Meridia Side Effects

Please note - some side effects for Meridia may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Meridia - for the Consumer

Meridia

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Meridia:

Back pain; constipation; dizziness; dry mouth; flu-like symptoms; headache; increased or decreased appetite; joint pain; nausea; nervousness; painful menstruation; runny nose; sleeplessness; sore throat; upset stomach; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); agitation; anxiety; blurred vision or other vision changes; change in amount of urine; chest pain; clumsiness; confusion; difficulty breathing; disorientation; excitement; eye pain; fainting; fast or irregular heartbeat; high fever; increased sweating; large, unchanging pupils; loss of consciousness; mood or mental changes (eg, depression, mania, psychosis, thoughts of suicide or suicide attempt); one-sided weakness; restlessness; seizures; severe or persistent dizziness, headache, or weakness; shivering; shortness of breath; stomach pain; swelling of the feet, ankles, or legs; tremors; unusual bruising or bleeding; vomiting.

Meridia Side Effects - for the Professional

Meridia

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.

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

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-controlled 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 treated 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.

Cases of depression, suicidal ideation and suicide have been reported rarely in patients on sibutramine treatment. However, a relationship has not been established between the occurrence of depression and/or suicidal ideation and the use of sibutramine. If depression occurs during treatment with sibutramine, further evaluation may be necessary.

Allergic hypersensitivity reactions ranging from mild skin eruptions and urticaria to angioedema and anaphylaxis have been reported.

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, manic reaction, mood changes, nightmares, serotonin syndrome, 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, otitis externa, otitis media, photosensitivity (eyes), tinnitus.

Urogenital System

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

Side Effects by Body System

General

General side effects, unrelated to a specific organ system, have included headaches (30.3%), back pain (8.2%), flu syndrome (8.2%), accidental injury (5.9%), asthenia (5.9%), abdominal pain (4.5%), chest pain (1.8%), and neck pain (1.6%).

Nervous system

Nervous system side effects have included dry mouth (17.2%), insomnia (10.7%), dizziness (7.0%), nervousness (5.2%), anxiety (4.5%), depression (4.3%), paresthesia (2.0%), somnolence (1.7%), CNS stimulation (1.5%), emotional lability (1.3%), amnesia, abnormal dreams, abnormal gait, amnesia, anger, cerebrovascular accident, impaired concentration, confusion, aggravated depression, Gilles de la Tourette's syndrome, hypesthesia, decreased libido, increased libido, mood changes, nightmares, short term memory loss, speech disorder, transient ischemic attack, tremor, twitch, and vertigo. Less than 0.1% of patients have experienced seizures during therapy.

Gastrointestinal

Gastrointestinal side effects have included anorexia (13.0%), constipation (11.5%), increased appetite (8.7%), nausea (5.9%), dyspepsia (5.0%), gastritis (1.7%), vomiting (1.5%), and rectal disorder (1.2%).

Respiratory

Respiratory system side effects have included rhinitis (10.2%), pharyngitis (10.0%), sinusitis (5.0%), increased cough (3.8%), and laryngitis (1.3%). Causal relationships have not been proven.

Musculoskeletal

Musculoskeletal aches and pains associated with the use of this drug have included arthralgia (5.9%), myalgia (1.9%), tenosynovitis (1.2%), and joint disorder (1.1%).

Dermatologic

Dermatologic side effects have included rash (3.8%), sweating (2.5%), herpes simplex (1.3%), and acne (1.0%). A case of severe bullous drug eruption due to sibutramine has also been reported.

Genitourinary

Genitourinary side effects have included dysmenorrhea (3.5%), urinary tract infection (2.3%), vaginal monilia (1.2%), metrorrhagia (1.0%), and urinary retention.

Cardiovascular

The manufacturer has reported that in placebo-controlled obesity studies, sibutramine 5 to 20 mg once a day has been associated with mean increases in systolic and diastolic blood pressure of approximately 1 to 3 mm Hg relative to placebo, and mean increases in pulse rate of approximately 4 to 5 beats per minute.

Cardiovascular side effects have included tachycardia (2.6%), vasodilation (2.4%), migraine (2.4%), hypertension/increased blood pressure (2.1%), and palpitation (2.0%), arrhythmias, myocardial infarction, and cardiac arrest. A few cases of QT interval prolongation have also been reported.

Other

Other side effects have included taste perversion (2.2%), ear disorder (1.7%), and ear pain (1.1%).

Metabolic

Metabolic side effects have included thirst (1.7%) and generalized edema (1.2%).

Hematologic

Hematologic side effects including significant improvements in serum triglyceride and HDL-C levels have been reported.

Psychiatric

If depression occurs during treatment with sibutramine, further evaluation of the patient may be necessary.

Psychiatric side effects including cases of depression, psychosis, mania, suicidal ideation and suicide have been reported. If any of these events should occur during treatment with sibutramine, discontinuation should be considered. One case of exacerbation of panic attacks has also been reported.

Hypersensitivity

Hypersensitivity side effects have included reactions ranging from mild skin eruptions and urticaria to angioedema and anaphylaxis.

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