Adcirca

Name: Adcirca

What side effects can this medication cause?

Tadalafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache
  • indigestion or heartburn
  • nausea
  • diarrhea
  • flushing
  • pain in the stomach, back, muscles, arms, or legs
  • cough

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

  • sudden decrease or loss of vision (see below for more information)
  • blurred vision
  • changes in color vision (seeing a blue tinge on objects or having difficulty telling the difference between blue and green)
  • sudden decrease or loss of hearing (see below for more information)
  • ringing in ears
  • erection that lasts longer than 4 hours
  • dizziness
  • chest pain
  • hives
  • rash
  • difficulty breathing or swallowing
  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
  • blistering or peeling of skin

Some patients experienced a sudden loss of some or all of their vision after they took tadalafil or other medications that are similar to tadalafil. The vision loss was permanent in some cases. It is not known if the vision loss was caused by the medication. If you experience a sudden loss of vision while you are taking tadalafil, call your doctor immediately or get emergency medical treatment. Do not take any more doses of tadalafil or similar medications such as sildenafil (Revatio, Viagra) or vardenafil (Levitra) until you talk to your doctor.

Some patients experienced a sudden decrease or loss of hearing after they took tadalafil or other medications that are similar to tadalafil. The hearing loss usually involved only one ear and did not always improve when the medication was stopped. It is not known if the hearing loss was caused by the medication. If you experience a sudden loss of hearing, sometimes with ringing in the ears or dizziness, while you are taking tadalafil, call your doctor immediately. Do not take any more doses of tadalafil or similar medications such as sildenafil (Revatio, Viagra) or vardenafil (Levitra) until you talk to your doctor.

Tadalafil may cause other side effects. Call your doctor if you have any unusual problems while taking this medication

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What is the most important information I should know about tadalafil?

Taking tadalafil with certain other medicines can cause a sudden and serious decrease in blood pressure.

Do not take tadalafil if you also use riociguat, or a nitrate drug such as nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, or recreational drugs such as "poppers."

Get medical help at once if you have nausea, chest pain, or dizziness during sex.

How should I take tadalafil?

Tadalafil is usually taken only once per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Tadalafil can be taken with or without food.

Do not break or split a Cialis tablet. Swallow it whole.

For erectile dysfunction, take Cialis just before sexual activity but not more than once per day.

Cialis can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor's instructions.

Do not take Cialis for erectile dysfunction if you are taking Adcirca for pulmonary arterial hypertension.

Store at room temperature away from moisture and heat.

Tadalafil side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop and get medical help at once if you have nausea, chest pain, or dizziness during sex. You could be having a life-threatening side effect.

Stop using tadalafil and call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • an erection is painful or lasts longer than 4 hours (prolonged erection can damage the penis);

  • vision changes or sudden vision loss;

  • ringing in your ears or sudden hearing loss; or

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Common side effects may include:

  • headache;

  • flushing (warmth, redness, or tingly feeling);

  • nausea, upset stomach;

  • stuffy nose; or

  • muscle pain, back pain, pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store and/or throw out Adcirca?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Adverse Reactions

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Hypotension [see Warnings and Precautions (5.1)]
  • Visual Loss [see Warnings and Precautions (5.5) and Patient Counseling Information (17)]
  • Hearing loss [see Warnings and Precautions (5.6)]
  • Priapism [see Warnings and Precautions (5.8)]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Tadalafil was administered to 398 patients with PAH during clinical trials worldwide. In trials of Adcirca, a total of 311 and 251 subjects have been treated for at least 182 days and 360 days, respectively. The overall rates of discontinuation because of an adverse event (AE) in the placebo-controlled trial were 9% for Adcirca 40 mg and 15% for placebo. The rates of discontinuation because of AEs, other than those related to worsening of PAH, in patients treated with Adcirca 40 mg was 4% compared to 5% in placebo-treated patients.

