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Belviq

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Belviq

Belviq Side Effects Center

Medical Editor: John Cunha, DO, FACOEP

Belviq (lorcaserin hydrochloride) is indicated for the treatment of chronic weight management in adults with a body mass index (BMI) of 30 or greater (obese) as an addition to a reduced-calorie diet and exercise. Belviq is also approved for use by adults with a BMI of 27 or greater (overweight) and who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia). It is a serotonin 2C receptor agonist. Side effects from Belviq may include low blood sugar (hypoglycemia), mental problems, slow heartbeat, headache, dizziness, fatigue, nausea, dry mouth, constipation, and painful erections.

Belviq is taken orally. The recommended dosage of Belviq is one 10mg tablets taken twice per day. Belviq should be discontinued if 5% weight loss is not achieved by week 12 of therapy. Belviq may interact with antidepressants, including selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), triptans, bupropion, dextromethorphan, or St. John's Wort). Tell your doctor all medications you use. Belviq should not be taken during pregnancy or by women who are planning to become pregnant. Belviq should not be taken while breastfeeding.

Our Belviq 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.

Belviq in Detail - Patient Information: Side Effects

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

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

  • unusual thoughts or behavior, feelings of extreme happiness or sadness;
  • feelings of standing next to yourself or being outside of your body;
  • thoughts of suicide or hurting yourself;
  • agitation, hallucinations, fever, rapid heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
  • trouble breathing, slow heart rate;
  • feeling short of breath, even with mild exertion;
  • swelling in your hands or feet;
  • pale skin, feeling light-headed or short of breath, trouble concentrating;
  • body aches, flu symptoms, sores in your mouth and throat;
  • low blood sugar (headache, hunger, weakness, sweating, confusion, irritability, dizziness, or feeling jittery);
  • breast swelling (in women or men), nipple discharge; or
  • penis erection lasting longer than 4 hours.

Less serious side effects may include:

  • headache;
  • dizziness, drowsiness, feeling tired;
  • nausea, constipation;
  • dry mouth, cough; or
  • back pain.

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 Belviq (Lorcaserin Hydrochloride) »

What is Prescribing information?

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

Belviq FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following important adverse reactions are described below and elsewhere in labeling:

Clinical Trials Experience

In the BELVIQ placebo-controlled clinical database of trials of at least one year in duration, of 6888 patients (3451 BELVIQ vs. 3437 placebo; age range 18-66 years, 79.3% women, 66.6% Caucasians, 19.2% Blacks, 11.8% Hispanics, 2.4% other, 7.4% type 2 diabetics), a total of 1969 patients were exposed to BELVIQ 10 mg twice daily for 1 year and 426 patients were exposed for 2 years.

In clinical trials of at least one year in duration, 8.6% of patients treated with BELVIQ prematurely discontinued treatment due to adverse reactions, compared with 6.7% of placebo-treated patients. The most common adverse reactions leading to discontinuation more often among BELVIQ treated patients than placebo were headache (1.3% vs. 0.8%), depression (0.9% vs. 0.5%) and dizziness (0.7% vs. 0.2%).

Most Common Adverse Reactions

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

The most common adverse reactions for non-diabetic patients (greater than 5% and more commonly than placebo) treated with BELVIQ compared to placebo were headache, dizziness, fatigue, nausea, dry mouth, and constipation. The most common adverse reactions for diabetic patients were hypoglycemia, headache, back pain, cough, and fatigue. Adverse reactions that were reported by greater than or equal to 2% of patients and were more frequently reported by patients taking BELVIQ compared to placebo are summarized in Table 2 (non-diabetic subjects) and Table 3 (subjects with type 2 diabetes mellitus).

Table 2: Adverse Reactions Reported by Greater Than or Equal to 2% of BELVIQ Patients and More Commonly than with Placebo in Patients without Diabetes Mellitus

