Avanafil: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: January 6, 2026🚩 Report this page

Avanafil

Drugs Used In Erectile Dysfunction

Sold as Spedra

GB MHRAEU EMA

Drug class: Drugs Used In Erectile Dysfunction
Availability: See label
Markets covered: 2
Products on record: 4

Overview

Avanafil is an active pharmaceutical ingredient in the Drugs Used In Erectile Dysfunction group (G04BE). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	3	October 4, 2024
EU European Union	EMA	1	January 6, 2026

GBUnited Kingdom· MHRA

3 products

Uses

GBOfficial regulatory label· revised October 4, 2024[1]

Treatment of erectile dysfunction in adult men. In order for Spedra to be effective, sexual stimulation is required.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised January 6, 2026[2]

Treatment of erectile dysfunction in adult men. In order for Spedra to be effective, sexual stimulation is required.

How to take

Drug interactions

Known interactions involving Avanafil. Select one for details. This list is informational and not a complete interaction checker.

Amprenavir Amyl Nitrite Aprepitant Atazanavir Berotralstat Boceprevir Ceritinib Ciprofloxacin Clarithromycin Cobicistat Conivaptan Crizotinib Dalfopristin Darunavir Delavirdine Diltiazem Dronedarone Duvelisib Erythromycin Fedratinib Fluconazole Fosamprenavir Fosaprepitant Idelalisib Imatinib Indinavir Isavuconazonium Isosorbide Isosorbide Dinitrate Itraconazole Ketoconazole Letermovir Lonafarnib Mifepristone Nefazodone Nelfinavir Netupitant Nitroglycerin Nitroprusside Posaconazole Ribociclib Riociguat Ritonavir Saquinavir Stiripentol Telaprevir Telithromycin Troleandomycin Tucatinib Verapamil Voriconazole Abametapir Acebutolol Acetazolamide Alfuzosin Aliskiren Alprostadil Ambrisentan Amiloride Aminoglutethimide Amlodipine Amobarbital Apalutamide Apraclonidine Atenolol Azilsartan Benazepril Bendroflumethiazide Benzthiazide Bepridil Betaxolol Bexarotene Bisoprolol Bosentan Brimonidine Bumetanide Butabarbital Butalbital Canagliflozin Captopril Carbamazepine Carteolol Carvedilol Cenobamate Chlorothiazide Chlorthalidone Clevidipine Clonidine Cyclandelate Dabrafenib Dapagliflozin Deferasirox Deserpidine Dexamethasone Diazoxide Doxazosin Efavirenz Elagolix Empagliflozin Enalapril Enzalutamide Eplerenone Epoprostenol Eprosartan Ertugliflozin Eslicarbazepine Esmolol Ethacrynate Ethanol Etravirine Felbamate Felodipine Fenoldopam Fosinopril Fosphenytoin Fostamatinib Furosemide Griseofulvin Guanabenz Guanadrel Guanethidine Guanfacine Hydralazine Hydrochlorothiazide Hydroflumethiazide Iloprost Indapamide Irbesartan Isocarboxazid Isoxsuprine Isradipine Ivosidenib Labetalol Larotrectinib Lefamulin Lemborexant Lesinurad Levamlodipine Linezolid Lisinopril Lofexidine Lorcaserin Lorlatinib Losartan Lumacaftor Mecamylamine Mephobarbital Methazolamide Methyldopa Metolazone Metoprolol Minoxidil Mitotane Moexipril Nadolol Nafcillin Nebivolol Nesiritide Nevirapine Nicardipine Nifedipine Nimodipine Nisoldipine Olmesartan Oxcarbazepine Ozanimod Papaverine Penbutolol Pentobarbital Pentoxifylline Perindopril Pexidartinib Phenelzine Phenobarbital Phenoxybenzamine Phentolamine Phenylbutazone Phenytoin Pindolol Polythiazide Prazosin Primidone Procarbazine Propranolol Quinapril Ramipril Rasagiline Reserpine Rifabutin Rifampin Rifapentine Rucaparib Rufinamide Safinamide Secobarbital Selegiline Selpercatinib Silodosin Simeprevir Somapacitan Somatrem Somatropin Sotalol Spironolactone Sulfinpyrazone Tamsulosin Tazemetostat Telmisartan Telotristat Ethyl Terazosin Timolol Tolazoline Torsemide Trandolapril Tranylcypromine Treprostinil Triamterene Trichlormethiazide Trimethaphan Troglitazone Valsartan Vemurafenib Voxelotor Armodafinil Modafinil

