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Tadalista® (Tadalafil): Uses, Dosage & Safety Information

Tadalista® (Tadalafil)

Tadalista® (Tadalafil)

Tadalista® (Tadalafil)

Tadalafil
Tadalista is an unapproved tadalafil tablet whose maker’s own materials give conflicting strengths and brand names in the same entry, so the amount in a tablet is uncertain. Approved tadalafil comes in fixed strengths with FDA-reviewed labelling and must never be combined with nitrates or riociguat.
  • ActiveIngredient: Tadalafil
  • DosageForm: Oral tablet
  • Dosage: 2.5 mg, 5 mg, 10 mg, 20 mg, 40 mg, 60 mg
  • Indications: Erectile dysfunction
  • Manufacturer: Fortune Healthcare Product Pvt Ltd
  • Storage: Store below 30°C
  • Drug Status: Not Approved
Drug Status: Not Approved
Description

What is Tadalista?

The manufacturer’s own catalogue contradicts itself about this product’s strength. Fortune Healthcare’s listing headed “Tadalista 60” gives a lower strength in its specification and names a competitor’s brand in its brand field. The range runs from the lowest approved strength to three times the approved maximum, and every dosing instruction for tadalafil is a number that assumes the figure on the box is real.

The maker’s own catalogue contradicts itself about the strength
Fortune Healthcare’s own product page for this item names one strength in its heading, a different strength in the listing and a different brand name in the same entry, so the amount of tadalafil in a tablet cannot be established from the maker’s materials.
Three statements about one product, none of which agree: the title gives one strength, the specification a lower one, and the brand field names a competitor’s product. This is the manufacturer’s own site, not a reseller.1

Tadalista is tadalafil from Fortune Healthcare Product Pvt Ltd of Vadodara, Gujarat, sold at a run of strengths from the lowest approved one to three times the approved maximum with a stated shelf life of 36 months.1

No product under this name has FDA approval, and none appears in FDA labelling, Drugs@FDA, the drug registry or the adverse event database.2

Listed under erectile dysfunction. What approved tadalafil is and does is on the approved tadalafil page.

General Instructions

How to Take Tadalista

Strength cannot be taken on trust

The maker’s own materials give conflicting strengths for this product, so the amount of tadalafil in a tablet is uncertain. Uncertain strength is a reason for extra caution with interacting medicines.

How approved tadalafil is taken

Approved tadalafil is dosed in fixed strengths of 2.5, 5, 10 and 20 mg; as-needed use usually starts at 10 mg and daily use at 2.5 or 5 mg.3

If the effect seems too strong or too weak

Stop and speak to a prescriber rather than cutting or doubling tablets; approved tadalafil tablets are not meant to be split. Keep the pack and leaflet so a pharmacist can check what you were given.3

What not to do

Do not take tadalafil in any form with nitrates or riociguat, and do not take more than one dose in a day. Tell any emergency team you have taken tadalafil, because it lasts up to 36 hours.3

Side Effects

What Are the Side Effects of Tadalista?

One adverse event report names this product in the FDA database. A single report describes one person and supports no conclusion.

What Rises With Dose
EffectBehaviour above 20 mg
HeadacheIncreases
Back pain and muscle achesIncreases
Dyspepsia, nasal congestion, flushingIncrease
Dizziness and blood-pressure loweringIncreases
Erectile responseFlattens — the reason titration stops at 20 mg

Source: 4

The last row is the argument against the upper half of this product range. Above the approved ceiling the unwanted effects keep climbing while the wanted one does not.

Emergency – seek care
  • An erection lasting more than four hours
  • Chest pain — and say you have taken tadalafil, with the strength on the pack if you have it
  • Sudden loss of vision or hearing
  • Fainting or severe dizziness
Uses

What is Tadalista Used For?

No approved use. The relevant question is whether the strength printed on a pack can be relied on, and the manufacturer’s own publishing answers part of it.1

What the catalogue states

Vidalista is a different company’s brand — Centurion Laboratories, also of Vadodara. Its name appearing in the brand field of a Tadalista listing is either a copy-paste error or an indication that the two products share more than a postcode.

Why this bears on dosing rather than on tidiness

Every instruction for this molecule is a number. The alpha-blocker precaution specifies a starting dose; the ceiling with CYP3A4 inhibitors is a fixed reduced dose; renal adjustment is expressed in milligrams and hours.4

Those instructions assume the figure on the box is the figure in the tablet. A catalogue that cannot hold one product’s strength steady across a single page is not evidence that the tablets are wrong, but it removes the basis for assuming they are right.

Safety Advice

Interactions Alcohol:

Unsafe
Both alcohol and tadalafil lower blood pressure, and the size of that effect depends on a strength that is not independently confirmed.

Interactions Other Medications:

Unsafe
Organic nitrates and guanylate cyclase stimulators are absolute contraindications with tadalafil at every strength. The alpha-blocker and CYP3A4 rules are expressed as milligram limits and cannot be applied to an unconfirmed tablet.

Special Groups Pregnancy:

Unsafe
Not applicable — the molecule is approved only in men for this indication.

