Spedra 100mg Side Effects: What is Common, What is Serious, and How to Reduce Them

Most reported side effects of Spedra are mild to moderate and short lived. Many are temporary, although the duration can vary. The NICE evidence summary states that "the majority of adverse events seen in clinical studies were mild-moderate in severity", and that "all drug-related adverse events were reported to be mild to moderate in severity".

The three most common are headache, flushing, and nasal and sinus congestion, each with an incidence between 1 in 10 and 1 in 100. They share one cause: avanafil widens blood vessels, and not only the ones you want it to.

Serious side effects exist and are rare, but two need urgent attention rather than a wait and see approach. Both are covered below, along with the situations in which Spedra must not be taken at all.

Do not combine Spedra with another ED medicine unless specifically instructed by a specialist. Combining PDE5 inhibitors or other ED treatments can increase the risk of adverse effects, including low blood pressure and prolonged erections, and the safety of such combinations has not been established.

Key things to know

• The most common side effects are headache, flushing, and nasal and sinus congestion, each between 1 in 10 and 1 in 100.
• NICE states the majority of adverse events in trials were mild to moderate, and that no treatment-related serious adverse events were seen in the three main trials.
• In the 52 week study, adverse events became less frequent the longer men took it.
• Dizziness, drowsiness and altered vision were reported between 1 in 100 and 1 in 1000. NICE advises knowing how you react before driving or using machines.
• Nitrates are an absolute contraindication. So are certain heart, liver, kidney and eye conditions, with specific thresholds.
• Never combine two erectile dysfunction medicines. NICE lists other ED treatments among the things requiring special warnings.
• An erection lasting more than four hours, or sudden vision or hearing loss, needs urgent medical attention.

Spedra 100mg side effects: the full picture

Avanafil is a PDE5 inhibitor, and avanafil 100mg side effects follow directly from how it works. It relaxes blood vessels so more blood can reach the erectile tissue, and blood vessels elsewhere relax too. That one mechanism explains almost the whole list: headache, flushing and a blocked nose are all vessels widening in places you did not intend.

Spedra 100mg common side effects, and how common they actually are

The NICE evidence summary gives frequency bands rather than a vague warning.

Those bands deserve reading properly. "Between 1 in 10 and 1 in 100" means common but not typical. Most men taking Spedra will not get a headache, a meaningful minority will.

Spedra side effects headache: does Spedra cause headaches?

It can, and headache is the most frequently reported side effect, with an incidence between 1 in 10 and 1 in 100.

The reason is the mechanism that makes the medicine work. Headache is thought to be related to the effects of PDE5 inhibition on blood vessels, although the exact mechanism of an individual headache is not always clear. It is often temporary, although the duration varies between people. A headache that is severe, unusual for you, or accompanied by visual changes is different, and belongs in the red flag list.

Spedra side effects flushing: why it happens

Flushing is warmth and reddening, usually of the face and neck, and sits in the same 1 in 10 to 1 in 100 band as headache. Flushing is usually mild and temporary, but severe or persistent symptoms should be discussed with a healthcare professional. It is consistent with the vasodilating effects of PDE5 inhibition.

Less common side effects, including the driving warning

Three effects sit in the 1 in 100 to 1 in 1000 band and matter more than their frequency suggests.

NICE states that "men should be aware of how they react to avanafil before driving or using machines because dizziness, somnolence and altered vision were reported in clinical studies with avanafil (incidence between 1 in 100 and 1 in 1000)".

Somnolence means drowsiness. The point is not that these are common, but that finding out how you react while driving is the wrong time to find out.

Other events reported across the trials included nasopharyngitis, inflammation of the nose and throat, along with sinusitis, dyspepsia and influenza. Those appeared in trial reporting but were not all attributed to the medicine.

How often do side effects actually happen?

More precisely than most pages state, because NICE publishes the trial rates with the placebo comparison.

Three things are worth pulling out.

The placebo column matters. Around a quarter of men taking a dummy tablet also reported an adverse event, so the difference between columns is what avanafil actually contributed, and it is smaller than the headline number suggests.

Discontinuation because of adverse events was uncommon. In the general population trial the discontinuation rate on avanafil overlapped with the rate on placebo. In the diabetes trial it was 0.1%, four men in total.

