Tadalafil Safety (Side Effects, Uses and Considerations)

Key takeaways
  • As a PDE5 inhibitor, tadalafil works by increasing blood flow and relaxing smooth muscles in specific body areas [1].
  • The primary FDA-approved uses for tadalafil:some text
    • Improvement of testosterone levels
    • Management of benign prostatic hyperplasia (BPH) symptoms
    • Treatment of pulmonary arterial hypertension (PAH)

Many people wonder about the safety of prescription medications, especially those taken regularly. Tadalafil, available as brand-name Cialis®, is available for certain medical conditions, leading to questions about its safety profile and appropriate use.

While tadalafil offers several therapeutic benefits when properly prescribed, it's essential to understand both its uses and potential side effects. This article takes a look at the safety aspects of tadalafil and its various applications. 

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Is Tadalafil Safe?

Research shows that tadalafil is generally well-tolerated across study groups, with a low discontinuation rate of only 1.3% compared to 1.1% in placebo groups [4]. Tadalafil may cause side effects such as headache, flushing, back pain, muscle aches, indigestion, and nasal congestion. Serious but rare side effects include sudden vision or hearing loss, priapism , and symptoms of heart problems like chest pain or shortness of breath.

In an 18-24 month study, the discontinuation rate due to adverse events was 6.3%, with no individual event causing more than 1% of discontinuations [5].

While tadalafil is generally safe, it must be emphasized that it's not suitable for everyone. Medical conditions which require careful consideration include:

  • Heart conditions requiring nitrate medications
  • Severe liver or kidney problems
  • Recent stroke or heart attack history
  • Uncontrolled blood pressure (high or low)
  • Blood cell disorders like sickle cell anemia
  • Certain eye conditions or vision loss history [6]

It's crucial to inform all healthcare providers about tadalafil use, especially in emergency situations [7]. Regular monitoring, particularly for those with pre-existing medical conditions, is important. Always consult a licensed healthcare provider with any questions regarding your dosage, potential side effects, or other health concerns to ensure safe and effective use of medications.

Side Effects of Tadalafil

Understanding potential side effects helps make informed decisions about medication use. While tadalafil is generally well-tolerated, it's important to be aware of possible adverse reactions.

Side Effect 1: Common Cardiovascular Effects

Cardiovascular effects are among the most frequently reported reactions. It’s been observed that flushing occurs in up to 14% of patients [8]. Some patients experience blood pressure changes, with systolic dropping approximately 7 mm Hg and diastolic dropping 5 mm Hg.

Tadalafil headache is another frequent side effect, caused by the medication’s ability to widen blood vessels, increasing blood flow and triggering pressure changes. This may headaches. Staying hydrated, avoiding excessive alcohol, and taking over-the-counter pain relievers may help manage these headaches. If headaches persist or become severe, consult your healthcare provider, as they may adjust your dosage or recommend alternative treatments.

Side Effect 2: Gastrointestinal Issues

Gastrointestinal symptoms are common, with dyspepsia affecting up to 13% of users and nausea occurring in up to 11% of cases [8]

Tadalafil heartburn is another side effect which may occur when the medication relaxes the lower esophageal sphincter, allowing stomach acid to flow back into the esophagus. This may lead to symptoms such as a burning sensation in the chest, discomfort after eating, and acid reflux. To minimize heartburn while taking tadalafil, avoid large meals, spicy foods, and alcohol prior to taking the medication, and consider using antacids if approved by your healthcare provider.

Side Effect 3: Musculoskeletal Symptoms

Data shows that musculoskeletal effects may be as follows:

  • Myalgia (muscle pain) affecting up to 14% of users
  • Back pain occurring in up to 12% of patients
  • Extremity pain reported in up to 11% of cases [8]

Side Effect 4: Vision and Hearing Concerns

Vision and hearing changes may also occur. While rare, some patients experience changes in color vision, and in uncommon cases, sudden vision or hearing loss may occur [2]. These symptoms require immediate medical attention if they develop.

Always consult a licensed healthcare provider with any questions regarding your dosage, potential side effects, or other health concerns to ensure safe and effective use of medications.

Potential Long-term Side Effects of Tadalafil

While examining long-term effects of tadalafil, an interesting challenge is limited long-term research data. A review indicates that most studies focus on short-term effects, with few extending beyond two years [9].

Long-term Side Effect 1: Vision and Hearing Concerns

A small number of patients may report vision changes [9]. Immediate medical attention is crucial if any vision changes occur, as they could indicate serious complications.

