What are the most common side effects of Ingrezza (valbenazine)?

Most Common Side Effects of Ingrezza (Valbenazine)

The most common side effects of Ingrezza (valbenazine) are sleepiness/tiredness (somnolence and sedation) that could cause slow reaction times, which was the most frequently reported adverse reaction in clinical trials. 1

Primary Side Effects

Ingrezza's FDA-approved drug label identifies the following common side effects:

• Most frequent adverse effects:

  • Sleepiness and tiredness (somnolence and sedation)
  • Slow reaction times

• Additional common side effects in patients with tardive dyskinesia:

  • No other common side effects were specifically listed for tardive dyskinesia patients

• Additional common side effects in patients with Huntington's disease chorea:

  • Raised itchy red areas on skin (hives)
  • Rash
  • Trouble getting to sleep or staying asleep 1

Serious Side Effects to Monitor

While less common, Ingrezza can cause several serious side effects that require monitoring:

1. Allergic reactions including angioedema

   • Swelling of face, lips, eyelids, tongue, or throat
   • Trouble breathing or swallowing
   • Rash or hives 1

2. QT prolongation (heart rhythm problems)

   • Fast, slow, or irregular heartbeat
   • Shortness of breath
   • Dizziness or lightheadedness
   • Fainting sensation 1

3. Neuroleptic Malignant Syndrome (NMS)

   • High fever
   • Stiff muscles
   • Confusion
   • Irregular pulse or blood pressure
   • Increased sweating
   • Very fast or uneven heartbeat 1

4. Parkinson-like symptoms

   • Body stiffness
   • Trouble moving or walking
   • Shaking (tremors)
   • Drooling
   • Balance problems
   • Falls 1

5. Depression and suicidal ideation (particularly in Huntington's disease patients)

   • Depression or depressed mood was reported in 4.7% of Huntington's disease patients taking Ingrezza compared to 1.6% on placebo 1

Incidence Rates from Clinical Studies

In clinical trials for tardive dyskinesia:

• Somnolence was reported in 10.9% of valbenazine-treated patients compared to 4.2% for placebo, resulting in a Number Needed to Harm (NNH) of 15 2
• Discontinuation rates due to adverse events were low at 2.9% for valbenazine vs 1.6% for placebo 2

In the KINECT-HD trial for Huntington's disease:

• Somnolence was reported in 16% of valbenazine-treated patients compared to 3% with placebo 3

Important Precautions

• Driving and operating machinery: Do not drive or operate dangerous machinery until you know how Ingrezza affects you, as it can cause sleepiness and slow reaction times 1

• Alcohol: Avoid drinking alcohol while taking Ingrezza as it may increase sleepiness 1

• Drug interactions: Be cautious with other medications that cause sleepiness 1

• Monitoring: Regular assessment for emergence of side effects is recommended, particularly when starting treatment or changing doses 1

Ingrezza has demonstrated a generally favorable safety profile in long-term studies, with no new safety concerns detected in patients who received once-daily valbenazine for up to 48 weeks 4.