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Meridia

Last reviewed on RxList: 10/12/2017
Meridia Side Effects Center

Last reviewed on RxList 10/12/2017

Meridia (sibutramine hydrochloride or sibutramine hydrochloride monohydrate) assists with weight-loss by altering neurotransmitters within the brain and is used along with a low-calorie diet to help people with obesity lose weight. Meridia (sibutramine) was withdrawn from the U.S. market due to the risk of serious cardiovascular events. Common side effects of Meridia (sibutramine hydrochloride) include:

The recommended starting dose of Meridia is 10 mg administered once daily with or without food. If there is inadequate weight loss, the dose may be adjusted after four weeks to a total of 15 mg once daily. Meridia may interact with other medicines that make you sleepy (such as cold or allergy medicines, sedatives, narcotics, sleeping pills, muscle relaxers, and medicines for seizures, depression, or anxiety), decongestants, cough medicines, other diet pills, lithium, L-tryptophan, ketoconazole, antibiotics, antidepressants, ergot medicines, or migraine headache medicines. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant while using Meridia; it is unknown if it will harm a fetus. It is unknown if Meridia passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Meridia 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.

Meridia Consumer Information

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

  • fast, pounding, or uneven heartbeats;
  • new or worsening shortness of breath;
  • agitation, hallucinations, fever, tremor, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, dilated pupils;
  • very stiff (rigid) muscles, high fever, sweating, confusion, feeling like you might pass out;
  • easy bruising or bleeding (nosebleeds, bleeding gums, or any bleeding that will not stop);
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, seizure);
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling; or
  • sudden numbness or weakness (especially on one side of the body), problems with vision, speech, or balance.

Less serious side effects may include:

  • dry mouth, upset stomach;
  • changes in appetite;
  • constipation, stomach pain;
  • headache, back pain, joint pain;
  • feeling nervous, dizzy, or depressed;
  • flu symptoms, runny or stuffy nose, sore throat, cough;
  • warmth, redness, or tingly feeling under your skin;
  • trouble sleeping (insomnia); or
  • mild skin rash.

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 Meridia (Sibutramine Hydrochloride Monohydrate)

Meridia Professional Information

SIDE EFFECTS

In placebo-controlled studies, 9% of patients treated with sibutramine (n = 2068) and 7% of patients treated with placebo (n = 884) withdrew for adverse events.

In placebo-controlled studies, the most common events were dry mouth, anorexia, insomnia, constipation and headache. Adverse events in these studies occurring in ≥ 1% of sibutramine treated patients and more frequently than in the placebo group are shown in the following table.

Obese Patients in Placebo-Controlled Studies

BODY SYSTEM
Adverse Event
Sibutramine
(n = 2068)
% Incidence
Placebo
(n = 884)
% Incidence
BODY AS A WHOLE
  Headache 30.3 18.6
  Back pain 8.2 5.5
  Flu syndrome 8.2 5.8
  Injury accident 5.9 4.1
  Asthenia 5.9 5.3
  Abdominal pain 4.5 3.6
  Chest pain 1.8 1.2
  Neck pain 1.6 1.1
  Allergic reaction 1.5 0.8
CARDIOVASCULAR SYSTEM
  Tachycardia 2.6 0.6
  Vasodilation 2.4 0.9
  Migraine 2.4 2.0
  Hypertension/increased blood pressure 2.1 0.9
  Palpitation 2.0 0.8
DIGESTIVE SYSTEM
  Anorexia 13.0 3.5
  Constipation 11.5 6.0
  Increased appetite 8.7 2.7
  Nausea 5.9 2.8
  Dyspepsia 5.0 2.6
  Gastritis 1.7 1.2
  Vomiting 1.5 1.4
  Rectal disorder 1.2 0.5
METABOLIC & NUTRITIONAL
  Thirst 1.7 0.9
  Generalized edema 1.2 0.8
MUSCULOSKELETAL SYSTEM
  Arthralgia 5.9 5.0
  Myalgia 1.9 1.1
  Tenosynovitis 1.2 0.5
  Joint disorder 1.1 0.6
NERVOUS SYSTEM
  Dry mouth 17.2 4.2
  Insomnia 10.7 4.5
  Dizziness 7.0 3.4
  Nervousness 5.2 2.9
  Anxiety  4.5 3.4
  Depression 4.3 2.5
  Paresthesia 2.0 0.5
  Somnolence 1.7 0.9
  CNS stimulation 1.5 0.5
  Emotional lability 1.3 0.6
RESPIRATORY SYSTEM
  Rhinitis 10.2 7.1
  Pharyngitis 10.0 8.4
  Sinusitis 5.0 2.6
  Cough incr ease 3.8 3.3
  Laryngitis 1.3 0.9
SKIN & APPENDAGES
  Rash 3.8 2.5
  Sweating 2.5 0.9
  Herpes simplex 1.3 1.0
  Acne 1.0 0.8
SPECIAL SENSES
  Taste perversion 2.2 0.8
  Ear disorder 1.7 0.9
  Ear pain 1.1 0.7
UROGENITAL SYSTEM
  Dysmenorrhea 3.5 1.4
  Urinary tract infection 2.3 2.0
  Vaginal monilia 1.2 0.5
  Metrorrhagia 1.0 0.8

The following additional adverse events were reported in ≥ 1% of all patients who received sibutramine in controlled and uncontrolled premarketing studies.

Body as a Whole: fever.

