Fildena 100 Mg

Description

Regulatory Note: Fildena 100mg contains Sildenafil Citrate 100mg, manufactured by Fortune Healthcare Pvt. Ltd., a WHO-GMP certified pharmaceutical company based in India. Sildenafil Citrate (as Viagra, Pfizer) received FDA approval on March 27, 1998 — the first oral PDE5 inhibitor approved for erectile dysfunction in the United States. Fildena 100mg is a generic formulation of Sildenafil; it is not independently FDA-approved but is manufactured to GMP standards for international markets.

Fildena 100mg: Complete Medical Guide

Fildena 100mg is a prescription oral tablet containing Sildenafil Citrate 100mg — the maximum FDA-approved single dose of Sildenafil for erectile dysfunction — manufactured by Fortune Healthcare Pvt. Ltd., India. Widely recognized as the “purple pill” (owing to its distinctive triangular purple tablet form), Fildena 100mg belongs to the phosphodiesterase type 5 (PDE5) inhibitor class of medications and is one of the most dispensed generic Sildenafil formulations internationally.

The clinical evidence base supporting Sildenafil 100mg is among the most extensive in urology. A landmark PMC safety review (Hatzimouratidis et al., BJU International, 2010) analysed data from 67 double-blind placebo-controlled trials (>14,000 men) and a post-marketing database of 39,277 patients. It concluded that Sildenafil 50 and 100mg were generally well tolerated — including in men aged ≥65 and ≥75 years — with no causal link identified between Sildenafil use and cardiovascular events, priapism, NAION, hearing loss, or unexpected drug interactions at approved doses. Success rates of 70–85%+ for achieving erections have been consistently reported across clinical populations.

Important: Fildena 100mg is not indicated for women, children, or patients taking nitrates in any form. Sexual stimulation is required for this medication to work. It provides no protection against sexually transmitted infections.

What is Fildena 100mg?

Fildena 100mg is a purple, triangular oral tablet containing 100mg of Sildenafil Citrate as its active pharmaceutical ingredient (API), manufactured by Fortune Healthcare Pvt. Ltd., a WHO-GMP certified pharmaceutical company based in India. Fortune Healthcare is a well-established generic pharmaceutical manufacturer supplying medications to multiple international markets.

Sildenafil Citrate, the active molecule, is the same compound found in Pfizer’s branded Viagra. First identified by Pfizer researchers while investigating treatments for angina, its potent effect on penile erection led to its development as the world’s first oral ED treatment. Fildena 100mg is often referred to as “generic Viagra” due to its identical active ingredient. The 100mg strength is the maximum FDA-approved single dose for ED.

The Fildena range produced by Fortune Healthcare covers multiple strengths and formulations: Fildena 25mg, 50mg, 100mg, 120mg, 150mg, 200mg (Double), Professional (sublingual), CT (chewable), XXX (fruit-flavoured), and Super Fildena (Sildenafil + Dapoxetine combination for ED with premature ejaculation).

How Does Fildena 100mg Work?

Mechanism of Action — The NO/cGMP Signalling Pathway

Fildena 100mg works through the nitric oxide (NO) / cyclic guanosine monophosphate (cGMP) pathway — a mechanism extensively documented in the DailyMed Sildenafil Citrate prescribing labels, the FDA-approved Viagra label, and multiple peer-reviewed pharmacology publications.

During sexual stimulation, peripheral nerves and endothelial cells lining the penile corpus cavernosum release nitric oxide (NO). This activates the enzyme guanylate cyclase, increasing intracellular levels of cyclic guanosine monophosphate (cGMP). Elevated cGMP triggers smooth muscle relaxation and vasodilation of the penile arteries and sinusoids, allowing blood to fill the erectile tissue of the corpus cavernosum and producing a firm erection.

In men with erectile dysfunction, the enzyme phosphodiesterase type 5 (PDE5) hydrolyses cGMP back to inactive GMP too rapidly, terminating the erectile response prematurely or preventing it from developing adequately. Sildenafil Citrate in Fildena 100mg acts as a selective, competitive inhibitor of PDE5 at its catalytic site — blocking cGMP breakdown and amplifying the erectile response to sexual stimulation.

