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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).

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

  1. Anxiety
  2. bladder pain
  3. bloody or cloudy urine
  4. blurred vision
  5. body aches or pain
  6. chills
  7. cold sweats
  8. coma
  9. confusion
  10. cool, pale skin
  11. cough
  12. depression
  13. difficult, burning, or painful urination
  14. difficulty with breathing
  15. dizziness
  16. ear congestion
  17. fast heartbeat
  18. fever
  19. frequent urge to urinate
  20. headache
  21. increased hunger
  22. loss of voice
  23. lower back or side pain
  24. nasal congestion
  25. nausea
  26. nightmares
  27. pounding in the ears
  28. runny nose
  29. seizures
  30. shakiness
  31. slow or fast heartbeat
  32. slurred speech
  33. sneezing
  34. sore throat
  35. swelling of the breasts or breast soreness in both females and males
  36. unexpected or excess milk flow from the breasts
  37. unusual tiredness or weakness

Less common

  1. Bloating or swelling of the face, arms, hands, lower legs, or feet
  2. decreased ability to exercise
  3. dry mouth
  4. flushed, dry skin
  5. fruit-like breath odor
  6. increased hunger
  7. increased sensitivity to sunlight
  8. increased thirst
  9. increased urination
  10. itching, pain, redness, or swelling of the eye or eyelid
  11. joint pain
  12. loss of consciousness
  13. rapid weight gain
  14. severe skin rash or hives
  15. stomachache
  16. sweating
  17. swollen glands
  18. tingling of the hands or feet
  19. trouble with breathing
  20. trouble with sleeping
  21. unexplained weight loss
  22. unusual weight gain or loss
  23. vomiting
  24. watering of the eyes

Rare

  1. Black, tarry, stools
  2. chest pain
  3. cough or hoarseness
  4. pale skin
  5. sores, ulcers, or white spots on the lips or in the mouth
  6. swollen glands
  7. unusual bleeding or bruising

Incidence not known

  1. Agitation
  2. confusion
  3. convulsions
  4. diarrhea
  5. high fever
  6. increased sweating
  7. loss of bladder control
  8. overactive reflexes
  9. painful or prolonged erection of the penis
  10. poor coordination
  11. restlessness
  12. severe muscle stiffness
  13. shivering
  14. talking or acting with excitement you cannot control
  15. trembling or shaking
  16. twitching
  17. unusually pale skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  1. Abdominal or stomach discomfort
  2. false or unusual sense of well-being
  3. 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

  1. Back pain
  2. difficulty having a bowel movement (stool)
  3. muscle aches

Less common

  1. Decreased appetite
  2. difficulty with concentration
  3. dry eyes
  4. muscle spasms
  5. muscle, joint, or bone pain
  6. problems with memory
  7. rash
  8. sleeplessness
  9. stress
  10. toothache
  11. 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.

Have You Been Diagnosed with Cancer After Using Belviq?

YOU MAY BE ENTITLED TO COMPENSATION. COMPLETE THE FORM BELOW FOR A FREE CASE EVALUATION.