1)]. 2)]. 3)]. 4)]. 5)]. 6)]. 7)]. 8)]. 9)]. Most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo): diarrhea, nausea, vomiting, and insomnia (6). gov/medwatch . 1 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 vilazodone hydrochloride tablets-treated 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 vilazodone hydrochloride tablets were evaluated in 3,007 patients (18 to 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 vilazodone hydrochloride tablets for a total of 348 patient-years.
The adverse reaction information presented below was derived from studies of vilazodone hydrochloride tablets 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 vilazodone hydrochloride tablets -treated patients; and • An open-label 52-week study of 599 vilazodone hydrochloride tablets -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, vilazodone hydrochloride tablets were administered with food. 5% of placebo-treated patients.
4%). Common adverse reactions in placebo-controlled MDD studies Table 2 shows the incidence of common adverse reactions occurring in ≥ 2% of vilazodone hydrochloride tablets-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 Vilazodone Hydrochloride Tablets-Treated Patients and Greater than the Rate of Placebo-Treated Patients System Organ Class Preferred Term Placebo N=967 Vilazodone Hydrochloride Tablets 20 mg/day N=288 Vilazodone Hydrochloride Tablets 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 pain 1 3% 7% 4% Dyspepsia 2% 2% 3% Flatulence 1% 3% 3% Gastroenteritis 1% 1% 2% Abdominal distension 1% 2% 1% Nervous system disorders Headache 2 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% Restlessness 3 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 Vilazodone Hydrochloride Tablets-Treated Patients and Greater than the Rate of Placebo-Treated Patients Preferred Term Males Females Placebo N=416 Vilazodone Hydrochloride Tablets 20 mg/day N=122 Vilazodone Hydrochloride Tablets 40 mg/day N=417 Placebo N=551 Vilazodone Hydrochloride Tablets 20 mg/day N=166 Vilazodone Hydrochloride Tablets 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 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.
2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of vilazodone hydrochloride tablets. 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 vilazodone hydrochloride tablets 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