In the placebo-controlled study, the most common AEs were generally transient and mild to moderate in intensity. Table 1 presents treatment-emergent adverse events reported by ≥9% of patients in the Adcirca 40 mg group and occurring more frequently than with placebo.

Table 1: Treatment-Emergent Adverse Events Reported by ≥9% of Patients in Adcirca and More Frequent than Placebo by 2%
EVENT Placebo (%)
(N=82)
Adcirca 20 mg (%)
(N=82)
Adcirca 40 mg (%)
(N=79)
Headache 15 32 42
Myalgia 4 9 14
Nasopharyngitis 7 2 13
Flushing 2 6 13
Respiratory Tract Infection (Upper and Lower) 6 7 13
Pain in Extremity 2 5 11
Nausea 6 10 11
Back Pain 6 12 10
Dyspepsia 2 13 10
Nasal Congestion (Including sinus congestion) 1 0 9

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of tadalafil. These events have been chosen for inclusion either because of their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. The list does not include adverse events that are reported from clinical trials and that are listed elsewhere in this section.

Cardiovascular and cerebrovascular Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported postmarketing in temporal association with the use of tadalafil. Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of tadalafil without sexual activity. Others were reported to have occurred hours to days after the use of tadalafil and sexual activity. It is not possible to determine whether these events are related directly to tadalafil, to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors, or to other factors [see Warnings and Precautions (5.1)].

Body as a whole Hypersensitivity reactions including urticaria, Stevens–Johnson syndrome, and exfoliative dermatitis

Nervous Migraine, seizure and seizure recurrence, and transient global amnesia

Ophthalmologic Visual field defect, retinal vein occlusion, retinal artery occlusion, and NAION [see Warnings and Precautions (5.5) and Patient Counseling Information (17)].

Otologic Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including tadalafil. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of tadalafil, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Warnings and Precautions (5.6) and Patient Counseling Information (17)].

Urogenital Priapism [see Warnings and Precautions (5.8)].

Drug Interactions

Potential for Pharmacodynamic Interactions with Adcirca

Nitrates

Do not use Adcirca in patients who are using any form of organic nitrate [see Contraindications (4.1)]. In clinical pharmacology studies Adcirca potentiated the hypotensive effect of nitrates [see Clinical Pharmacology (12.2)]. In a patient who has taken Adcirca, where nitrate administration is deemed medically necessary in a life–threatening situation, at least 48 hours should elapse after the last dose of Adcirca before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring.

Alpha-Blockers

PDE5 inhibitors, including Adcirca, 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. Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin, alfuzosin or tamsulosin [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2)].

Antihypertensives

PDE5 inhibitors, including Adcirca, are mild systemic vasodilators. Clinical pharmacology studies were conducted to assess the effect of tadalafil on the potentiation of the blood–pressure–lowering effects of selected antihypertensive medications (amlodipine, angiotensin II receptor blockers, bendroflumethiazide, enalapril, and metoprolol). Small reductions in blood pressure occurred following coadministration of tadalafil with these agents compared with placebo [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2)].

Alcohol

Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood pressure–lowering effects of each individual compound may be increased. Substantial consumption of alcohol (e.g., 5 units or greater) in combination with Adcirca can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache. Tadalafil (10 mg or 20 mg) did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations. [See Warnings and Precautions (5.1) and Clinical Pharmacology (12.2)].

Potential for Other Drugs to Affect Adcirca

Ritonavir

Ritonavir initially inhibits and later induces CYP3A, the enzyme involved in the metabolism of tadalafil. At steady state of ritonavir (about 1 week), the exposure to tadalafil is similar as in the absence of ritonavir [see Dosage and Administration (2.3), Warnings and Precautions (5.2), and Clinical Pharmacology (12.3)].

