February 12, 2016
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Viibryd

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Viibryd




Viibryd Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 7/2/2015

Viibryd (vilazodone hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) type antidepressant used to treat major depressive disorder in adults. Common side effects of Viibryd include diarrhea, nausea, vomiting, and sleep problems (insomnia). Contact your doctor if you have serious side effects of Viibryd including easy bruising, unusual bleeding, blood in your urine or stools, agitation, hallucinations, fever, loss of coordination, fainting, very stiff (rigid) muscles, sweating, confusion, fast or uneven heartbeats, tremors, racing thoughts, risk-taking behavior, decreased inhibitions, feelings of extreme happiness or sadness, extreme thirst with headache, weakness, trouble concentrating, memory problems, confusion, seizure, or shallow breathing.

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 labeling:

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 2 shows the incidence of common adverse reactions occuring 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 2: Common Adverse Reactions Occurring in ≥ 2% of VIIBRYD-treated Patients and Greater than the Rate of Placebo-Treated Patients

System Organ Class Preferred Term Placebo
N=967
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 are presented in Table 3

Sexual Adverse Reactions

Table 3 displays the most common sexual adverse reactions in the placebo-controlled MDD studies.

Table 3: 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

Post-marketing 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

Psychiatric Disorders: hallucinations, suicide attempt, suicidal ideation

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

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

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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