Key clinical point: Fildena 100mg requires sexual stimulation to work. It does not independently produce an erection without arousal. It amplifies an existing physiological response — it is not an aphrodisiac and does not increase sexual desire.

Pharmacokinetics

Sildenafil is rapidly absorbed following oral administration, with peak plasma concentration reached within 30–120 minutes (typically ~60 minutes on an empty stomach). The elimination half-life is approximately 3–5 hours. Sildenafil is primarily metabolized in the liver by CYP3A4 (major) and CYP2D6 (minor), and is a substrate of the P-glycoprotein (ABCB1) efflux transporter

Effect of food: High-fat meals delay peak Sildenafil plasma concentration by approximately 60 minutes and reduce Cmax by 29% per the DailyMed prescribing label. For fastest and most consistent onset, Fildena 100mg should be taken on an empty stomach or after a light, low-fat meal. Grapefruit and grapefruit juice must be avoided — they inhibit intestinal CYP3A4, raising Sildenafil plasma levels unpredictably.

Uses of Fildena 100mg

Primary Indication: Erectile Dysfunction (ED)

Fildena 100mg is indicated for the treatment of erectile dysfunction — defined as the persistent or recurrent inability to achieve or maintain a penile erection sufficient for satisfactory sexual intercourse — in adult men aged 18 years and above.

Fildena 100mg is typically prescribed when the 50mg starting dose has proven insufficient. Erectile dysfunction has multiple aetiologies:

• Vasculogenic: atherosclerosis, hypertension, diabetes mellitus, metabolic syndrome — impaired penile blood flow; most common cause
• Neurogenic: post-radical prostatectomy nerve injury, spinal cord injury, multiple sclerosis, Parkinson’s disease
• Hormonal: hypogonadism (low testosterone), hyperprolactinaemia, thyroid dysfunction
• Psychogenic: performance anxiety, depression, stress, relationship difficulties
• Drug-induced: SSRIs/SNRIs, antihypertensives (beta-blockers, thiazides), antiandrogens, opioids
• Mixed aetiology: most common presentation in clinical practice; Sildenafil effective across all subgroups per PubMed clinical review (1999)

Other Uses of Sildenafil Citrate

While Fildena 100mg is indicated for ED, the active molecule Sildenafil Citrate has additional approved applications:

• Pulmonary Arterial Hypertension (PAH): FDA-approved at 20mg three times daily as Revatio (Pfizer) to improve exercise capacity in WHO Group I PAH. Fildena 100mg is not appropriate for PAH — the dose, dosing frequency, and clinical monitoring context are entirely different.
• Post-prostatectomy penile rehabilitation (off-label): Multiple completed clinical trials (ClinicalTrials.gov NCT01054001) have evaluated early Sildenafil administration after nerve-sparing radical prostatectomy for erectile tissue preservation — demonstrating the drug’s role in penile rehabilitation following prostate cancer surgery.

Regarding arrow.docx claim about BPH: arrow.docx states Fildena Professional “has a proven record of treating symptoms of benign prostate hyperplasia (BPH).” This is incorrect for Sildenafil. BPH is an approved indication for Tadalafil (Cialis, 5mg daily) — not Sildenafil. Fildena 100mg should not be taken for BPH symptoms.

Dosage and Administration of Fildena 100mg

Sildenafil dosage for ED is adjusted based on clinical response, tolerability, and co-medications. The DailyMed prescribing label establishes the following framework:

 

Patient / Dosage Scenario	Recommended Sildenafil Dose
Standard starting dose	50 mg orally, as needed, ~1 hour before sexual activity
Dose range	25 mg to 100 mg; adjusted based on response and tolerance
Maximum dose	100 mg per 24-hour period (FDA-approved ceiling)
Patients on ritonavir	Max 25 mg per 48-hour period (ritonavir increases sildenafil 11-fold)
Strong CYP3A4 inhibitors (ketoconazole, itraconazole, saquinavir, erythromycin)	Consider starting at 25 mg
Elderly patients (≥65 years)	Consider starting at 25 mg — reduced sildenafil clearance
Severe renal impairment (CrCl <30 mL/min)	Consider starting at 25 mg
Hepatic impairment	Consider starting at 25 mg — reduced CYP3A4 metabolism
Timing window	30 minutes to 4 hours before sexual activity
Frequency	Once per 24 hours maximum

