Important Safety Information for Tadalafil Tablets
Atlas HRT safety summary derived from the FDA-approved Prescribing Information and Patient Information for tadalafil tablets, DailyMed label effective March 1, 2025. Last reviewed September 11, 2026.
What is the Most Important Information I Should Know about Tadalafil Tablets?
Tadalafil tablets can cause your blood pressure to drop suddenly to an unsafe level if they are taken with certain other medicines. You could get dizzy, faint, or have a heart attack or stroke. Never take tadalafil tablets with any nitrate or guanylate cyclase stimulator medicines.
Do not take tadalafil tablets if you take any medicines called “nitrates.” Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm.
Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrite and butyl nitrite. Do not take tadalafil tablets if you take medicines called guanylate cyclase stimulators which include:
Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension.
Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates or guanylate cyclase stimulators, such as riociguat.
Tell all of your healthcare providers that you take tadalafil tablets. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took tadalafil tablets.
After taking a single tablet, some of the active ingredient of tadalafil tablets remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications (see “Can Other Medicines Affect Tadalafil Tablets?”).
Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.
See also “What are the Possible Side Effects of Tadalafil Tablets?”
What are Tadalafil Tablets?
Tadalafil tablets are a prescription medicine taken by mouth for the treatment of:
- men with erectile dysfunction (ED)
- men with symptoms of benign prostatic hyperplasia (BPH)
- men with both ED and BPH
- Tadalafil Tablets for the Treatment of ED
- ED is a condition where the penis does not fill with enough blood to harden and expand when a man is sexually excited, or when he cannot keep an erection. A man who has trouble getting or keeping an erection should see his healthcare provider for help if the condition bothers him. Tadalafil tablets help increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away.
- Some form of sexual stimulation is needed for an erection to happen with tadalafil tablets.
- Tadalafil tablets do not: cure ED, increase a man’s sexual desire.
- protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your healthcare provider about ways to guard against sexually transmitted diseases.
- serve as a male form of birth control
- Tadalafil tablets are only for men over the age of 18, including men with diabetes or who have undergone prostatectomy.
- Tadalafil Tablets for the Treatment of Symptoms of BPH
- BPH is a condition that happens in men, where the prostate gland enlarges which can cause urinary symptoms.
- Tadalafil Tablets for the Treatment of ED and Symptoms of BPH
- ED and symptoms of BPH may happen in the same person and at the same time. Men who have both ED and symptoms of BPH may take tadalafil tablets for the treatment of both conditions.
- Tadalafil tablets are not for women or children.
- Tadalafil tablets must be used only under a healthcare provider’s care.
Who Should Not Take Tadalafil Tablets?
Do not take tadalafil tablets if you:
- take any medicines called “nitrates”.
- use recreational drugs called “poppers” like amyl nitrite and butyl nitrite (see “What Is The Most Important Information I Should Know About Tadalafil Tablets?”)
- take any medicines called guanylate cyclase stimulators, such as riociguat.
- are allergic to tadalafil tablets or ADCIRCA®, or any of the ingredients. Symptoms of an allergic reaction may include: rash hives swelling of the lips, tongue, or throat difficulty breathing or swallowing
- Call your healthcare provider or get help right away if you have any of the symptoms of an allergic reaction listed above.
What Should I Tell My Healthcare Provider Before Taking Tadalafil Tablets?
Tadalafil tablets are not right for everyone. Only your healthcare provider and you can decide if tadalafil tablets are right for you. Before taking tadalafil tablets, tell your healthcare provider about all your medical problems, including if you:
- have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack. Ask your healthcare provider if it is safe for you to have sexual activity. You should not take tadalafil tablets if your healthcare provider has told you not to have sexual activity because of your health problems.
- have pulmonary hypertension
- have low blood pressure or have high blood pressure that is not controlled
- have had a stroke
- have liver problems
- have kidney problems or require dialysis
- have retinitis pigmentosa, a rare genetic (runs in families) eye disease
- have ever had severe vision loss, including a condition called NAION
- have stomach ulcers
- have a bleeding problem
- have a deformed penis shape or Peyronie’s disease
- have had an erection that lasted more than 4 hours
- have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia
What Should I Avoid While Taking Tadalafil Tablets?
Do not use other ED medicines or ED treatments while taking tadalafil tablets.
Do not drink too much alcohol when taking tadalafil tablets (for example, 5 glasses of wine or 5 shots of whiskey). Drinking too much alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.
What are the Possible Side Effects of Tadalafil Tablets?
The most common side effects with tadalafil tablets are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking tadalafil tablets. Back pain and muscle aches usually go away within 2 days.
Call your healthcare provider if you get any side effect that bothers you or one that does not go away.
Uncommon side effects include:
An erection that won’t go away (priapism). If you get an erection that lasts more than 4 hours, get medical help right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis, including the inability to have erections.
Color vision changes, such as seeing a blue tinge (shade) to objects or having difficulty telling the difference between the colors blue and green.
In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including tadalafil tablets) reported a sudden decrease or loss of vision in one or both eyes. It is uncertain whether PDE5 inhibitors directly cause the vision loss. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including tadalafil tablets, and call a healthcare provider right away.
Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including tadalafil tablets. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking tadalafil tablets and contact a healthcare provider right away.
These are not all the possible side effects of tadalafil tablets. For more information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Your prescription label and the physician’s written directions take precedence.
Read the full tadalafil Prescribing Information and Patient Information on DailyMed.
Back to tadalafil for ED and how it works
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Atlas HRT is not a healthcare provider, clinic, or pharmacy. It is a care-coordination platform: we connect you with independent, Florida-licensed physicians who decide whether treatment is appropriate, and with licensed partner pharmacies that fill and ship any prescription they write.
