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Important safety information

TabsRx sexual health products are prescription products for men 21 and over. Sildenafil + tadalafil (with or without apomorphine and L-citrulline) and daily low-dose tadalafil are prescribed for erectile dysfunction, and silodosin + tadalafil for ejaculation that comes sooner than you want (premature ejaculation). They are not for use by women or by anyone under 21.

Do not take a TabsRx sexual health product if you:

  • Take any nitrate medicine in any form, including nitroglycerin tablets, patches, sprays or ointments, isosorbide mononitrate or dinitrate, or recreational amyl or butyl nitrite (“poppers”). Taken together, these can cause a sudden and unsafe drop in blood pressure.
  • Take riociguat or another soluble guanylate cyclase stimulator.
  • Have had an allergic reaction to sildenafil, tadalafil, vardenafil, apomorphine, silodosin, sulfites (such as sodium metabisulfite), or any ingredient in the product you are prescribed.
  • Take another product that contains sildenafil, tadalafil or another PDE5 inhibitor (such as vardenafil or avanafil), including one prescribed for pulmonary arterial hypertension. Do not take sildenafil + tadalafil or the 4-ingredient formula with daily low-dose tadalafil or with silodosin + tadalafil: each of these contains tadalafil.
  • Silodosin + tadalafil: take another alpha-blocker (such as tamsulosin, alfuzosin, doxazosin, terazosin or prazosin); take a strong CYP3A4 inhibitor such as ketoconazole, itraconazole, clarithromycin or ritonavir; or have severe kidney disease or severe liver disease.

Sildenafil + tadalafil combines two PDE5 inhibitors

  • Sildenafil and tadalafil are both PDE5 inhibitors. The prescribing information for each says not to take it with another PDE5 inhibitor: the combination has not been studied and may lower blood pressure further. Sildenafil + tadalafil and the 4-ingredient formula combine the two in every dose. Your provider weighs this before prescribing.
  • Take no more than one dose in 24 hours. The prescribing information for sildenafil and for tadalafil each sets a maximum of once a day.

The 4-ingredient formula contains apomorphine

Apomorphine can lower your blood pressure, especially when you stand up (orthostatic hypotension), and can cause dizziness or fainting. Its prescribing information warns that vasodilators and blood pressure medicines, especially nitrates, can add to that effect. Sildenafil and tadalafil are vasodilators that also lower blood pressure, and the 4-ingredient formula combines all three in one dose. Sit or lie down if you feel dizzy or light-headed, and stand up slowly. Do not drink alcohol around a dose: it increases the drop in blood pressure.

Apomorphine can make you suddenly sleepy or fall asleep without warning, including during everyday activities. Do not drive or operate machinery until you know how it affects you. It can also cause nausea and vomiting, which can be severe, and irritation in the mouth where the dose is held.

  • Do not take the 4-ingredient formula if you are allergic to apomorphine or to sulfites such as sodium metabisulfite.
  • Do not take the 4-ingredient formula if you take an anti-nausea medicine of the 5-HT3 type, such as ondansetron, granisetron, dolasetron or palonosetron, or take alosetron. With apomorphine, these have caused a severe drop in blood pressure and loss of consciousness.
  • Tell your provider before you start if you have Parkinson’s disease or take any medicine for it (apomorphine is itself a Parkinson’s medicine); have a major psychotic disorder or have had hallucinations; take an antipsychotic or metoclopramide; have a heart rhythm problem such as long QT, or take a medicine that affects heart rhythm; or faint easily.
  • Heart problems. In studies of apomorphine injection in people with Parkinson’s disease, some had chest pain (angina), a heart attack, cardiac arrest or sudden death. Some cases of angina and heart attack happened within 2 hours of a dose. Get emergency help for chest pain.
  • Erections. Apomorphine can itself cause prolonged, painful erections (priapism).
  • Falls. By lowering blood pressure, apomorphine can raise the risk of a fall.
  • Hemolytic anemia. Apomorphine has caused hemolytic anemia (destruction of red blood cells), in some cases needing hospital treatment. It can appear at any time while you take it. Tell your provider if you feel unusually tired or short of breath.
  • Get emergency help if you faint or lose consciousness.
  • Apomorphine can also cause hallucinations or confusion, and strong urges that are hard to control, such as gambling, spending or sexual urges. Tell your provider if you notice any of these.

Silodosin + tadalafil contains silodosin

Silodosin is an alpha-blocker. The prescribing information for alpha-blockers and for PDE5 inhibitors such as tadalafil both warn that taking the two together can lower blood pressure enough to cause symptoms such as dizziness or fainting, and silodosin + tadalafil combines them in one dose. Stand up slowly, and take care driving or doing anything hazardous until you know how it affects you.

Silodosin commonly causes little or no semen when you ejaculate (retrograde ejaculation): 28% of men in studies of daily silodosin for an enlarged prostate, compared with 1% on placebo. This goes away when you stop taking it. If you are planning cataract surgery, tell your eye surgeon you take silodosin: alpha-blockers can cause a problem during the operation called intraoperative floppy iris syndrome.