How to Take Fildena 100mg

• Take one tablet only with a full glass of water, as needed, approximately 30 minutes to 1 hour before planned sexual activity
• May be taken up to 4 hours before sexual activity; the clinical effect window extends to 4–6 hours
• Take on an empty stomach or after a light, low-fat meal for fastest and most consistent onset. High-fat meals delay peak plasma concentration by ~60 minutes
• Do not take more than one 100mg tablet in any 24-hour period
• Swallow the tablet whole with water. Do not crush, chew, or break it
• Sexual stimulation is required for Fildena 100mg to be effective
• Do not combine with other PDE5 inhibitors (Tadalafil, Vardenafil) or other ED treatments without medical guidance

Missed Dose

Fildena 100mg is taken on an as-needed basis before anticipated sexual activity. There is no regular daily dosing schedule — therefore no concept of a missed dose. If you did not take the medication before intercourse, do not take a compensatory dose after the fact.

Overdose

Taking more than 100mg in a 24-hour period constitutes an overdose of Sildenafil. Symptoms may include severe headache, intense flushing, severe dizziness, hypotension, chest pain, priapism, and sudden vision changes. DailyMed clinical data from high-dose exposure studies (200–800mg in healthy volunteers) documented decreased blood pressure, syncope, and prolonged erection.

In the event of an overdose: discontinue immediately and seek emergency medical care. Priapism — erection lasting more than 4 hours — is a urological emergency. The DailyMed label states: “if priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.” Seek emergency treatment without delay.

Side Effects of Fildena 100mg

The side effect profile of Fildena 100mg is derived from the well-documented pharmacological profile of Sildenafil Citrate established across 67 double-blind placebo-controlled trials (>14,000 men) and a post-marketing safety database of 39,277 patients (Hatzimouratidis et al., PMC/BJU International, 2010). The DailyMed Sildenafil Citrate prescribing labels list adverse reactions occurring in clinical trials.

Common Side Effects

• Headache — most frequently reported; related to cerebral vasodilation via cGMP pathway
• Flushing — facial and neck warmth and redness from peripheral vasodilation
• Nasal congestion (rhinitis)
• Dyspepsia — indigestion or heartburn
• Dizziness or lightheadedness
• Back pain and myalgia — muscle pain
• Nausea
• Vision changes — blurred vision, blue-green colour tinge (PDE6 cross-inhibition), increased light sensitivity
• Epistaxis — nosebleed

Serious Side Effects — Seek Emergency Medical Attention

• Priapism: Prolonged painful erection lasting more than 4 hours (emergency at >6 hours per DailyMed label). Urological emergency — penile tissue damage and permanent loss of erectile function if untreated. Seek emergency care immediately.
• NAION (Non-Arteritic Anterior Ischaemic Optic Neuropathy): Rare but serious — sudden vision decrease or loss in one or both eyes, reported post-marketing in temporal association with PDE5 inhibitors including Sildenafil. Documented in the DailyMed label. Risk factors include low cup-to-disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidaemia, and smoking. Discontinue immediately and seek emergency ophthalmological care.
• Sudden hearing loss: Post-marketing reports of sudden decrease or loss of hearing, possibly with tinnitus or vertigo — mandated warning in all Sildenafil DailyMed prescribing labels. Seek immediate medical care.
• Severe hypotension: Particularly dangerous when combined with nitrates, alpha-blockers, alcohol, or antihypertensives. Presents as severe dizziness, fainting, or collapse.
• Chest pain or cardiac events: Sexual activity carries inherent cardiac risk in men with pre-existing cardiovascular disease. Seek emergency evaluation if chest pain occurs during or after intercourse.
• Haematuria: Blood in urine — documented in DailyMed urogenital adverse reactions list; requires medical evaluation.

