Important Safety Information — Tadalafil

What is this?

This Important Safety Information summarizes key warnings, precautions, contraindications, and possible side effects for tadalafil, a prescription medication indicated for the treatment of erectile dysfunction, the signs and symptoms of benign prostatic hyperplasia, and erectile dysfunction with benign prostatic hyperplasia.

This page does not include all possible information about tadalafil. Always follow your prescription label, pharmacy instructions, and the instructions provided by your ATHS healthcare provider.

Tadalafil is a phosphodiesterase type 5, or PDE5, inhibitor. Sexual stimulation is required for tadalafil to help produce an erectile response.

Who should not take tadalafil?

Do not take tadalafil if you use any form of organic nitrate medication, either regularly or occasionally. Taking tadalafil with nitrates can cause blood pressure to suddenly drop to an unsafe level, which may result in dizziness, fainting, heart attack, or stroke.

Do not take tadalafil if you have had a known serious hypersensitivity reaction to tadalafil or any tadalafil-containing product, including Cialis^® or Adcirca^®. Serious hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis.

Do not take tadalafil with guanylate cyclase stimulators, such as riociguat. Taking tadalafil with these medications may cause blood pressure to drop to an unsafe level.

Cardiovascular warning

Sexual activity carries a degree of cardiac risk, especially in patients with preexisting cardiovascular disease. Tadalafil should not be used by patients for whom sexual activity is inadvisable because of their cardiovascular status.

Tell your provider if you have a history of heart attack, stroke, chest pain, heart failure, abnormal heart rhythm, low blood pressure, uncontrolled high blood pressure, or other cardiovascular conditions.

Tadalafil is not recommended for patients who have had a heart attack within the last 90 days, unstable angina or chest pain during sexual intercourse, New York Heart Association Class 2 or greater heart failure within the last 6 months, uncontrolled arrhythmias, low blood pressure, uncontrolled high blood pressure, or a stroke within the last 6 months.

If you experience chest pain after taking tadalafil, seek immediate medical attention. Do not take nitrates unless directed by a healthcare professional in a medically supervised emergency setting.

Blood pressure effects

Tadalafil can cause mild decreases in blood pressure. This may be more concerning in patients with cardiovascular disease or patients taking medications that lower blood pressure.

Use caution when taking tadalafil with alpha-blockers, blood pressure medications, or substantial amounts of alcohol, because these combinations may increase the risk of dizziness, fainting, low blood pressure, headache, or changes in heart rate.

Prolonged erection

Rare cases of prolonged erections lasting more than 4 hours and priapism, which is a painful erection lasting more than 6 hours, have been reported with this class of medications.

An erection lasting more than 4 hours requires emergency medical attention. If not treated promptly, priapism can cause permanent damage to erectile tissue.

Use tadalafil with caution if you have a condition that may predispose you to priapism, including sickle cell anemia, multiple myeloma, leukemia, Peyronie’s disease, or anatomical deformation of the penis.

Vision changes

Stop taking tadalafil and seek medical attention right away if you experience sudden loss of vision in one or both eyes. This may be a sign of non-arteritic anterior ischemic optic neuropathy, or NAION, a rare condition that can cause decreased vision or permanent vision loss.

Use tadalafil with caution if you have a history of NAION or risk factors for this condition. Tadalafil is not recommended for patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa.

Hearing changes

Stop taking tadalafil and seek prompt medical attention if you experience sudden decrease or loss of hearing. This may occur with ringing in the ears or dizziness.

Possible side effects

The most common side effects of tadalafil include headache, indigestion, back pain, muscle aches, nasal congestion, flushing, and pain in the arms or legs.

Other reported side effects include upper respiratory tract infection, cough, diarrhea, urinary tract infection, gastroesophageal reflux disease, abdominal pain, nausea, vomiting, joint pain, muscle spasm, dizziness, fatigue, swelling, low blood pressure, palpitations, rapid heartbeat, chest pain, rash, itching, sweating, blurred vision, eye pain, changes in color vision, ringing in the ears, and spontaneous or increased erections.

Back pain or muscle aches may occur 12 to 24 hours after taking tadalafil and usually resolve within 48 hours. Contact your provider if pain is severe, persistent, or concerning.

Serious reported adverse events

Serious cardiovascular and cerebrovascular events have been reported after tadalafil use, including heart attack, sudden cardiac death, stroke, chest pain, palpitations, and rapid heartbeat. Many, but not all, of these patients had preexisting cardiovascular risk factors.

Serious hypersensitivity reactions have been reported, including hives, Stevens-Johnson syndrome, and exfoliative dermatitis. Other postmarketing reports include migraine, seizure and seizure recurrence, transient global amnesia, visual field defect, retinal vein occlusion, retinal artery occlusion, sudden hearing decrease or loss, and priapism.

Drug interactions

Tell your provider about all medications you take, including prescription medications, over-the-counter medications, vitamins, and supplements.

Do not take tadalafil with nitrates in any form. Do not take tadalafil with guanylate cyclase stimulators such as riociguat.