Long-term Side Effect 2: Cardiovascular Considerations

In 18-24 months, studies reveal cardiovascular safety data. Findings include:

  • No significant ECG changes
  • No concerning vital sign alterations
  • No pattern of serious cardiovascular events [5]

Long-term Side Effect 3: Musculoskeletal Effects

Extended use shows consistent rates of:

  • Back pain (8.2% of patients)
  • General muscle discomfort
  • Joint-related issues

Long-term Side Effect 4: Organ System Impact

Studies spanning 18-24 months show:

  • No drug-induced hepatotoxicity
  • No renal dysfunction
  • No blood cell count abnormalities 

The overall discontinuation rate due to adverse events in long-term studies was 6.3%, with no single effect causing more than 1% of discontinuations [5]. Always consult a licensed healthcare provider with any questions regarding your dosage, potential side effects, or other health concerns to ensure safe and effective use of medications.

Is Low-dose Daily Tadalafil Safe?

It has been found that daily administration of tadalafil 5mg demonstrates effectiveness while maintaining a strong safety profile [10].

Findings from research show:

  • Significant improvement in erectile function scores from baseline 
  • Low adverse effect rates of 5.51% at first follow-up and 3.94% at second follow-up 
  • No significant changes in blood pressure or heart rate measurements 

Consistent daily dosing with low-dose tadalafil (2.5mg and 5mg) aligns with pharmacokinetic predictions [11]. It’s important to perform proper medical screening and regular monitoring, especially for patients with pre-existing conditions.

Who Shouldn't Take Tadalafil

Safety considerations are paramount when prescribing tadalafil and several groups who should avoid this medication have been identified: 

User 1: Patients Taking Nitrates or GC Stimulators

It is suggested that patients taking nitrate medications or guanylate cyclase stimulators should not use tadalafil [12]. This combination may cause dangerous drops in blood pressure. Common nitrates include:

  • Nitroglycerin
  • Isosorbide dinitrate
  • Isosorbide mononitrate

Always consult a licensed healthcare provider with any questions regarding your dosage, potential side effects, or other health concerns to ensure safe and effective use of medications.

User 2: Individuals with Severe Cardiovascular Conditions

Research shows tadalafil is contraindicated for patients who have:

  • Had a heart attack within the past 90 days 
  • Experienced a stroke within 6 months 
  • Uncontrolled blood pressure (high or low) [7]

User 3: Patients with Specific Medical Conditions

Several conditions which require careful consideration:

  • Severe liver impairment 
  • Kidney disease requiring dosage adjustment 
  • Retinitis pigmentosa [13]
  • Blood disorders including leukemia and multiple myeloma

User 4: Those with Anatomical Considerations

In clinical experience, patients with certain physical conditions should exercise caution:

  • Peyronie's disease or penile deformities 
  • Active peptic ulcers 
  • Bleeding disorders requiring medical evaluation [12]

Always consult healthcare providers about any pre-existing conditions before starting tadalafil treatment.

Always consult a licensed healthcare provider with any questions regarding your dosage, potential side effects, or other health concerns to ensure safe and effective use of medications.

Health Benefits of Taking Low-dose Tadalafil

Tadalafil benefits go beyond treating improvement of testosterone levels; it also helps manage symptoms of benign prostatic hyperplasia (BPH) by relaxing muscles in the bladder and prostate, improving urinary flow. 

Health Benefit 1: Cardiovascular Health

Research shows that PDE5 inhibitors like tadalafil reduce cardiovascular-related events significantly. Studies demonstrate a 33% lower chance of heart-related mortality and 40% lower risk of heart failure hospitalization [16].

Health Benefit 2: Anti-inflammatory Effects

Studies indicate that tadalafil demonstrates powerful anti-inflammatory properties. Research shows normalized levels of pro-inflammatory interleukins after 6 months of treatment [18].

Health Benefit 3: Prostate Health

Tadalafil effectively manages BPH symptoms, with clinical trials showing improvement in urinary symptoms [16]. Benefits include:

  • Improved urinary flow
  • Reduced nighttime urination
  • Better bladder emptying 

Tadalafil Dosage

If you find tadalafil not working for your health, it may be due to several factors, such as improper dosage, timing of intake, underlying health conditions, or interactions with other medications. Always consult a licensed healthcare provider with any questions regarding your dosage, potential side effects, or other health concerns to ensure safe and effective use of medications.

Tadalafil dosage generally starts with a dose of 2.5 mg to 5 mg recommended for daily use, or as prescribed to you for your health conditions. Always follow your healthcare provider's guidance.

