Can Humira Cause Tinnitus?
Tinnitus has been reported with adalimumab (Humira) use, though it is not listed among the commonly recognized adverse effects in major clinical guidelines or FDA-approved labeling. A recent pharmacovigilance analysis of the FDA Adverse Event Reporting System identified adalimumab as having a signal for tinnitus-related adverse events, though the association was weaker compared to other medications 1.
Evidence for Tinnitus Association
The most relevant data comes from post-marketing surveillance rather than controlled clinical trials:
A 2024 analysis of the FDA Adverse Event Reporting System (FAERS) database identified 759 reports of tinnitus associated with adalimumab, with a reporting odds ratio (ROR) of 0.68 (95% CI 0.64-0.73) 1. This ROR below 1.0 suggests that tinnitus reports with adalimumab were actually less frequent than expected compared to other drugs in the database, indicating a weak or potentially absent causal relationship 1.
Among the 759 tinnitus cases associated with adalimumab, the most common underlying indication was rheumatoid arthritis (n=947 across all tinnitus-related drugs), which itself may be associated with auditory symptoms independent of medication 1.
Context from Clinical Guidelines
Major clinical guidelines and comprehensive safety reviews do not list tinnitus as a recognized adverse effect of adalimumab:
The American Academy of Dermatology guidelines (2008) detail adalimumab toxicities including injection site reactions, serious infections, malignancies, lupus-like syndrome, cytopenias, demyelinating disorders, and congestive heart failure, but do not mention tinnitus or auditory symptoms 2.
The American College of Chest Physicians evidence-based guidelines (2012) comprehensively review adalimumab adverse effects including infections, autoimmune phenomena, pulmonary complications, and CNS events, without reference to tinnitus 2.
A systematic literature review informing the 2019 EULAR recommendations for rheumatoid arthritis management does not identify tinnitus among adalimumab's safety concerns 2.
Documented Adverse Effects for Comparison
The well-established adverse effect profile of adalimumab includes 3:
Common effects: Injection site reactions (15%), nasopharyngitis (19%), headaches, dizziness, vertigo, upper respiratory infections, gastrointestinal upset, and musculoskeletal pain 3, 4.
Serious effects: Infections (2.03 per 100 patient-years), tuberculosis reactivation, opportunistic infections, malignancies, lupus-like reactions, cytopenias, demyelinating disorders, congestive heart failure, and pulmonary complications 2, 3, 4.
Clinical Interpretation
The reported association between adalimumab and tinnitus appears weak and may reflect confounding factors:
The ROR of 0.68 suggests no increased risk compared to baseline expectations 1.
Patients with autoimmune diseases (rheumatoid arthritis, psoriatic arthritis, Crohn's disease) may experience tinnitus as part of their underlying disease process or from concomitant medications 1.
Vertigo and dizziness are recognized adalimumab side effects that could be misreported or confused with tinnitus 3.
Clinical Recommendation
If a patient on adalimumab develops tinnitus, consider alternative explanations first including:
- Underlying autoimmune disease manifestations (particularly in rheumatoid arthritis patients) 1
- Concomitant medications known to cause tinnitus (NSAIDs, antimalarials, methotrexate) 1
- Unrelated otologic pathology requiring standard audiologic evaluation 1
Discontinuation of adalimumab solely for tinnitus is not supported by current evidence, given the weak association and the significant morbidity risks of undertreated autoimmune disease 2, 1. However, if tinnitus is severe, persistent, and temporally related to adalimumab initiation with no other identifiable cause, switching to an alternative biologic agent could be considered 1.