Other Potent Inhibitors of CYP3A

Tadalafil is metabolized predominantly by CYP3A in the liver. In patients taking potent inhibitors of CYP3A such as ketoconazole, and itraconazole, avoid use of Adcirca [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

Potent Inducers of CYP3A

For patients chronically taking potent inducers of CYP3A, such as rifampin, avoid use of Adcirca [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

Potential for Adcirca to Affect Other Drugs

Cytochrome P450 Substrates

Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolized by cytochrome P450 (CYP) isoforms (e.g., theophylline, warfarin, midazolam, lovastatin, bosentan) [see Clinical Pharmacology (12.3)].

Aspirin

Tadalafil (10 mg and 20 mg once daily) does not potentiate the increase in bleeding time caused by aspirin [see Clinical Pharmacology (12.3)].

P-glycoprotein (e.g., digoxin)

Coadministration of tadalafil (40 mg once daily) for 10 days did not significantly alter digoxin pharmacokinetics in healthy subjects [see Clinical Pharmacology (12.3)].

Use in specific populations

Pregnancy

Pregnancy Category B

Animal reproduction studies in rats and mice revealed no evidence of fetal harm. There are, however, no adequate and well-controlled studies of tadalafil in pregnant women. Because animal reproduction studies are not always predictive of human response, tadalafil should be used during pregnancy only if clearly needed.

Non–teratogenic effects

Animal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when tadalafil was given to pregnant rats or mice at unbound tadalafil exposures up to 7 times the maximum recommended human dose (MRHD) of 40 mg/day during organogenesis. In one of two perinatal/postnatal developmental studies in rats, postnatal pup survival decreased following maternal exposure to unbound tadalafil concentrations greater than 5 times the MRHD based on AUC. Signs of maternal toxicity occurred at doses greater than 8 times the MRHD based on AUC. Surviving offspring had normal development and reproductive performance [see Nonclinical Toxicology (13.3)].

Nursing Mothers

It is not known whether tadalafil is excreted into human milk. While tadalafil or some metabolite of tadalafil was excreted into rat milk, drug levels in animal breast milk may not accurately predict levels of drug in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when Adcirca is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Adcirca in pediatric patients have not been established.

Geriatric Use

Of the total number of subjects in the clinical study of tadalafil for pulmonary arterial hypertension, 28 percent were 65 and over, while 8 percent were 75 and over. No overall differences in safety were observed between subjects over 65 years of age compared to younger subjects or those over 75 years of age. No dose adjustment is warranted based on age alone; however, a greater sensitivity to medications in some older individuals should be considered. [See Dosage and Administration (2.2) and Clinical Pharmacology (12.3)].

Renal Impairment

For patients with mild or moderate renal impairment, start Adcirca at 20 mg once daily. Increase the dose to 40 mg once daily based upon individual tolerability [see Dosage and Administration (2.2), Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

In patients with severe renal impairment, avoid use of Adcirca because of increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

Hepatic Impairment

Because of limited clinical experience in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A or B), consider a starting dose of Adcirca 20 mg once daily. Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied, thus avoid use of Adcirca in such patients [see Dosage and Administration (2.2), Warnings and Precautions (5.4) and Clinical Pharmacology (12.3)].

PACKAGE LABEL – Adcirca 20 mg

60 tablets

NDC 66302-467-60

Rx only

TA 4467

Adcirca®

tadalafil tablets

20 mg

United Therapeutics Corporation

Lilly

Same active ingredient as Cialis

Adcirca 
tadalafil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66302-467
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tadalafil (tadalafil) Tadalafil 20 mg
Inactive Ingredients
Ingredient Name Strength
Croscarmellose sodium  
Hydroxypropyl cellulose (Type H)  
Hypromellose, unspecified  
Microcrystalline cellulose  
Lactose monohydrate  
Magnesium stearate  
Sodium lauryl sulfate  
Talc  
Titanium dioxide  
Triacetin  
Ferric oxide yellow  
Ferric oxide red  
Product Characteristics
Color ORANGE (ORANGE) Score no score
Shape OVAL (ALMOND) Size 12mm
Flavor Imprint Code 4467
Contains     
Packaging
# Item Code Package Description
1 NDC:66302-467-60 60 TABLET in 1 BOTTLE
2 NDC:66302-467-61 14 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022332 05/22/2009
Labeler - United Therapeutics Corporation (965460025)
Registrant - Eli Lilly and Company (006421325)
Revised: 08/2017   United Therapeutics Corporation