Adverse Reaction Number of patients (%)
BELVIQ 10 mg BID
N=3195
Placebo
N=3185
Gastrointestinal Disorders
  Nausea 264 (8.3) 170 (5.3)
  Diarrhea 207 (6.5) 179 (5.6)
  Constipation 186 (5.8) 125 (3.9)
  Dry mouth 169 (5.3) 74 (2.3)
  Vomiting 122 (3.8) 83 (2.6)
General Disorders And Administration Site Conditions
  Fatigue 229 (7.2) 114 (3.6)
Infections And Infestations
  Upper respiratory tract infection 439 (13.7) 391 (12.3)
  Nasopharyngitis 414 (13.0) 381 (12.0)
  Urinary tract infection 207 (6.5) 171 (5.4)
Musculoskeletal And Connective Tissue Disorders
  Back pain 201 (6.3) 178 (5.6)
  Musculoskeletal pain 65 (2.0) 43 (1.4)
Nervous System Disorders
  Headache 537 (16.8) 321 (10.1)
  Dizziness 270 (8.5) 122 (3.8)
Respiratory, Thoracic And Mediastinal Disorders
  Cough 136 (4.3) 109 (3.4)
  Oropharyngeal pain 111 (3.5) 80 (2.5)
  Sinus congestion 93 (2.9) 78 (2.4)
Skin And Subcutaneous Tissue Disorders
  Rash 67 (2.1) 58 (1.8)

Table 3: Adverse Reactions Reported by Greater Than or Equal to 2% of BELVIQ Patients and More Commonly than with Placebo in Patients with Type 2 Diabetes Mellitus

Adverse Reaction Number of patients (%)
BELVIQ 10 mg BID
N=256
Placebo
N=252
Gastrointestinal Disorders
  Nausea 24 (9.4) 20 (7.9)
  Toothache 7 (2.7) 0
General Disorders And Administration Site Conditions
  Fatigue 19 (7.4) 10 (4.0)
  Peripheral edema 12 (4.7) 6 (2.4)
Immune System Disorders
  Seasonal allergy 8 (3.1) 2 (0.8)
Infections And Infestations
  Nasopharyngitis 29 (11.3) 25 (9.9)
  Urinary tract infection 23 (9.0) 15 (6.0)
  Gastroenteritis 8 (3.1) 5 (2.0)
Metabolism And Nutrition Disorders
  Hypoglycemia 75 (29.3) 53 (21.0)
  Worsening of diabetes mellitus 7 (2.7) 2 (0.8)
  Decreased appetite 6 (2.3) 1 (0.4)
Musculoskeletal And Connective Tissue Disorders
  Back pain 30 (11.7) 20 (7.9)
  Muscle spasms 12 (4.7) 9 (3.6)
Nervous System Disorders
  Headache 37 (14.5) 18 (7.1)
  Dizziness 18 (7.0) 16 (6.3)
Psychiatric Disorders
  Anxiety 9 (3.5) 8 (3.2)
  Insomnia 9 (3.5) 6 (2.4)
  Stress 7 (2.7) 3 (1.2)
  Depression 6 (2.3) 5 (2.0)
Respiratory, Thoracic And Mediastinal Disorders
  Cough 21 (8.2) 11 (4.4)
Vascular Disorders
  Hypertension 13 (5.1) 8 (3.2)

Other Adverse Reactions

Serotonin-associated Adverse Reactions

SSRIs, SNRIs, bupropion, tricyclic antidepressants, and MAOIs were excluded from the BELVIQ trials. Triptans and dextromethorphan were permitted: 2% and 15%, respectively, of patients without diabetes and 1% and 12%, respectively, of patients with type 2 diabetes experienced concomitant use at some point during the trials. Two patients treated with BELVIQ in the clinical program experienced a constellation of symptoms and signs consistent with serotonergic excess, including one patient on concomitant dextromethorphan who reported an event of serotonin syndrome. Some symptoms of possible serotonergic etiology that are included in the criteria for serotonin syndrome were reported by patients treated with BELVIQ and placebo during clinical trials of at least 1 year in duration. In both groups, chills were the most frequent of these events (1.0% vs. 0.2%, respectively), followed by tremor (0.3% vs. 0.2%), confusional state (0.2% vs. less than 0.1%), disorientation (0.1% vs. 0.1%) and hyperhidrosis (0.1% vs. 0.2%). Because serotonin syndrome has a very low incidence, an association between BELVIQ and serotonin syndrome cannot be excluded on the basis of clinical trial results [see WARNINGS AND PRECAUTIONS].

Hypoglycemia in Patients with Type 2 Diabetes

In a clinical trial of patients with type 2 diabetes mellitus, hypoglycemia requiring the assistance of another person occurred in 4 (1.6%) of BELVIQ-treated patients and in 1 (0.4%) placebo-treated patient. Of these 4 BELVIQ-treated patients, all were concomitantly using a sulfonylurea (with or without metformin). BELVIQ has not been studied in patients taking insulin. Hypoglycemia defined as blood sugar less than or equal to 65 mg/dL and with symptoms occurred in 19 (7.4%) BELVIQ-treated patients and 16 (6.3%) placebo-treated patients.

