Does Belviq (lorcaserin) cause side effects?
Belviq (lorcaserin) is a serotonin 2C (5-HT2C) receptor agonist that promotes weight loss when used with diet and exercise in overweight adults with a weight-related medical problem or obese adults to lose weight and keep it off.
Although the exact mechanism of action is not known, Belviq is thought to selectively stimulate 5-HT2C receptors in the hypothalamus, the area of the brain known to play a major role in regulating hunger and food intake. By activating these receptors, Belviq may decrease food consumption by decreasing appetite and making a person feel full even after eating less food than usual.
Common side effects of Belviq include
Serious side effects of Belviq include
- heart valve problems,
- changes in attention or memory,
- mental problems,
- depression or thoughts of suicide,
- painful erections,
- slow heartbeat,
- a drop in blood cell count, and
- an increase in the hormone, prolactin.
Drug interactions of Belviq include triptans, linezolid, tryptophan, lithium, tramadol, St. John's wort, dextromethorphan (a common over-the-counter medicine for treating colds and coughs), and various classes of commonly used antidepressants including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MOAIs), due to the potential risk for serotonin syndrome, a rare but serious disorder caused by abnormally high levels of serotonin.
Belviq may increase blood levels of drugs broken down by CYP 2D6 liver enzymes. Caution must be used if Belviq is used with drugs that are extensively metabolized via this pathway.
Weight loss offers no potential benefit during pregnancy and may harm a fetus. Use of Belviq during pregnancy is not recommended.
It is unknown if Belviq is excreted in breast milk. Many drugs are excreted in breast milk and have the potential of causing harm to the nursing infant. A decision should be made to either discontinue breastfeeding or taking the drug.
What are the important side effects of Belviq (lorcaserin)?
The most common side effects are:
Other less common but serious side effects associated with lorcaserin include:
- heart valve problems,
- changes in attention or memory,
- mental problems,
- depression or thoughts of suicide,
- painful erections,
- slow heartbeat,
- a drop in blood cell count, and
- an increase in the hormone, prolactin.
Belviq (lorcaserin) side effects list for healthcare professionals
The following important adverse reactions are described below and elsewhere in labeling:
- Serotonin Syndrome or NMS-like Reactions
- Valvular Heart Disease
- Cognitive Impairment
- Psychiatric Disorders
- Hypoglycemia
- Heart Rate Decreases
- Hematological Changes
- Prolactin Elevation
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
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.
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. 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.
Table 4: Incidence of FDA-Defined Valvulopathy at Week
52 by Treatment Group1
Stutuy 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 |
Post-Marketing Experience
The following adverse reactions have been identified during post approval use of lorcaserin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: drug hypersensitivity
What drugs interact with Belviq (lorcaserin)?
Use With Other Agents That Affect Serotonin Pathways
Based on the mechanism of action of Belviq and the theoretical potential for serotonin syndrome, use with extreme caution in combination with other drugs that may affect the serotonergic neurotransmitter systems, including, but not limited to,
- triptans,
- monoamine oxidase inhibitors (MAOIs, including linezolid, an antibiotic which is a reversible non-selective MAOI),
- selective serotonin reuptake inhibitors (SSRIs),
- selective serotonin-norepinephrine reuptake inhibitors (SNRIs),
- dextromethorphan,
- tricyclic antidepressants (TCAs),
- bupropion,
- lithium,
- tramadol,
- tryptophan, and
- St. John's Wort.
Cytochrome P450 (2D6) Substrates
- Use caution when administering Belviq together with drugs that are CYP 2D6 substrates, as Belviq can increase exposure of these drugs.
Does Belviq (lorcaserin) cause addiction or withdrawal symptoms?
Drug Abuse And Dependence
Controlled Substance
- Belviq is listed in Schedule IV of the Controlled Substances Act.
Abuse
- In a human abuse potential study in recreational drug abusers, supratherapeutic oral doses of lorcaserin (40 and 60 mg) produced up to two- to six-fold increases on measures of “High”, “Good Drug Effects”, “Hallucinations” and “Sedation” compared to placebo.
- These responses were similar to those produced by oral administration of the positive control drugs, zolpidem (15 and 30 mg) and ketamine (100 mg). In this study, the incidence of the adverse reaction of euphoria following lorcaserin administration (40 and 60 mg; 19%) is similar to the incidence following zolpidem administration (13- 16%), but less than the incidence following ketamine administration (50%).
