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Cenforce-D: Uses, Dosage & Safety Information

Cenforce-D

Cenforce-D
Cenforce D
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Cenforce-D

Sildenafil citrate + Dapoxetine hydrochloride
Cenforce D is an unapproved combination tablet stated by its manufacturer to contain sildenafil citrate 100 mg with dapoxetine 60 mg, marketed for erectile dysfunction and premature ejaculation. It has no FDA approval, and dapoxetine has never been approved in the United States in any product. Using it without medical supervision is dangerous: sildenafil taken with nitrates can cause a fatal drop in blood pressure, and dapoxetine can cause serotonin syndrome with common antidepressants. The information here comes from the manufacturer’s own documentation and from FDA labelling for sildenafil, and is identified accordingly.
  • ActiveIngredient: Sildenafil citrate + Dapoxetine hydrochloride
  • DosageForm: Oral tablet
  • Dosage: Sildenafil 100 mg + dapoxetine 60 mg per tablet (stated by the manufacturer; unverified)
  • Indications: No approved indication. Marketed by the manufacturer for erectile dysfunction and premature ejaculation
  • Manufacturer: Indian manufacture, distributed through export channels; not marketed under any FDA approval
  • Storage: No approved storage instructions exist for this product
  • Drug Status: Not Approved
Drug Status: Not Approved
Description
Not approved by the FDA — and one of its ingredients never has been
Cenforce D is not an FDA-approved medicine. Dapoxetine, one of its two ingredients, has no FDA approval in any product: searches of Drugs@FDA and of FDA labelling return no record of it at all.
Using this tablet without medical supervision is dangerous. The specific dangers are set out below, and they are not theoretical: sildenafil with nitrates can drop blood pressure fatally, and dapoxetine is an SSRI that can cause serotonin syndrome with common antidepressants.3

Cenforce D is sold as a tablet combining sildenafil citrate 100 mg with dapoxetine 60 mg, marketed for erectile dysfunction and premature ejaculation together. It is manufactured in India and distributed through business-to-business export channels rather than through a regulated pharmacy supply chain.1 It is listed under erectile dysfunction and premature ejaculation on iMedix.

What is known about this product comes from sales documentation, not from a regulator. There is no FDA-approved prescribing information for it, no application number, and no post-marketing safety file. The information on this page about the combination itself is drawn from the manufacturer and distributor brochures; the pharmacology and risks of sildenafil come from the FDA-approved labelling for that ingredient.2

The 100 mg sildenafil content is the maximum approved single dose of that drug, not a starting dose. The approved starting dose for erectile dysfunction is 50 mg.

General Instructions

The single most important instruction is to involve a doctor before taking anything containing sildenafil. The interaction that kills people is with nitrates, and it is silent until it happens.2

Tell any prescriber what you have taken. If chest pain develops after this tablet and a doctor gives nitroglycerin without knowing, the combination can be fatal.

List every antidepressant and migraine medicine you take. Dapoxetine is an SSRI, and combining SSRIs with other serotonergic drugs can produce serotonin syndrome.

An erection lasting more than four hours is an emergency. Priapism can cause permanent damage to erectile tissue and needs treatment within hours, not the next day.

Side Effects
Reported Side Effects
SystemEffectSource of the information
CardiovascularSevere hypotension with nitrates, potentially fatalFDA labelling for sildenafil; an absolute contraindication
UrogenitalPriapism — erection lasting over 4 hoursFDA labelling for sildenafil; can permanently damage erectile tissue
EyeSudden vision loss in one or both eyes, colour vision changeFDA labelling for sildenafil, non-arteritic anterior ischaemic optic neuropathy
EarSudden hearing loss, tinnitusFDA labelling for sildenafil
Nervous systemSerotonin syndrome with other serotonergic drugsClass effect of SSRIs; no FDA labelling exists for dapoxetine
GeneralHeadache, dizziness, flushing, nasal congestion, nausea, dry mouthSeller documentation, consistent with both ingredient classes

Source: 21

Emergency – seek care immediately
  • Chest pain during or after sexual activity — tell the medical team you have taken sildenafil
  • An erection lasting more than four hours
  • Sudden loss of vision or hearing in one or both ears or eyes
  • Agitation, sweating, tremor, fever or a racing heart — possible serotonin syndrome
Uses

This product has no approved indication. What follows is what the manufacturer and distributor documentation claims, which is a different kind of statement from an approved use.1

Of those two, only one has an FDA-approved counterpart. Sildenafil is approved for erectile dysfunction as Viagra, and separately for pulmonary arterial hypertension as Revatio.2 Premature ejaculation has no FDA-approved drug treatment at all, which is the gap this product is sold into.

