Spedra 200mg Side Effects: Common, Serious and How to Reduce Them

• Publishes the full frequency banded side effect list, including the ones most pages leave out
• Gives all eight contraindications NICE states, including the blood pressure limits nobody quotes
• Reports the 52 week safety findings, including how many events were considered drug related
• States plainly why avanafil must never be combined with another erectile dysfunction medicine

The most common Spedra 200mg side effects are headache, flushing, and nasal and sinus congestion, each affecting between 1 in 10 and 1 in 100 people. NICE reports that all drug related adverse events in the main trial were mild to moderate in severity, and that no serious adverse events in any study were considered treatment related.

That is the reassuring part. The part needing equal weight is the list of people who should not take avanafil at all, which is longer than most pages report and includes two blood pressure thresholds almost nobody quotes. There is also one finding that runs against expectation: in the main trial, the 200mg group reported fewer adverse events than the 100mg group.

One thing before any of it. Spedra should not be taken with another erectile dysfunction medicine. The UK product information states that the safety and efficacy of combining avanafil with other PDE5 inhibitors or other erectile dysfunction treatments have not been studied, and patients should be advised not to use them together.

Key things to know

• Common effects are headache, flushing, and nasal and sinus congestion, each between 1 in 10 and 1 in 100.
• Less common are back pain, dizziness, drowsiness and altered vision, each between 1 in 100 and 1 in 1,000.
• NICE states all drug related adverse events in the general population trial were "mild to moderate in severity".
• No serious adverse events in any of the studies were considered treatment related, and no deaths were reported.
• Over 52 weeks, 38.7% of men reported an adverse event, but only 11.1% were considered drug related.
• Eight distinct contraindications apply, including resting blood pressure below 90/50 or above 170/100.
• Do not take it with another erectile dysfunction medicine.
• An erection lasting more than four hours, or sudden vision or hearing loss, needs urgent medical attention.

Spedra 200mg common side effects: the full frequency list

Here is every adverse event NICE reports for avanafil, grouped by how often it occurred. These figures come from clinical studies with 2,144 participants and describe avanafil as a whole rather than one strength.

Spedra 200 mg side effects, spedra 200 side effects and avanafil 200mg side effects all describe this same list. Spedra is the brand, avanafil is the active ingredient, and these side effects are reported across the avanafil clinical studies rather than being specific to one strength.

Most side effect lists stop at the first four. Dizziness, drowsiness and altered vision may affect your ability to drive or operate machinery. If you experience these effects, do not drive or operate machinery until you are no longer affected. Altered vision in particular is worth understanding, and it is not the same thing as the sudden vision loss described further down.

Why these four dominate the list

These common side effects are consistent with the vasodilatory effects of PDE5 inhibition. Because PDE5 inhibitors can affect blood vessels beyond the penile tissues, effects such as headache, flushing and nasal or sinus congestion can occur.

The same class of medicine can therefore produce a similar pattern of adverse effects, although individual responses vary.

That is why the whole class shares a side effect profile rather than each medicine having its own, and why these effects cannot be engineered out.

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Spedra 200mg side effects headache and flushing: what to expect

Headache and flushing are the two most frequently reported effects of avanafil, each occurring in between 1 in 10 and 1 in 100 people, and NICE describes drug related events in the main trial as mild to moderate in severity.

Spedra 200mg side effects headache searches usually mean two questions. Is it normal? Yes, it is the most commonly reported effect of the whole class and a direct consequence of how the medicine works. Is it dangerous? A mild headache is a recognised side effect and is not usually a medical emergency. A severe or unusual headache, particularly with chest pain, fainting or vision changes, needs medical attention. A severe or unusual headache, particularly with chest pain, fainting or vision changes, is different and needs medical attention rather than a painkiller.

Spedra 200mg side effects flushing means a warm, reddened face, neck or chest. It comes from the same vessel widening and NICE places it in the same frequency band as headache.

Alcohol can increase the risk of dizziness and low blood pressure when taken with avanafil, and may also make headache or flushing more troublesome. Speak to your prescriber or pharmacist if either persists or is severe. The answer is often a change of medicine rather than putting up with it.