No treatment-related serious adverse events were seen in the general population or prostate surgery trials, and in the diabetes and long term studies NICE records that none of the serious adverse events reported were considered treatment related.

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Spedra 100mg how long do side effects last?

There is no single duration that applies to every Spedra side effect. NICE does not provide a separate duration figure for adverse effects, and how long a symptom lasts can vary between people.

Many of the commonly reported effects, such as headache, flushing and nasal congestion, are temporary. If a side effect is severe, persistent, or continues after you would normally expect the medicine's effects to have worn off, contact your prescriber rather than taking another dose.

An erection lasting four hours or more is different and requires urgent medical attention because prolonged erections can damage erectile tissue.

NICE publishes no separate duration figure for avanafil side effects, so this page does not invent one.

Spedra contains the active ingredient avanafil, a PDE5 inhibitor that works by increasing blood flow to the corpora cavernosa during sexual stimulation. It is important to take Spedra on an empty stomach or after a light meal, as a large meal can delay its onset. Avoid drinking grapefruit juice while using Spedra, as it can interfere with the metabolism of the medication and increase the risk of side effects.

Spedra is available in tablet form in doses of 50mg, 100mg, and 200mg.

Because Spedra affects blood flow and blood pressure, it should not be used by individuals taking nitrate medicines or amyl nitrate recreational drugs, as this can cause a dangerous drop in blood pressure. It is also contraindicated for people with certain medical conditions such as recent myocardial infarction, unstable angina, or severe cardiovascular disease.

If you experience blurred vision or sudden decrease in vision, dizziness, or facial flushing, contact your doctor immediately. These symptoms may indicate significant side effects affecting the nervous system or eyes sudden decrease in function.

Always inform your doctor straight away if you are using other medications, including those to treat high blood pressure or Peyronie's disease, as Spedra may interact with other drugs, requiring dose adjustments or avoidance.

For further information, consult your healthcare provider or the patient information leaflet supplied with your medication.

Spedra 100mg long term side effects

The long term data is more reassuring than most people expect, and contains one counterintuitive finding.

NICE describes a 52 week open label extension study in 711 men. In it, 38.7% reported an adverse event of any kind, and in 11.1% of men these were considered drug related. The most frequently reported events, seen in at least 2% of men, were headache, flushing, nasopharyngitis and nasal congestion, the same short list as in the shorter trials. Two findings matter most.

Side effects became less frequent over time, not more. NICE states that "in the long-term clinical study, the percentage of men who experienced adverse events decreased with increasing length of exposure". That is the opposite of what most people assume about a medicine taken over a year.

Discontinuation because of adverse events was 2.8% across 52 weeks.

NICE also records that none of the serious adverse events in the extension study were considered treatment related, and concludes that "the overall safety profile of avanafil appears to be similar to that of other PDE5 inhibitors and no new safety concerns have been raised".

In this particular 52-week study, the proportion of men reporting adverse events decreased as exposure continued.

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Is Spedra safe? The serious risks

For people who have been assessed as suitable, the clinical trial data provide a generally reassuring safety profile, although serious adverse reactions can occur and certain conditions and medicines make avanafil unsuitable.

The Spedra 100mg warnings NICE publishes are specific. It lists the special warnings and precautions for avanafil as cardiovascular disease, priapism, and visual, bleeding and hearing disorders.

Priapism

An erection lasting more than four hours, known as priapism, is a medical emergency and needs immediate attention whether or not it is painful. Do not wait to see whether it resolves: prolonged erections can damage the tissue permanently, and the window in which that is avoidable is measured in hours.

This risk is not unique to avanafil. It is a recognised warning across the whole PDE5 inhibitor class, and one of the strongest arguments for taking these medicines only under prescriber supervision.

Spedra works by enhancing erectile function through increased blood flow during stimulation, but misuse or combining with other ED medication can increase the risk of priapism and other potential risks.

For men who have undergone nerve sparing radical prostatectomy, Spedra has been shown in clinical trials to be an effective treatment to improve erectile function and maintain erections.

It is important to take the correct dose prescribed by your healthcare provider to minimise side effects and achieve significant improvement.