Dapoxetine is approved in a number of other countries — it was developed specifically as a short-acting SSRI for premature ejaculation — but it has never been approved in the United States. A product containing it cannot be lawfully marketed there, and a US buyer obtaining it online is outside the system that would otherwise check their heart medicines and their antidepressants before dispensing.

Safety Advice

Interactions Alcohol:

Unsafe
Alcohol adds to the blood pressure drop sildenafil causes and to the dizziness both ingredients produce. The seller documentation itself advises avoiding alcohol before taking the tablet.

Interactions Other Medications:

Unsafe
Nitrates in any form are an absolute contraindication with sildenafil and the combination can be fatal. Riociguat is also contraindicated. Serotonergic medicines — SSRIs, SNRIs, tricyclics, triptans, tramadol, MAO inhibitors — risk serotonin syndrome with the dapoxetine component. Alpha-blockers and strong CYP3A4 inhibitors add further hazard.

Special Groups Pregnancy:

Unsafe
This product is marketed for men and has no role in pregnancy. An unapproved medicine should not be taken by anyone who is pregnant.

Special Groups Breastfeeding:

Unsafe
Not applicable to the marketed use, and an unapproved product with no regulatory review should not be taken while breastfeeding.

Special Groups Elderly:

Unsafe
Older men are more likely to take nitrates for angina, alpha-blockers for the prostate, and antidepressants — the three interaction groups that matter most here. They are also the group in whom cardiovascular fitness for sexual activity most needs assessment before treatment.

Special Groups Children:

Unsafe
There is no use for this product in anyone under 18.

Effects on Activities Driving:

Unsafe
Dizziness and visual disturbance are documented effects of sildenafil, and dapoxetine adds sedation and the risk of fainting reported with this class. Neither ingredient has been assessed for driving impairment in this combination.

Effects on Activities Operating Machinery:

Unsafe
The same dizziness and possible syncope apply. With no approved labelling, no formal assessment of these effects exists for this product.
Concerns

Cenforce D has no FDA approval and cannot be lawfully marketed in the United States. It reaches buyers through online sellers and business-to-business export listings rather than through pharmacies.13

The concern is not only regulatory. Both conditions this tablet claims to treat are worth a consultation in their own right: erectile dysfunction is an early marker of cardiovascular disease often enough that it is treated as a reason to check the heart, and premature ejaculation has behavioural and psychological treatments that a tablet bypasses. Someone self-treating with an unapproved combination may be managing the symptom of a condition that has not been looked at.

A practical note on the source documentation: the distributor brochure for this product contains a section heading referring to a different product entirely, which indicates it was assembled by copying material rather than prepared as a controlled document. That is worth knowing when weighing how much any figure in it can be relied on. The approved alternative for this indication is Viagra (sildenafil).

Warnings

The status is the first warning

Cenforce D is not approved by the FDA, and dapoxetine has never been approved in the United States in any product. There is no approved prescribing information, no application number and no regulatory review of this tablet’s content, purity or bioequivalence. Everything quantitative about it rests on the documentation of the company selling it.

Nitrates: the interaction that kills

Sildenafil potentiates the hypotensive effect of nitrates, and co-administration with any nitrate or nitric oxide donor is an absolute contraindication in the FDA labelling for that ingredient. This includes nitroglycerin taken for angina, isosorbide preparations, and recreational amyl nitrite. The resulting fall in blood pressure can be fatal. A man buying this tablet online is not asked what he takes for his heart.

Serotonin syndrome

Dapoxetine is a selective serotonin reuptake inhibitor. Taken with other serotonergic medicines — SSRIs, SNRIs, tricyclics, triptans, tramadol, monoamine oxidase inhibitors, St John’s wort — it can precipitate serotonin syndrome, which presents as agitation, sweating, tremor, fever and a racing heart and can be life-threatening. Nobody checks this at the point of an online purchase.