Food can affect how quickly avanafil is absorbed. Spedra can be taken with or without food, although a high-fat meal can delay its onset. Grapefruit juice should be avoided within 24 hours before taking avanafil because it can increase avanafil exposure.

Spedra contains the active ingredient avanafil, a PDE5 inhibitor used to treat erectile dysfunction. It requires stimulation to work and does not cause an erection automatically.

Tell your prescriber if you have high or low blood pressure, a bleeding disorder, sickle cell disease or multiple myeloma, as these conditions may affect whether avanafil is appropriate for you.

Taking other medications, including those for fungal infections, bacterial infections, or HIV, can interact with Spedra and increase side effects or reduce effectiveness. Always disclose all medicines to your healthcare provider.

Sudden loss or marked deterioration of vision requires urgent medical attention. If you experience persistent or troublesome altered vision, speak to your prescriber. These are among the following serious side effects that require urgent medical treatment.

Do not take more than one dose of Spedra in 24 hours, and do not combine it with another erectile dysfunction medicine unless specifically advised by a healthcare professional.

Spedra 200mg serious side effects: the ones that need urgent action

No serious adverse event in any of the avanafil studies was considered treatment related, and no deaths were reported. There are still four situations that require urgent medical attention if they happen after taking it.

That combination is the honest position. The trials found no treatment related serious events, and rare serious events are still recognised for this class and belong on any safety page.

Seek urgent medical attention if you experience:

• An erection lasting more than four hours, known as priapism, whether or not it is painful. Untreated, it can cause permanent damage to the tissue.
• Sudden loss of vision in one or both eyes. Not the same as the mild altered vision listed above.
• Sudden loss of hearing, with or without ringing in the ears or dizziness.
• Chest pain, especially during or shortly after exertion. If you have taken avanafil, tell the medical team before taking or being given nitrate treatment.

Also seek urgent help for fainting, dizziness severe enough to make you fall, or signs of an allergic reaction including swelling of the face, lips or throat, or difficulty breathing.

Being straightforward with a medical team about what you have taken changes what they can safely give you.

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Why Spedra must never be taken with another ED medicine

Do not take Spedra with another erectile dysfunction medicine. The UK product information states that the safety and efficacy of combining avanafil with other PDE5 inhibitors or other erectile dysfunction treatments have not been studied, and patients should be advised not to use them together.

This is particularly important if you are considering changing from one erectile dysfunction treatment to another. If Spedra is not working as expected or side effects are troublesome, speak to your prescriber rather than adding another medicine yourself.

The product information does not establish a general safe interval for combining Spedra with another PDE5 inhibitor or ED treatment. Any change in treatment should therefore be discussed with the prescriber.

Spedra 200mg vs 100mg side effects: the result nobody expects

In the main trial, the 200mg group reported fewer adverse events than the 100mg group, and had the fewest discontinuations of any group including placebo.

The same pattern appeared in the diabetes trial, where adverse events were reported by 35.4% on 100mg and 32.1% on 200mg.

Two caveats belong with that. It did not hold everywhere: after prostate surgery, adverse events ran at 38.4% on 100mg and 45.5% on 200mg. And these are differences between groups of roughly 160 men, not a demonstrated dose response.

What it does support: side effects with avanafil are not simply proportional to strength. The common assumption that 200mg automatically means double the side effects of 100mg is not what the published data shows. It also does not mean 200mg is safer, and it is not a reason to ask for a higher strength. Your prescriber will determine the appropriate treatment and strength.

How long do Spedra 200mg side effects last?

No duration figure for avanafil side effects is published in the NICE guidance this page draws on, and this page will not invent one.

That is a real gap worth being straight about, because plenty of pages state a confident number without a source.

What NICE does state is about severity rather than duration. In the general population trial, "all drug-related adverse events were reported to be mild to moderate in severity". Across the wider programme, "the majority of adverse events seen in clinical studies were mild-moderate in severity and resulted in infrequent discontinuations".

Severity is the more useful measure here. Mild to moderate events that rarely led anyone to stop treatment describe a tolerability profile, which is closer to what people are really asking.

