ADVERSE REACTIONS
The following adverse reaction is described elsewhere in labeling:
Renal dysfunction upon use with
ramipril
[see Warnings and Precautions ]
Clinical TrialsExperience
Because clinical
studies are conducted under widely varying conditions, adverse reactions
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.
Hypertension
MICARDIS has been evaluated for safety in more than 3700 patients,
including 1900 treated for over 6 months and more than 1300 for over
one year. Adverse experiences have generally been mild and transient
in nature and have infrequently required discontinuation of therapy.
In placebo-controlled trials involving 1041
patients treated with various doses of MICARDIS (20 to 160 mg) monotherapy
for up to 12 weeks, the overall incidence of adverse events was similar
to that in patients treated with placebo.
Adverse events occurring at an incidence of ≥1% in patients
treated with MICARDIS 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 at an Incidence of ≥1% in Patients Treated
with MICARDIS and at a Greater Rate Than Patients Treated with Placebo
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Telmisartan n=1455 %
|
Placebo n=380 %
|
Upper respiratory
tract infection |
7 |
6 |
Back pain |
3 |
1 |
Sinusitis |
3 |
2 |
Diarrhea |
3 |
2 |
Pharyngitis |
1 |
0 |
In addition to the adverse events
in the table, the following events occurred at a rate of ≥1% but were
at least as frequent in the placebo group: influenza-like symptoms,
dyspepsia, myalgia, urinary tract infection, abdominal pain, headache,
dizziness, pain, fatigue, coughing, hypertension, chest pain, nausea,
and peripheral edema. Discontinuation of therapy because of adverse
events was required in 2.8% of 1455 patients treated with MICARDIS
tablets and 6.1% of 380 placebo patients in placebo-controlled clinical
trials.
The incidence of adverse
events was not dose-related and did not correlate with gender, age,
or race of patients.
The incidence
of cough occurring with telmisartan in 6 placebo-controlled trials
was identical to that noted for placebo-treated patients (1.6%).
In addition to those listed above, adverse
events that occurred in more than 0.3% of 3500 patients treated with
MICARDIS monotherapy in controlled or open trials are listed below.
It cannot be determined whether these events were causally related
to MICARDIS tablets:
Autonomic Nervous System
: impotence, increased
sweating, flushing;
Body as a Whole
: allergy, fever, leg pain,
malaise;
Cardiovascular
: palpitation,
dependent edema, angina pectoris, tachycardia, leg edema, abnormal
ECG;
CNS
: insomnia, somnolence,
migraine, vertigo, paresthesia, involuntary muscle contractions, hypoesthesia;
Gastrointestinal
: flatulence, constipation,
gastritis, vomiting, dry mouth, hemorrhoids, gastroenteritis, enteritis,
gastroesophageal reflux, toothache, non-specific gastrointestinal
disorders;
Metabolic
: gout,
hypercholesterolemia, diabetes mellitus;
Musculoskeletal
: arthritis, arthralgia, leg cramps;
Psychiatric
: anxiety, depression, nervousness;
Resistance Mechanism
: infection, fungal
infection, abscess, otitis media;
Respiratory
: asthma, bronchitis, rhinitis, dyspnea, epistaxis;
Skin
: dermatitis, rash, eczema, pruritus;
Urinary
: micturition frequency, cystitis;
Vascular
: cerebrovascular disorder;
and
Special Senses
: abnormal
vision, conjunctivitis, tinnitus, earache.
During initial clinical studies, a single case of angioedema
was reported (among a total of 3781 patients treated).
Clinical Laboratory Findings
In placebo-controlled
clinical trials, clinically relevant changes in standard laboratory
test parameters were rarely associated with administration of MICARDIS
tablets.
Hemoglobin: A greater than 2 g/dL decrease in hemoglobin was observed in 0.8%
telmisartan patients compared with 0.3% placebo patients. No patients
discontinued therapy because of anemia.
Creatinine: A 0.5 mg/dL rise
or greater in creatinine was observed in 0.4% telmisartan patients
compared with 0.3% placebo patients. One telmisartan-treated patient
discontinued therapy because of increases in creatinine and blood
urea nitrogen.
