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.
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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).
Belviq is a prescription medicine used to treat the symptoms of Obesity. Belviq may be used alone or with other medications. Belviq belongs to a class of drugs called CNS Stimulants, Anorexiants; Serotonin 5-HT2C-Receptor Agonists.
Check with your doctor immediately if any of the following side effects occur:
More common
- Anxiety
- bladder pain
- bloody or cloudy urine
- blurred vision
- body aches or pain
- chills
- cold sweats
- coma
- confusion
- cool, pale skin
- cough
- depression
- difficult, burning, or painful urination
- difficulty with breathing
- dizziness
- ear congestion
- fast heartbeat
- fever
- frequent urge to urinate
- headache
- increased hunger
- loss of voice
- lower back or side pain
- nasal congestion
- nausea
- nightmares
- pounding in the ears
- runny nose
- seizures
- shakiness
- slow or fast heartbeat
- slurred speech
- sneezing
- sore throat
- swelling of the breasts or breast soreness in both females and males
- unexpected or excess milk flow from the breasts
- unusual tiredness or weakness
Less common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- decreased ability to exercise
- dry mouth
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased sensitivity to sunlight
- increased thirst
- increased urination
- itching, pain, redness, or swelling of the eye or eyelid
- joint pain
- loss of consciousness
- rapid weight gain
- severe skin rash or hives
- stomachache
- sweating
- swollen glands
- tingling of the hands or feet
- trouble with breathing
- trouble with sleeping
- unexplained weight loss
- unusual weight gain or loss
- vomiting
- watering of the eyes
Rare
- Black, tarry, stools
- chest pain
- cough or hoarseness
- pale skin
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- unusual bleeding or bruising
Incidence not known
- Agitation
- confusion
- convulsions
- diarrhea
- high fever
- increased sweating
- loss of bladder control
- overactive reflexes
- painful or prolonged erection of the penis
- poor coordination
- restlessness
- severe muscle stiffness
- shivering
- talking or acting with excitement you cannot control
- trembling or shaking
- twitching
- unusually pale skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Abdominal or stomach discomfort
- false or unusual sense of well-being
- seeing, hearing, or feeling things that are not there
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Back pain
- difficulty having a bowel movement (stool)
- muscle aches
Less common
- Decreased appetite
- difficulty with concentration
- dry eyes
- muscle spasms
- muscle, joint, or bone pain
- problems with memory
- rash
- sleeplessness
- stress
- toothache
- trouble seeing
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
BELVIQ DISCLAIMER: Do not stop taking a prescribed medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor’s advice can result in injury or death.