"Oct. 17, 2012 -- Some antidepressants are linked to a slight increased risk of bleeding stroke, according to a new analysis.
Researchers looked at 16 published studies that included more than 500,000 people.
They focused o"...
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see WARNINGS AND PRECAUTIONS].
- Serotonin Syndrome [see WARNINGS AND PRECAUTIONS].
- Increased Risk of Bleeding [see WARNINGS AND PRECAUTIONS].
- Activation of Mania or Hypomania [see WARNINGS AND PRECAUTIONS].
- Discontinuation Syndrome [see WARNINGS AND PRECAUTIONS].
- Seizures [see WARNINGS AND PRECAUTIONS]
- Angle-Closure Glaucoma [see WARNINGS AND PRECAUTIONS].
- Hyponatremia [see WARNINGS AND PRECAUTIONS].
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.
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
|System Organ Class Preferred Term||Placebo
|VIIBRYD 20 mg/day
|VIIBRYD 40 mg/day
|Nervous system disorders|
|Metabolism and nutrition disorders|
|Musculoskeletal and connective tissue disorders|
|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
|VIIBRYD 20 mg/day
|VIIBRYD 40 mg/day
|VIIBRYD 20 mg/day
|VIIBRYD 40 mg/day
|Abnormal Orgasm*||< 1%||2%||2%||0%||1%||1%|
|Libido decreased||< 1%||3%||4%||< 1%||2%||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
Psychiatric disorders: infrequent: panic attack
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 Viibryd (vilazodone hydrochloride) Side Effects Center for a complete guide to possible side effects
Drugs Having Clinically Important Interactions With VIIBRYD
Table 4: Clinically Important Drug Interactions with
|Concomitant Drug Name or Drug Class||Clinical Rationale||Clinical Recommendation|
|Monoamine Oxidase Inhibitors (MAOIs)||The concomitant use of MAOIs and serotonergic drugs including VIIBRYD increases the risk of serotonin syndrome.||VIIBRYD is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see CONTRAINDICATIONS, DOSAGE AND ADMINISTRATION, and WARNINGS AND PRECAUTIONS].|
|Other Serotonergic Drugs||The concomitant use of serotonergic drugs including VIIBRYD and other serotonergic drugs increases the risk of serotonin syndrome.||Monitor patients for signs and symptoms of serotonin syndrome, particularly during VIIBRYD initiation. If serotonin syndrome occurs, consider discontinuation of VIIBRYD and/or concomitant serotonergic drugs [see WARNINGS AND PRECAUTIONS].|
|Antiplatelet Agents and Anticoagulants||Serotonin release by platelets plays an important role in hemostasis. The concurrent use of an antiplatelet agent or anticoagulant with VIIBRYD may potentiate the risk of bleeding.||Inform patients of the increased risk of bleeding with the concomitant use of VIIBRYD and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio (INR) when initiating or discontinuing VIIBRYD [see WARNINGS AND PRECAUTIONS].|
|Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin, voriconazole)||The concomitant use of VIIBRYD and strong CYP3A4 inhibitors increased the exposure of vilazodone compared to the use of VIIBRYD alone [see CLINICAL PHARMACOLOGY].||The VIIBRYD dose should not exceed 20 mg once daily with the concomitant use of a strong CYP3A4 inhibitor [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY].|
|Strong CYP3A4 Inducers (e.g., carbamazepine, phenytoin, rifampin)||The concomitant use of VIIBRYD and strong CYP3A4 inducers decreased the exposure of vilazodone compared to the use of VIIBRYD alone [see CLINICAL PHARMACOLOGY].||Based on clinical response, consider increasing the dosage of VIIBRYD, over 1 to 2 weeks in patients taking strong CYP3A4 inducers for greater than 14 days [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY].|
|Digoxin||Digoxin is a narrow therapeutic index drug. Concomitant use of VIIBRYD increased digoxin concentrations [see CLINICAL PHARMACOLOGY].||Measure serum digoxin concentrations before initiating concomitant use of VIIBRYD. Continue monitoring and reduce digoxin dose as necessary.|
Drugs Having No Clinically Important Interactions With VIIBRYD
Based on pharmacokinetic studies, no dosage adjustment is required for drugs that are substrates of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4, and/or P-glycoprotein (except narrow therapeutic index drugs, e.g., digoxin), when VIIBRYD is administered concomitantly [see Drugs Having Clinically Important Interactions With VIIBRYD above and CLINICAL PHARMACOLOGY].
Drug Abuse And Dependence
VIIBRYD is not a controlled substance.
Abuse And Dependence
VIIBRYD has been systematically studied in animals and did not demonstrate abuse or dependence potential. While VIIBRYD has not been systematically studied in humans for its potential for abuse, there was no suggested evidence of drug-seeking behavior in the clinical studies.
Read the Viibryd Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 1/9/2016
Additional Viibryd Information
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.
Get tips on therapy and treatment.