The Benefits of Compounded Semaglutide with B12 for Weight Loss

Most side effects of LIPO-B are generally mild in nature and dissipate within a short time frame following administration.

Most common LIPO-B side effects

• Pain or redness at the injection site
• Itching or a feeling of swelling all over the body
• Muscle cramps and weakness
• Upset stomach and urinary problems
• Swelling in the ankles or feet
• Unusual tiredness

If irritation continues to occur, apply an over-the-counter itch cream, preferably with hydrocortisone, or discontinue use entirely.

In more rare yet severe cases, you may experience irregular heartbeat or trouble breathing. If this happens, discontinue use immediately and contact your healthcare provider.

Other important safety information

Do not use LIPO-B if you are currently pregnant, breastfeeding or plan to become pregnant or breastfeed.

Note: The above statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

According to the National Institutes of Health, carnitine interacts with pivalate-conjugated antibiotics such as pivampicillin which are used in the treatment of urinary tract infections. Taking these antibiotics increases the excretion of pivaloyl-carnitine, which can lead to carnitine depletion. Carnitine also interacts with the anticonvulsants valproic acid, phenobarbital, phenytoin, or carbamazepine. Taking these have been shown to significantly decrease blood levels of carnitine. In addition, the use of valproic acid with or without other anticonvulsants may cause hepatotoxicity and increase plasma ammonia concentrations, leading to encephalopathy.

Some common side effects include:

• – Nausea
• – Vomiting
• – Stuffy nose
• – Diarrhea
• – Restlessness
• – Insomnia
• – Body odor (“fishy” smell)

Some serious side effects may include:

• – Tachycardia (fast heart rate)
• – Hypertension (high blood pressure)
• – Fever

Compounded Drugs

Compounded drugs are permitted to be prescribed under federal law but are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. Your Custom Health Centers-affiliated provider may recommend certain doses of compounded Tirzepatide based on your medical evaluation.

Warning: Risk of Thyroid C-Cell Tumors

In rats, Tirzepatide (known as Zepbound®) caused thyroid tumors, including thyroid cancer. It is not known if Tirzepatide will cause thyroid tumors or medullary thyroid carcinoma (MTC) in people. Inform your provider if you notice a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath, as these may be symptoms of thyroid cancer.

Do not use Tirzepatide if you or any family member have had MTC or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

What is the FDA-approved use of Tirzepatide?

Tirzepatide is used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

• 30 kg/m² or greater (obesity), or
• 27 kg/m² or greater (overweight) with at least one weight-related condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease).

Limitations of Use:

• Tirzepatide should not be used with other Tirzepatide-containing products or any other GLP-1 receptor agonist.
• The safety and efficacy of using Tirzepatide with other weight management products have not been established.
• Tirzepatide has not been studied in patients with a history of pancreatitis.

Who should not use Tirzepatide?

Do not use Tirzepatide if:

• You or any family member have had MTC or if you have MEN 2.
• You have a known allergy to Tirzepatide.

How should I take Tirzepatide?

Tirzepatide can be taken with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your Custom Health Centers-affiliated provider will guide you on a treatment regimen that may include dose adjustments every four weeks.

Do not alter your dosing regimen or stop taking Tirzepatide without consulting your provider.

What should I tell my Custom Health Centers-affiliated provider before using Tirzepatide?

It’s important to inform your Custom Health Centers-affiliated provider of all medications you are taking, including prescription, over-the-counter, vitamins, and herbal supplements.

Be mindful of the following:

• Medications for diabetes: Including insulin or sulfonylureas (e.g., Amaryl, Glucotrol XL).
• Other oral medications: Tirzepatide may impact the absorption of oral medications due to delayed gastric emptying. Your provider can guide you on medication scheduling.
• Hormonal birth control: Tirzepatide may decrease the efficacy of oral contraceptives. Use a non-oral contraceptive method or a barrier method for 4 weeks after starting Tirzepatide and after each dose escalation until reaching a maintenance dose.
• Other GLP-1 medications: Including Mounjaro, Wegovy, Ozempic, Saxenda, Victoza, Byetta, or Bydureon. Do not take these with Tirzepatide.
• Weight loss products: Including dietary supplements.

