Ingrezza
- Generic Name: valbenazine capsules
- Brand Name: Ingrezza
- Drug Class: VMAT2 Inhibitors
Ingrezza (Valbenazine Capsules) side effects drug center
- Related Drugs
- drowsiness,
- fatigue,
- dry mouth,
- constipation,
- difficulty paying attention,
- blurred vision,
- urinary retention,
- falls,
- gait disturbance,
- dizziness,
- trouble with balance or coordination,
- headache,
- restlessness,
- vomiting,
- nausea, and
- joint pain.
- extreme drowsiness;
- fast, slow, or uneven heartbeats;
- pounding heartbeats or fluttering in your chest;
- shortness of breath; or
- a light-headed feeling, like you might pass out.
- headache, dizziness, drowsiness;
- problems with balance or coordination;
- dry mouth;
- feeling restless;
- constipation; or
- blurred vision.
- Hypersensitivity [see CONTRAINDICATIONS]
- Somnolence [see WARNINGS AND PRECAUTIONS]
- QT Prolongation [see WARNINGS AND PRECAUTIONS]
- Parkinsonism [see WARNINGS AND PRECAUTIONS]
What Is Ingrezza?
Ingrezza (valbenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with tardive dyskinesia.
What Are Side Effects of Ingrezza?
Common side effects of Ingrezza include:
Dosage for Ingrezza
The initial dose of Ingrezza is 40 mg once daily. After one week, increase the dose to the recommended dose of 80 mg once daily.
What Drugs, Substances, or Supplements Interact with Ingrezza?
Ingrezza may interact with monoamine oxidase inhibitors (MAOIs), itraconazole, ketoconazole, clarithromycin, paroxetine, fluoxetine, quinidine, rifampin, carbamazepine, phenytoin, St. John's wort, and digoxin.
Ingrezza During Pregnancy and Breastfeeding
Tell your doctor all medications and supplements you use. Ingrezza is not recommended for use during pregnancy. It is unknown if Ingrezza passes into breast milk. Breastfeeding is not recommended while using Ingrezza and for 5 days following the final dose.
Additional Information
Our Ingrezza (valbenazine) CapsulesSide Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
Common side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Ingrezza (Valbenazine Capsules)
SIDE EFFECTS
The following adverse reactions are discussed in more detail in other sections of the labeling:
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Variable And Fixed Dose Placebo-Controlled Trial Experience
The safety of INGREZZA was evaluated in 3 placebo-controlled studies, each 6 weeks in duration (fixed dose, dose escalation, dose reduction), including 445 patients. Patients were 26 to 84 years of age with moderate to severe tardive dyskinesia and had concurrent diagnoses of mood disorder (27%) or schizophrenia/ schizoaffective disorder (72%). The mean age was 56 years. Patients were 57% Caucasian, 39% African- American, and 4% other. With respect to ethnicity, 28% were Hispanic or Latino. All subjects continued previous stable regimens of antipsychotics; 85% and 27% of subjects, respectively, were taking atypical and typical antipsychotic medications at study entry.
Adverse Reactions Leading to Discontinuation of Treatment
A total of 3% of INGREZZA treated patients and 2% of placebo-treated patients discontinued because of adverse reactions.
Common Adverse Reactions
Adverse reactions that occurred in the 3 placebo-controlled studies at an incidence of ≥2% and greater than placebo are presented in Table 1.
Table 1: Adverse Reactions in 3 Placebo-Controlled Studies of 6-week Treatment Duration Reported at ≥2% and >Placebo
| Adverse Reaction1 | INGREZZA (n=262) (%) | Placebo (n=183) (%) |
| General Disorders | ||
| Somnolence (somnolence, fatigue, sedation) | 10.9% | 4.2% |
| Nervous System Disorders | ||
| Anticholinergic effects (dry mouth, constipation, disturbance in attention, vision blurred, urinary retention) | 5.4% | 4.9% |
| Balance disorders/fall (fall, gait disturbance, dizziness, balance disorder) | 4.1% | 2.2% |
| Headache | 3.4% | 2.7% |
| Akathisia (akathisia, restlessness) | 2.7% | 0.5% |
| Gastrointestinal Disorders | ||
| Vomiting | 2.6% | 0.6% |
| Nausea | 2.3% | 2.1% |
| Musculoskeletal Disorders | ||
| Arthralgia | 2.3% | 0.5% |
| 1 Within each adverse reaction category, the observed adverse reactions are listed in order of decreasing frequency. | ||
Other Adverse Reactions Observed During the Premarketing Evaluation of INGREZZA
Other adverse reactions of ≥1% incidence and greater than placebo are shown below. The following list does not include adverse reactions: 1) already listed in previous tables or elsewhere in the labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have clinically significant implications, or 5) which occurred at a rate equal to or less than placebo.
Endocrine Disorders: blood glucose increased
General Disorders: weight increased
Infectious Disorders: respiratory infections
Neurologic Disorders: drooling, dyskinesia, extrapyramidal symptoms (non-akathisia)
Psychiatric Disorders: anxiety, insomnia
During controlled trials, there was a dose-related increase in prolactin. Additionally, there was a dose-related increase in alkaline phosphatase and bilirubin, suggesting a potential risk for cholestasis.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of INGREZZA that are not included in other sections of labeling. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: hypersensitivity reactions (including allergic dermatitis, angioedema, pruritis, and urticaria)
Skin and Subcutaneous Tissue Disorders: rash
Read the entire FDA prescribing information for Ingrezza (Valbenazine Capsules)
© Ingrezza Patient Information is supplied by Cerner Multum, Inc. and Ingrezza Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.