Discontinue Fildena 100mg and contact emergency services immediately if any serious adverse effects occur. Report adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Sildenafil’s interaction profile is determined primarily by its vasodilatory properties and its hepatic metabolism via CYP3A4 and P-glycoprotein (ABCB1) transporter substrate status. Multiple DailyMed Sildenafil Citrate prescribing labels and the PMC clinical review consistently document the following interactions:

 

Drug / Substance	Clinical Action	Mechanism / Risk
Nitrates (ALL forms)	ABSOLUTE CONTRAINDICATION	Potentially fatal BP drop via dual NO/cGMP pathway activation
Recreational nitrites (“poppers”)	ABSOLUTE CONTRAINDICATION	Same mechanism as organic nitrates — absolutely contraindicated
Riociguat (Adempas)	ABSOLUTE CONTRAINDICATION	Additive hypotension; co-use explicitly contraindicated in FDA label
Ritonavir	Max 25 mg per 48 hours	11-fold increase in sildenafil AUC via CYP3A4 inhibition
Ketoconazole / Itraconazole / Saquinavir	Consider 25 mg starting dose	Strong CYP3A4 inhibitors; substantially elevate sildenafil exposure
Erythromycin	Consider 25 mg starting dose	Moderate CYP3A4 inhibitor; 160% Cmax / 182% AUC increase
Alpha-blockers (doxazosin, tamsulosin)	Start at 25 mg; patient must be stable first	Additional BP reduction of 7–9 mmHg systolic documented in label
Antihypertensive medications	Monitor blood pressure	Additive vasodilation; hypotension risk
Other PDE5 inhibitors	Do not combine	Unstudied; additive hypotension risk
CYP3A4 inducers (rifampicin, phenytoin)	May reduce efficacy	Accelerated sildenafil metabolism; lower plasma levels
Grapefruit / grapefruit juice	Avoid entirely	Inhibits intestinal CYP3A4; unpredictable sildenafil level rise
Alcohol (heavy use)	Avoid / minimise	Additive vasodilation; hypotension, dizziness, impaired erection quality

Critical Interactions — Detail

Nitrates — ABSOLUTE CONTRAINDICATION: The most clinically significant and potentially fatal drug interaction with Fildena 100mg. Both nitrates and Sildenafil act on the NO/cGMP pathway — their combination causes a sudden, severe, potentially fatal drop in blood pressure. The DailyMed label states: “Administration of sildenafil citrate tablets with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated.” This includes nitroglycerin (GTN), isosorbide dinitrate, isosorbide mononitrate, and recreational “poppers” (amyl/butyl nitrate).

Ritonavir — 11-fold Sildenafil AUC increase: Ritonavir (HIV protease inhibitor and strong CYP3A4 inhibitor) raises Sildenafil systemic exposure by approximately 11-fold (1100%)

Alpha-Blockers — documented BP reduction: The DailyMed label documents specific data from drug-drug interaction studies: simultaneous administration of Sildenafil (25mg, 50mg, or 100mg) with doxazosin (4mg or 8mg) in BPH patients produced mean additional reductions in supine systolic/diastolic BP of 7/7, 9/5, and 8/4 mmHg at the respective doses. Patients must be stable on alpha-blocker therapy before Sildenafil is initiated, and Fildena 100mg should start at 25mg in this population.

Precautions and Warnings

Fildena 100mg carries critical safety precautions and absolute contraindications established through clinical evidence and the DailyMed Sildenafil Citrate prescribing labels.

Absolute Contraindications — Do NOT Take Fildena 100mg If:

• You take nitrates or nitric oxide donors in any form — risk of potentially fatal hypotension; absolutely contraindicated in DailyMed label
• You take riociguat (Adempas) — additive hypotension; explicitly contraindicated
• Known hypersensitivity to Sildenafil or any tablet component — anaphylaxis, anaphylactic shock, rash, and urticaria have been reported
• You are a woman or under 18 years of age — not indicated for these populations
• Sexual activity is medically inadvisable due to cardiovascular status

Cardiovascular Safety

Sildenafil produces mild, transient vasodilation and blood pressure decreases. Fildena 100mg should be used with extreme caution or avoided entirely in patients with:

