Can Tadalafil Cause Tinnitus?
Yes, tadalafil and other phosphodiesterase-5 inhibitors can cause tinnitus, though it is not among the most commonly reported adverse effects.
Common Adverse Effects of PDE5 Inhibitors
The most frequently reported side effects of tadalafil are vasodilation-related and include 1:
- Headache (most common) 1
- Flushing 1
- Dyspepsia 1
- Back pain and myalgia 1, 2
- Nasal congestion 1
- Dizziness 2
- Gastro-oesophageal reflux 1
Otorhinolaryngological Effects Including Tinnitus
A comprehensive review of urological drugs specifically identified tinnitus as a reported adverse effect of phosphodiesterase inhibitors 3. This 2021 systematic review examining otorhinolaryngological adverse effects found that PDE5 inhibitors can cause 3:
- Tinnitus (ringing in the ears)
- Hearing loss
- Epistaxis (nosebleeds)
- Rhinitis and nasal congestion
- Rhinorrhea
- Dizziness
The mechanism likely relates to the widespread distribution of PDE-5 throughout the body, including the auditory system, where inhibition can affect vascular tone and potentially cochlear function 4.
Clinical Significance and Risk Assessment
While tinnitus is a recognized adverse effect, it occurs less frequently than the vasodilation-related symptoms listed above 3. The risk-benefit assessment depends on the indication 2:
- For pulmonary arterial hypertension: Higher doses (up to 40 mg daily) are justified given the life-threatening nature of the condition 2
- For erectile dysfunction: Lower doses (5-20 mg) are used with a more conservative approach to side effects 2
Important Contraindications
Tadalafil is contraindicated in patients who have experienced sudden vision loss due to anterior ischemic optic neuropathy after previous PDE5 inhibitor use 1. This suggests the drug class can affect sensory organs, supporting the plausibility of auditory effects like tinnitus.
Clinical Recommendation
If a patient develops tinnitus after starting tadalafil, evaluate whether the symptom is tolerable relative to the therapeutic benefit. For erectile dysfunction, consider switching to an alternative treatment given the quality-of-life indication 2. For pulmonary arterial hypertension, the decision is more complex given the life-threatening nature of the underlying condition, and specialist consultation is warranted 1, 2.