DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Micardis HCT (Telmisartan / Hydrochlorothiazide) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Micardis® HCT (telmisartan and hydrochlorothiazide) tablets has been evaluated for safety in over 1700 patients, including 716 treated for over six months and 420 for over one year. In clinical trials with MICARDIS HCT tablets, no unexpected adverse events have been observed. Adverse experiences have been limited to those that have been previously reported with telmisartan and/or hydrochlorothiazide. The overall incidence of adverse experiences reported with the combination was comparable to placebo. Most adverse experiences were mild in intensity and transient in nature and did not require discontinuation of therapy.

Adverse events occurring at an incidence of 2% or more in patients treated with telmisartan/hydrochlorothiazide and at a greater rate than in patients treated with placebo, irrespective of their causal association, are presented in Table 1.

TABLE 1 Adverse Events Occurring in ≥ 2% of Telmisartan/Hydrochlorothiazide (HCTZ) Patients*
* includes all doses of telmisartan (20-160 mg), hydrochlorothiazide (6.25-25 mg), and combinations thereof
  Telm/HCTZ Placebo Telm HCTZ
  (N=414) (N=74) (N=209) (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

The following adverse events were reported at a rate less than 2% in patients treated with telmisartan/hydrochlorothiazide and at a greater rate than in patients treated with placebo: back pain, dyspepsia, vomiting, tachycardia, hypokalemia, bronchitis, pharyngitis, rash, hypotension postural, abdominal pain.

Finally, the following adverse events were reported at a rate of 2% or greater in patients treated with telmisartan/hydrochlorothiazide, but were as, or more common in the placebo group: pain, headache, cough, urinary tract infection.

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

In controlled trials (n=1017), 0.3% of patients treated with Micardis® HCT (telmisartan and hydrochlorothiazide) tablets 40/12.5 mg, 80/12.5 mg or 80/25 mg discontinued due to orthostatic hypotension, and the incidence of dizziness was 4%, 7%, and 1%, respectively.

Telmisartan

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

Autonomic Nervous System : impotence, increased sweating, flushing

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

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

CNS : insomnia, somnolence, migraine, vertigo, paresthesia, involuntary muscle contractions, hypoaesthesia

Gastrointestinal : flatulence, constipation, gastritis, dry mouth, hemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache, non-specific gastrointestinal disorders

Metabolic : gout, hypercholesterolemia, diabetes mellitus

Musculoskeletal : arthritis, arthralgia, leg cramps, myalgia

Psychiatric : anxiety, depression, nervousness

Resistance Mechanism : infection, fungal 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

A single case of angioedema was reported (among a total of 3781 patients treated with telmisartan).

Hydrochlorothiazide

Other adverse experiences that have been reported with hydrochlorothiazide, without regard to causality, 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, hyperuricemia

Musculoskeletal : muscle spasm

Nervous System/Psychiatric : restlessness

Renal : renal failure, renal dysfunction, interstitial nephritis

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

Special Senses : transient blurred vision, xanthopsia

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of Micardis® (telmisartan) tablets. 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. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to MICARDIS tablets. The most frequently spontaneously reported events include: headache, dizziness, asthenia, coughing, nausea, fatigue, weakness, edema, face edema, lower limb edema, angioneurotic edema, urticaria, hypersensitivity, sweating increased, erythema, chest pain, atrial fibrillation, congestive heart failure, myocardial infarction, blood pressure increased, hypertension aggravated, hypotension (including postural hypotension), hyperkalemia, syncope, dyspepsia, diarrhea, pain, urinary tract infection, erectile dysfunction, back pain, abdominal pain, muscle cramps (including leg cramps), myalgia, bradycardia, eosinophilia, thrombocytopenia, uric acid increased, abnormal hepatic function/liver disorder, renal impairment including acute renal failure, anemia, increased CPK, anaphylactic reaction, tendon pain (including tendonitis, tenosynovitis), drug eruption (toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), hypoglycemia (in diabetic patients), and angioedema (with fatal outcome).

Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers, including MICARDIS tablets.

Clinical Laboratory Findings

In controlled trials, clinically relevant changes in standard laboratory test parameters were rarely associated with administration of Micardis® HCT (telmisartan and hydrochlorothiazide) tablets.

Hemoglobin and Hematocrit : Decreases in hemoglobin (≥ 2 g/dL) and hematocrit (≥ 9%) were observed in 1.2% and 0.6% of telmisartan/hydrochlorothiazide patients, respectively, in controlled trials. Changes in hemoglobin and hematocrit were not considered clinically significant and there were no discontinuations due to anemia.

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 due to an increase in BUN or creatinine.

Liver Function Tests : Occasional elevations of liver enzymes and/or serum bilirubin have occurred. No telmisartan/hydrochlorothiazide treated patients discontinued therapy due to abnormal hepatic function.

Serum Electrolytes : See PRECAUTIONS .



REPORTS OF SUSPECTED MICARDIS HCT SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Micardis HCT side effects / adverse reactions in 81 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-10-03

Patient: 81 year old female

Reactions: Confusional State, Agitation, Blood Creatine Phosphokinase Increased, Hyponatraemia, Coma, Delirium, Blood Creatinine Increased

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Micardis HCT
    Dosage: 80mg/12.5mg
    Start date: 2008-05-06
    End date: 2008-11-20

Lyrica
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2008-11-08
    End date: 2008-11-17

Acetaminophen with Propoxyphene HCL TAB
    Administration route: Oral
    Start date: 2008-11-08
    End date: 2008-11-17

Other drugs received by patient: Rosuvastatin; Levothyroxine; Aspirin; Micardis HCT; Betaxolol; Dextropropoxyphene Hydrochloride



Possible Micardis HCT side effects / adverse reactions in 74 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-10-19

Patient: 74 year old female

Reactions: Food Intolerance, Diarrhoea, Drug Interaction, Rash, Device Related Infection, Renal Failure Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Doxycycline
    Administration route: Oral
    Indication: Device Related Infection
    Start date: 2011-04-19

Perindopril Erbumine
    Administration route: Oral
    End date: 2011-05-14

Celebrex
    Administration route: Oral
    End date: 2011-05-14

Clindamycin HCL
    Indication: Device Related Infection

Micardis HCT
    Dosage: 80mg/12.5mg
    Administration route: Oral
    End date: 2011-05-14

Bactrim
    Indication: Device Related Infection
    Start date: 2011-04-13
    End date: 2011-05-14

Ofloxacin
    Indication: Device Related Infection

Other drugs received by patient: Ginkor Fort; Acetaminophen; Structum; Oxacillin



Possible Micardis HCT side effects / adverse reactions in 89 year old male

Reported by a consumer/non-health professional from United States on 2011-10-28

Patient: 89 year old male

Reactions: Hypertension

Suspect drug(s):
Micardis HCT

Other drugs received by patient: Coreg; Aspirin; Norvasc; Plavix



See index of all Micardis HCT side effect reports >>

Drug label data at the top of this Page last updated: 2014-12-19

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017