Understanding the correct dosage is important for both tadalafil and Cialis® effectiveness. Both medications come in identical strength options:

  • 2.5mg - recommended starting dose for daily use
  • 5mg - standard daily dose
  • 20mg - maximum available dose [10]

These medications' long-lasting effects may last up to 36 hours. This extended duration of action sets them apart from other medications, which typically last only 4-6 hours. 

It is suggested that the daily dose be taken at approximately the same time each day. This consistency helps maintain steady medication levels in your system. Always consult a licensed healthcare provider with any questions regarding your dosage, potential side effects, or other health concerns to ensure safe and effective use of medications.

The maximum recommended dose is 20mg per day. Always start with lower doses and adjust based on individual response and tolerance to the medication.

Low Dose Tadalafil Daily Dosage

The extended half-life of tadalafil makes it particularly suitable for daily dosing, allowing patients to maintain steady medication levels. 

Several advantages of daily dosing have been identified:

  • Potentially lower incidence of side effects
  • Consistent therapeutic levels
  • Greater spontaneity in intimate moments

For optimal results, it’s recommended to take the medication at approximately the same time each day [21]. The starting dose for daily use in erectile dysfunction treatment is 2.5mg, which can be adjusted to 5mg if needed. For those managing benign prostatic hyperplasia, healthcare providers may prescribe 5mg as a single daily dose.

Tadalafil may cause side effects such as headache, flushing, back pain, muscle aches, indigestion, and nasal congestion. Serious but rare side effects include sudden vision or hearing loss, priapism (prolonged erection), and symptoms of heart problems like chest pain or shortness of breath.

Always consult a licensed healthcare provider for questions about your dosage, side effects, or other health concerns to ensure safe and effective medication use.

Is it Safe to Combine Tadalafil with Vardenafil?

Based on clinical experience, combining tadalafil with vardenafil raises safety concerns that must be addressed. Research shows that taking these medications together may lead to dangerous drops in blood pressure [22].

It’s strongly cautioned against combining tadalafil and verdenafil medications without proper medical supervision. When used together, these drugs may increase the risk of several side effects:

  • Severe dizziness and lightheadedness
  • Heart palpitations
  • Fainting episodes
  • Prolonged and painful erections
  • Severe headaches 

If you're currently taking either medication, it’s recommended to consult with your healthcare provider before making any changes. It's crucial to disclose all medications, including vitamins and herbs, to your healthcare team.

Final Thoughts

Tadalafil may improve testosterone levels in men, energy metabolism in skeletal muscle cells, and bone density. It is also approved for managing benign prostatic hyperplasia symptoms, pulmonary arterial hypertension, and improving urinary symptoms

Medical supervision plays an important role in tadalafil's safe use. Regular monitoring helps ensure optimal outcomes while minimizing potential risks. Patients should always discuss their complete medical history and current medications with healthcare providers in order to determine whether or not you are an eligible candidate for any new medication. 

Please note that this article is not meant to be medical advice; Always consult a licensed healthcare provider for questions about your dosage, side effects, or other health concerns to ensure safe and effective medication use.

FAQ

Is tadalafil safer than Viagra?

When prescribed appropriately, both medications demonstrate comparable profiles [25]. Clinical experience shows that while both are PDE-5 inhibitors, tadalafil offers the following:

  • Longer duration of action (up to 36 hours) 
  • Less affected by food intake 
  • Lower incidence of vision-related side effects 

How long is it safe to take tadalafil?

Tadalafil maintains its effectiveness and safety profile when taken as prescribed. Safety considerations for long-term use include:

  • Regular medical monitoring
  • Consistent dosing schedule
  • Prompt reporting of side effects

Is it safe to take tadalafil and sildenafil together?

No, taking tadalafil and sildenafil together is not recommended, as combining them can increase the risk of severe side effects like dangerously low blood pressure, dizziness, and headaches. Please consult your licensed healthcare provider to determine whether or not you are an eligible candidate for either medication separately based on your health needs.

Always consult a licensed healthcare provider for questions about your dosage, side effects, or other health concerns to ensure safe and effective medication use.

Disclaimer: The FDA does not approve compounded medications for safety, quality, or manufacturing. Prescriptions and a medical evaluation are required for certain products. The information provided on this blog is for general informational purposes only. It is not intended as a substitute for professional advice from a qualified healthcare professional and should not be relied upon as personal health advice. The information contained in this blog is not meant to diagnose, treat, cure, or prevent any disease. Readers are advised to consult with a qualified healthcare professional for any medical concerns, including side effects. Use of this blog's information is at your own risk. The blog owner is not responsible for any adverse effects or consequences resulting from the use of any suggestions or information provided in this blog.