Share your complete medical history, especially if you have:

• Type 1 or type 2 diabetes
• Thyroid cancer
• Gastrointestinal disease
• Pancreatitis
• Kidney disease
• Diabetic retinopathy
• Depression or suicidal thoughts

Notify your provider if you are pregnant, planning to become pregnant, or breastfeeding:

• Pregnancy: Tirzepatide should not be used during pregnancy due to potential risks to the unborn baby.
• Reproductive potential: Tirzepatide may reduce the efficacy of oral contraceptives. Use a non-oral contraceptive method or add a barrier method for 4 weeks after starting and after each dose escalation until reaching a maintenance dose.
• Breastfeeding: It is unknown if Tirzepatide passes into breast milk. Discuss the benefits and risks with your provider.

Pregnancy registry: A pregnancy exposure registry monitors outcomes in women exposed to Tirzepatide during pregnancy. Pregnant patients and healthcare providers can contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).

Providing inaccurate health information to obtain treatment may result in harm, including death.

What are the most serious side effects to monitor for when taking Tirzepatide?

If you experience a medical emergency, call 911 or seek immediate medical attention.

These serious side effects are rare but can occur with Tirzepatide. Monitor for these, especially at the start of treatment or with dose changes:

• Thyroid C-Cell Tumors: Tirzepatide may increase the risk of thyroid tumors. Report any lumps or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.
• Severe Gastrointestinal Disease: Tirzepatide can cause severe gastrointestinal side effects such as nausea, diarrhea, vomiting, constipation, and stomach pain.
• Acute Kidney Injury: Gastrointestinal side effects like diarrhea, nausea, and vomiting may cause dehydration, worsening kidney problems. Drink plenty of water to stay hydrated.
• Acute Gallbladder Disease: Tirzepatide and weight loss may increase the risk of gallbladder disease. Report pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.
• Acute Pancreatitis: Watch for severe abdominal pain that may radiate to the back, with or without vomiting.
• Allergic Reactions: Stop Tirzepatide if you experience symptoms such as facial swelling, severe rash, rapid heartbeat, breathing difficulties, or fainting.
• Low Blood Sugar (Hypoglycemia): Tirzepatide may lower blood glucose, causing hypoglycemia in patients taking other glucose control medications. Monitor blood sugar and watch for dizziness, blurred vision, mood changes, sweating, or rapid heartbeat.
• Diabetic Retinopathy Complications: Rapid glucose control improvement may temporarily worsen diabetic retinopathy. Report any vision changes.
• Suicidal Behavior and Ideation: Monitor for sudden changes in mood, behaviors, thoughts, or feelings. Contact your provider if mental health changes occur.
• Never Share a Pen: Sharing pens poses an infection risk.

What are the most common side effects of Tirzepatide?

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Stomach pain
• Indigestion
• Injection site reactions
• Feeling tired
• Allergic reactions
• Belching
• Hair loss
• Gastroesophageal reflux disease (heartburn)

Report negative side effects to the FDA: Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety details.

Compounded Drugs

Compounded drugs are permitted to be prescribed under federal law but are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. Your Custom Health Centers-affiliated provider may recommend certain doses of compounded Semaglutide based on your medical evaluation.

Warning: Risk of Thyroid C-Cell Tumors

In studies with mice and rats, Semaglutide (the active ingredient in Wegovy and Ozempic) caused thyroid tumors, including thyroid cancer. It is unknown if Semaglutide will cause thyroid tumors or medullary thyroid carcinoma (MTC) in people. Inform your provider if you notice a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath, as these may be symptoms of thyroid cancer.

Do not use Semaglutide if you or any family member have had MTC or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

What is Semaglutide used for?

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management, alongside a reduced-calorie diet and increased physical activity, for people with an initial body mass index (BMI) of:

• 30 kg/m² or greater (obesity), or
• 27 kg/m² or greater (overweight) with at least one weight-related condition (e.g., hypertension, type 2 diabetes, or dyslipidemia).

Limitations of Use:

• Semaglutide should not be used with other Semaglutide products or GLP-1 receptor agonists.
• The safety and efficacy of using Semaglutide with other weight loss products have not been established.
• Semaglutide has not been studied in patients with a history of pancreatitis.
• Semaglutide should not be used in patients with type 1 diabetes.

Who should not use Semaglutide?

Do not use Semaglutide if:

• You or any family member have had MTC or if you have MEN 2.
• You have a known allergy to Semaglutide.

