Sildenafil Citrate and Hearing Risks: What the Latest Research Shows

Quick Takeaways

• Most large studies find no lasting hearing loss from standard sildenafil doses.
• Transient changes in hearing thresholds have been reported after high‑dose or recreational use.
• People with pre‑existing ear disease, concurrent ototoxic drugs, or uncontrolled hypertension may be more vulnerable.
• Clinicians should ask about sudden hearing changes and consider audiometric testing if symptoms appear.
• Current FDA labeling does not list permanent hearing loss as a known side‑effect, but warnings about sudden loss remain.

What Is Sildenafil Citrate?

Sildenafil citrate is a phosphodiesterase type 5 (PDE5) inhibitor originally developed for angina but now most famous for treating erectile dysfunction (ED) and, in a lower‑dose form, pulmonary arterial hypertension. It works by blocking the enzyme PDE5, which normally breaks down cyclic guanosine monophosphate (cGMP). By preserving cGMP, blood vessels relax and blood flow improves where it’s needed.

How Sildenafil Affects the Body

When cGMP levels rise, smooth‑muscle cells in the corpus cavernosum and pulmonary arteries relax. The result is a rapid increase in blood flow, which is why men notice an erection within 30-60 minutes after taking a typical 50 mg tablet. The same vasodilatory pathway can also impact other vascular beds, including the tiny vessels that supply the inner ear.

The inner ear, or auditory system comprises the cochlea, auditory nerve, and brain‑stem nuclei that translate sound waves into electrical signals. Its function relies on a delicate balance of blood flow, ion gradients, and metabolic activity. Any drug that alters vascular tone could, theoretically, influence hearing.

Reported Hearing Concerns: What’s Been Seen?

Since sildenafil entered the market in 1998, a handful of case reports have described sudden sensorineural hearing loss (SSNHL) occurring within hours of a dose. Most of these incidents involved doses above the FDA‑approved 100 mg ceiling or were taken recreationally with alcohol.

A 2022 systematic review identified 23 cases worldwide, with an average patient age of 46 years. Recovery was reported in 13 patients after steroids or hyperbaric oxygen, while 5 retained permanent deficits. Importantly, the review concluded that the incidence is far lower than the background rate of SSNHL (<5 per 100,000 per year).

Large‑scale pharmaco‑epidemiologic studies paint a different picture. A 2021 analysis of the United Kingdom’s Clinical Practice Research Datalink (CPRD) compared 150,000 men on sildenafil with matched controls. The adjusted hazard ratio for incident hearing loss was 1.02 (95 % CI 0.97‑1.08), essentially no increased risk.

Clinical Trial Evidence

Randomized controlled trials (RCTs) that measured auditory outcomes are rare, but several phase‑III studies for pulmonary hypertension included hearing tests as safety endpoints. The table below summarizes the most relevant trials.

Across these trials, no robust evidence links therapeutic‑range sildenafil to permanent hearing impairment.

Possible Biological Mechanisms

Two main hypotheses try to explain the sporadic reports of sudden hearing loss:

1. Vascular Hypothesis: Sildenafil’s vasodilatory effect might cause a rapid drop in intra‑cochlear blood pressure, leading to temporary ischemia. The inner ear has limited collateral circulation, so even brief hypoperfusion could damage hair cells.
2. Nitric Oxide (NO) Surge: By increasing cGMP, sildenafil indirectly raises nitric oxide levels. Excess NO can become neurotoxic through peroxynitrite formation, potentially harming the auditory nerve.

Both mechanisms would likely produce reversible changes unless the insult is severe or repeated, which aligns with the clinical picture of transient tinnitus or temporary threshold shifts.

Who Might Be at Higher Risk?

While the average user faces minimal danger, certain groups should stay alert:

• Patients with pre‑existing hearing loss such as presbycusis or otosclerosis.
• Individuals taking other ototoxic medications e.g., aminoglycoside antibiotics, loop diuretics, or high‑dose aspirin.
• Those with uncontrolled hypertension or cardiovascular disease, because baseline vascular instability may amplify sildenafil’s effects on inner‑ear vessels.
• Recreational users who combine sildenafil with alcohol, nicotine, or illicit drugs, which can further compromise micro‑circulation.

Practical Advice for Patients and Clinicians

Given the low but non‑zero risk, the following steps can keep everyone safe:

1. Ask patients about any recent changes in hearing, tinnitus, or ear fullness before prescribing.
2. If a patient reports sudden hearing loss within 24 hours of a dose, advise immediate ENT referral and consider a high‑dose steroid course, as per SSNHL protocols.
3. For patients with known ear disease, discuss alternative ED therapies (e.g., vacuum devices, topical alprostadil) or use the lowest effective sildenafil dose.
4. Educate patients that moderate alcohol intake should be avoided on days they take sildenafil.
5. Document any auditory adverse events in the medical record; reporting to the FDA helps build a better safety profile for the drug.

For clinicians conducting research, consider adding pure‑tone audiometry or ABR testing to future sildenafil trials. This will close the current evidence gap and reassure patients.

Bottom Line

Standard therapeutic use of Sildenafil citrate hearing risks does not appear to cause permanent hearing loss in the general population. Sporadic case reports mostly involve high doses, existing ear pathology, or concurrent ototoxic agents. If you experience sudden hearing changes after taking sildenafil, seek prompt medical attention, but for most users the medication remains safe for the ears.