Never combine Spedra with other ed medication, as these can react immediately, causing dangerously low blood pressure and increasing the risk of adverse effects such as dizziness or blurred vision and sudden decrease in sight.

Always inform your doctor about any other medications you are taking, including those for high blood pressure or Peyronie's disease, as interactions with Spedra can occur, especially with alpha blockers and potent CYP3A4 inhibitors.

Spedra is clinically proven in placebo controlled study settings to be a fast-acting and effective treatment for erectile dysfunction, helping men who are sexually stimulated to maintain erections and improve sexual desire safely.

If you experience any serious side effects, such as sudden decrease in vision or hearing, seek urgent medical advice to manage potential risks properly.

Sudden vision or hearing changes

Sudden loss of vision or sudden loss of hearing after taking any medicine in this group needs urgent medical attention.

These are rare. They are also why avanafil is contraindicated in anyone with a previous history of non-arteritic anterior ischaemic optic neuropathy, a condition affecting the optic nerve, or with known hereditary degenerative retinal disorders. Altered vision as a mild, temporary effect is a separate thing and sits in the 1 in 100 to 1 in 1000 band above. Sudden loss is not that, and the difference is the word sudden.

Spedra contraindications: who should not take Spedra

The following reflects the contraindications listed in the NICE evidence summary. The current product information should be checked for the complete and most up-to-date prescribing information.

That table is why the consultation exists. Most of those items are things you would not necessarily volunteer, and several require a number rather than an impression.

Nitrates deserve their own line. Anyone taking a nitrate such as glyceryl trinitrate or isosorbide mononitrate must not take avanafil. The combination can cause a dangerous fall in blood pressure. No strength makes it acceptable, and never stop a prescribed heart medicine in order to take a treatment for erectile dysfunction.

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Spedra drug interactions

NICE lists the special warnings and precautions as including "concomitant use of alpha-blockers, antihypertensive drugs, alcohol, and other treatments for erectile dysfunction". Each of those four is covered below.

Why you must never take two erectile dysfunction medicines together

This is the most important safety point on the page, and it is the one most often missed.

Never take Spedra alongside another erectile dysfunction medicine. NICE names other treatments for erectile dysfunction among the things requiring special warnings for exactly this reason.

The logic is straightforward. All four first line tablets work the same way, by slowing the same enzyme. Taking two does not combine two mechanisms, it doubles one, which means:

• The blood pressure lowering effect is compounded, not simply added to a different effect.
• The side effect burden increases, because both medicines produce the same vessel widening.
• The priapism risk rises, since the mechanism driving it is the one being doubled.
• There is no evidence base at all, because no trial has studied the combination.

If one tablet has not worked as expected, the answer is a conversation with the prescriber, not taking a different one alongside it or on the same day. Switching between medicines is a clinical decision with a washout consideration, not something to organise yourself.

The same applies to any other erectile dysfunction treatment, including anything bought without a prescription. If you are already taking something, say so at the consultation even if you obtained it elsewhere.

Alpha blockers and blood pressure medicines

Both appear in NICE's special warnings list, and both act on blood pressure, which is where the interaction sits.

Alpha blockers are often prescribed for prostate symptoms or blood pressure. Taken with a PDE5 inhibitor, the combined effect on blood pressure can be greater than either alone, which can cause dizziness or fainting. Anyone taking an alpha blocker must raise it before starting. The same applies to other antihypertensive medicines. This is usually a matter for careful assessment rather than an absolute bar, which is the distinction a prescriber makes and a website cannot.

Medicines that must not be combined

NICE states that co-administration of avanafil with potent inhibitors of a liver enzyme called CYP3A4, such as ketoconazole or clarithromycin, is contraindicated.

CYP3A4 is the enzyme that clears avanafil from the body. Blocking it means the medicine clears more slowly, so more stays in the system, raising the risk of side effects.

The instruction is simple: give the prescriber your complete medicine list, including anything prescribed short term such as a course of antibiotics or antifungals, and anything bought over the counter. An interaction cannot be assessed against an incomplete list.

Spedra and alcohol

Alcohol appears in NICE's special warnings list for avanafil, and there are two separate reasons for that.

Alcohol and avanafil both lower blood pressure. Taken together, that effect can compound, which increases the chance of dizziness, flushing and fainting.

