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Metoprolol (Metoprolol Tartrate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Hypertension and Angina

Most adverse effects have been mild and transient.

Central Nervous System

Tiredness and dizziness have occurred in about 10 of 100 patients. Depression has been reported in about 5 of 100 patients. Mental confusion and short-term memory loss have been reported. Headache, nightmares, and insomnia have also been reported.

Cardiovascular

Shortness of breath and bradycardia have occurred in approximately 3 of 100 patients. Cold extremities; arterial insufficiency, usually of the Raynaud type; palpitations; congestive heart failure; peripheral edema; and hypotension have been reported in about 1 of 100 patients. Gangrene in patients with pre-existing severe peripheral circulatory disorders has also been reported very rarely. (See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS.)

Respiratory

Wheezing (bronchospasm) and dyspnea have been reported in about 1 of 100 patients (see WARNINGS). Rhinitis has also been reported.

Gastrointestinal

Diarrhea has occurred in about 5 of 100 patients. Nausea, dry mouth, gastric pain, constipation, flatulence, and heartburn have been reported in about 1 of 100 patients. Vomiting was a common occurrence. Post-marketing experience reveals very rare reports of hepatitis, jaundice and non-specific hepatic dysfunction. Isolated cases of transaminase, alkaline phosphatase, and lactic dehydrogenase elevations have also been reported.

Hypersensitive Reactions

Pruritus or rash have occurred in about 5 of 100 patients. Very rarely, photosensitivity and worsening of psoriasis has been reported.

Miscellaneous

Peyronie’s disease has been reported in fewer than 1 of 100,000 patients. Musculoskeletal pain, blurred vision, and tinnitus have also been reported.

There have been rare reports of reversible alopecia, agranulocytosis, and dry eyes. Discontinuation of the drug should be considered if any such reaction is not otherwise explicable. There have been very rare reports of weight gain, arthritis, and retroperitoneal fibrosis (relationship to metoprolol tartrate has not been definitely established).

The oculomucocutaneous syndrome associated with the beta blocker practolol has not been reported with metoprolol tartrate.

Myocardial Infarction

Central Nervous System

Tiredness has been reported in about 1 of 100 patients. Vertigo, sleep disturbances, hallucinations, headache, dizziness, visual disturbances, confusion, and reduced libido have also been reported, but a drug relationship is not clear.

Cardiovascular

In the randomized comparison of metoprolol tartrate and placebo described in the CLINICAL PHARMACOLOGY section, the following adverse reactions were reported:

Metoprolol

Tartrate

Placebo
Hypotension (systolic BP <90 mmHg)27.4%23.2%
Bradycardia (heart rate <40 beats/min)15.9% 6.7%
Second- or third-degree heart block 4.7% 4.7%
First-degree heart block (P-R ≥0.26 sec) 5.3% 1.9%
Heart failure27.5%29.6%

Respiratory

Dyspnea of pulmonary origin has been reported in fewer than 1 of 100 patients.

Gastrointestinal

Nausea and abdominal pain have been reported in fewer than 1 of 100 patients.

Dermatologic

Rash and worsened psoriasis have been reported, but a drug relationship is not clear.

Miscellaneous

Unstable diabetes and claudication have been reported, but a drug relationship is not clear.

Potential Adverse Reactions

A variety of adverse reactions not listed above have been reported with other beta-adrenergic blocking agents and should be considered potential adverse reactions to metoprolol tartrate.

Central Nervous System

Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics.


Cardiovascular

Intensification of AV block (see CONTRAINDICATIONS).

Hematologic

Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura.

Hypersensitive Reactions

Fever combined with aching and sore throat, laryngospasm, and respiratory distress.

Postmarketing Experience

The following adverse reactions have been reported during postapproval use of metoprolol tartrate: confusional state, an increase in blood triglycerides and a decrease in High Density Lipoprotein (HDL). Because these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency.



REPORTS OF SUSPECTED METOPROLOL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Metoprolol. The information is not vetted and should not be considered as verified clinical evidence.

Possible Metoprolol side effects / adverse reactions in 63 year old male

Reported by a physician from Brazil on 2011-10-28

Patient: 63 year old male

Reactions: Ventricular Tachycardia

Suspect drug(s):
Spironolactone
    Dosage: 25 mg, unk

Atorvastatin Calcium
    Dosage: 20 mg, unk

Diovan HCT
    Dosage: 12.5/160 mg
    Start date: 2010-12-01

Metoprolol
    Dosage: 50 mg, unk



Possible Metoprolol side effects / adverse reactions in 74 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-01

Patient: 74 year old male weighing 32.1 kg (70.6 pounds)

Reactions: Haemoglobin Decreased, Drug Dose Omission, Blood Bilirubin Increased, Subarachnoid Haemorrhage, Blood Potassium Decreased, Tension Headache, Unresponsive TO Stimuli, Platelet Count Decreased, Blood Glucose Increased

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Metoprolol
    Dosage: 50 mg (25 mg,2 in 1 d)
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2010-09-02

Plavix
    Dosage: (25 mg)
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2010-09-02

Aspirin
    Dosage: (81 mg)
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2010-08-31

Bapineuzumab
    Dosage: 0.0055 mg/kg (0.5 mg/kg, 1 in 13 wk),parenteral
    Indication: Dementia Alzheimer's Type
    Start date: 2011-08-31
    End date: 2011-08-31

Other drugs received by patient: Lovastatin; Aricept; Vesicare; Namenda; Florinef



Possible Metoprolol side effects / adverse reactions in 71 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-03

Patient: 71 year old female weighing 58.0 kg (127.6 pounds)

Reactions: Weight Decreased, Oesophageal Pain, Paraesthesia Oral, Drug Hypersensitivity, Tongue DRY, Drug Abuser, Abdominal Discomfort, Muscle Strain, Anxiety, Hair Texture Abnormal, DRY Mouth, Adverse Event, Hypertension, Decreased Appetite

Adverse event resulted in: disablity

Suspect drug(s):
Celexa

Zantac
    Indication: Burn Oesophageal

Zantac
    Indication: Gastrooesophageal Reflux Disease

Benicar
    Indication: Hypertension
    Start date: 2010-01-01

Metoprolol
    Indication: Hypertension
    Start date: 2010-01-01

Xanax
    Administration route: Oral
    Indication: Anxiety
    Start date: 2010-06-08

Prinivil
    Administration route: Oral
    Indication: Hypertension

Norvasc
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-01-01

Plavix
    Indication: Thrombosis

Catapres
    Indication: Hypertension
    Start date: 2010-01-01

Other drugs received by patient: Aspirin



See index of all Metoprolol side effect reports >>

Drug label data at the top of this Page last updated: 2008-10-09

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