VIIBRYD SIDE EFFECTS

  • Generic Name: vilazodone hydrochloride
  • Brand Name: Viibryd
  • Drug Class: How Do SSRI/5HT-1A Partial Agonist Antidepressants Work?
Last updated on MDtodate: 10/8/2022

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Suicidal Thoughts and Behaviors in Adolescents and Young Adults
  • Serotonin Syndrome
  • Increased Risk of Bleeding
  • Activation of Mania or Hypomania
  • Discontinuation Syndrome
  • Seizures
  • Angle-Closure Glaucoma
  • Hyponatremia

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions and varying lengths of time, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice.

The most commonly observed adverse reactions in VIIBRYD-treated patients with major depressive disorder (MDD) in placebo-controlled studies (incidence ≥ 5% and at least twice the rate of placebo) were diarrhea, nausea, vomiting, and insomnia.

Patient Exposure

The safety of VIIBRYD was evaluated in 3,007 patients (18-70 years of age) diagnosed with MDD who participated in clinical studies, representing 676 patient-years of exposure. In an open-label 52 week study at 40 mg daily, 599 patients were exposed to VIIBRYD for a total of 348 patient-years.

The adverse reaction information presented below was derived from studies of VIIBRYD 20 mg and 40 mg daily in patients with MDD including:

  • Four placebo-controlled 8 to 10-week studies in 2,233 patients, including 1,266 VIIBRYD-treated patients; and
  • An open-label 52-week study of 599 VIIBRYD-treated patients.

These studies included a titration period of 10 mg daily for 7 days, followed by 20 mg daily for 7 days or to 40 mg daily over 2 weeks. In these clinical trials, VIIBRYD was administered with food.

Adverse Reactions Reported As Reasons For Discontinuation Of Treatment

In these studies, 7.3% of the VIIBRYD-treated patients discontinued treatment due to an adverse reaction, compared with 3.5% of placebo-treated patients. The most common adverse reaction leading to discontinuation in at least 1% of the VIIBRYD-treated patients in the placebo-controlled studies was nausea (1.4%).

Common Adverse Reactions In Placebo-Controlled MDD Studies

Table 1 shows the incidence of common adverse reactions occurring in ≥ 2% of VIIBRYD-treated patients and greater than the rate of placebo-treated patients in MDD Studies. There were no dose-related adverse reactions between 20 mg and 40 mg reported.

Table 1: Common Adverse Reactions Occurring in ≥ 2% of VIIBRYD-treated Patients and Greater than the Rate of Placebo-Treated Patients

System Organ Class
Preferred Term
VIIBRYD
40 mg/day
N=978
VIIBRYD
20 mg/day
N=288
VIIBRYD
40 mg/day
N=978
Gastrointestinal disorders
  Diarrhea 10% 26% 29%
  Nausea 7% 22% 24%
  Dry mouth 5% 8% 7%
  Vomiting 2% 4% 5%
  Abdominal pain1 3% 7% 4%
  Dyspepsia 2% 2% 3%
  Flatulence 1% 3% 3%
  Gastroenteritis 1% 1% 2%
  Abdominal distension 1% 2% 1%
Nervous system disorders
  Headache2 14% 15% 14%
  Dizziness 5% 6% 8%
  Somnolence 2% 4% 5%
  Paresthesia 1% 1% 2%
Psychiatric disorders
  Insomnia 2% 7% 6%
  Abnormal dreams 2% 2% 3%
  Restlessness3 1% 2% 3%
General disorders
  Fatigue 3% 4% 3%
Cardiac disorders
  Palpitations <1% 1% 2%
Metabolism and nutrition disorders
  Increased appetite 1% 1% 3%
Musculoskeletal and connective tissue disorders
  Arthralgia 1% 2% 1%
Investigations
  Increased weight 1% 1% 2%
1 Includes abdominal discomfort, abdominal pain upper, and abdominal pain.
2 Includes headache and tension headache
3 Includes restlessness, akathisia, and restless legs syndrome

 

Sexual Adverse Reactions

Table 2 displays the most common sexual adverse reactions in the placebo-controlled MDD studies.

Table 2: Common Sexual Adverse Reactions Occurring in ≥ 2% of VIIBRYD-treated Patients and Greater than the Rate of Placebo-Treated Patients

Preferred Term Males Females
Placebo
N=416
VIIBRYD
20 mg/day
N=122
VIIBRYD
40 mg/day
N=417
Placebo
N=551
VIIBRYD
20 mg/day
N=166
VIIBRYD
40 mg/day
N=561
Abnormal Orgasm* <1% 2% 2% 0% 1% 1%
Erectile dysfunction 1% 0% 3%
Libido decreased <1% 3% 4% <1% 2% 2%
Ejaculation disorder 0% 1% 2%
− Not applicable
* Includes abnormal orgasm and anorgasmia

 

Other Adverse Reactions Observed In Clinical Studies

The following list does not include reactions: 1) already listed in previous tables or elsewhere in 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 significant clinical implications, or 5) which occurred at a rate equal to or less than placebo.

Reactions are categorized by body system according to the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients:

Cardiac disorders: infrequent: ventricular extrasystoles

Eye disorders: infrequent: dry eye, vision blurred, rare: cataracts

Nervous System: frequent: sedation, tremor; infrequent: migraine

Psychiatric disorders: infrequent: panic attack

Skin and subcutaneous tissue disorders: infrequent: hyperhidrosis, night sweats

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of VIIBRYD. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure. Reports of adverse reactions temporally associated with VIIBRYD that have been received since market introduction and that are not listed above include the following:

General Disorders and Administration Site Conditions: irritability

Nervous System Disorders: sleep paralysis

Psychiatric Disorders: hallucinations, suicide attempt, suicidal ideation

Skin and subcutaneous tissue disorders: rash, generalized rash, urticaria, drug eruption

Gastrointestinal System: acute pancreatitis.

 

SRC: NLM .