Liver
Enzymes: Occasional elevations of liver chemistries occurred
in patients treated with telmisartan; all marked elevations occurred
at a higher frequency with placebo. No telmisartan-treated patients
discontinued therapy because of abnormal hepatic function.
Cardiovascular Risk Reduction
Because common adverse
reactions were well characterized in studies of telmisartan in hypertension,
only adverse events leading to discontinuation and serious adverse
events were recorded in subsequent studies of telmisartan for cardiovascular
risk reduction. In TRANSCEND (N=5926, 4 years and 8 months of follow-up),
discontinuations for adverse events were 8.4% on telmisartan and 7.6%
on placebo. The only serious adverse events at least 1% more common
on telmisartan than placebo were intermittent claudication (7% vs
6%) and skin ulcer (3% vs 2%).
Postmarketing Experience
The following adverse reactions have been
identified during post-approval use of MICARDIS. 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.
The most frequent 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.
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REPORTS OF SUSPECTED MICARDIS SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Micardis. The information is not vetted and should not be considered as verified clinical evidence.
Possible Micardis side effects / adverse reactions in 80 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-04
Patient: 80 year old female
Reactions: Malaise, Acute Generalised Exanthematous Pustulosis, Pyrexia, Erythema Multiforme, Dermatitis Exfoliative
Adverse event resulted in: hospitalization
Suspect drug(s):
Voltaren
Acetaminophen
Indication: Pyrexia
End date: 2008-11-01
Micardis
End date: 2008-11-01
Cefdinir
End date: 2008-11-01
Diltiazem HCL
End date: 2008-11-01
Sucralfate
End date: 2008-11-01
Possible Micardis side effects / adverse reactions in 81 year old male
Reported by a individual with unspecified qualification from Japan on 2011-10-04
Patient: 81 year old male
Reactions: Bladder Cancer
Adverse event resulted in: life threatening event
Suspect drug(s):
Livalo
Dosage: 1 mg (1 mg, 1 in 1 d), per oral
Administration route: Oral
Indication: Hyperlipidaemia
Start date: 2006-06-24
Magmitt (Magnesium Oxide)
Dosage: 1500 mg (500 mg, 3 in 1 d), per oral
Administration route: Oral
Indication: Constipation
Start date: 2006-06-24
Micardis
Dosage: 40 mg (40 mg, 1 in 1 d), per oral
Administration route: Oral
Indication: Hypertension
Start date: 2006-06-24
Actos
Dosage: 15 mg (15 mg, 1 in 1 d), per oral;
Indication: Blood Glucose Abnormal
Start date: 2006-06-24
End date: 2008-05-16
Actos
Dosage: 15 mg (15 mg, 1 in 1 d), per oral;
Indication: Blood Glucose Abnormal
Start date: 2008-10-10
End date: 2010-08-21
Possible Micardis side effects / adverse reactions in 60 year old male
Reported by a physician from Japan on 2011-10-05
Patient: 60 year old male
Reactions: Road Traffic Accident, Dizziness, Loss of Consciousness
Suspect drug(s):
Aspirin
Dosage: unk
Administration route: Oral
Januvia
Dosage: unk
Administration route: Oral
Omeprazole
Dosage: unk
Administration route: Oral
Micardis
Dosage: unk
Administration route: Oral
Isosorbide Dinitrate
Dosage: unk
Varenicline Tartrate
Dosage: 0.5 mg, 2x/day
Administration route: Oral
Start date: 2011-06-04
End date: 2011-06-07
Varenicline Tartrate
Dosage: 1 mg, 2x/day
Administration route: Oral
Start date: 2011-06-08
End date: 2011-08-24
Crestor
Dosage: unk
Administration route: Oral
Plavix
Dosage: unk
Administration route: Oral
Varenicline Tartrate
Dosage: 0.5 mg, 1x/day
Administration route: Oral
Indication: Smoking Cessation Therapy
Start date: 2011-06-01
End date: 2011-06-03
Levothyroxine Sodium
Dosage: unk
Administration route: Oral
Halcion
Dosage: unk
Administration route: Oral
Indication: Insomnia
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