Special Groups Breastfeeding:

Unsafe
Not applicable to the approved indications.

Special Groups Elderly:

Unsafe
Older men are likelier to take nitrates or alpha-blockers, and strengths of 40 and 60 mg exceed every dose evaluated for this use in any age group.

Special Groups Children:

Unsafe
No approved paediatric use exists for tadalafil in this indication.

Effects on Activities Driving:

Unsafe
Dizziness rises with dose, and the dose taken is not established. Sudden vision changes mean stopping and seeking care.

Effects on Activities Operating Machinery:

Unsafe
The same applies, for the same reason.
Concerns

Tadalista is made by Fortune Healthcare Product Pvt Ltd of Vadodara, Gujarat. No product under this name has FDA approval or appears in any FDA record.12

The concern here is unusually concrete. On its own website, the page for Tadalista 60 describes the product as 60 mg in its title, states 20 mg in its specification field, and names Vidalista — a different company’s brand — in its brand field. That is not a reseller’s sloppiness passed along a chain of middlemen; it is the manufacturer’s own published description of what it makes.

What follows is narrow and worth stating precisely. It does not establish that any tablet contains the wrong amount. It establishes that the strength on the packaging carries no more authority than the strength on that page, and every dosing instruction for this molecule is a number that assumes otherwise.

The Vidalista reference is worth a second look for a different reason. That brand belongs to Centurion Laboratories, also of Vadodara, whose plant received an FDA Warning Letter in 2019 over destroyed and falsified laboratory records — documented on the Vidalista page. Whether the two products share anything beyond a city is not established here, and this page does not assert that they do.

Warnings

Critical Warnings for Tadalista Use

The strength on the pack is not independently confirmed

The manufacturer’s own listing states three different things about one product’s strength within a single page. No regulator has verified the content of any tablet sold under this name.

Strengths of 40 and 60 mg exceed every approved dose for this use

Approved tadalafil for erectile dysfunction stops at 20 mg once daily. The 40 mg figure belongs to pulmonary arterial hypertension under separate brands and specialist supervision; 60 mg is not evaluated anywhere.

Nitrates

Tadalafil is contraindicated with any form of organic nitrate.3

Tadalafil hypersensitivity

Contraindicated after a serious hypersensitivity reaction to tadalafil (Cialis or Adcirca).3

Guanylate cyclase stimulators

Contraindicated with guanylate cyclase stimulators such as riociguat.3

Dose-based precautions cannot be applied

The alpha-blocker rule and the reduced ceiling alongside CYP3A4 inhibitors are numbers, and they require a tablet whose content is established.

Source: 145

See Interactions.

Dosage

Dosage

Two of the six strengths exceed every approved dose
The range runs 2.5 to 60 mg. Approved tadalafil for erectile dysfunction stops at 20 mg a day, and 40 mg is the approved dose per day for pulmonary arterial hypertension under separate brands. Nothing evaluates 60 mg for any indication.145
Marketed Strengths Against Approved
StrengthApproved for erectile dysfunction?Note
2.5 mg, 5 mgYesThe everyday doses
10 mgYesThe usual as-needed starting dose
20 mgYesThe ceiling
40 mgNoApproved dose per day for pulmonary arterial hypertension, a different disease
60 mgNoThree times the ceiling; not evaluated for any indication

Source: 145

▶Clinical detailstechnical detail

The 40 mg figure is the one most likely to mislead, because it exists in approved medicine — just not for this purpose. Tadalafil 40 mg per day is licensed for pulmonary arterial hypertension, where it is prescribed by specialists to patients whose pulmonary arteries are progressively narrowing, and where the risk balance is entirely different from that of a man seeking a stronger erection.

Someone reasoning that 40 mg must be safe because a 40 mg tadalafil product is approved has drawn the right inference from the wrong premise. Dose limits are set per indication and per population, not per molecule. The 20 mg ceiling for erectile dysfunction reflects what was studied in men with that condition, and the flattening of the dose-response curve above it means the extra 20 mg buys side effects rather than effect.45

Kidney and Liver Limits
FormulationActive IngredientsClinical Note
Renal impairmentTadalafilApproved labelling lowers or caps doses
Hepatic impairmentTadalafilApproved labelling caps doses in mild or moderate impairment and advises against use in severe impairment

Source: 3

Interactions

What Does Tadalista Interact With?

These are the labelled interactions of tadalafil.

