been rare reports of prolonged erections >4 hr and priapism (painful erections greater than 6 hours in duration) for this class of compounds, including vardenafil; in the event that an erection persists >4 hours, the patient should seek immediate medical assistance; if priapism is not treated immediately, penile tissue damage and permanent loss of potency may result Physicians should consider the cardiovascular status of their patients; there is a degree of cardiac risk associated with sexual activity; treatment for erectile dysfunction, should not be used in men for whom sexual activity is not recommended because of their underlying cardiovascular status Patients with left ventricular outflow obstruction, (for example, aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators including PDE5 inhibitors Until further information available, use is not recommended in unstable angina; hypotension (resting systolic blood pressure of <90 mmHg); uncontrolled hypertension (>170/110 mmHg); recent history of stroke, life-threatening arrhythmia, or myocardial infarction (within last 6 months); severe cardiac failure Consider counseling patients about protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV); drug offers no protection against sexually transmitted diseases Patients taking Class 1A (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using drug Safety and efficacy of drug used in combination with other treatments for erectile dysfunction not studied; use of such combinations not recommended Vision loss may occur rarely and may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION); patient should seek medical assistance for sudden loss in one or both eyes; patients who have already experienced NAION are at increased risk of recurrence; use is not recommended in patients with known degenerative retinal disorders May increase risk of rare sudden vision loss attributed to nonarteritic ischemic optic neuropathy; if vision problems arise, discontinue, and contact physician The drug has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 7 mmHg systolic and 8 mmHg diastolic); while this normally would be expected to be of little consequence in most patients, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects Physicians should advise patients to stop taking all PDE5 inhibitors, and seek prompt medical attention in event of sudden decrease or loss of hearing; these events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to intake of PDE5 inhibitors, including vardenafil; it is not possible to determine whether these events are related directly to use of PDE5 inhibitors or to other factors CYP3A4 inhibitorsConcomitant administration with potent CYP3A4 inhibitors (eg, ritonavir, indinavir, cobicistat, ketoconazole) or moderate CYP3A4 inhibitors (eg, erythromycin) increases plasma concentrations of drug; dosage adjustment is necessary when drug is administered with certain CYP3A4 inhibitorsLong-term safety information is not available on concomitant administration of drug with HIV protease inhibitors Concomitant administration with potent CYP3A4 inhibitors (eg, ritonavir, indinavir, cobicistat, ketoconazole) or moderate CYP3A4 inhibitors (eg, erythromycin) increases plasma concentrations of drug; dosage adjustment is necessary when drug is administered with certain CYP3A4 inhibitors Long-term safety information is not available on concomitant administration of drug with HIV protease inhibitors Alpha blockersCaution advised when PDE5 inhibitors co-administered with alpha-blockers; PDE5 inhibitors, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure lowering effects; when vasodilators are used in combination, an additive effect on blood pressure may be anticipated; in some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (eg, fainting)Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor; patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitorsIn patients who are stable on alpha-blocker therapy, initiate PDE5 inhibitors at lowest recommended starting doseIn patients already taking optimized dose of PDE5 inhibitor, initiate alpha-blocker therapy at lowest dose; stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a PDE5 inhibitorSafety of combined use of other PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs Caution advised when PDE5 inhibitors co-administered with alpha-blockers; PDE5 inhibitors, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure lowering effects; when vasodilators are used in combination, an additive effect on blood pressure may be anticipated; in some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (eg, fainting) Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor; patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors In patients who are stable on alpha-blocker therapy, initiate PDE5 inhibitors at lowest recommended starting dose In patients already taking optimized dose of PDE5 inhibitor, initiate alpha-blocker therapy at lowest dose; stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a PDE5 inhibitor Safety of combined use of other PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs QT prolonging drugsAvoid coadministration with drugs that have a high risk for QT prolonationPatients taking Class 1A (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using drug Avoid coadministration with drugs that have a high risk for QT prolonation Patients taking Class 1A (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using drug Controlled studies in pregnant women show no evidence of fetal risk. chloroquine increases toxicity of vardenafil by QTc interval. cyclophosphamidecyclophosphamide will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. cyclophosphamide will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. drospirenonedrospirenone will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
drospirenone will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. labetalolvardenafil increases effects of labetalol by pharmacodynamic synergism. vardenafil increases effects of labetalol by pharmacodynamic synergism. Possible additive vasorelaxation, leading to low blood pressure.