How should Semaglutide be administered?

Semaglutide can be taken with or without food. It is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. For detailed instructions, refer to your treatment plan or contact your Custom Health Centers-affiliated provider. They will guide you on your treatment regimen, which may include dose adjustments every four weeks.

Do not alter your dosing regimen or stop taking Semaglutide without consulting your provider.

What should I tell my Custom Health Centers-affiliated provider before using Semaglutide?

It’s important to inform your Custom Health Centers-affiliated provider of all medications you are taking, including prescription, over-the-counter, vitamins, and herbal supplements.

Be mindful of the following:

• Medications for diabetes: Including insulin or sulfonylureas (e.g., Amaryl, Glucotrol XL). Semaglutide may impact the absorption of these medications.
• Other GLP-1 receptor agonists: Including Wegovy, Ozempic, Saxenda, Victoza, Trulicity, Byetta, or Bydureon.
• Weight loss products: Including dietary supplements.

Share your complete medical history, especially if you have:

• Type 1 or type 2 diabetes
• Thyroid cancer
• Pancreatitis
• Kidney disease
• Diabetic retinopathy
• Depression or suicidal thoughts
• Ileus

Notify your provider if you are pregnant, planning to become pregnant, or breastfeeding:

• Pregnancy: Semaglutide should not be used during pregnancy due to potential risks to the unborn baby.
• Reproductive potential: Discontinue Semaglutide at least 2 months before planning pregnancy.
• Breastfeeding: Semaglutide has been found in the milk of lactating rats. Inform your provider if you are breastfeeding.

Providing inaccurate health information to obtain treatment may result in harm, including death.

What are the most serious side effects to monitor for when taking Semaglutide?

If you experience a medical emergency, call 911 or seek immediate medical attention.

Monitor for these serious side effects, especially at the start of treatment or with dose changes:

• Thyroid C-Cell Tumors: Semaglutide may increase the risk of thyroid tumors. Report any lumps or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.
• Acute Pancreatitis: Watch for severe abdominal pain, potentially radiating to the back, with or without vomiting.
• Gallbladder Disease: Report pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.
• Low Blood Sugar (Hypoglycemia): Monitor blood sugar levels, especially if taking other glucose control medications. Look for signs of low blood sugar such as dizziness, blurred vision, mood changes, sweating, or rapid heartbeat.
• Acute Kidney Injury: Maintain adequate hydration to avoid dehydration and worsening kidney issues.
• Serious Allergic Reactions: Stop Semaglutide and seek medical attention for symptoms such as facial swelling, severe rash, rapid heartbeat, breathing difficulties, or fainting.
• Diabetic Retinopathy Complications: Report any vision changes if you have type 2 diabetes.
• Increased Heart Rate: Notify your provider of a racing heartbeat while at rest.
• Suicidal Behavior: Watch for changes in mood, behavior, thoughts, or feelings and contact your provider if you experience any concerning mental health changes.

Never share needles or syringes to avoid infection risk.

What are the most common side effects of Semaglutide?

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Abdominal pain
• Headache
• Fatigue
• Indigestion
• Dizziness
• Abdominal distension
• Burping
• Hypoglycemia in type 2 diabetes patients
• Flatulence
• Gastroenteritis
• Gastroesophageal reflux disease

Report negative side effects to the FDA: Call 1-800-FDA-1088 or visit www.fda.gov/medwatch.

This information is not comprehensive. Please see the full Consumer Medical Information for complete safety details.

All medications have the potential for side effects. Side effects may vary based on the individual.

Most common GSH side effects

• Irritation at the injection site
• Gastrointestinal discomfort (nausea, bloating, cramping)
• A rotten egg (sulfur) taste in the mouth, usually mild

If irritation at the injection site occurs, you can: consider alternating injection sites on the body, apply an over-the-counter itch cream (preferably with hydrocortisone), use injections less frequently, or discontinue use entirely.

Signs of an allergic reaction to glutathione may include hives, itching, swelling of the face or lips, tongue or throat, or difficulty breathing. If any of this occurs, discontinue use and seek emergency care.

Other important safety information

Taking glutathione long-term may lead to lower zinc levels. Avoid taking glutathione if you’re sensitive to it or allergic to any related ingredients. Do not use GSH if you are pregnant or breastfeeding.