Tadalafil may increase the blood-pressure-lowering effects of alpha-blockers, antihypertensive medications, and alcohol. Caution is advised when tadalafil is used with these medications or substances.

Tadalafil is not recommended in combination with alpha-blockers for the treatment of benign prostatic hyperplasia because the combination may lower blood pressure and the effectiveness of the combination has not been adequately studied.

Certain medications can increase tadalafil exposure, including potent CYP3A4 inhibitors such as ketoconazole, ritonavir, itraconazole, erythromycin, and grapefruit juice. Dose adjustment may be required.

Certain medications can decrease tadalafil exposure, including CYP3A4 inducers such as rifampin, carbamazepine, phenytoin, and phenobarbital.

Do not take tadalafil with other PDE5 inhibitors or other erectile dysfunction therapies unless specifically directed by your healthcare provider.

Alcohol

Substantial alcohol consumption while taking tadalafil may increase the risk of low blood pressure symptoms, including dizziness, headache, increased heart rate, and decreased standing blood pressure.

Bleeding disorders and stomach ulcers

Tadalafil has not been administered to patients with bleeding disorders or significant active peptic ulceration. Use in these patients should be based on a careful risk-benefit assessment by a healthcare provider.

Sexually transmitted diseases

Tadalafil does not protect against sexually transmitted diseases, including HIV. Use appropriate protective measures to reduce the risk of sexually transmitted infections.

Benign prostatic hyperplasia considerations

Before starting tadalafil for symptoms of benign prostatic hyperplasia, your provider should consider other urological conditions that may cause similar symptoms. Prostate cancer and benign prostatic hyperplasia may exist at the same time.

Kidney or liver impairment

Patients with kidney impairment or liver impairment may require dose adjustment or may not be appropriate candidates for certain tadalafil dosing schedules.

Tadalafil for once daily use is not recommended in patients with severe kidney impairment or end-stage renal disease on hemodialysis. Tadalafil is not recommended in patients with severe liver impairment.

Pregnancy and breastfeeding

Tadalafil for erectile dysfunction or benign prostatic hyperplasia is not indicated for use in females. There are no data with tadalafil use in pregnant women to inform drug-associated risks for adverse developmental outcomes.

It is not known whether tadalafil or its metabolites are present in human milk, affect a breastfed child, or affect milk production.

Use in pediatric or geriatric patients

Tadalafil for erectile dysfunction or benign prostatic hyperplasia is not indicated for use in pediatric patients. Safety and effectiveness in patients under 18 years of age have not been established.

No dose adjustment is required based on age alone, but greater sensitivity to medications in some older adults should be considered.

Missed Dose

If you miss a dose, follow the instructions on your prescription label or contact your healthcare provider or pharmacy.

Do not take extra tadalafil to make up for a missed dose. Do not change your dosing schedule without medical direction.

Overdose

In cases of overdose, adverse events are expected to be similar to those seen at lower doses. Hemodialysis contributes negligibly to tadalafil elimination.

In case of overdose or accidental exposure, seek medical attention immediately or contact Poison Control at 1-800-222-1222.

Storage

Store tadalafil at 25°C / 77°F, with excursions permitted to 15°C to 30°C / 59°F to 86°F.

Keep out of reach of children.

In general:

• Store medication according to the instructions on the prescription label.
• Keep medication away from excessive heat, moisture, and direct light.
• Keep out of reach of children and pets.
• Do not use medication that appears contaminated, discolored, damaged, or otherwise unusual.

Medication Disposal

Do not flush unused medication down the toilet or pour it into a sink or drain unless specifically instructed.

Follow local disposal guidance or ask your pharmacist for instructions.

When to contact your provider

Contact your provider if you experience bothersome headache, indigestion, back pain, muscle aches, nasal congestion, flushing, pain in the arms or legs, dizziness, rash, hearing changes, vision changes, chest symptoms, urinary symptoms, or any side effect that feels unusual or concerning.

Seek emergency medical care

Seek emergency medical care if you experience chest pain, fainting, symptoms of heart attack or stroke, sudden vision loss, sudden hearing loss, severe allergic reaction, severe dizziness, a sudden drop in blood pressure, or an erection lasting more than four hours.

Reporting Side Effects

Tell your healthcare provider if you experience side effects or symptoms that concern you.

You may report suspected adverse reactions to the FDA through MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch.

Telemedicine Disclosure

This prescription may be issued through telemedicine after review by a licensed healthcare provider. If you experience concerning symptoms, contact your ATHS provider or seek emergency medical care.

Withholding or providing inaccurate information about your symptoms, medical history, medications, substance use, allergies, prior reactions, cardiovascular history, blood pressure, kidney function, liver function, vision history, hearing history, or other relevant health information may result in serious harm.

Disclaimer

This information is not comprehensive and does not include all possible risks, side effects, interactions, warnings, or precautions associated with tadalafil. This page does not provide medical advice, diagnosis, or treatment.

For questions about your medication, prescription, dosing, side effects, or treatment plan, contact your healthcare provider or pharmacist.

For complete prescribing information, refer to the Cialis^® Full Prescribing Information for tadalafil.