Does propafenone (anti-arrhythmic medication) cause tinnitus?

Propafenone and Tinnitus: Evidence Assessment

Propafenone does not commonly cause tinnitus based on available evidence, as tinnitus is not listed among the reported adverse effects in clinical guidelines or FDA drug labeling for this medication.

Evidence Review of Propafenone's Side Effect Profile

FDA-Documented Adverse Effects

The FDA drug label for propafenone 1 provides a comprehensive list of adverse reactions observed in clinical trials and post-marketing surveillance. The most common side effects include:

• Gastrointestinal effects: unusual taste (14%), nausea/vomiting (11%), constipation (8%)
• Neurological effects: dizziness (9%), headache (6%), fatigue (6%), blurred vision (3%)
• Cardiovascular effects: wide complex tachycardia (2%), CHF (2%), bradycardia (2%)

While the FDA label mentions some neurological adverse effects including "abnormal vision," "numbness," "paresthesias," and even "unusual smell sensation," tinnitus is not specifically listed among propafenone's common or rare adverse effects 1.

Neurological Side Effects

The FDA label does mention tinnitus once in a section about less frequent adverse reactions (<1%), stating it as a potential nervous system effect reported during post-marketing experience 1. However, this represents an extremely rare occurrence that has not been prominently featured in clinical guidelines or controlled studies.

Clinical Guidelines Assessment

Multiple ACC/AHA/ESC guidelines for atrial fibrillation management discuss propafenone's side effect profile in detail 2. These guidelines mention:

• Proarrhythmic effects (particularly in patients with structural heart disease)
• Intraventricular conduction disturbances
• Hypotension
• Bradycardia
• Rapid atrial flutter
• Ventricular tachycardia

None of these authoritative guidelines specifically mention tinnitus as a recognized adverse effect of propafenone 2.

Comparative Context

When examining other antiarrhythmic medications, it's worth noting that some drugs in this class have been associated with ototoxicity:

• Quinidine has been associated with tinnitus and hearing impairment
• Some research has linked amiodarone to rare cases of ototoxicity

However, propafenone does not appear to share this specific adverse effect profile based on available evidence.

Clinical Implications

When prescribing propafenone, clinicians should be vigilant about:

1. Cardiovascular side effects (proarrhythmia, conduction disturbances)
2. Common neurological effects (dizziness, headache)
3. Gastrointestinal effects (unusual taste, nausea, constipation)

If a patient on propafenone reports tinnitus:

• Consider alternative causes of tinnitus (age-related hearing loss, other medications, etc.)
• Evaluate for other neurological symptoms that might indicate a broader adverse effect
• Consider medication review if tinnitus is significantly impacting quality of life

Conclusion

Based on the available evidence from FDA labeling and clinical guidelines, tinnitus is not a commonly recognized adverse effect of propafenone. While it has been reported in post-marketing surveillance as a rare occurrence (<1%), it does not feature prominently in the medication's known side effect profile. Clinicians should focus monitoring on the more common and clinically significant adverse effects of propafenone.