iMedix Medical Content Engine 3.13.37
Home/Drugs/Tadacip

Tadacip: Uses, Dosage & Safety Information

Tadacip

Tadacip
tadacip 20
1 / 3

Tadacip

Tadalafil
Tadacip is a tadalafil tablet attributed to Cipla that holds no FDA approval under this name, although Cipla markets FDA-approved generic tadalafil in the United States. Only the approved tablets carry FDA-reviewed labelling, and tadalafil must never be combined with nitrates or riociguat.
  • ActiveIngredient: Tadalafil
  • DosageForm: Oral tablet
  • Dosage: 20 mg
  • Indications: Erectile dysfunction
  • Manufacturer: Cipla Ltd
  • Storage: Store below 30°C
  • Drug Status: Not Approved
Drug Status: Not Approved
Description

What is Tadacip?

Tadacip has no FDA approval — but its manufacturer, Cipla, does hold approvals for tadalafil. Cipla markets FDA-approved tadalafil in the United States at all four approved strengths under two abbreviated applications. Choosing this brand means declining the registered equivalent made by the same company.

The same company sells an FDA-approved version of this exact drug
Cipla holds two FDA approvals for tadalafil — ANDA 209539 at all four approved strengths, and ANDA 210255 at the highest strength. Both are marketed in the United States as prescription products.
Tadacip is not among them. A user choosing it is choosing the unapproved product from a manufacturer whose approved equivalent, at the same strengths, is already on the shelf.12

Tadacip itself has no FDA labelling, no application number and no entry in the drug registry.

This is not a story about an unreliable manufacturer. Cipla holds over a hundred FDA applications and supplies the American market with atorvastatin, pregabalin, topiramate and diltiazem among others. The company clears the same inspections as any other supplier.

Listed under erectile dysfunction. The molecule’s approved uses and limits are set out under the brand-name tadalafil product.

General Instructions

How to Take Tadacip

The approved version from the same maker

Cipla holds FDA approvals for generic tadalafil tablets; those tablets, not this product, carry FDA-reviewed labelling and a US National Drug Code. Generic tadalafil is widely stocked by US pharmacies.

How approved tadalafil is taken

Approved tadalafil as needed usually starts at 10 mg before sexual activity, adjustable to 5 mg or 20 mg; once-daily use is 2.5 mg or 5 mg.5

Asking for the approved product

A prescription can name generic tadalafil, and the pharmacist can show the manufacturer and NDC on the label before you take it. The approved tablets come in the same four strengths as brand Cialis.

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. Do not assume a familiar maker name means the same approved product.5

Side Effects

What Are the Side Effects of Tadacip?

Three reports name this product in the FDA database, each term appearing once. A set that small supports no inference about anything.

All Reported Terms, One Report Each
TermReports
Drug ineffective1
Blood pressure increased1
Anxiety1
Emotional distress1
Basal cell carcinoma1
Malignant melanoma1

Source:

Six terms across three reports means most came bundled from single patients, and the two skin cancer entries almost certainly appeared in one record together. Nothing here establishes a relationship of any kind, and reading a pattern into single reports is the commonest error made with this database.

The effects genuinely associated with tadalafil — headache, back pain, dyspepsia, nasal congestion, flushing — are set out on the the reference tadalafil product page, where they rest on trial data rather than on three spontaneous reports.

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

What is Tadacip Used For?

No approved use under this brand. What the record does show is the approved alternative from the same source.1

What a generic application actually certifies

It is not a lighter form of approval. It requires the same active ingredient at the same strength in the same dosage form, manufactured under the same good manufacturing practice rules, plus bioequivalence data showing the copy delivers the drug into the bloodstream as the original does.

That last piece is what a branded export product skips. Nothing establishes that a tablet sold under this name behaves in the body like the approved one, even when it comes off a line in the same country and from the same company.

Safety Advice

Interactions Alcohol:

Consult your doctor
No assessment is possible for a product of unknown exposure. If tadalafil is present, alcohol adds to its blood-pressure lowering.

Interactions Other Medications:

Unsafe
Organic nitrates and guanylate cyclase stimulators are absolute contraindications with tadalafil. The alpha-blocker and CYP3A4 rules are expressed as dose limits, and those require a product whose exposure has been measured.