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PLGB162390058 · revised October 4, 2024
[2]European Medicines Agency · EMEA/H/C/002581 · revised January 6, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised October 4, 2024[1]

Summary of the safety profile The safety profile of Spedra is based on 2,566 subjects exposed to avanafil during the clinical development program. The most common adverse reactions reported in clinical studies were headache, flushing, nasal and sinus congestion and back pain.
Overall adverse events and adverse reactions for avanafil-treated subjects were more frequent in subjects with a Body Mass Index (BMI) <25 (normal BMI subjects). In the long term clinical study, the percentage of patients who experienced adverse reactions decreased with increasing length of exposure.
Tabulated list of adverse reactions The table below lists the adverse reactions observed in placebo-controlled clinical trials according to the MedDRA frequency convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Adverse reaction (MedDRA Preferred Term) System Organ Class Common Uncommon Rare Infections and infestations Influenza Nasopharyngitis Immune system disorders Seasonal allergy Metabolism and nutrition disorders Gout Psychiatric disorders Insomnia Premature ejaculation Inappropriate affect Nervous system disorders Headache Dizziness Somnolence Sinus headache Psychomotor hyperactivity Eye disorders Vision blurred Cardiac disorders Palpitations Angina pectoris Tachycardia Vascular disorders Flushing Hot flush Hypertension Respiratory, thoracic and mediastinal disorders Nasal congestion Sinus congestion Dyspnoea exertional Rhinorrhoea Upper respiratory tract congestion Epistaxis Gastrointestinal disorders Dyspepsia Nausea Vomiting Stomach discomfort Dry mouth Gastritis Abdominal pain lower Diarrhoea Skin and subcutaneous tissue disorders Rash Musculoskeletal and connective tissue disorders Back pain Muscle tightness Flank pain Myalgia Muscle spasms Renal and urinary disorders Pollakiuria Reproductive system and breast disorders Penis disorder Spontaneous penile erection Pruritus genital General disorders and administration site conditions Fatigue Asthenia Chest pain Influenza like illness Oedema peripheral Investigations Hepatic enzyme increased Electrocardiogram abnormal Heart rate increased Blood pressure increased Blood urine present Cardiac murmur Prostate specific antigen increased Weight increased Blood bilirubin increased Blood creatinine increased Body temperature increased Description of selected adverse reactions observed with other PDE5 inhibitors Non-arteritic anterior ischaemic optic neuropathy (NAION) and sudden loss of hearing have been reported in a small number of postmarketing and clinical trial cases with other PDE5 inhibitors.
4). Priapism has been reported in a small number of post-marketing and clinical trial cases with other PDE5 inhibitors. No cases were reported during clinical trials of avanafil. Haematuria, haematospermia and penile haemorrhage has been reported in a small number of post-marketing and clinical trial cases with other PDE5 inhibitors.
5). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised October 4, 2024[1]

A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered. 3). 3). g. aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators, including PDE5 inhibitors.
Priapism Patients who experience erections lasting 4 hours or more (priapism) should be instructed to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
Avanafil should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Visual problems Visual defects, including Central Serous Chorioretinopathy (CSCR) and cases of non- arteritic anterior ischaemic optic neuropathy (NAION) have been reported in connection with the intake of PDE5 inhibitors. 3). Effect on bleeding In vitro studies with human platelets indicate that PDE5 inhibitors do not have an effect on platelet aggregation on their own, but at supratherapeutic doses they potentiate the anti-aggregatory effect of the nitric oxide donor sodium nitroprusside.
In humans, PDE5 inhibitors do not appear to affect bleeding time alone or in combination with acetylsalicylic acid. There is no safety information on the administration of avanafil to patients with bleeding disorders or active peptic ulceration.
Therefore, avanafil should be administered to such patients only after careful benefit-risk assessment. Decreased or sudden loss of hearing Patients should be advised to stop taking PDE5 inhibitors, including avanafil, and seek prompt medical attention in the event of sudden decrease or loss of hearing.
These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors.
5). Consideration should be given to the following: • Patients should be stable on alpha-blocker therapy prior to initiating Spedra. Patients who demonstrate haemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of avanafil.

This is not medical advice. Consult a qualified healthcare professional.