Duration figures do not transfer between medicines. Pharmacokinetics belong to a single molecule, so a figure quoted for another medicine in this class tells you nothing reliable about avanafil.

The patient information leaflet supplied with your medicine is the authoritative document on what to expect and how long for. Contact your prescriber if a side effect persists, worsens, or does not settle in the way the leaflet describes, rather than waiting it out indefinitely.

Spedra 200mg tablets contain the active ingredient avanafil, which works by increasing blood flow to the penis to help get an erection when you are stimulated. It is important to note that Spedra requires stimulation to be effective and does not cause an erection automatically.

Taking medications such as nitrate medicines (used to treat angina) alongside Spedra is strictly contraindicated. This combination can cause a potentially dangerous fall in blood pressure. If you experience chest pain after taking avanafil, seek urgent medical attention and tell the medical team when you took it.

Grapefruit juice should be avoided within 24 hours of taking Spedra, as it can increase the levels of avanafil in your body and potentially increase side effects.

Alcohol can increase the risk of dizziness, low blood pressure and other side effects when taken with avanafil. It is advisable to limit alcohol intake when using Spedra.

If you take too much Spedra, you may experience more severe side effects and should contact your doctor straight away. Never take more than one dose in 24 hours.

Persistent erection lasting more than four hours (priapism) is a medical emergency and requires immediate attention to prevent permanent damage.

Tell your prescriber if you have liver or kidney problems. Severe hepatic impairment and severe renal impairment are contraindications, while some milder forms of impairment may require dose adjustments or additional caution.

Clinical trials have demonstrated the safety and efficacy of Spedra, but it is important to discuss your physical condition and any other medications you are taking with your doctor straight before starting treatment.

Do not use Spedra tablets in combination with other erectile dysfunction treatments, as this can cause serious adverse effects.

If you experience symptoms such as sudden decrease or loss of vision in one or both eyes, or sudden hearing loss, seek medical help immediately.

Spedra is licensed to be taken approximately 15 to 30 minutes before sexual activity.

Always follow your healthcare provider's instructions and disclose all medications you are taking to avoid harmful interactions.

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Spedra 200mg long term side effects: the 52 week data

In a 52 week open label extension study in 712 men, 38.7% reported an adverse event, but only 11.1% of men had events considered drug related. Discontinuations due to adverse events occurred in 2.8%, and none of the serious adverse events reported were considered treatment related.

The gap between the first two rows is the important part. Over a year, most reported events were not attributed to the medicine. People develop headaches, colds and back pain over twelve months whether or not they take anything, which is why long term uncontrolled reports are hard to interpret.

On discontinuation, 2.8% is low. In the same study 30.6% stopped for all reasons combined, so side effects accounted for under a tenth of everyone who stopped.

What the data does not cover: avanafil was licensed in 2013, and NICE's summarised evidence extends to 52 weeks. There is no published multi year safety dataset in the sources this page uses. Anyone telling you what happens after a decade of use is going beyond the evidence.

Spedra 200mg contraindications: who should not take it

NICE states avanafil is contraindicated in eight distinct situations. If any of these apply to you, avanafil is not suitable at any strength.

The blood pressure thresholds are the ones most pages omit, and they are the easiest to check before a consultation. If your resting reading sits outside 90/50 to 170/100, raise it specifically.

Who should not take Spedra 200mg, in plain terms

Beyond the contraindications above, avanafil is not licensed for women and not licensed for anyone under 18. NICE also states that "avanafil has not been evaluated in men with erectile dysfunction due to spinal cord injury or other neurological disorders", and that "limited data are available in older men aged 70 years or above". Those last two are evidence gaps rather than bars, and both are worth raising at a consultation.

Spedra 200mg warnings and drug interactions

Beyond the outright contraindications, NICE lists four categories in the special warnings and precautions for avanafil: alpha blockers, antihypertensive drugs, alcohol, and other treatments for erectile dysfunction.

Tell the prescriber about everything you take, including medicines bought without a prescription, supplements, and anything prescribed by someone else. A prescriber cannot work around something they were not told about.