- The duration of euphoria following lorcaserin administration persisted longer ( > 9 hours) than that following zolpidem (1.5 hours) or ketamine (2.5 hours) administration.
- Overall, in short-term studies with healthy individuals, the rate of euphoria following oral administration of lorcaserin was 16% following 40 mg (n = 11 of 70) and 19% following 60 mg (n = 6 of 31).
- However, in clinical studies with obese patients with durations of 4 weeks to 2 years, the incidence of euphoria and hallucinations following oral doses of lorcaserin up to 40 mg was low ( < 1.0%).
Dependence
- There are no data from well-conducted animal or human studies that evaluate whether lorcaserin can induce physical dependence, as evidenced by a withdrawal syndrome.
- However, the ability of lorcaserin to produce hallucinations, euphoria, and positive subjective responses at supratherapeutic doses suggests that lorcaserin may produce psychic dependence.
Summary
Belviq (lorcaserin) is a serotonin 2C (5-HT2C) receptor agonist that promotes weight loss when used with diet and exercise in overweight adults with a weight-related medical problem or obese adults to lose weight and keep it off. Common side effects of Belviq include headache, dizziness, fatigue, nausea, dry mouth, constipation, and low blood sugar (hypoglycemia). Use of Belviq during pregnancy is not recommended. It is unknown if Belviq is excreted in breast milk.
Multimedia: Slideshows, Images & Quizzes
-
Fasting: What You Should Know
Fasting: It's simple and trending, though it's been around for thousands of years. Find out whether it might be a good option for...
-
Diet and Weight Loss: Your Best Ways to Beat Belly Fat
Could your job be to blame for your belly fat? It might be, if it stresses you out. But there are a number of ways to get rid of...
-
The Best Diet Tips: How to Lose Weight the Healthy Way
Learn to lose weight in a realistic way that works. Find healthy weight loss by eating right, sleeping more, understanding...
-
Diet & Weight Loss: Reasons You're Not Losing Belly Fat
If you're trying to lose belly fat but can't, there's probably a reason.
-
Diet and Weight Loss: What’s a Ketogenic Diet?
These are low-carb diets -- the basic idea is to get most of your calories from protein and fat. There are some benefits, but you...
-
Surprising Causes of Weight Gain
There are many reasons for sudden weight gain when there are no changes in diet or exercise. Learn to identify the cause of your...
-
Weight Loss Challenges: Why Can't I Lose Weight?
Finding it difficult to lose weight? It’s a hard thing to do, and there are some surprising reasons you may not be losing weight...
-
Diet and Weight Loss: How to Cut Calories From Your Day
When you want to lose weight, you’ll probably need to find a way to eat fewer calories. Try these tips to trim them from your...
-
How to Lose Weight Fast: Easy Weight Loss Tips
Here are the best ways to lose weight. From calories to fitness, learn these weight loss tips and win your battle with losing...
-
How to Lose Weight Without Dieting: 24 Fast Facts
Get surprising weight loss tips to help you slim down without starving or following a complicated diet. Lose weight without...
-
Weight Loss Surgery: What to Expect
Are you considering weight loss (bariatic) surgery? WebMD helps you know what makes you a good candidate and the pros and cons of...
-
Weight Loss Surgery Quiz
What happens after weight loss surgery? What should you eat? Take this quiz to learn about bariatric surgery. Are you a candidate?
-
10 Metabolism Boosting Facts and Myths
Losing weight by increasing your metabolism is challenging. There are many metabolism myths and only a few surefire tricks to get...
-
Weight Loss Quiz: Test Your Weight Control IQ
Are you trying to lose weight? Take this quiz to see what you can add to routine to get on the right track for results!
-
Diet and Weight Loss: Best and Worst Late Night Snacks for Your Health
If you're truly hungry for a bedtime snack, don't ignore your body's signals. It's hard to fall asleep when your tummy's rumbling...
-
Diet and Weight Loss: The 80-20 (or Weekend) Diet
The idea here is that you get to splurge a bit if you eat healthy most of the time. Find out more about this approach and what it...
-
Bad Foods That Are Good for Weight Loss in Pictures
Are you avoiding foods you could be enjoying as you try to lose weight? Get the skinny on "bad" foods like potatoes, cheese, and...
