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Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of tadalafil in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tadalafil in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving tadalafil.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | B | Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. |
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Erythrityl Tetranitrate
- Isosorbide Dinitrate
- Isosorbide Mononitrate
- Nitroglycerin
- Pentaerythritol Tetranitrate
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Atazanavir
- Bunazosin
- Clarithromycin
- Erythromycin
- Indinavir
- Itraconazole
- Ketoconazole
- Moxisylyte
- Nefazodone
- Nelfinavir
- Phenoxybenzamine
- Phentolamine
- Prazosin
- Saquinavir
- Telithromycin
- Terazosin
- Trimazosin
- Urapidil
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Alfuzosin
- Doxazosin
- Rifampin
- Ritonavir
- Tamsulosin
- Tipranavir
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Abnormal penis, including curved penis and birth defects of the penis—Chance of problems occurring may be increased and this medicine should be used with caution in these patients.
- Age greater than 50 years or
- Coronary artery disease or
- Diabetes or
- Hyperlipidemia (excess of lipids in the blood) or
- Hypertension (high blood pressure) or
- Low cup to disc ratio ("crowded disc") or
- Smoking—These conditions may increase risk for a serious eye problem called NAION.
- Angina (reoccurring chest pain) or
- Arrhythmia (irregular heartbeat) or
- Heart attack (within the last 3 months) or
- Heart failure (within the last 6 months) or
- Hypertension (high blood pressure) or
- Hypotension (low blood pressure) or
- Retinal disorders (rare hereditary eye problem) or
- Stroke, recent history of—Tadalafil has not been studied in patients with these medical conditions and should not be used.
- Bleeding disorders or
- Stomach ulcers—Chance of problems occurring may be increased; it is not known if the medicine is safe for use in these patients.
- Bone marrow cancer or
- Leukemia (blood related cancer)
- Sickle-cell anemia (blood disorder)—Tadalafil should be used with caution in these patients as problems with prolonged erection of the penis may occur.
- Heart blood flow problems—These conditions may cause you to be more sensitive to tadalafil.
- Heart disease, underlying—Chance of low blood pressure occurring is greater; tadalafil should be used carefully in these patients.
- Hypersensitivity reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome)—Should not be used in patients with these conditions.
- Kidney disease, severe or
- Liver disease, severe—May increase risk of having unwanted effects. Lower starting doses may be used and doses increased as needed and as tolerated.
- NAION (serious eye condition) in one or both eyes, previously—May increase your chance of getting NAION again.