A practical point about nitrates. People sometimes carry a glyceryl trinitrate spray prescribed years ago and no longer think of it as a current medicine. It still counts, and it still rules avanafil out.

Spedra 200mg and alcohol

NICE lists alcohol among the special warnings and precautions for avanafil, and the reason is that both lower blood pressure.

Alcohol is a vasodilator. So is avanafil. Taking alcohol with avanafil can increase the risk of dizziness, low blood pressure and fainting.

There is a second problem unrelated to the interaction. Alcohol works against erectile function directly. Alcohol can also impair erectile function, so drinking may make it harder to achieve or maintain an erection even when using treatment.

NICE publishes no specific safe threshold for alcohol with avanafil in the guidance used here, so this page states none. Raise it at your consultation, because the answer depends on your blood pressure and other medicines.

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How to reduce Spedra 200mg side effects

Some practical steps can reduce avoidable problems, but you should not change the dose yourself.

• Never double up. Never take a second tablet in the same day, and never take an extra one because the first did not appear to work. NICE states the maximum recommended dosing frequency is once daily.
• Never add another erectile dysfunction medicine. This is the single largest avoidable risk.
• Be careful with alcohol. Alcohol can increase the risk of dizziness and low blood pressure and may also make erectile difficulties worse.
• Take it at the licensed timing. Take Spedra approximately 15 to 30 minutes before sexual activity, as prescribed. If it is taken with food, particularly a high-fat meal, onset may be delayed.
• Do not drive or operate machinery if affected. Dizziness, drowsiness and altered vision are all on the reported list.
• Report persistent effects rather than simply tolerating them. A side effect that persists or becomes troublesome is information your prescriber needs, and they can advise whether a different treatment is appropriate.
• Tell your prescriber about every medicine and supplement you take so they can check for potential interactions.

What is not on this list is adjusting your own strength. Moving between 50mg, 100mg and 200mg is a prescribing decision. Treatment suitability depends on an individual clinical assessment, and your prescriber will determine the appropriate treatment and strength.

If side effects are making treatment difficult, that is a consultation. You can view the erectile dysfunction treatments available and complete an online consultation with UK registered prescribers, or see the Spedra tablets product page for the licensed strengths. EveryDayMeds is a GPhC registered pharmacy, and clinical assessment happens before supply.

Is Spedra 200mg safe? The overall picture

Avanafil is a licensed UK medicine with safety data from controlled clinical trials and longer-term extension studies.

NICE 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". It is not safe for everyone, which is what the eight contraindications and the clinical assessment exist to establish.

Spedra 200mg safety questions split into three, with different answers.

Is the medicine itself safe? In the studied populations, NICE reports a generally similar safety profile to other PDE5 inhibitors, with most reported adverse events mild to moderate in severity.

Is 200mg riskier than lower strengths? The published data does not show that.

Is it safe for me? That depends on your history, and it is the only one of the three that matters for your decision. It is answered by an assessment, not by an article.

Red flags: when to seek urgent help

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

• An erection lasting more than four hours, known as priapism, 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

Do not take a nitrate for chest pain if you have taken avanafil. Tell the medical team what you have taken and when, because avanafil can significantly increase the blood-pressure-lowering effect of nitrates.

Speak to your prescriber, if side effects persist, if the medicine consistently does not work as expected, or if you are considering a change. Do not resolve any of those by taking more, or by adding something else.

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.

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.

The side effect and contraindication information here is a summary of published regulatory guidance and is not a complete account of avanafil. The patient information leaflet supplied with your medicine is the authoritative document and should be read in full before you take anything.

Trial figures describe average rates across defined study populations over defined periods. They are not predictions for any individual, and the comparison between strengths comes from groups within the same studies rather than from trials designed to compare safety between doses.

Nothing on this page should be read as a reason to change the strength you have been prescribed, in either direction. Both the strength and the amount supplied are prescribing decisions.

Never take more than the prescribed amount of any medicine, never take an extra tablet because the first dose did not appear to work, and do not combine Spedra with another erectile dysfunction medicine unless specifically advised by a healthcare professional.

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