Can Qsymia Cause Tinnitus?
Yes, tinnitus is a recognized adverse effect of Qsymia, attributable to its topiramate component, though it occurs infrequently (reported in approximately 2% of patients in clinical trials). 1
Evidence from FDA Drug Labeling
The FDA-approved prescribing information for topiramate, one of the two active components in Qsymia, explicitly lists tinnitus as an adverse event occurring in clinical trials. 1 In the controlled epilepsy studies that form the basis of topiramate's safety profile, tinnitus was reported in 2% of patients receiving topiramate 200 mg/day compared to 0% in the placebo group. 1
Mechanism and Clinical Context
Topiramate's ototoxic potential manifests as tinnitus through mechanisms that remain incompletely understood, but the risk appears dose-dependent. 1 The topiramate component in Qsymia ranges from 23 mg to 92 mg daily depending on the dose strength (with the maximum dose being 15 mg phentermine/92 mg topiramate). 2 This is within the range where auditory side effects have been documented in clinical trials. 1
Monitoring Recommendations
Patients prescribed Qsymia should be counseled about the possibility of tinnitus at initiation, and any new-onset ringing in the ears warrants clinical evaluation. 3 The American College of Clinical Pharmacology emphasizes that patients need to be aware of psychiatric and cognitive adverse effects from Qsymia, and sensory disturbances like tinnitus fall within this spectrum of neurological side effects. 3
- If tinnitus develops and is bothersome or persistent, dose reduction or discontinuation should be considered 3
- Qsymia should not be stopped abruptly and requires tapering over at least 1 week to minimize withdrawal effects 3
- The gradual dose escalation protocol (starting at 3.75/23 mg for 14 days, then 7.5/46 mg) may help identify patients who develop tinnitus at lower doses before reaching maximum dosing 2
Clinical Pitfalls
Do not dismiss patient reports of tinnitus as unrelated to medication, as this is a documented topiramate-associated adverse effect. 1 While the incidence is relatively low (2%), it represents a real risk that should be part of informed consent discussions before initiating therapy. The combination formulation in Qsymia does not eliminate this risk inherent to the topiramate component. 3, 1