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Dutoprol (Metoprolol Succinate / Hydrochlorothiazide) - Side Effects and Adverse Reactions



Metoprolol succinate extended release/hydrochlorothiazide

The metoprolol succinate extended release and hydrochlorothiazide combination was evaluated for safety in 891 patients treated for hypertension in clinical trials. In a placebo-controlled trial, 843 patients were treated with various combinations of metoprolol succinate (doses of 25 to 200 mg) and hydrochlorothiazide (doses of 6.25 to 25 mg). Overall, the incidence of adverse experiences reported with the combination was comparable to placebo. Adverse events, whether or not attributed to treatment, occurring in greater than 1% of patients treated with DUTOPROL and at a rate equal to or greater than with placebo were: nasopharyngitis (3.4% vs 1.3%), fatigue (2.6% vs 0.7%), dizziness (2.6% vs 2.6%), back pain (1.7% vs 1.3%), and nausea (1.4% vs 0.7%). Adverse experiences were usually mild and transient in nature and infrequently required discontinuation of therapy (2.7% vs 2.6% with placebo).


Most adverse effects have been mild and transient. The following adverse reactions have been reported for immediate release metoprolol tartrate.

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, somnolence, 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; syncope; chest pain; and hypotension have been reported in about 1 of 100 patients (see CONTRAINDICATIONS WARNINGS, and PRECAUTIONS).

Respiratory: Wheezing (bronchospasm) and dyspnea have been reported in about 1 of 100 patients (see WARNINGS).

Gastrointestinal: Diarrhea has occurred in about 5 of 100 patients. Nausea, dry mouth, gastric pain, constipation, flatulence, digestive tract disorders, and heartburn have been reported in about 1 of 100 patients.

Hypersensitive Reactions: Pruritus or rash have occurred in about 5 of 100 patients. Worsening of psoriasis has also been reported.

Miscellaneous: Peyronie’s disease has been reported in fewer than 1 of 100,000 patients. Musculoskeletal pain, blurred vision, decreased libido, 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. The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with metoprolol.

Potential Adverse Reactions

In addition, there are a variety of adverse reactions not listed above, which have been reported with other beta-adrenergic blocking agents and should be considered potential adverse reactions to DUTOPROL.

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.

Post-Marketing Experience

In addition, the following adverse reactions have been reported with metoprolol succinate in worldwide post-marketing use, regardless of causality:

Cardiovascular: 2nd and 3rd degree heart block.

Gastrointestinal: hepatitis, vomiting.

Hematologic: thrombocytopenia.

Musculoskeletal: arthralgia.

Nervous System/Psychiatric: anxiety/nervousness, hallucinations, paresthesia.

Reproductive, male: impotence.

Skin: increased sweating, photosensitivity, urticaria.

Special Sense Organs: taste disturbances.


Other adverse experiences that have been reported with hydrochlorothiazide, without regard to causality, are listed below:

Body As A Whole: weakness; Cardiovascular: hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs); Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia; Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia; Hypersensitivity: anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura; Metabolic: electrolyte imbalance, glycosuria; Musculoskeletal: muscle spasm; Nervous System/Psychiatric: Vertigo, paresthesias, dizziness, headache, restlessness; Renal: renal failure, renal dysfunction, interstitial nephritis; Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia; Special Senses: transient blurred vision, xanthopsia; Urogenital: impotence.


In controlled clinical trials, clinically important changes in standard laboratory parameters were infrequently associated with the administration of DUTOPROL. The laboratory test findings with metoprolol or hydrochlorothiazide or their combination may include:

Creatinine, Blood Urea Nitrogen —Minor increases in blood urea nitrogen (BUN). (See WARNINGS, Renal Disease.)

Serum Electrolytes —Declines in serum potassium, sodium, chloride, magnesium. Increases in serum calcium and uric acid. (See PRECAUTIONS).

Glucose —Increase in serum or blood glucose. (See PRECAUTIONS, General, Hydrochlorothiazide.)

Lipids —Increase in serum total cholesterol, triglycerides. Decreases in high density lipoprotein (HDL).

Liver Function Tests —Increases in liver enzymes and/or serum bilirubin.


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

Possible Dutoprol side effects / adverse reactions in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-07-19

Patient: 69 year old female weighing 56.7 kg (124.7 pounds)

Reactions: OFF Label USE, Body Height Decreased, Diarrhoea, Clostridial Infection, Chronic Obstructive Pulmonary Disease

Suspect drug(s):
    Administration route: Oral

    Administration route: Oral

    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Other drugs received by patient: Vitamin B-12; Tremarin; Plavix; Hydrocodone/azetaminophine; Zetia; Diovan

See index of all Dutoprol side effect reports >>

Drug label data at the top of this Page last updated: 2007-10-16

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