Riociguat and other guanylate cyclase stimulators

Also contraindicated with sildenafil in the FDA labelling, for the same haemodynamic reason as nitrates.

Cardiovascular fitness for sexual activity

The approved labelling for sildenafil notes that sexual activity itself carries cardiac risk, and that men with cardiovascular disease should be assessed before treatment for erectile dysfunction is started. That assessment does not happen when the tablet arrives by post.

Source: 23

Dosage
No approved dosing exists
Because this combination has no FDA approval, there is no verified dosing schedule for it. The figures below are what the seller documentation states, reproduced so that readers can see what is being claimed — not as instructions to follow.1
Manufacturer’s Stated Use — Not an Approved Regimen
ItemWhat the seller documentation statesRegulatory statusNote
CompositionSildenafil citrate 100 mg with dapoxetine 60 mgNeither combination nor dapoxetine is FDA-approved100 mg sildenafil is the maximum approved single dose of that ingredient
TimingAbout one hour before sexual activityNot an approved regimenMatches the approved timing for sildenafil alone
FrequencyNot more than once per dayNot an approved regimenThe approved maximum for sildenafil alone is also once daily
Approved comparison—Sildenafil 50 mg is the recommended starting dose for erectile dysfunctionFrom the FDA label for Viagra

Source: 2

▶Clinical detailstechnical detail

The two ingredients act on unrelated systems. Sildenafil inhibits phosphodiesterase type 5, so cyclic GMP is not broken down and smooth muscle in the corpus cavernosum stays relaxed — it amplifies a signal that arousal starts, rather than creating one. Dapoxetine is a selective serotonin reuptake inhibitor with unusually rapid absorption and a short half-life, designed to be taken on demand rather than daily like the SSRIs used for depression.

Combining them is pharmacologically coherent, which is why such products exist. The problem is not the idea but the absence of any regulator having examined this particular tablet: no confirmed content uniformity, no bioequivalence data, no verified impurity profile, and no adverse event file. Every quantitative claim about it rests on the word of the company selling it.3

Interactions
Significant Interactions
Interacting substanceEffect and riskSeverityDocumentation
nitrates such as nitroglycerin in any form — nitroglycerin, isosorbide, amyl nitritePotentiated hypotension; can be fatal. Absolute contraindication with sildenafilContraindicatedExcellent
Riociguat and other guanylate cyclase stimulatorsSymptomatic hypotension; contraindicated with sildenafilContraindicatedExcellent
MAO inhibitors, SSRIs such as sertraline, SNRIs, tricyclics, triptans, tramadolSerotonin syndrome with the dapoxetine componentContraindicatedGood
Alpha-blockers for prostate or blood pressureAdditive hypotension with sildenafilMajorExcellent
Strong CYP3A4 inhibitors — ritonavir, ketoconazole, clarithromycinRaise sildenafil concentrations substantially; the approved label reduces the dose for theseMajorExcellent
AlcoholAdds to hypotension and to the dizziness both ingredients causeModerateGood

Source: 2

Every entry above comes from what is known about the two ingredients separately. No interaction study exists for this combination as a product, because no regulator has required one.

FAQs
No. Neither the product nor its dapoxetine component has FDA approval. Searches of Drugs@FDA and FDA labelling return no record of dapoxetine at all, and the combination cannot be lawfully marketed in the United States.
It has never received FDA approval, and no application record for it appears in Drugs@FDA. It is approved in a number of other countries as a short-acting SSRI for premature ejaculation, but that does not extend to the United States, where no drug is approved for that condition.
Two specific interactions, neither of which is checked when a tablet is bought online. Sildenafil taken with nitrates — nitroglycerin, isosorbide, amyl nitrite — can cause a fatal drop in blood pressure. Dapoxetine is an SSRI and can cause serotonin syndrome with common antidepressants, triptans or tramadol.
No. Dapoxetine is a selective serotonin reuptake inhibitor, and combining it with SSRIs, SNRIs, tricyclics, MAO inhibitors, triptans or tramadol risks serotonin syndrome, which can be life-threatening.
For erectile dysfunction, yes: sildenafil is FDA-approved as Viagra, prescribed after a check of your heart medicines and cardiovascular fitness for sexual activity. For premature ejaculation there is no FDA-approved medicine, and the treatments a clinician can offer include behavioural approaches as well as off-label options.
Statements about the product come from the manufacturer and distributor brochures published on a business marketplace, and are identified as such. Everything about pharmacology, contraindications and interactions comes from FDA-approved labelling for sildenafil, since no approved labelling exists for this combination.
Evidence and Reported Data