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 take more medicines, so automatic interaction checking at a pharmacy matters more — and it is available with the approved version from the same manufacturer.

Special Groups Children:

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

Effects on Activities Driving:

Consult your doctor
Unknown for this product. If tadalafil is present, dizziness from blood-pressure lowering is possible.

Effects on Activities Operating Machinery:

Consult your doctor
Unknown, for the same reason.
Concerns

Tadacip has no FDA labelling, application number or registry entry. Its manufacturer, Cipla, holds two approvals for tadalafil and markets the approved product in the United States.31

Most pages in this group describe a gap between an unapproved product and a distant originator. This one describes something narrower and more awkward: the gap sits inside a single company catalogue. The firm that clears FDA inspections to supply atorvastatin and pregabalin to American pharmacies also sells a branded tadalafil that has never been submitted anywhere.

That makes the usual framing unhelpful. The question is not whether Indian manufacturing can be trusted — the approvals answer it — but what a user gives up by taking the branded export instead of the registered product. The answer is everything registration consists of: bioequivalence data, a product code, published labelling, recall coverage and automatic interaction checking.

Warnings

Critical Warnings for Tadacip Use

The approved equivalent comes from the same manufacturer

Cipla holds FDA approval for tadalafil at 2.5, 5, 10 and 20 mg and markets it in the United States. Choosing an unapproved brand from that company means declining its approved product rather than escaping a bad one.

No bioequivalence data exists for this brand

An approved generic must show that it delivers the drug into the bloodstream as the originator does. Nothing establishes that for a branded export product, so the dosing instructions written around exposure figures cannot be applied to it.

Nitrates

Tadalafil is contraindicated with any form of organic nitrate.5

Tadalafil hypersensitivity

Contraindicated after a serious hypersensitivity reaction to tadalafil (Cialis or Adcirca).5

Guanylate cyclase stimulators

Contraindicated with guanylate cyclase stimulators such as riociguat.5

Three adverse event reports prove nothing

Six terms appear once each. A set that size cannot show either safety or harm, and should not be read as doing either.

Source: 15

See Interactions.

Dosage

Dosage

No dose is registered under this name
The approved tadalafil from the same company is registered at 2.5, 5, 10 and 20 mg, each with its own product code and published labelling. Nothing comparable exists for this brand.13
What the Registered Route Provides
StepWhat happens
PrescriptionA clinician confirms the diagnosis and checks nitrates, alpha-blockers and other medicines
DispensingThe product code is scanned; strength and identity are confirmed at the counter
Interaction checkPharmacy systems compare it against the rest of a patient record automatically
Recall coverBatches remain traceable if a defect is found later
ReportingAn adverse event attaches to a specific product and accumulates with others

Source: 21

▶Clinical detailstechnical detail

Bioequivalence is established by dosing volunteers with the generic and the reference product and comparing two measures: peak concentration and total exposure over time. The generic must fall within a defined range of the original on both, which is why a substituted tablet can be expected to behave like the one it replaces.

For tadalafil that testing carries more weight than it might elsewhere, because the clinical instructions are built directly on exposure figures. The alpha-blocker precaution, the reduced ceiling alongside CYP3A4 inhibitors and the renal dose adjustments are all expressed as limits on how much drug reaches the blood. A product never measured against the reference cannot be slotted into those instructions, whatever its packaging claims to contain.15

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: 5

Interactions

What Does Tadacip 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: 5

FAQs
No. It has no application number, no product code and no published labelling. Its manufacturer, Cipla, does hold FDA approval for tadalafil — but for a separate, registered product rather than for this brand.
Cipla holds over a hundred FDA applications and supplies the American market with atorvastatin, pregabalin, topiramate and diltiazem among others. The question is not the company but which of its products you are obtaining.
Bioequivalence data, a product code, published labelling, recall coverage and automatic interaction checking at a pharmacy. Those are what registration consists of, and none of them attaches to an unregistered brand.
It is a demonstration that a copy delivers the drug into the bloodstream as the original does, measured by peak concentration and total exposure. Tadalafil dosing rules — the alpha-blocker precaution, the reduced ceiling with CYP3A4 inhibitors — are written as exposure limits, so they cannot be applied to a product that has never been measured.
No, and it is not alarming either. Six terms appear once each across three reports, which is far too few to characterise. The honest reading is that the dataset is empty of information rather than empty of harm.
Evidence and Reported Data

Evidence scope

What we know
  • Cipla holds ANDA 209539 (2.5, 5, 10 and 20 mg) and ANDA 210255 (20 mg) for tadalafil, both marketed.
  • Cipla supplies the United States with atorvastatin, pregabalin, topiramate and diltiazem among others.
  • Tadacip has no application, no product code and no published labelling.
What remains uncertain
  • Whether a tablet sold under this brand is manufactured to the same standard as the approved line.
  • What exposure it delivers, since no bioequivalence data exists for it.
  • What any individual package contains.