Interactions by Severity
Interacting SubstanceEffect and RiskSeverityDocumentation
Organic nitrates in any form, including nitroglycerinDangerous fall in blood pressureContraindicatedExcellent — labelled contraindication
Guanylate cyclase stimulators such as riociguatLow blood pressureContraindicatedExcellent — labelled contraindication
Strong CYP3A4 inhibitors such as ketoconazole, ritonavirHigher exposure; as needed no more than 10 mg every 72 hoursMajorExcellent — labelled interaction
Alpha-blockers, other blood pressure medicines, alcoholAdditive fall in blood pressureModerateGood — labelled interaction
CYP3A4 inducers such as rifampinLower tadalafil exposureMinorGood — labelled interaction

Source: 3

FAQs
Fortune Healthcare Product Pvt Ltd, of Vadodara in Gujarat, India. The brand is sold at 2.5, 5, 10, 20, 40 and 60 mg with a stated 36-month shelf life.
Nothing independently confirms it. The manufacturer’s own listing for its 60 mg product states 60 mg in the title, 20 mg in the strength field, and names a different company’s brand — three conflicting statements about one product on one page.
No. That dose is licensed for pulmonary arterial hypertension under separate brands and specialist supervision, where the risk balance is entirely different. Dose limits are set per indication, not per molecule.
No regulator has evaluated 60 mg of tadalafil for any indication. Approved dosing for erectile dysfunction stops at 20 mg once daily.
The evidence points the other way. Headache, back pain, dizziness and flushing keep rising with dose while the erectile response flattens, which is why titration stops at 20 mg.
Evidence and Reported Data

Evidence scope

What we know
  • The manufacturer is Fortune Healthcare Product Pvt Ltd, Vadodara, Gujarat.
  • Strengths of 2.5, 5, 10, 20, 40 and 60 mg are listed, with a 36-month shelf life and 10×10 packs.
  • The manufacturer’s own listing for the 60 mg product states 20 mg as its strength and names a different company’s brand.
  • Nothing under this brand name is recorded in any FDA system.
What remains uncertain
  • Which of the three conflicting values on that listing describes the actual product.
  • What any individual tablet contains.
  • Whether the appearance of a competitor’s brand name reflects an error or a manufacturing relationship.

Source: 12

What has been reported to the FDA

One report at the 30 July 2026 data cut.

One report is not a small dataset — it is no dataset

FAERS records what was reported, not what a medicine caused, and has no denominator.

Population note: a single report describes one person on one occasion. It cannot establish frequency, cannot be compared against anything, and cannot be distinguished from coincidence. Quoting its contents would give a single individual’s experience the appearance of a safety profile, which is why the terms are not reproduced here. The useful statement is the count itself: essentially nobody has reported anything under this name, and for an unapproved product sold outside the health system that is the expected result whether or not harm has occurred.

Who was this medicine studied in?

No one. No product under this name has been submitted for approval, and the 40 and 60 mg strengths have no evaluation for erectile dysfunction from any source.24

Who this is and is not appropriate for

No one, while the manufacturer’s own listing cannot agree with itself on how much drug is in the tablet. The contraindications of tadalafil apply at every strength, and the strength itself is not independently confirmed.4

Approved generic tadalafil is prescription-only, inexpensive and registered at four strengths with published labelling behind each.

Dose Figures Behind This Page

One Product Listing
Field on the pageValue
Page titleTadalista 60
Product descriptionTadalafil Tablets USP 60mg
Strength20 mg
BrandVidalista 60 mg
Pack size10×10
Shelf life36 months

Source: 1

Where to report and verify

Routing to Official Registries
What you needWhere to go
Report a side effectFDA MedWatch
Pregnancy-specific dataMotherToBaby
Full prescribing informationDailyMed
Verify a pharmacy websiteFDA BeSafeRx · LegitScript
References

References

  1. Fortune Healthcare Product Pvt Ltd — published product listings
    Manufacturer material, not verified by any regulator · Accessed 2026-09-23
    Used for: the manufacturer identity, the strength range from 2.5 to 60 mg, pack size and shelf life, and the internal contradiction on the Tadalista 60 listing between its title, its strength field and its brand field.
  2. Centurion Laboratories — published listings for Vidalista
    Manufacturer material · Accessed 2026-09-23
    Used for: confirmation that the brand named in that field belongs to a different company.
  3. FDA Prescribing Information, CIALIS (tadalafil) — Sections 2.1, 2.4, 6 and 7.2
    Revised 2026-06 · Accessed 2026-09-23
    Used for: the 20 mg ceiling for erectile dysfunction, the dose-based interaction rules, and the flattening of the dose-response curve above that ceiling.
    dailymed.nlm.nih.gov — CIALIS SPL
  4. Drugs@FDA — NDA 022332, ADCIRCA (tadalafil 40 mg once daily)
    Records accessed 2026-09-23
    Used for: the approved context for the 40 mg figure, which belongs to pulmonary arterial hypertension under specialist supervision rather than to this indication.
    accessdata.fda.gov — Drugs@FDA
  5. openFDA — labelling, NDC Directory and FAERS queries for TADALISTA
    Data cut 2026-07-30 · Accessed 2026-09-23
    Used for: the absence of any approval or product code under this name, and the single adverse event report filed against it.
    open.fda.gov — drug adverse event API

How this page was sourced

The contradiction is quoted from the manufacturer’s own page so that a reader can compare the three fields directly rather than accept a characterisation of them.

The single adverse event report is reported as a count only. Its terms are not reproduced, because one report describes one person and quoting it would give an individual case the appearance of a pattern.

Review cycle. Clinical review completed 28 September 2026. Next review due by 28 September 2027, or earlier if the labelling is revised.

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