Meridia
- Generic Name: sibutramine hydrochloride monohydrate
- Brand Name: Meridia
Meridia (Sibutramine Hydrochloride Monohydrate) side effects drug center
What Is Meridia?
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 Meridia (sibutramine) was withdrawn from the U.S. market due to the risk of serious cardiovascular events.
What Are Side Effects of Meridia?
Common side effects of Meridia (sibutramine hydrochloride) include:
- flu symptoms,
- runny or stuffy nose,
- sore throat,
- cough,
- fast or pounding heartbeats,
- high blood pressure,
- new or worsening shortness of breath,
- seizure (convulsions),
- fast or uneven heartbeats,
- dry mouth,
- upset stomach,
- loss of appetite,
- constipation,
- stomach pain,
- headache,
- back pain,
- joint pain,
- nervousness,
- dizziness,
- depression,
- trouble sleeping (insomnia),
- skin rash, and
- warmth, redness, or tingly feeling under your skin.
Dosage for Meridia
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.
What Drugs, Substances, or Supplements Interact with Meridia?
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.
Meridia During Pregnancy and Breastfeeding
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.
Additional Information
Our Meridia Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview 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)