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

For the Consumer

Applies to tadalafil: oral tablet

Along with its needed effects, tadalafil (the active ingredient contained in Adcirca) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tadalafil:

Less common
  • Arm, back, or jaw pain
  • blurred vision
  • chest pain or discomfort
  • chest tightness or heaviness
  • chills
  • cold sweats
  • confusion
  • dizziness
  • fainting
  • faintness or lightheadedness when getting up suddenly from a lying or sitting position
  • fast or irregular heartbeat
  • headache
  • hearing loss
  • nausea
  • nervousness
  • pain or discomfort in the arms, jaw, back, or neck
  • pounding in the ears
  • shortness of breath
  • slow or fast heartbeat
  • sweating
  • unusual tiredness or weakness
  • vomiting
Rare
  • Painful or prolonged erection of the penis
Incidence not known
  • Abdominal or stomach pain
  • blindness
  • blistering, peeling, or loosening of the skin
  • cough
  • cracks in the skin
  • decrease or change in vision
  • diarrhea
  • difficulty with speaking
  • double vision
  • fast, irregular, pounding, or racing heartbeat or pulse
  • headache, severe and throbbing
  • hives or welts
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • itching
  • joint or muscle pain
  • loss of heat from the body
  • numbness or tingling of the face, hands, or feet
  • red irritated eyes
  • red skin lesions, often with a purple center
  • red, swollen skin
  • redness of the skin
  • redness or soreness of the eyes
  • scaly skin
  • skin rash
  • slow speech
  • sores, ulcers, or white spots in the mouth or on the lips
  • sudden cardiac death
  • swelling of the feet or lower legs

Some side effects of tadalafil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • belching
  • heartburn
  • indigestion
  • stomach discomfort, upset, or pain
Less common
  • Bloody nose
  • body aches or pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • burning, dry, or itching eyes
  • burning feeling in the chest or stomach
  • congestion
  • difficulty with moving
  • difficulty with swallowing
  • dry mouth
  • dryness or soreness of the throat
  • excessive eye discharge
  • eye pain
  • feeling of constant movement of self or surroundings
  • feeling of warmth, redness of the face, neck, arms and occasionally, upper chest
  • fever
  • hoarseness
  • increased erection
  • lack or loss of strength
  • loose stools
  • muscle aching or cramping
  • muscle stiffness
  • nasal congestion
  • neck pain
  • pain
  • pain in the arms or legs
  • pain or burning in the throat
  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  • reduced sensitivity to touch
  • runny nose
  • sensation of spinning
  • sleepiness or unusual drowsiness
  • sleeplessness
  • spontaneous penile erection
  • stomach upset
  • swelling of the eyelids
  • swelling or puffiness of the eyes or face
  • swollen joints
  • tearing
  • tender, swollen glands in the neck
  • tenderness in the stomach area
  • trouble with sleeping
  • unable to sleep
  • upper abdominal or stomach pain
  • voice changes
  • watering of the eyes
Rare
  • Changes in color vision

For Healthcare Professionals

Applies to tadalafil: oral tablet

General

The most commonly reported adverse reactions were headache, nausea, dyspepsia, back pain, myalgia, flushing, nasopharyngitis, and pain in the extremity. These adverse reactions were dose dependent, transient, and generally mild or moderate.[Ref]

Cardiovascular

Most patients that experienced side effects such as myocardial infarction, sudden cardiac death, stroke, palpitations, and tachycardia had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity.[Ref]