References

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  2. National Library of Medicine. Tadalafil. In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. https://www.ncbi.nlm.nih.gov/books/NBK603743/

  3. NHS. Common questions about tadalafil. NHS. https://www.nhs.uk/medicines/tadalafil/common-questions-about-tadalafil/

  4. Brock GB, McMahon CG, Chen KK, et al. Efficacy and safety of tadalafil in men with erectile dysfunction. J Sex Med. 2013;10(4):908-917. PMC3735316

  5. Porst H, Padma-Nathan H, Giuliano F, et al. Efficacy of tadalafil once daily in men with erectile dysfunction. Eur Urol. 2003;44(6):815-825. https://doi.org/10.1016/S0302-2838(03)00585-2

  6. NHS. Who can and cannot take tadalafil. NHS. https://www.nhs.uk/medicines/tadalafil/who-can-and-cannot-take-tadalafil/

  7. Mayo Clinic. Tadalafil (oral route). Mayo Clinic. https://www.mayoclinic.org/drugs-supplements/tadalafil-oral-route/description/drg-20067204

  8. Drugs.com. Tadalafil side effects. Drugs.com. https://www.drugs.com/sfx/tadalafil-side-effects.html

  9. Montorsi, F., Verheyden, B., Meuleman, E., Jünemann, K. P., Moncada, I., Valiquette, L., Casabé, A., Pacheco, C., Denne, J., Knight, J., Segal, S., & Watkins, V. S. (2004). Long-term safety and tolerability of tadalafil in the treatment of erectile dysfunction. European urology, 45(3), 339–345. https://pubmed.ncbi.nlm.nih.gov/15036680/.

  10. Montorsi F, Salonia A, Deho F, et al. The long-term safety of tadalafil in men with erectile dysfunction. Urology. 2010;75(6):1387-1393. PMC2941815

  11. Kim ED, Dobbs RW, Wang R. Tadalafil and cardiovascular health: a review. J Sex Med. 2016;13(6):905-913. https://doi.org/10.1016/j.jsxm.2016.03.003

  12. Medical News Today. Cialis interactions: what to know. Medical News Today. https://www.medicalnewstoday.com/articles/drugs-cialis-interactions

  13. Cascorbi I. (2012). Drug interactions—principles, examples and clinical consequences. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3444856/

  14. Chemist Click. Cialis for women: current research and applications. Chemist Click. https://www.chemistclick.co.uk/news/cialis-for-women

  15. Porst H, et al. Mechanism of action of tadalafil in erectile dysfunction. J Sex Med. 2010;7(8):2922-2931. https://doi.org/10.1016/j.jsxm.2010.01.019

  16. Warde, N. Two birds, one stone: tadalafil is an effective treatment for men with both BPH-LUTS and ED. Nat Rev Urol 8, 643 (2011). https://doi.org/10.1038/nrurol.2011.165

  17. Corona G, Rastrelli G, Maggi M. Tadalafil for the management of sexual health in aging males. Andrology. 2022;10(3):564-573. PMC9022238

  18. Matsumoto S, Hashimoto M, Nishimoto H, et al. Mechanistic insights into tadalafil use for erectile dysfunction. Sci Rep. 2019;9(1):152. https://doi.org/10.1038/s41598-019-53136-y

  19. Medical News Today. Tadalafil dosage: what to know. Medical News Today. https://www.medicalnewstoday.com/articles/drugs-tadalafil-dosage

  20. Giuliano F, Sanchez-Ramos L, Jackson G. Comparison of tadalafil with sildenafil for erectile dysfunction. Urology. 2010;75(6):1206-1212. PMC2939761

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Disclaimer: The FDA does not approve compounded medications for safety, quality, or manufacturing. Prescriptions and a medical evaluation are required for certain products. The information provided on this blog is for general informational purposes only. It is not intended as a substitute for professional advice from a qualified healthcare professional and should not be relied upon as personal health advice. The information contained in this blog is not meant to diagnose, treat, cure, or prevent any disease. Readers are advised to consult with a qualified healthcare professional for any medical concerns, including side effects. Use of this blog's information is at your own risk. The blog owner is not responsible for any adverse effects or consequences resulting from the use of any suggestions or information provided in this blog.

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