Can duloxetine (Cymbalta) cause tinnitus?

Duloxetine and Tinnitus: Evidence-Based Assessment

Yes, duloxetine can cause tinnitus as a documented adverse effect, with recent evidence showing a strong association between duloxetine use and tinnitus development. 1

Evidence for Duloxetine-Induced Tinnitus

FDA Documentation and Recent Research

The FDA drug label for duloxetine specifically lists tinnitus as a postmarketing adverse reaction that occurs upon treatment discontinuation 2. However, more recent evidence from a 2024 analysis of the FDA Adverse Event Reporting System database revealed that duloxetine has one of the strongest associations with tinnitus among all medications, with a reporting odds ratio of 11.99 1. This places duloxetine as the medication most strongly associated with tinnitus reports in this comprehensive analysis.

Mechanism of Action

Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) that affects neurotransmitter levels in the central nervous system 3. The auditory system contains serotonin receptors, and alterations in serotonergic transmission may affect how auditory stimuli are processed 4. This provides a plausible biological mechanism for how duloxetine could cause tinnitus in some patients.

Clinical Approach to Duloxetine-Related Tinnitus

Assessment

When a patient on duloxetine reports tinnitus:

• Document the temporal relationship between duloxetine initiation and tinnitus onset
• Assess tinnitus severity and impact on quality of life
• Rule out other potential causes of tinnitus (hearing loss, other medications, etc.)
• Consider audiometric testing if tinnitus persists

Management Options

1. For mild tinnitus with good therapeutic response to duloxetine:

   • Continue monitoring
   • Consider non-pharmacological tinnitus management strategies

2. For bothersome tinnitus significantly affecting quality of life:

   • Consider dose reduction if clinically appropriate
   • If tinnitus persists, consider switching to an alternative medication
   • For patients with diabetic neuropathic pain, consider pregabalin or gabapentin as alternatives 5
   • For patients with depression, consider an SSRI or other antidepressant class

3. If discontinuation is necessary:

   • Implement gradual tapering to minimize discontinuation symptoms 6
   • Monitor for tinnitus resolution, which may occur after discontinuation 4

Special Considerations

Risk Factors for Duloxetine-Induced Tinnitus

• Prior use of salicylates (e.g., aspirin) may create a priming effect that increases susceptibility to medication-induced tinnitus 4
• Patients with pre-existing hearing issues may be at higher risk

Tinnitus Management

For patients experiencing tinnitus while on duloxetine who need to continue the medication:

• Cognitive behavioral strategies may help manage tinnitus symptoms 5
• Various acoustic therapies can be considered to diminish tinnitus perception 5

Clinical Perspective

While duloxetine is an effective medication for diabetic neuropathic pain 5, 7, fibromyalgia, and depression, the potential for tinnitus as an adverse effect should be considered in the risk-benefit assessment, particularly in patients with pre-existing auditory issues or those who have previously experienced medication-induced tinnitus.

The decision to continue, adjust, or discontinue duloxetine should be based on the severity of tinnitus, the therapeutic benefit being derived from duloxetine, and the availability of suitable alternatives for the patient's condition.