• Recent myocardial infarction (within 90 days) or stroke (within 6 months)
• Unstable angina or angina occurring during sexual intercourse
• Resting hypotension (BP <90/50 mmHg) or uncontrolled hypertension (BP >170/110 mmHg)
• Severe cardiac failure, life-threatening arrhythmia within 6 months, or coronary artery disease causing unstable angina
• Left ventricular hypertrophy or mitral valve prolapse history with cardiovascular symptoms — Sildenafil not recommended per DailyMed label

Vision and Hearing Warnings

• NAION: Patients with history of NAION in one eye, or with anatomic risk factors (crowded optic disc, age >50, diabetes, hypertension, coronary artery disease, hyperlipidaemia, smoking), are at elevated risk. The DailyMed label states: “Physicians should advise patients to stop use of all PDE5 inhibitors and seek medical attention in the event of a sudden loss of vision.” Discontinue Fildena 100mg immediately and seek emergency ophthalmological care.
• Sudden hearing loss: Stop Fildena 100mg and seek prompt medical attention if sudden hearing decrease or loss occurs. This is an FDA-mandated warning across all Sildenafil DailyMed prescribing labels.
• Retinitis pigmentosa: Patients with this genetic retinal disorder may have elevated sensitivity to PDE6 inhibitory effects. Use under specialist ophthalmological guidance.

Priapism Risk — Conditions Requiring Special Caution

Fildena 100mg should be used with caution in patients with:

• Peyronie’s disease (penile anatomical deformity including cavernosal fibrosis or angulation)
• Sickle cell anaemia, multiple myeloma, or leukaemia — all predispose to priapism per the DailyMed label

If priapism occurs (painful erection >4 hours), seek emergency treatment immediately. The DailyMed label warns that erection >6 hours without treatment causes permanent penile tissue damage and permanent loss of erectile function

Liver Disease

Hepatic impairment reduces CYP3A4-mediated Sildenafil metabolism, increasing drug accumulation. The DailyMed label recommends considering a starting dose of 25mg in patients with hepatic impairment. Regular liver function monitoring is advisable during therapy.

Kidney Disease

Severe renal impairment (creatinine clearance <30 mL/min) reduces metabolite clearance, increasing Sildenafil plasma exposure. The DailyMed label recommends considering a starting dose of 25mg in severe renal impairment. Fildena 100mg should be titrated up from lower doses in this population under medical supervision.

Elderly Patients (≥65 Years)

Reduced hepatic and renal Sildenafil clearance in older men leads to higher plasma concentrations. The DailyMed label recommends considering a starting dose of 25mg in geriatric patients. The PMC safety review (67 trials) confirmed Sildenafil 50 and 100mg were well tolerated in men aged ≥65 and ≥75, but dose titration from lower strengths is advisable.

Bleeding Disorders and Active Peptic Ulcer

Safety of Sildenafil has not been established in patients with bleeding disorders or active peptic ulceration — use with caution per the DailyMed label.

Driving and Machinery

Fildena 100mg may cause dizziness, blurred vision, and colour vision disturbances. Patients should not drive or operate heavy machinery if these effects occur until the individual response has been assessed.

Alcohol

Heavy alcohol use with Fildena 100mg is not advisable. Both cause vasodilation — their combination amplifies hypotension risk and may impair erectile quality. Moderate intake (1–2 units) may be acceptable; discuss with your healthcare provider.

Fildena 100mg vs. Viagra — How Do They Compare?

Factor	Fildena 100mg (Fortune Healthcare)	Viagra 100mg (Pfizer)
Active ingredient	Sildenafil Citrate 100mg	Sildenafil Citrate 100mg
Manufacturer	Fortune Healthcare Pvt. Ltd., India	Pfizer Inc., USA
Regulatory status	Generic; not independently FDA-reviewed	FDA-approved (NDA 20-895, March 27, 1998)
Mechanism of action	Identical — PDE5 inhibitor	Identical — PDE5 inhibitor
Standard dose	100 mg as needed	50–100 mg as needed
Tablet colour / shape	Purple, triangular (“purple pill”)	Blue, diamond-shaped (“blue pill”)
Typical cost	Substantially lower (generic)	Higher (branded originator)
Duration	4–6 hours	4–6 hours

 

Clinical equivalence: Fildena 100mg and Viagra 100mg share the identical active molecule (Sildenafil Citrate 100mg) and mechanism of action through PDE5 inhibition. Generic Sildenafil tablets approved in regulated markets must demonstrate bioequivalence to Viagra. The primary differences are manufacturer, regulatory history, inactive ingredients, and price. These differences do not affect Sildenafil’s pharmacological action in the body.