Cognitive Impairment

In clinical trials of at least 1-year duration, adverse reactions related to cognitive impairment (e.g., difficulty with concentration/attention, difficulty with memory, and confusion) occurred in 2.3% of patients taking BELVIQ and 0.7% of patients taking placebo.

Psychiatric Disorders

Psychiatric disorders leading to hospitalization or drug withdrawal occurred more frequently in patients treated with BELVIQ (2.2%) as compared to placebo (1.1%) in non-diabetic patients.

Euphoria. In short-term studies with healthy individuals, the incidence of euphoric mood following supratherapeutic doses of BELVIQ (40 and 60 mg) was increased as compared to placebo [see Drug Abuse and Dependence]. In clinical trials of at least 1-year duration in obese patients, euphoria was observed in 0.17% of patients taking BELVIQ and 0.03% taking placebo.

Depression and Suicidality. In trials of at least one year in duration, reports of depression/mood problems occurred in 2.6% BELVIQ-treated vs. 2.4% placebo-treated and suicidal ideation occurred in 0.6% BELVIQ-treated vs. 0.4% placebo-treated patients. 1.3% of BELVIQ patients vs. 0.6% of placebo patients discontinued drug due to depression-, mood-, or suicidal ideation-related events.

Laboratory Abnormalities

Lymphocyte and Neutrophil Counts. In clinical trials of at least 1-year duration, lymphocyte counts were below the lower limit of normal in 12.2% of patients taking BELVIQ and 9.0% taking placebo, and neutrophil counts were low in 5.6% and 4.3%, respectively.

Hemoglobin. In clinical trials of at least 1-year duration, 10.4% of patients taking BELVIQ and 9.3% taking placebo had hemoglobin below the lower limit of normal at some point during the trials.

Prolactin. In clinical trials, elevations of prolactin greater than the upper limit of normal, two times the upper limit of normal, and five times the upper limit of normal, occurred in 6.7%, 1.7%, and 0.1% of BELVIQ-treated patients and 4.8%, 0.8%, and 0.0% of placebo-treated patients, respectively.

Eye disorders

More patients on BELVIQ reported an eye disorder than patients on placebo in clinical trials of patients without diabetes (4.5% vs. 3.0%) and with type 2 diabetes (6.3% vs. 1.6%). In the population without diabetes, events of blurred vision, dry eye, and visual impairment occurred in BELVIQ-treated patients at an incidence greater than that of placebo. In the population with type 2 diabetes, visual disorders, conjunctival infections, irritations, and inflammations, ocular sensation disorders, and cataract conditions occurred in BELVIQ-treated patients at an incidence greater than placebo.

Echocardiographic Safety Assessments

The possible occurrence of regurgitant cardiac valve disease was prospectively evaluated in 7794 patients in three clinical trials of at least one year in duration, 3451 of whom took BELVIQ 10 mg twice daily. The primary echocardiographic safety parameter was the proportion of patients who developed echocardiographic criteria of mild or greater aortic insufficiency and/or moderate or greater mitral insufficiency from baseline to 1 year. At 1 year, 2.4% of patients who received BELVIQ and 2.0% of patients who received placebo developed valvular regurgitation. The relative risk for valvulopathy with BELVIQ is summarized in Table 4. BELVIQ was not studied in patients with congestive heart failure or hemodynamically-significant valvular heart disease [see WARNINGS AND PRECAUTIONS].

Table 4: Incidence of FDA-Defined Valvulopathy at Week 52 by Treatment Group1

  Study 1 Study 2 Study 3
BELVIQ
N=1278
Placebo
N=1191
BELVIQ
N=1208
Placebo
N=1153
BELVIQ
N=210
Placebo
N=209
FDA-defined Valvulopathy, n (%) 34 (2.7) 28 (2.4) 24 (2.0) 23 (2.0) 6 (2.9) 1 (0.5)
Relative Risk (95% CI) 1.13 (0.69, 1.85) 1.00 (0.57, 1.75) 5.97 (0.73, 49.17)
Pooled RR (95% CI) 1.16 (0.81, 1.67)
1Patients without valvulopathy at baseline who received study medication and had a post-baseline echocardiogram; ITT-intention-to-treat; LOCF-last observation carried forward

Read the entire FDA prescribing information for Belviq (Lorcaserin Hydrochloride) »

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