MICARDIS SIDE EFFECTS

Last updated on MDtodate: 10/7/2022

SIDE EFFECTS

The following adverse reactions are discussed elsewhere in labeling:

• Hypotension
• Renal Impairment
• Electrolytes and Metabolic Disorders

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

MICARDIS HCT has been evaluated for safety in more than 1700 patients, including 716 treated for hypertension for longer than 6 months and 420 for more than 1 year. Adverse reactions have been limited to those that have been previously reported with telmisartan and/or hydrochlorothiazide.

Adverse reactions occurring at an incidence of ≥2% in patients treated with telmisartan/hydrochlorothiazide and at a greater rate than in patients treated with placebo, are presented in Table 1.

Table 1 Adverse Reactions Occurring at an Incidence of ≥2% in Patients Treated with Telmisartan/Hydrochlorothiazide and at a Greater Rate Than in Patients Treated with Placebo*

	Telmisartan/ Hydrochlorothiazide (n = 414)	Placebo (n = 74)	Telmisartan (n = 209)	Hydrochlorothiazide (n = 121)
Body as a whole
Fatigue	3%	1%	3%	3%
Influenza-like symptoms	2%	1%	2%	3%
Central/Peripheral nervous system
Dizziness	5%	1%	4%	6%
Gastrointestinal system
Diarrhea	3%	0%	5%	2%
Nausea	2%	0%	1%	2%
Respiratory system disorder
Sinusitis	4%	3%	3%	6%
Upper respiratory tract infection	8%	7%	7%	10%
* includes all doses of telmisartan (20 to 160 mg), hydrochlorothiazide (6.25 to 25 mg), and combinations thereof

 

Other adverse reactions observed for telmisartan/hydrochlorothiazide were: pain (including back and abdominal), dyspepsia, erythema, vomiting, bronchitis, and pharyngitis.

Adverse reactions occurred at approximately the same rates in men and women, older and younger patients, and black and non-black patients.

Telmisartan

Other adverse events that have been reported with telmisartan are listed below:

Autonomic Nervous System: impotence, increased sweating, flushing

Body as a Whole: allergy, fever, leg pain, chest pain

Cardiovascular: palpitation, angina pectoris, abnormal ECG, hypertension, peripheral edema

Central Nervous System: insomnia, somnolence, migraine, paresthesia, involuntary muscle contractions, hypoesthesia

Gastrointestinal: flatulence, constipation, gastritis, dry mouth, hemorrhoids, gastroesophageal reflux, toothache

Hepato-biliary: elevations of liver enzymes or serum bilirubin

Metabolic: gout, hypercholesterolemia, diabetes mellitus

Musculoskeletal: arthritis, arthralgia, leg cramps, myalgia

Psychiatric: anxiety, depression, nervousness

Resistance Mechanism: infection, abscess, otitis media

Respiratory: asthma, rhinitis, dyspnea, epistaxis

Skin: dermatitis, eczema, pruritus

Urinary: micturition frequency, cystitis

Vascular: cerebrovascular disorder

Special Senses: abnormal vision, conjunctivitis, tinnitus, earache

Hydrochlorothiazide

Other adverse events that have been reported with hydrochlorothiazide are listed below:

Body as a Whole: weakness

Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation

Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia

Hypersensitivity: purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions

Metabolic: hyperglycemia, glycosuria

Musculoskeletal: muscle spasm

Nervous System/Psychiatric: restlessness

Renal: interstitial nephritis

Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis

Special Senses: transient blurred vision, xanthopsia

Clinical Laboratory Findings

Creatinine, Blood Urea Nitrogen (BUN)

Increases in BUN (≥11.2 mg/dL) and serum creatinine (≥0.5 mg/dL) were observed in 2.8% and 1.4%, respectively, of patients with essential hypertension treated with MICARDIS HCT tablets in controlled trials. No patient discontinued treatment with MICARDIS HCT tablets because of an increase in BUN or creatinine.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of MICARDIS HCT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: eosinophilia

Cardiac Disorders: atrial fibrillation, congestive heart failure, myocardial infarction, tachycardia, bradycardia

Ear and Labyrinth Disorders: vertigo

General Disorders and Administration Site Conditions: asthenia, edema

Hepato-biliary: Abnormal hepatic function/liver disorder

Immune System Disorders: anaphylactic reaction

Infections and Infestations: urinary tract infection

Investigations: increased CPK

Metabolism and Nutrition Disorders: hypoglycemia (in diabetic patients)

Musculoskeletal and Connective Tissue Disorders: tendon pain (including tendonitis, tenosynovitis), rhabdomyolysis

Nervous System Disorders: syncope, headache

Renal and Urinary Disorders: renal failure, renal impairment including acute renal failure

Reproductive System and Breast Disorders: erectile dysfunction

Respiratory, Thoracic and Mediastinal Disorders: coughing

Skin and Subcutaneous Tissue Disorders: drug eruption (toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), angioedema (with fatal outcome)

Vascular Disorder: orthostatic hypotension