​Note: The above statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

The most common side effect of B12 injections is irritation at the injection site. If this occurs, consider changing placement on the body or use injections less often.

For a complete list of possible side effects, click here.

Do not use B12 injections if you are currently pregnant, breastfeeding or plan to become pregnant or breastfeed.

Note: The above statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

• are pregnant or may become pregnant. Finasteride may harm your unborn baby.
  • Finasteride tablets are coated and will prevent contact with the medicine during handling, as long as the tablets are not broken or crushed. Females who are pregnant or who may become pregnant should not come in contact with broken or crushed finasteride tablets.
  • If a pregnant woman comes in contact with crushed or broken finasteride tablets, wash the contact area right away with soap and water. If a woman who is pregnant comes into contact with the active ingredient in finasteride, a healthcare provider should be consulted. If a woman who is pregnant with a male baby swallows or comes in contact with the medicine in finasteride, the male baby may be born with sex organs that are not normal.
• are allergic to any of the ingredients in finasteride.

• have any other medical conditions, including problems with your prostate or liver.

• Take finasteride exactly as your healthcare provider tells you to take it.
• You may take finasteride with or without food.
• If you forget to take finasteride, do not take an extra tablet. Just take the next tablet as usual.

• Decreased libido 1.8%
• Erectile dysfunction 1.3%
• Decreased volume of ejaculate 1.2%

• Allergic reactions including: rash, itching, hives and swelling of the lips, tongue, throat, and face
• Testicular pain
• Male infertility and/or poor quality of semen
• In rare cases, male breast cancer

• breast tenderness and enlargement. Tell your healthcare provider about any changes in your breasts such as lumps, pain or nipple discharge.
• decrease in sex drive that continued after stopping the medication.
• allergic reactions including rash, itching, hives and swelling of the lips, tongue, throat, and face.
• problems with ejaculation that continued after stopping medication.
• testicular pain.
• difficulty in achieving an erection that continued after stopping the medication.
• male infertility and/or poor quality of semen.
• in rare cases, male breast cancer.

• Store finasteride at room temperature between 59˚F to 86˚F (15˚C to 30˚C).
• Keep finasteride in a closed container and keep finasteride tablets dry (protect from moisture).

While NAD+ supplements have shown promise in supporting cellular health and combating the effects of aging, it is essential to be aware of some important safety information before starting supplementation:

1. Consult a healthcare professional: Before beginning any new supplement, including NAD+, it is important to consult a healthcare professional to determine if it is appropriate for your specific needs and health conditions.
2. Potential side effects: Some individuals may experience mild side effects when supplementing with NAD+, such as nausea, headache, fatigue, or stomach discomfort. If you experience any severe or persistent side effects, discontinue use and consult your healthcare provider.
3. Drug interactions: NAD+ supplements may interact with certain medications, such as blood thinners, blood pressure medications, or chemotherapy drugs. Consult your healthcare professional to discuss potential interactions before starting NAD+ supplementation.
4. Allergies and sensitivities: If you have any known allergies or sensitivities to ingredients found in NAD+ supplements, avoid using the product or consult your healthcare provider for guidance.
5. Dosage and administration: Follow the recommended dosage and administration guidelines provided by your healthcare professional. Taking more than the recommended dose can increase the risk of side effects and may not provide additional benefits.
6. Pregnancy and breastfeeding: The safety of NAD+ supplementation during pregnancy and breastfeeding has not been well-studied. If you are pregnant or nursing, consult your healthcare provider before using NAD+ supplements.
7. Pre-existing health conditions: Individuals with certain pre-existing health conditions, such as kidney or liver disease, should consult their healthcare provider before starting NAD+ supplementation to ensure it is safe and appropriate for their specific situation.

What is the FDA-approved use of sildenafil?

Sildenafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED).

Who should not use sildenafil?

Do not use sildenafil if:

• You are taking a class of medications called nitric oxide donors, including organic nitrates or organic nitrites in any form. Sildenafil can increase the blood pressure-lowering effect of nitrates.
• You have a known allergy to sildenafil.
• You are taking a class of medications called guanylate cyclase (GC) stimulators, such as riociguat. Sildenafil can increase the blood pressure-lowering effect of these medications.

How should I take sildenafil?