Silodosin is FDA approved only for the symptoms of an enlarged prostate (benign prostatic hyperplasia). Prescribing it for premature ejaculation is off-label.

Tell your provider before you start if you:

  • Have heart disease, or have had a heart attack, stroke, or a life-threatening irregular heartbeat within the last 6 months.
  • Have uncontrolled high blood pressure, low blood pressure, unstable angina, angina during sex, or heart failure.
  • Have a narrowing of the aortic valve (aortic stenosis) or another blockage of blood flow out of the heart, such as idiopathic hypertrophic subaortic stenosis, or a condition that severely affects your body’s control of blood pressure.
  • Take an alpha blocker for blood pressure or an enlarged prostate, or any other blood pressure medication. Your provider may need to change your dose or timing.
  • Take a protease inhibitor or other HIV medication, an antifungal such as ketoconazole or itraconazole, or an antibiotic such as clarithromycin or erythromycin. With strong CYP3A4 inhibitors such as ritonavir, ketoconazole or itraconazole, the tadalafil prescribing information limits as-needed tadalafil to 10 mg no more than once every 72 hours, and daily tadalafil to 2.5 mg.
  • Use any other treatment for erectile dysfunction.
  • Have liver or kidney problems, or are on dialysis. With severe kidney disease or dialysis, the tadalafil prescribing information limits as-needed tadalafil to 5 mg no more than once every 72 hours and does not recommend daily tadalafil. It does not recommend tadalafil with severe liver disease.
  • Have a bleeding disorder, or an active stomach ulcer.
  • Have retinitis pigmentosa or another inherited degenerative eye disease, or have ever had NAION (sudden vision loss in one eye).
  • Have a deformed penis, Peyronie’s disease, or have ever had an erection lasting more than 4 hours.
  • Have sickle cell anemia, multiple myeloma, or leukemia.
  • Silodosin + tadalafil: have moderate kidney problems; take diltiazem, verapamil, erythromycin or cyclosporine; or are planning cataract surgery.

Get emergency medical help right away if you have:

  • An erection lasting more than 4 hours. Priapism can permanently damage the penis if it is not treated immediately.
  • Sudden loss of vision in one or both eyes.
  • Sudden decrease or loss of hearing, sometimes with ringing in the ears or dizziness.
  • Chest pain, or any heart symptom during sexual activity.

If you need a nitrate in an emergency, tell the medical team when you last took a dose. After tadalafil, at least 48 hours should pass before a nitrate is considered.

Common side effects include headache, flushing, indigestion, stuffy or runny nose, back pain, muscle aches, dizziness, and changes in vision such as a blue tinge to objects or blurred vision. With the 4-ingredient formula, also nausea and vomiting, yawning, drowsiness, dizziness on standing, and irritation in the mouth where the dose is held. With silodosin + tadalafil, also little or no semen, dizziness (including on standing), diarrhea, headache and stuffy nose.

The 4-ingredient formula also contains L-citrulline, an amino acid. It is not an FDA-approved drug, so no FDA prescribing information lists its risks or interactions. Tell your provider about any supplements you take, including L-citrulline, L-arginine or a nitric oxide booster.

Sexual activity carries a degree of cardiac risk. Tell your provider if you have heart problems and you experience chest pain, dizziness or nausea during sex.

Drinking alcohol while taking a PDE5 inhibitor can increase the chance of headache, dizziness, and low blood pressure. Grapefruit and grapefruit juice can raise tadalafil levels in your blood.

These products do not protect against sexually transmitted infections.

This is not a complete list of risks, drug interactions, or side effects. Read the information that comes with your prescription and talk to your provider or pharmacist about any medication or supplement you take. You are encouraged to report negative side effects of prescription drugs to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Indication

Sildenafil + tadalafil and daily low-dose tadalafil are prescribed for erectile dysfunction; the 4-ingredient formula also contains apomorphine and L-citrulline, an amino acid. Silodosin + tadalafil is prescribed for premature ejaculation and contains silodosin and tadalafil; this use of silodosin is off-label. TabsRx products are compounded products and are not FDA approved. See “About compounded products” below.

About compounded products

The featured products include compounded products that have not been approved by the FDA. Compounded products may be prescribed under federal law, but are not the same as, nor are they generic versions of, any FDA-approved medication. The FDA does not verify the safety, effectiveness, or manufacturing quality of compounded products. A prescription will only be written if deemed appropriate after the digital consultation by a licensed medical provider. Individual results may vary.

TabsRx products are compounded by state-licensed compounding pharmacies in the USA in partnership with TabsRx. TabsRx is not a compounding pharmacy. TabsRx does not produce, manufacture or compound medications, and the medication you receive may look different from any product shown on this site.

TabsRx does not provide medical advice, diagnosis or treatment, and does not make prescribing decisions. Medical services are provided by independent licensed providers practicing through OpenLoop Healthcare Partners, PC and its affiliated entities. Pharmacy services are provided by a state-licensed compounding pharmacy. This site is not a substitute for a relationship with your own physician. If you think you may be having a medical emergency, call 911.