Austedo XR and Ingrezza Do Not Increase Risk of Shortness of Breath
Neither Austedo XR (deutetrabenazine) nor Ingrezza (valbenazine) list dyspnea or shortness of breath as adverse reactions in their FDA-approved labeling. Based on the official drug labels, respiratory symptoms are not recognized side effects of these VMAT2 inhibitors 1, 2.
Evidence from FDA Drug Labels
Ingrezza (Valbenazine)
The FDA label for Ingrezza lists the following adverse reactions occurring at ≥4% and greater than placebo:
- Nervous system: Somnolence, lethargy, sedation (18.8%), akathisia (6.3%)
- General disorders: Fatigue (14.1%)
- Skin: Urticaria (9.4%), rash (7.8%)
- Gastrointestinal: Diarrhea (4.7%), nausea (4.7%)
- Psychiatric: Insomnia (6.3%), depression (4.7%)
- Musculoskeletal: Back pain (4.7%)
The label specifically mentions "respiratory infections" as an adverse reaction but does not list dyspnea, shortness of breath, or any respiratory difficulty 1.
Austedo XR (Deutetrabenazine)
The FDA label for Austedo XR similarly does not include dyspnea or shortness of breath in its adverse reaction profile. The drug information focuses on neurological, psychiatric, and metabolic effects but makes no mention of respiratory impairment as a side effect 2.
Clinical Context
While one research study examined dextromethorphan/quinidine (a different combination drug) in ALS patients with respiratory impairment, this was evaluating the drug's effect on existing respiratory dysfunction from the underlying disease, not drug-induced dyspnea 3. This study is not relevant to the safety profile of Austedo XR or Ingrezza.
Bottom line: You can reassure patients that shortness of breath is not a recognized adverse effect of either medication. If a patient on these medications develops dyspnea, investigate other causes rather than attributing it to the VMAT2 inhibitor.