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Viibryd

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Viibryd

Viibryd Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Viibryd tablets (vilazodone hydrochloride) are indicated for the treatment of major depressive disorder in adults. Signs and symptoms of major depression include depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide. Common side effects of Viibryd are diarrhea, nausea, vomiting, and insomnia.

The recommended dose for Viibryd is 40 mg once daily. Patients taking Viibryd will start with an initial dose of 10 mg once daily for 7 days, followed by 20 mg once daily for an additional 7 days, and then an increase to 40 mg once daily.

Newborns exposed to Viibryd late in the third trimester of their mothers' pregnancies have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Doctors treating pregnant women with Viibryd shall consider whether the potential benefits outweigh the potential risks of treatment. Breastfeeding in women treated with Viibryd should be considered only if the potential benefit outweighs the potential risk.

Our Viibryd Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Viibryd in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Stop taking vilazodone and call your doctor at once if you have a serious side effect such as:

  • seizures (convulsions);
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), blood in your urine or stools, purple or red pinpoint spots under your skin;
  • agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, overactive reflexes, feeling like you might pass out;
  • racing thoughts, unusual risk-taking behavior, decreased inhibitions, feelings of extreme happiness or sadness; or
  • extreme thirst with headache, nausea, vomiting, weakness, trouble concentrating, memory problems, confusion, fainting, seizure, shallow breathing or breathing that stops.

Less serious side effects may include:

  • diarrhea, mild nausea; or
  • sleep problems (insomnia).

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 Viibryd (Vilazodone Hydrochloride) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Viibryd FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the label.

Clinical Studies Experience

The most commonly observed adverse reactions in VIIBRYD-treated MDD patients 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 2,177 patients (1870 years of age) diagnosed with MDD who participated in clinical studies, representing 552 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 information presented in these sections was derived from studies of VIIBRYD 40 mg daily in major depressive disorder including: 1) 2 placebo-controlled 8-week studies in 861 patients, including 436 receiving vilazodone; and 2) an open-label 52-week study of 599 patients. These studies included a titration period of 10 mg daily for 7 days followed by 20 mg daily for 7 days. In these clinical trials, VIIBRYD was administered with food.

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.

Adverse Reactions Reported As Reasons For Discontinuation Of Treatment

In the placebo-controlled studies of MDD there was no single adverse reaction leading to discontinuation in > 1% of the patients. Overall, 7.1% of the patients who received VIIBRYD discontinued treatment due to an adverse reaction, compared with 3.2% of placebo-treated patients in these studies.

Common Adverse Reactions In Placebo-Controlled MDD Studies

Table 2 shows the incidence of common adverse reactions that occurred in ≥ 2% of VIIBRYD-treated MDD patients (and greater than in placebo-treated patients) in the placebo-controlled studies.

Table 2: Common Adverse Reactions Occurring in ≥ 2% of VIIBRYD-treated Patients and > Placebotreated Patients

System Organ Class
Preferred Term
VIIBRYD 40 mg/day
N = 436
Placebo
N = 433
Gastrointestinal disorders
  Diarrhea 28 9
  Nausea 23 5
  Dry mouth 8 5
  Vomiting 5 1
  Dyspepsia 3 2
  Flatulence 3 2
  Gastroenteritis 3 < 1
Nervous system disorders
  Dizziness 9 5
  Somnolence 3 2
  Paresthesia 3 1
  Tremor 2 0
Psychiatric disorders
  Insomnia 6 2
  Abnormal dreams 4 1
  Libido decreased 4 < 1
  Restlessness * 3 < 1
  Orgasm abnormal** 3 0
General disorders
  Fatigue 4 3
  Feeling jittery 2 < 1
  Cardiac disorders
  Palpitations 2 < 1
Musculoskeletal and connective tissue disorders
  Arthralgia 3 2
Reproductive system and breast disorders
  Delayed ejaculation*** 2 0
  Erectile dysfunction*** 2 1
Metabolism and nutrition disorders
  Increased appetite 2 1
*Includes restlessness, akathisia, and restless legs syndrome
**Includes orgasm abnormal and anorgasmia
***Male patients only (Placebo n=182; VIIBRYD n=170)

Table 3: Sexual Adverse Reactions: Percentage in the Placebo-Controlled Studies

Preferred Term Males Females
VIIBRYD
N= 170
Placebo
N= 182
VIIBRYD
N=266
Placebo
N=251
Decreased libido 5 0 3 < 1
Abnormal orgasm* 4 0 2 0
Delayed ejaculation 2 0 - -
Erectile dysfunction 2 1 - -
Sexual dysfunction 2 0 < 1 < 1
- Not applicable
*Includes anorgasmia

Laboratory Tests

VIIBRYD has not been associated with any clinically important changes in laboratory test parameters in serum chemistry (including liver function tests), hematology and urinalysis, as measured in placebo-controlled studies. These studies include analysis of (1) mean change from baseline and (2) the proportion of patients meeting criteria for potentially clinically significant changes from baseline. Results from a 52-week open-label study were consistent with the findings from the placebo-controlled studies.

ECG

VIIBRYD has not been associated with any clinically significant effect on ECG parameters, including QT, QTc, PR and QRS intervals, or with any arrhythmogenic potential. ECGs were evaluated in a thorough QTc study at doses up to 80 mg daily with food and in the placebo-controlled studies [see CLINICAL PHARMACOLOGY].

Vital Signs

VIIBRYD has not been associated with any clinically significant effect on vital signs, including systolic and diastolic blood pressure and heart rate, as measured in placebo-controlled studies. These studies included analyses of (1) change from baseline, and (2) the proportion of patients meeting criteria for potentially clinically significant changes from baseline. Results from a 52-week open-label study were consistent with the findings from the placebo-controlled studies.

Weight

VIIBRYD had no effect on body weight as measured by the mean change from baseline in the 8-week, placebo-controlled studies. The mean changes in weight were +0.16 kg in the VIIBRYD group and +0.18 kg in the placebo group. The proportions of patients with a weight gain ≥ 7% were 0.9% in the VIIBRYD group and 1.2% in the placebo group. The proportions of patients with a weight decrease ≥ 7% were 1.4% in the VIIBRYD group and 1.4% in the placebo group.

Other Adverse Reactions Observed In Clinical Studies

The following listing 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: frequent: vision blurred, dry eye; infrequent: cataracts

General disorders: infrequent: feeling abnormal

Metabolism and nutrition disorders: frequent: decreased appetite

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

Psychiatric disorders: infrequent: panic attack, mania

Renal and Urinary disorder: infrequent: pollakiuria

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

Post-marketing Experience

The following adverse reactions have been identified during postapproval 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. These events include:

General Disorders and administrative site conditions -irritability

Psychiatric Disorders - hallucinations, suicide attempt, suicidal ideation

Read the entire FDA prescribing information for Viibryd (Vilazodone Hydrochloride) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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