Fildena Range — Available Strengths and Formulations

Fortune Healthcare produces the complete Fildena range to accommodate varying patient needs and dosing requirements:

• Fildena 25mg, 50mg — standard starting doses per FDA dosing framework
• Fildena 100mg — maximum FDA-approved single dose; most commonly prescribed strength
• Fildena 120mg, 150mg, 200mg (Double) — high-strength formulations exceeding the FDA-approved 100mg maximum; require strict medical supervision
• Fildena Professional 100mg — sublingual tablet; placed under the tongue for faster absorption (~15 minutes onset); same Sildenafil 100mg active ingredient
• Fildena CT 50mg — chewable tablet for patients who prefer not to swallow standard tablets
• Fildena XXX 100mg — fruit-flavoured tablet; same active ingredient
• Super Fildena — combination tablet: Sildenafil 100mg + Dapoxetine 60mg; for men with both ED and premature ejaculation; requires specialist assessment

Note: Fildena formulations above 100mg (120mg, 150mg, 200mg) exceed the FDA-approved maximum single dose for Sildenafil. They should only be considered under direct medical supervision when the 100mg dose has proven insufficient, following careful cardiovascular risk assessment.

Storage Instructions

• Store Fildena 100mg tablets at room temperature, 20–25°C (68–77°F), away from direct sunlight, moisture, and heat
• Keep in the original sealed packaging, away from bathroom and kitchen environments with high humidity
• Store out of reach of children and pets at all times
• Check the expiry date before each use. Do not take expired tablets
• Dispose of unused or expired medication through a medicine take-back programme — do not flush or discard in household waste

Frequently Asked Questions (FAQs)

What is Fildena 100mg used for?

Fildena 100mg is prescribed for the treatment of erectile dysfunction in adult men — specifically when the standard 50mg starting dose has proven insufficient. It is not indicated for women, children, pulmonary hypertension at this dose, or for BPH.

Is Fildena 100mg the same as Viagra?

Both contain Sildenafil Citrate 100mg as the active ingredient and work through identical PDE5 inhibitor mechanisms. Viagra is the FDA-approved branded originator (Pfizer); Fildena is a generic formulation (Fortune Healthcare). The pharmacological action is the same; the differences are manufacturer, regulatory status, inactive ingredients, and price.

How long does Fildena 100mg take to work?

Fildena 100mg typically begins working within 30–60 minutes on an empty stomach. After a high-fat meal, onset may be delayed by ~60 minutes. The tablet may be taken up to 4 hours before sexual activity.

How long does Fildena 100mg last?

The clinical effects of Fildena 100mg typically last 4 to 6 hours. This is the window during which sexual stimulation can produce an erection — not a continuous erection for this duration. Individual factors including age, metabolism, food intake, and co-medications affect duration.

Can I take Fildena 100mg daily?

Fildena 100mg is taken on an as-needed basis, not more than once per 24 hours. Daily use is not recommended at 100mg unless specifically evaluated and prescribed by a healthcare provider for a clinical reason. Daily Sildenafil therapy is an off-label use and requires medical supervision.

What should I do if Fildena 100mg doesn’t work?

If Fildena 100mg does not produce the desired results, consult your healthcare provider before making any changes. Multiple factors can affect efficacy: insufficient sexual stimulation, psychological factors, underlying health conditions, food intake, or co-medications. Your doctor may adjust the dosage, change timing, recommend a different PDE5 inhibitor (Tadalafil, Vardenafil), or evaluate for underlying causes of treatment-resistant ED.

Can I take Fildena 100mg with food?

Yes, but with caution regarding meal type. High-fat meals delay peak Sildenafil absorption by approximately 60 minutes and reduce peak plasma concentration. For fastest and most consistent onset, take on an empty stomach or after a light low-fat meal. Avoid grapefruit and grapefruit juice entirely.

