Sublingual Sildenafil Side Effects: Common Ones and Emergencies

Key facts

• Compounded sublingual and dissolving tablets are not FDA-approved and have no label of their own, so this page draws on the labels for their medicines.
• No study shows that these tablets cause fewer side effects than a swallowed tablet.
• These tablets are not for use with nitrates or guanylate cyclase stimulators such as riociguat.
• CHROMA 3X and CHROMA 4X each hold more than one PDE5 inhibitor. Never add another ED medicine on top.
• An erection lasting longer than 4 hours is a medical emergency.

What are the side effects of sublingual sildenafil?

No published study has measured side effects for the tablets on CHROMA23®, and none of them is sildenafil alone. The nearest guide is the FDA label for Viagra®, a swallowed tablet. The most common side effects on that label are:

• Headache
• Flushing
• Upset stomach
• Abnormal vision, mainly a color tinge, sensitivity to light or blurring
• Stuffy or runny nose
• Back pain and muscle pain
• Nausea
• Dizziness
• Rash

That list belongs to Viagra®. The Cialis® label lists a similar group for that product and adds pain in the limbs. The American Urological Association guideline says most side effects of PDE5 inhibitors are mild to moderate. Report any that continue or bother you, because your provider can review the prescription.

What about the other medicines in these tablets?

The other medicines in these tablets have their own warnings. The labels below describe injections given for other conditions, or a different tablet, so their findings are a guide and not a forecast:

• Apomorphine, in CHROMA 4X: the Apokyn® label warns of nausea and vomiting that may be severe, sleepiness, dizziness, fainting, low blood pressure, heart rhythm changes and prolonged painful erections. That label also warns of heart attack, cardiac arrest and sudden sleep, and says vasodilators can deepen blood pressure drops.
• Vardenafil, in CHROMA 4X: the label for vardenafil orally disintegrating tablets warns of an effect on heart rhythm called QT prolongation. Apomorphine and vardenafil can each affect heart rhythm.
• PT-141, in CHROMA X Max and CHROMA X Max Peak: the Vyleesi® label warns of nausea, flushing, headache, vomiting, a temporary rise in blood pressure, a lower heart rate and darkening of the skin or gums

Oxytocin is also in CHROMA X Max tablets. The Pitocin® label covers injection in labor and after delivery, so it says nothing about oxytocin under the tongue.

Does a tablet that dissolves under the tongue cause fewer side effects?

That has not been shown for these tablets. One small study of a sildenafil film used under the tongue reported less headache than with a swallowed tablet. That result belongs to that film.

A dissolving form can also raise exposure. The label for vardenafil orally disintegrating tablets says they deliver more vardenafil to the body than film-coated vardenafil tablets, and that the two are not interchangeable. The same label warns people with phenylketonuria about the aspartame in that product. If you have phenylketonuria, ask your provider what your tablets contain.

Why does more than one PDE5 inhibitor in a tablet matter?

CHROMA 3X holds two PDE5 inhibitors and CHROMA 4X holds three. The Viagra® label says combining it with other PDE5 inhibitors has not been studied, may further lower blood pressure and is not recommended. The Cialis® label also says combinations have not been studied and tells patients not to take it with other PDE5 inhibitors.

These tablets hold those same medicines, and no study shows a combination tablet avoids that risk. The label for vardenafil orally disintegrating tablets agrees. The labels are also why you should never add another ED medicine to these tablets. The American Urological Association guideline adds that many side effects of PDE5 inhibitors rise more clearly with dose than the benefit does. This article on taking tadalafil and sildenafil together goes further.

What is priapism, and when is it an emergency?

Priapism is an erection that lasts far too long. The Viagra® and Cialis® labels report prolonged erections of more than 4 hours and priapism, a painful erection of more than 6 hours, and describe them as infrequent or rare. The Apokyn® label also reports prolonged painful erections.

An erection lasting longer than 4 hours is a medical emergency. Go to an emergency department, whether it hurts or not. Do not wait for it to pass. Tell the staff which tablets you took and the medicines in them. Without prompt treatment, the labels warn of lasting damage to the erectile tissue and permanent loss of potency.

What other symptoms need urgent help?

The labels name these warning signs. Stop taking the tablets and get medical help if you have:

• Sudden loss of vision in one or both eyes
• Sudden loss or decrease of hearing, sometimes with ringing in the ears or dizziness
• Chest pain, dizziness or nausea during sex
• Fainting

If you need emergency care for chest pain, tell the staff what you took and when, because nitrates are dangerous with PDE5 inhibitors. All four tablets hold tadalafil. The Cialis® label says at least 48 hours should pass after a dose of that product before nitrates are considered, and then only for a life-threatening situation under close medical supervision.

Who should not use sublingual ED tablets?

Tell your provider about every medicine and condition before you start. The labels for these medicines rule out or warn against:

• Nitrates in any form, including nitroglycerin and the street drugs called poppers
• Guanylate cyclase stimulators such as riociguat
• Heart conditions that make sexual activity inadvisable, including a recent heart attack or stroke, unstable angina, heart failure, uncontrolled heart rhythm problems, and very low or uncontrolled high blood pressure
• A serious allergy to any of these medicines
• For the PT-141 in CHROMA X Max tablets: known cardiovascular disease, uncontrolled high blood pressure, and naltrexone taken by mouth
• For the apomorphine in CHROMA 4X: ondansetron and related anti-nausea medicines, which have caused a severe drop in blood pressure and loss of consciousness with it
• For the vardenafil in CHROMA 4X: congenital QT prolongation and certain heart rhythm medicines, such as amiodarone or sotalol

Tell your provider too if you take alpha-blockers, blood pressure medicines, ritonavir or certain antibiotics and antifungals. The same goes for severe kidney or liver disease, sickle cell anemia, multiple myeloma, leukemia, Peyronie's disease or any past vision loss.

Frequently asked questions

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Sources

1. Viagra® (sildenafil) full prescribing information
2. Cialis® (tadalafil) full prescribing information
3. Vardenafil orally disintegrating tablets label (DailyMed)
4. Apokyn® (apomorphine) injection label (DailyMed)
5. Vyleesi® (bremelanotide) injection label (DailyMed)
6. Pitocin® (oxytocin) injection label (DailyMed)
7. American Urological Association: erectile dysfunction guideline
8. De Toni et al.: sublingual administration of sildenafil oro-dispersible film (Frontiers in Pharmacology, 2018)
9. FDA: compounding and the FDA, questions and answers

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