Sildenafil can be taken with or without food. Take about 30 minutes to 1 hour before anticipated sexual activity.

• Do not take sildenafil more than once in a 24-hour period or within 24 hours of any other ED medications or PDE-5 inhibitors.
• You should take the medication exactly as prescribed. If your symptoms are not improving or you have any questions about changing or stopping medication, reach out to your Custom Health Centers-affiliated provider for guidance.

What should I tell my Custom Health Centers-affiliated provider before using sildenafil?

Sildenafil has certain drug interactions. It’s important to tell your Custom Health Centers-affiliated provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.

Some medications to watch out for include:

• Nitrates, alpha-blockers, and antihypertensives: When these medications are taken with sildenafil, a sudden drop in blood pressure can occur.
• CYP3A4 inhibitors: Such as ritonavir, ketoconazole, itraconazole, and erythromycin. These medications increase sildenafil levels in the bloodstream, which can cause a sudden drop in blood pressure and prolonged erection.

It’s important to share your entire medical history with your provider. In particular, tell your provider if you have or have a past history of:

• Cardiovascular risk that prevents you from partaking in sexual activity
• Chest pain requiring nitroglycerin
• Predisposition to priapism (painful erection that lasts more than 4 hours)
• Ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis)
• Severely impaired autonomic control of blood pressure
• Myocardial infarction, stroke, or life-threatening arrhythmia
• Low or high blood pressure
• Cardiac failure or coronary artery disease causing unstable angina
• Anterior ischemic optic neuropathy (NAION) or a “crowded” optic disc
• Bleeding disorders or ulcers
• Kidney or liver disease
• Pulmonary hypertension
• Retinitis pigmentosa

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What are the most serious side effects that I or a caregiver should monitor for when taking sildenafil?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

You or a caregiver should carefully monitor for these side effects, especially at the beginning of treatment:

• Cardiac risk of sexual activity: ED medication should not be used by men for whom sexual activity is not advised because of their underlying cardiovascular status.
• Prolonged erections: Seek immediate emergency treatment for an erection lasting more than 4 hours.
• Effects on the eye: Seek medical care and stop medication if you experience a sudden loss of vision in one or both eyes. Sudden loss of vision could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION).
• Sudden hearing loss: Stop medication and seek prompt medical attention if you experience a sudden decrease or loss of hearing, which may be accompanied by ringing in the ears.
• Co-administering with alpha-blockers or other blood pressure-lowering drugs: If you are taking a medication to lower your blood pressure or taking an alpha-blocker, sildenafil may increase the blood-pressure-lowering effect, leading to a sudden drop in blood pressure. When starting sildenafil, monitor carefully for signs of low blood pressure, including dizziness, lightheadedness, or fainting.
• Co-administering with ritonavir: If you are taking a medication called ritonavir at the same time as sildenafil, ritonavir can increase the amount of sildenafil in your system. Monitor for lowered blood pressure, fainting, and prolonged erection.
• Combination with other PDE-5 inhibitors: Do not take sildenafil more than once in a 24-hour period or within 24 hours of any other ED medications or PDE-5 inhibitors.
• Effects on bleeding: Sildenafil has no effect on bleeding time when taken alone or with aspirin; however, there have been reports of bleeding with the use of sildenafil. Tell your Custom Health Centers-affiliated provider if you have a history of bleeding disorders or ulcers.
• Sexually transmitted infections: Sildenafil does not protect against sexually transmitted diseases. Use safe sex practices.

What are the most common side effects of sildenafil?

• Headache
• Flushing
• Indigestion
• Vision changes
• Nasal congestion
• Back pain
• Muscle pain
• Nausea
• Dizziness
• Rash

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.

What is the FDA-approved use of tadalafil?

Tadalafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED).

Who should not use tadalafil?

Do not use tadalafil if:

• You are taking a class of medications called nitric oxide donors, including organic nitrates or organic nitrites in any form. Tadalafil can increase the blood pressure-lowering effect of nitrates.
• You have a known allergy to tadalafil.
• You are taking a class of medications called guanylate cyclase (GC) stimulators, such as riociguat. Tadalafil can increase the blood pressure-lowering effects of these medications.

How should I take tadalafil?

Tadalafil can be taken with or without food. Limit the amount of alcohol to less than 5 drinks.