-
Diet and Weight Loss: What's an Elimination Diet?
Ever wonder if a certain food causes your headaches or makes you tired or uncomfortable? You might try to find out with an...
-
Diet and Weight Loss: Healthy Fat Foods
From fish to avocados, nuts to beans, WebMD shows you what tasty foods have healthy fats. See the benefits of adding omega 3s and...
-
Diet and Weight Loss: Why Are You Always Hungry?
What are the causes of hunger? There are more reasons you get hungry than just an empty stomach. Food cravings, pregnancy, blood...
-
Diet and Weight Loss: Which Has More Sugar?
Trying to eat less sugar? Find out where it may be hiding in your diet.
-
Healthy Living: 15 Numbers That Matter as Much as Your Weight
Instead of focusing just on the scale when you're trying to lose weight and improve your health, there are other numbers you...
-
Best and Worst Drinks For Weight Loss
From coffee to cocktails, learn which beverages can help or hinder a healthy lifestyle. See the best and worst drinks for weight...
-
Diet and Weight Loss: Best and Worst Salads for Your Health
Some salads are loaded with nutrition, while others serve up more fat than a cheeseburger. Learn which ones you should choose --...
-
Weight Management: Medical Conditions That Can Cause Weight Gain
Could a medical condition be the reason for your recent weight gain? Find out some possible causes and how best to manage them.
-
Portion Control: Plate Photos to Lose Weight, Maintain Diet
Portion control can help with weight loss. The right plate amount can help you stick to a healthy diet. Learn to lose weight with...
-
Diet and Weight Loss: The Best and Worst Thai Dishes for Your Health
Thai cuisine is loaded with fresh veggies and spices. But some dishes are packed with calories and fat. Learn what foods you...
-
Diet and Weight Loss: 14 Ways to Shed Pounds After 40
Losing weight after 40 can be hard, especially if you don't have a lot of time to exercise and eat right. But some simple...
Related Disease Conditions
-
Obesity and Overweight
Get the facts on obesity and being overweight, including the health risks, causes, reviews of weight-loss diet plans, BMI chart, symptoms, causes, surgical and nonsurgical treatments, and medications.
-
Weight Cycling
Second Source article from WebMD
-
Weight Loss - The Basics
There are lots of reasons for people who are overweight or obese to lose weight. To be healthier. To look better. To feel better. To have more energy.
-
Mirena Weight Gain: Do IUDs Cause Weight Gain?
Nonhormonal IUDs generally do not cause any weight gain. Hormonal IUDs cause weight gain in about 5% of patients. As Mirena is a hormonal IUD, there are chances of weight gain. This weight gain is mainly due to the hormone progestin that causes water retention and bloating.
-
Complications Of Hypothyroidism: Fertility, Weight And More
The thyroid gland is a small butterfly-shaped gland located in the front of the neck. Hypothyroidism is a medical condition in which the thyroid gland becomes underactive.
-
How to Lose Weight Fast: Four Simple Steps
Aggressive efforts to lose weight faster can damage your joints and reduce your muscle mass. Here are four simple steps—which if followed religiously—can help you lose weight fast and at the same time help you achieve sustained weight loss too.
Treatment & Diagnosis
- Weight Loss FAQs
- Weight Loss Surgery FAQs
- Alli OTC Weight Loss Medication
- Plate Size Might Influence Weight Gain
- Being Overweight Doesn't Mean You're Unhealthy!
- Cough, Cold, Weight Loss Drug Dangerous - Warning
- Childhood and Obesity
- Can You Target Specific Body Parts for Weight Loss?
- Can I Lift Weights with High Blood Pressure?
- 7 Ways to Measure Health and Fitness
- 7 Tips to Avoid Holiday Weight Gain
- Weight Management - Maintain a Healthy Weight
- Resolved to Lose Weight? Tips to Make it Work.
- Attitude Makeover: Believe You Can Lose Weight
- Positive Attitude Key to Weight Loss Success
- Calcium Intake Can Enhance Weight Loss
Medications & Supplements
![FDA Logo](https://images.medicinenet.com/images/logo_fda.png)
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.
Professional side effects, drug interactions, and addiction sections courtesy of the U.S. Food and Drug Administration.