Digestive System : diarrhea, flatulence, gastroenteritis, tooth disorder.

Metabolic and Nutritional: peripheral edema.

Musculoskeletal System: arthritis.

Nervous System: agitation, leg cramps, hypertonia, thinking abnormal.

Respiratory System: bronchitis, dyspnea.

Skin and Appendages: pruritus.

Special Senses: amblyopia.

Urogenital System: menstrual disorders.

Other Adverse Events

Clinical Studies

Seizures

Convulsions were reported as an adverse event in three of 2068 (0.1%) sibutramine treated patients and in none of 884 placebo-treated patients in placebo-cont rolled premarketing obesity studies. Two of the three patients with seizures had potentially predisposing factors (one had a prior history of epilepsy; one had a subsequent diagnosis of brain tumor). The incidence in all subjects who received sibutramine (three of 4,588 subjects) was less than 0.1%.

Ecchymosis/Bleeding Disorders

Ecchymosis (bruising) was observed in 0.7% of sibutramine trea ted patients and in 0.2% of placebo-treated patients in premarketing placebo-controlled obesity studies. One patient had prolonged bleeding of a small amount which occurred during minor facial surgery. Sibutramine may have an effect on platelet function due to its effect on serotonin uptake.

Interstitial Nephritis

Acute interstitial nephritis (confirmed by biopsy) was reported in one obese patient receiving sibutramine during premarketing studies. After discontinuation of the medication, dialysis and oral corticosteroids were administered; renal function normalized. The patient made a full recovery.

Altered Laboratory Findings

Abnormal liver function tests, including increases in AST, ALT, GGT, LDH, alkaline phosphatase and bilirubin, were reported as adverse events in 1.6% of sibutramine-treated obese patients in placebo-controlled trials compared with 0.8% of placebo patients. In these studies, potentially clinically significant values (total bilirubin ≥ 2 mg/dL; ALT, AST, GGT, LDH, or alkaline phosphatase ≥ 3 � upper limit of normal) occurred in 0% (alkaline phosphatase) to 0.6% (ALT) of the sibutramine treated patients and in none of the placebo-treated patients. Abnormal values tended to be sporadic, often diminished with continued treatment, and did not show a clear dose-response relationship.

Postmarketing Reports

Voluntary reports of adverse events temporally associated with the use of sibutramine are listed below. It is important to emphasize that although these events occurred during treatment with sibutramine, they may have no causal relationship with the drug. Obesity itself, concurrent disease states/risk factors, or weight reduction may be associated with an increased risk for some of these events.

Psychiatric

Cases of depression, psychosis, mania, suicidal ideation and suicide have been reported rarely in patients on sibutramine treatment. However, a relationship has not been established between these events and the use of sibutramine. If any of these events should occur during treatment with sibutramine, discontinuation should be considered.

Hypersensitivity

Allergic hypersensitivity reactions ranging from mild skin eruptions and urticaria to angioedema and anaphylaxis have been reported (see CONTRAINDICATIONS and PATIENT INFORMATION, and other reports of allergic reactions listed below).

Other Postmarketing Reported Events

Body as a Whole: anaphylactic shock, anaphylactoid reaction, chest pressure, chest tightness, facial edema, limb pain, sudden unexplained death.

Cardiovascular System: angina pectoris, atrial fibrillation, congestive heart failure, heart arrest, heart rate decreased, myocardial infarction, supraventricular tachycardia, syncope, torsade de pointes, vascular headache, ventricular tachycardia, ventricular extrasystoles, ventricular fibrillation.

Digestive System: cholecystitis, cholelithiasis, duodenal ulcer, eructation, gastrointestinal hemorrhage, increased salivation, intestinal obstruction, mouth ulcer, stomach ulcer, tongue edema.

Endocrine System: goiter, hyperthyroidism, hypothyroidism.

Hemic and Lymphatic System: anemia, leukopenia, lymphadenopathy, petechiae, thrombocytopenia. Metabolic and Nutritional hyperglycemia, hypoglycemia.

Musculoskeletal System: arthrosis, bursitis.

Nervous System: abnormal dreams, abnormal gait, amnesia, anger, cerebrovascular accident, concentration impaired, confusion, depression aggravated, Gilles de la Tourette's syndrome, hypesthesia, libido decreased, libido increased, mood changes, nightmares, short term memory loss, speech disorder, transient ischemic attack, tremor, twitch, vertigo.

Respiratory System: epistaxis, nasal congestion, respiratory disorder, yawn. Skin and Appendages alopecia, dermatitis, photosensitivity (skin), urticaria.

Special Senses: abnormal vision, blurred vision , dry eye, eye pain, increased intraocular pressure, otitisexterna, otitis media, photosensitivity (eyes), tinnitus.

Urogenital System: abnormal ejaculation, hematuria, impotence, increased urinary frequency, micturition difficulty, urinary retention.

Drug Abuse And Dependence

Controlled Substance

MERIDIA (sibutramine hydrochloride monohydrate) is controlled in Schedule IV of the Controlled Substances Act (CSA).

Abuse and Physical and Psychological Dependence

Physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (e.g., drug development of tolerance, incrementation of doses, drug seeking behavior).

Read the entire FDA prescribing information for Meridia (Sibutramine Hydrochloride Monohydrate)

Related Resources for Meridia

Read the Meridia User Reviews »

© Meridia Patient Information is supplied by Cerner Multum, Inc. and Meridia Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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