Excessive alcohol can itself make it harder to achieve an erection, so drinking heavily may work against the intended effect. So alcohol works against the outcome while adding to the side effects, which is an unhelpful combination in both directions.

The UK Chief Medical Officers' guidance, published in August 2016, states that "to keep health risks from alcohol to a low level it is safest not to drink more than 14 units a week on a regular basis". That is general health guidance rather than an instruction about this medicine, but it is a sensible reference point.

How to avoid Spedra side effects, and reduce the ones you get

No technique removes side effects, and any page claiming one is overselling. What helps is a short list of practical measures.

• Complete the consultation honestly and completely. Providing a complete medicine list and relevant medical history helps the prescriber identify potential interactions and contraindications.
• Never take more than the prescribed amount in a day. Side effect frequency is dose related, and extra increases risk without improving the outcome.
• Never double up for an occasion that fell short. That is information for the prescriber, not a reason to take another tablet.
• Reduce alcohol around the time you take it, since the effects on blood pressure compound.
• Find out how you react before driving or using machines, following NICE's own advice.
• Report anything persistent to your prescriber. There may be an alternative that suits you better.
• Read the patient information leaflet supplied with your medicine. It contains the complete list, including rare effects this page does not cover.

Report side effects to the MHRA. Suspected side effects from any medicine can be reported through the Yellow Card scheme, which is how safety signals are identified after a medicine reaches the market.

How the safety profile compares with other tablets

NICE answers this directly, and the answer is broadly similar rather than better or worse.

The NICE evidence summary concludes that "the overall safety profile of avanafil appears to be similar to that of other PDE5 inhibitors and no new safety concerns have been raised". Read that alongside the other NICE finding on this class: that "it is not known how avanafil compares to other PDE5 inhibitors", because no double or triple blind multicentre studies compare their efficacy.

So on safety, similar. On effectiveness, not established either way. Anyone ranking these medicines on either axis is comparing figures from separate trials in different populations, never designed to be compared.

Side effects are therefore not a good reason to self-select a different tablet. They are a good reason to have a conversation with your prescriber, who can weigh your reaction against your history and the alternatives. Treatment suitability depends on an individual clinical assessment.

For what avanafil is, how it is taken and what the effectiveness data shows, see our guide to Spedra 100mg, its dosage and how to buy it.

Red flags: when to seek urgent help

Seek urgent medical attention if any of the following happen after taking Spedra:

• An erection lasting more than four hours, whether or not it is painful.
• Sudden loss of vision in one or both eyes.
• Sudden loss of hearing, with or without ringing or dizziness.
• Chest pain, especially during or shortly after exertion.
• Fainting, or dizziness severe enough to make you fall.
• Signs of an allergic reaction, including swelling of the face, lips or throat, or difficulty breathing.
• Severe or unusual headache, particularly if accompanied by neurological or visual symptoms, should be assessed promptly.

Speak to your prescriber, without urgency, if a side effect persists after the medicine should have cleared, if mild side effects consistently spoil the outcome, if you start any new medicine including a short course, or if your blood pressure, heart or kidney health changes.

To find out whether treatment is appropriate for you, you can check your eligibility for erectile dysfunction treatment through an online consultation with UK registered prescribers. EveryDayMeds is a GPhC registered pharmacy, and clinical assessment happens before supply.

Medical Disclaimer

This article is general information and does not replace personalised medical advice. It gives no dosing instructions and should not be used to self diagnose, self prescribe, self medicate, or to start, stop or change any medicine.

The side effect information here is not a complete list. Read the patient information leaflet supplied with your medicine, which is specific to your product and includes rare effects not covered here.

Avanafil is a prescription only medicine. Suitability depends on an individual clinical assessment by an appropriately qualified prescriber, who will consider your medical history, current medicines and cardiovascular health. This medicine should only be used under the supervision of an appropriately qualified prescriber. Results vary between individuals.

Trial figures on this page describe averages across defined study populations and are not predictions for any individual.

Never take more than the prescribed amount of any medicine, never take an extra tablet to make up for one that did not appear to work, and never take two erectile dysfunction medicines together.

If you experience chest pain, an erection lasting more than four hours, sudden vision loss or sudden hearing loss, seek urgent medical attention.

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