Evidence scope

What we know
  • Sildenafil is thoroughly characterised: FDA-approved since 1998, with a full labelling document covering dosing, contraindications and interactions.
  • Dapoxetine has no FDA approval; three separate queries of FDA labelling and application records return nothing.
  • The claimed composition and timing come from seller documentation that is publicly available and can be read directly.
What remains uncertain
  • Whether any given tablet contains what the brochure says has not been verified by any regulator.
  • No bioequivalence, content uniformity or impurity data exist in the public record for this product.
  • There is no adverse event file for the combination, so its real-world safety profile is unmeasured rather than reassuring.

Source: 231

What has been reported to the FDA

The FDA Adverse Event Reporting System holds no reports under this product name, which is expected: FAERS collects reports about medicines within the US regulatory system, and this product is outside it. The absence of reports is a consequence of the regulatory status, not evidence of safety.

Why there is no table here

Every other drug page on this site shows the most reported adverse event terms. That table cannot be built for a product with no reports and no approval.

What can be said is that sildenafil, as an approved ingredient, has one of the largest adverse event records of any medicine, and the events that matter most — cardiac events during sexual activity, priapism, sudden vision and hearing loss — are documented there rather than here. An unapproved copy of a drug does not have a different safety profile because nobody is counting.

Who was this medicine studied in?

This combination has not been studied in any trial submitted to the FDA. Sildenafil’s approval rests on trials in men with erectile dysfunction; dapoxetine was studied for premature ejaculation in trials submitted to other regulators, but its US application record does not exist.

Who this is and is not appropriate for

It is not appropriate for anyone taking nitrates in any form, anyone taking riociguat, anyone on serotonergic medication including common antidepressants, and anyone whose cardiovascular fitness for sexual activity has not been assessed.

For erectile dysfunction there is an approved alternative containing the same active ingredient, prescribed after the checks described above. For premature ejaculation there is no FDA-approved drug, and the options a clinician can offer include behavioural approaches and off-label use of licensed medicines — a conversation worth having rather than a gap to fill by post.

Where to go next

  • Report a problem with an unapproved product – MedWatch
  • Buying medicines online safely – FDA guidance
  • The approved sildenafil labelling – DailyMed
References

References — verified Sep 5, 2026

  1. Cenforce D tablets — product brochures issued by the manufacturer and by distributor Gleason Healthcare, as hosted on the IndiaMART business marketplace. These are sales and distribution documents rather than regulatory filings, and are cited here as the source of the manufacturer’s own claims about composition and use. Product brochure and distributor brochure. Accessed September 5, 2026.
  2. Pfizer Laboratories Div Pfizer Inc. VIAGRA (sildenafil citrate) tablets — prescribing information. DailyMed SPL set ID 0b0be196-0c62-461c-94f4-9a35339b4501, version 32. Cited for the pharmacology, contraindications and interactions of the sildenafil component. dailymed.nlm.nih.gov. Accessed September 5, 2026.
  3. US Food and Drug Administration. Drugs@FDA, openFDA labelling and FDA Adverse Event Reporting System, queried for dapoxetine and for Cenforce D. No approval record, no labelling and no adverse event reports are returned. Accessed September 5, 2026.

Three sources are listed because three are cited. Regulatory and pharmacological statements come from FDA records; statements about the product itself come from the seller documentation and are identified as such throughout.

Disclaimer

This product is not approved by the FDA and is dangerous to use without medical supervision. The information below about the product itself is based on the manufacturer’s and distributor’s own brochures and accompanying documentation; it is not a prescribing instruction and not a guide to self-treatment. Using potent ingredients such as sildenafil and dapoxetine without a doctor’s oversight is hazardous: sildenafil taken with nitrates can cause a fatal fall in blood pressure, and dapoxetine can cause serotonin syndrome with common antidepressants. Nothing here replaces assessment by a qualified clinician.