• As-needed use: Take about 30 minutes before anticipated sexual activity.
• Daily use: Take once daily at about the same time every day, without regard to the timing of sexual activity.

Do not take tadalafil more than once in a 24-hour period or within 24 hours of any other ED medications or PDE-5 inhibitors. Take the medication exactly as prescribed. If your symptoms are not improving or you have any questions about changing or stopping medication, reach out to your Custom Health Centers-affiliated provider for guidance.

What should I tell my Custom Health Centers-affiliated provider before using tadalafil?

Tadalafil has certain drug interactions. It’s important to tell your Custom Health Centers-affiliated provider about all the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.

Some medications to watch out for include:

• Nitrates, alpha-blockers, and antihypertensives: When these medications are taken with tadalafil, a sudden drop in blood pressure can occur.
• CYP3A4 inhibitors: Such as ritonavir, ketoconazole, itraconazole, and erythromycin. These medications increase tadalafil levels in the bloodstream, which can cause a sudden drop in blood pressure and prolonged erection.
• Alcohol: Drinking large amounts of alcohol (more than 5 units) with tadalafil can increase the potential for a sudden drop in blood pressure.

It’s important to share your entire medical history with your provider. In particular, tell your provider if you have or have a past history of:

• Cardiovascular risk that prevents you from partaking in sexual activity
• Chest pain requiring nitroglycerin
• Predisposition to priapism (painful erection that lasts more than 4 hours)
• Benign prostatic hyperplasia (BPH) and are being treated with alpha-blockers
• Ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis)
• Severely impaired autonomic control of blood pressure
• Myocardial infarction, stroke, or life-threatening arrhythmia
• Low or high blood pressure
• Cardiac failure or coronary artery disease causing unstable angina
• Anterior ischemic optic neuropathy (NAION) or a “crowded” optic disc
• Bleeding disorders or ulcers
• Kidney or liver disease
• Pulmonary hypertension
• Retinitis pigmentosa

Withholding or providing inaccurate information about your health and medical history to obtain treatment may result in harm, including, in some cases, death.

What are the most serious side effects that I or a caregiver should monitor for when taking tadalafil?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

You or a caregiver should carefully monitor for these side effects, especially at the beginning of treatment:

• Cardiac risk of sexual activity: ED medication should not be used by men for whom sexual activity is not advised because of their underlying cardiovascular status.
• Prolonged erections: Seek immediate emergency treatment for an erection lasting more than 4 hours.
• Effects on the eye: Seek medical care and stop medication if you experience a sudden loss of vision in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION).
• Sudden hearing loss: Stop medication and seek prompt medical attention if you experience a sudden decrease or loss of hearing, which may be accompanied by ringing in the ears.
• Co-administering with alpha-blockers or other blood pressure-lowering drugs: If you are taking a medication to lower your blood pressure or an alpha-blocker, tadalafil may increase the blood-pressure-lowering effect, leading to a sudden drop in blood pressure. When starting tadalafil, monitor carefully for signs of low blood pressure, including dizziness, lightheadedness, or fainting.
• Kidney impairment: Talk to your Custom Health Centers-affiliated provider about the appropriate dose of tadalafil if you have kidney impairment.
• Liver impairment: Talk to your Custom Health Centers-affiliated provider about the appropriate dose of tadalafil if you have liver impairment.
• Alcohol: Drinking large amounts of alcohol (more than 5 units) with tadalafil can increase the potential for a sudden drop in blood pressure.
• Co-administering with CYP3A4 inhibitors: Talk to your Custom Health Centers-affiliated provider about the appropriate dose of tadalafil if you are taking potent inhibitors of CYP3A such as ritonavir, ketoconazole, and itraconazole.
• Combination with other PDE-5 inhibitors: Do not take tadalafil more than once in a 24-hour period or within 24 hours of any other ED medications or PDE-5 inhibitors.
• Effects on bleeding: Tadalafil did not affect bleeding time when taken alone or with aspirin. Tell your Custom Health Centers-affiliated provider if you have a bleeding disorder or ulcers.
• Sexually transmitted infections: Tadalafil does not protect against sexually transmitted diseases. Use safe sex practices.

What are the most common side effects of tadalafil?

• Headache
• Indigestion
• Back pain
• Muscle pain
• Nasal congestion
• Flushing
• Pain in limb

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.