Source: 1243

What has been reported to the FDA

Three reports at the 30 July 2026 data cut, containing six terms between them, each appearing once.

Why three reports cannot be read at all

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

Population note: at this size the ordinary cautions do not apply — something stronger does. Six terms across three reports means most arrived bundled from single patients, and two of the six are skin cancers that almost certainly appeared in one record together. A reader inclined to see a signal would find one; a reader inclined to see reassurance would find that too. Neither reading is available from three reports, and the honest statement is that this dataset is empty of information rather than empty of harm.

Who was this medicine studied in?

No one, under this brand. The manufacturer approved tadalafil rests on bioequivalence data submitted with its applications, and that evidence does not transfer to a product outside them.1

Who this is and is not appropriate for

No one, on the available evidence — and the alternative here is unusually direct. The same manufacturer approved tadalafil is prescription-only, inexpensive, registered at four strengths and dispensed through a pharmacy that will check it against your other medicines.12

The contraindications of tadalafil — nitrates, guanylate cyclase stimulators, serious hypersensitivity — apply to either version.5

Dose Figures Behind This Page

Two Products, One Manufacturer
FeatureCipla tadalafil (approved)Tadacip
ApplicationANDA 209539 and ANDA 210255None
Strengths2.5 mg, 5 mg, 10 mg, 20 mgNot registered
Product code69097-526 and othersNone
Published labellingYes, with a set ID and dateNone
Marketing statusPrescription, marketedNot marketed in the United States
Bioequivalence to the originatorDemonstrated as part of the applicationNever submitted

Source: 123

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. Drugs@FDA — ANDA 209539 and ANDA 210255, tadalafil tablets, sponsor Cipla
    Approved and marketed as prescription products · Records accessed 2026-09-23
    Used for: the existence of FDA-approved tadalafil from this manufacturer, the strengths covered and their prescription status.
    accessdata.fda.gov — Drugs@FDA
  2. FDA National Drug Code Directory — Cipla tadalafil, product code 69097-526
    Directory accessed 2026-09-23
    Used for: confirmation that the approved product is actually marketed, with a product code that resolves publicly.
    accessdata.fda.gov — NDC Directory
  3. openFDA — labelling, Drugs@FDA, NDC Directory and FAERS queries for TADACIP
    Data cut 2026-07-30 · Accessed 2026-09-23
    Used for: the absence of any application, product code, labelling or adverse event record under this brand name.
    open.fda.gov — drug adverse event API
  4. Drugs@FDA and FDA NDC Directory — applications and marketed products sponsored by Cipla
    Records accessed 2026-09-23
    Used for: the scale of this manufacturer’s approved presence in the United States, including atorvastatin, pregabalin, topiramate and diltiazem.
    accessdata.fda.gov — Drugs@FDA
  5. FDA Prescribing Information, CIALIS (tadalafil) — Sections 2, 4.1–4.3, 7.2
    Revised 2026-06 · Accessed 2026-09-23
    Used for: the dosing ceiling, contraindications and the exposure-based interaction rules that a bioequivalence finding underwrites.
    dailymed.nlm.nih.gov — CIALIS SPL

How this page was sourced

The comparison at the centre of this page is between two products of one company, so both sides are read from the same regulatory system rather than from anything the company says about itself.

The product code is quoted in full because it is the single item a reader can paste into a public directory to check the claim in a few seconds.

Nothing is asserted about the contents of a tablet sold under this brand, because no source establishes it.

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

Disclaimer

Disclaimer: The information on this site is provided for informational purposes only and is not medical advice. It does not replace professional medical consultation, diagnosis, or treatment. Do not self-medicate based on the information presented on this site. Always consult with a doctor or other qualified healthcare professional before making any decisions about your health.