| Contraindication | Reason | Alternative Action |
|---|---|---|
| Use with Nitrates | Severe hypotension risk | Seek alternative ED treatment |
| Severe Liver Impairment | Reduced metabolism, increased risk | Dose adjustment or avoidance |
| Hypotension (<90/60 mm Hg) | Risk of significant blood pressure drop | Monitor blood pressure |
| Concomitant Potent CYP3A4 Inhibitors | Increased Vardenafil levels | Dose reduction |
Soluble guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension Coadministration with nitrates (either regularly and/or intermittently) and nitric oxide donors Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates A suitable time interval following PDE5 dosing for the safe administration of nitrates or nitric oxide donors has not been determined Use with caution in anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease), cardiovascular disease, left ventricular outflow obstruction, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, multidrug antihypertensive regimens, retinitis pigmentosa, concomitant use of CYP3A4 inhibitors, patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia) There have been rare reports of prolonged erections >4 hr and priapism (painful erections greater than 6 hours in duration) for this class of compounds, including vardenafil; in the event that an erection persists >4 hours, the patient should seek immediate medical assistance; if priapism is not treated immediately, penile tissue damage and permanent loss of potency may result Physicians should consider the cardiovascular status of their patients; there is a degree of cardiac risk associated with sexual activity; treatment for erectile dysfunction, should not be used in men for whom sexual activity is not recommended because of their underlying cardiovascular status Patients with left ventricular outflow obstruction, (for example, aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators including PDE5 inhibitors Until further information available, use is not recommended in unstable angina; hypotension (resting systolic blood pressure of <90 mmHg); uncontrolled hypertension (>170/110 mmHg); recent history of stroke, life-threatening arrhythmia, or myocardial infarction (within last 6 months); severe cardiac failure Consider counseling patients about protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV); drug offers no protection against sexually transmitted diseases Patients taking Class 1A (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using drug Safety and efficacy of drug used in combination with other treatments for erectile dysfunction not studied; use of such combinations not recommended Vision loss may occur rarely and may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION); patient should seek medical assistance for sudden loss in one or both eyes; patients who have already experienced NAION are at increased risk of recurrence; use is not recommended in patients with known degenerative retinal disorders May increase risk of rare sudden vision loss attributed to nonarteritic ischemic optic neuropathy; if vision problems arise, discontinue, and contact physician The drug has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 7 mmHg systolic and 8 mmHg diastolic); while this normally would be expected to be of little consequence in most patients, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects Physicians should advise patients to stop taking all PDE5 inhibitors, and seek prompt medical attention in event of sudden decrease or loss of hearing; these events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to intake of PDE5 inhibitors, including vardenafil; it is not possible to determine whether these events are related directly to use of PDE5 inhibitors or to other factors CYP3A4 inhibitorsConcomitant administration with potent CYP3A4 inhibitors (eg, ritonavir, indinavir, cobicistat, ketoconazole) or moderate CYP3A4 inhibitors (eg, erythromycin) increases plasma concentrations of drug; dosage adjustment is necessary when drug is administered with certain CYP3A4 inhibitorsLong-term safety information is not available on concomitant administration of drug with HIV protease inhibitors Concomitant administration with potent CYP3A4 inhibitors (eg, ritonavir, indinavir, cobicistat, ketoconazole) or moderate CYP3A4 inhibitors (eg, erythromycin) increases plasma concentrations of drug; dosage adjustment is necessary when drug is administered with certain CYP3A4 inhibitors Long-term safety information is not available on concomitant administration of drug with HIV protease inhibitors Alpha blockersCaution advised when PDE5 inhibitors co-administered with alpha-blockers; PDE5 inhibitors, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure lowering effects; when vasodilators are used in combination, an additive effect on blood pressure may be anticipated; in some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (eg, fainting)Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor; patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitorsIn patients who are stable on alpha-blocker therapy, initiate PDE5 inhibitors at lowest recommended starting doseIn patients already taking optimized dose of PDE5 inhibitor, initiate alpha-blocker therapy at lowest dose; stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a PDE5 inhibitorSafety of combined use of other PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs Caution advised when PDE5 inhibitors co-administered with alpha-blockers; PDE5 inhibitors, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure lowering effects; when vasodilators are used in combination, an additive effect on blood pressure may be anticipated; in some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (eg, fainting) Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor; patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors In patients who are stable on alpha-blocker therapy, initiate PDE5 inhibitors at lowest recommended starting dose In patients already taking optimized dose of PDE5 inhibitor, initiate alpha-blocker therapy at lowest dose; stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a PDE5 inhibitor Safety of combined use of other PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs QT prolonging drugsAvoid coadministration with drugs that have a high risk for QT prolonationPatients taking Class 1A (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using drug Avoid coadministration with drugs that have a high risk for QT prolonation Patients taking Class 1A (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using drug Controlled studies in pregnant women show no evidence of fetal risk.