Very common (10% or more): Flushing (up to 14%)
Common (1% to 10%): Hypertension, hot flush
Uncommon (0.1% to 1%): Hypotension
Frequency not reported: Unstable angina pectoris, postural hypotension, ventricular arrhythmia
Postmarketing reports: Myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported in temporal association with the use of this drug.[Ref]

Gastrointestinal

Very common (10% or more): Dyspepsia (up to 13%), nausea (up to 11%)
Common (1% to 10%): Diarrhea, gastroesophageal reflux disease, abdominal pain, gastroenteritis, constipation
Uncommon (0.1% to 1%): Vomiting
Frequency not reported: Dry mouth, dysphagia, esophagitis, gastritis, loose stools, nausea, upper abdominal pain, hemorrhoidal hemorrhage, rectal hemorrhage[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (up to 14%), back pain (up to 12%), pain in extremity (up to 11%)
Common (1% to 10%): Pain in limb, musculoskeletal stiffness
Uncommon (0.1% to 1%): Arthralgia, muscle spasm
Frequency not reported: Neck pain[Ref]

Nervous system

Very common (10% or more): Headache (up to 42%)
Common (1% to 10%): Dizziness (1%)
Rare (less than 0.1%): Transient global amnesia, transient ischemic attacks
Frequency not reported: Hypesthesia, somnolence, syncope, paraesthesia
Postmarketing reports: Migraine, seizure and seizure recurrence[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (up to 13%), upper and lower respiratory tract infection (up to 13%)
Common (1% to 10%): Nasal congestion (including sinus congestion), cough, influenza, pulmonary hypertension, rhinitis
Uncommon (0.1% to 1%): Dyspnea, epistaxis
Frequency not reported: Pharyngitis[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, menorrhagia (including uterine bleeding)
Uncommon (0.1% to 1%): Penile hemorrhage, hematospermia
Rare (less than 0.1%): Prolonged erections
Frequency not reported: Erection increased, spontaneous penile erection
Postmarketing reports: Priapism[Ref]

Other

In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited.[Ref]

Common (1% to 10%): Peripheral edema, fatigue, edema
Uncommon (0.1% to 1%): Tinnitus
Rare (less than 0.1%): Facial edema
Frequency not reported: Vertigo, asthenia, pain
Postmarketing reports: Cases of sudden decrease or loss of hearing have been reported in temporal association with the use of this drug.[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, urticaria, hyperhidrosis (sweating)
Rare (less than 0.1%): Angioedema
Frequency not reported: Pruritus
Postmarketing reports: Stevens-Johnson syndrome, exfoliative dermatitis[Ref]

Ocular

Most of the patients with NAION, but not all, had underlying anatomic or vascular risk factors, including but not necessarily limited to: Low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking.[Ref]

Uncommon (0.1% to 1%): Ocular hyperemia, eye pain, eyelid edema
Rare (less than 0.1%): Changes in color vision
Frequency not reported: Blurred vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increased
Postmarketing reports: Visual field defect, retinal vein occlusion, and retinal artery occlusion. Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported in temporal association with the use of this drug.[Ref]

Renal

Uncommon (0.1% to 1%): Hematuria
Frequency not reported: Renal impairment[Ref]

Hepatic

Frequency not reported: Abnormal liver function tests, GGTP increased[Ref]

Some side effects of Adcirca may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Tadalafil Pregnancy Warnings

This drug is not indicated for use in women. Adcirca (R): UK: Use should be avoided. AU and US: This drug should be used only if clearly needed. AU TGA pregnancy category: B1 US FDA pregnancy category: B

No evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or mice during organogenesis, at exposure up to 7 times maximum the recommended human dose (MRHD) of 40 mg/day. In a perinatal/postnatal developmental study in rats, postnatal pup survival decreased following maternal exposure to unbound tadalafil concentrations greater than 5 times the MRHD. Signs of maternal toxicity occurred at doses greater than 8 times the MRHD. Surviving offspring had normal development and reproductive performance. There are no controlled data in human pregnancy. AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

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