What is the difference between Fildena Professional and Fildena 100mg?

Both contain Sildenafil Citrate 100mg. Fildena Professional is a sublingual tablet — it dissolves under the tongue rather than being swallowed, allowing direct mucosal absorption and a faster onset of approximately 15 minutes versus 30–60 minutes for the standard tablet. The systemic pharmacological effects, safety profile, and contraindications are the same for both formulations.

Is Fildena 100mg safe for men with heart disease?

Not without medical evaluation. Fildena 100mg’s vasodilatory properties, combined with the inherent cardiac demand of sexual activity, create cardiovascular risk in patients with pre-existing heart disease. Men with recent myocardial infarction, stroke, unstable angina, severe cardiac failure, uncontrolled hypertension, or hypotension should not take Fildena 100mg without thorough cardiovascular assessment by a qualified healthcare provider.

What if I experience vision or hearing changes while taking Fildena 100mg?

Stop taking Fildena 100mg immediately and seek emergency medical care. The DailyMed prescribing label mandates that patients stop all PDE5 inhibitors and seek medical attention for sudden vision loss (NAION) or sudden hearing loss. These are rare but serious adverse effects requiring immediate evaluation.

Medical Disclaimer

All information in this guide is provided for educational purposes only. It does not constitute medical advice, diagnosis, or treatment. Fildena 100mg is a prescription medication that should only be obtained and used under the supervision of a licensed healthcare provider. Never self-medicate or adjust your dose without medical guidance. In an emergency, contact local emergency services immediately. Report adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References

• DailyMed / U.S. National Library of Medicine. Sildenafil Citrate Tablets — Full Prescribing Information (multiple manufacturer versions; NAION warning, priapism >6 hours, nitrate contraindication, ritonavir max 25mg/48h, alpha-blocker BP reduction data, haematuria). https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98a9897b-0cbc-4ea6-9ac2-4dd719a2ede0
• DailyMed / U.S. National Library of Medicine. Sildenafil Citrate Consumer Label — “patients should seek emergency treatment if erection lasts >4 hours”; NAION, sudden hearing loss warnings; nitrate absolute contraindication. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d35f8d6b-e642-78bb-e053-2995a90abb2e&audience=consumer
• Hatzimouratidis K, et al. (2010). Safety of sildenafil citrate: review of 67 double-blind placebo-controlled trials (>14,000 men) and post-marketing safety database (39,277 patients) — no causal link to cardiovascular events, priapism, NAION, or hearing loss at approved doses; 50 and 100mg well tolerated including in men aged ≥65 and ≥75. BJU International / PMC. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2810448/
• Drugs.com. (Updated February 2026). Sildenafil: Usage, Dosage, Side Effects & Warnings. https://www.drugs.com/sildenafil.html
• Drugs.com Dosage Guide. (Updated December 2025). Sildenafil Dosage Guide + Max Dose, Adjustments — 50mg standard; 100mg maximum; 25mg for elderly, hepatic impairment, renal impairment, ritonavir co-administration. https://www.drugs.com/dosage/sildenafil.html
• Dhaliwal A, Gupta M. (Updated February 2023). Sildenafil — StatPearls. National Center for Biotechnology Information, NIH. https://www.ncbi.nlm.nih.gov/books/NBK558978/
• GoodRxMedicine. (March 2026). Fildena 100 mg: Uses, Benefits, and Safety — WHO-GMP certified Fortune Healthcare manufacturing; 70–85%+ efficacy rates. https://www.goodrxmedicine.com/fildena-100-mg-sildenafil-tablets.html
• John R. Curran MD. (Updated March 2026). Fildena (Sildenafil) Dosage, Price and Safety Guide — Fildena vs Viagra comparison, bioequivalence, generic pharmacology. https://johncurranmd.com/fildena-an-in-depth-look/
• ClinicalTrials.gov. (NCT01054001, Seoul National University). Early Start of Oral Sildenafil 100mg for ED After Nerve-Sparing Radical Prostatectomy (SILRALP trial) — post-prostatectomy penile rehabilitation use. https://clinicaltrials.gov/study/NCT01054001