Telsat AM Adverse Reactions

Fixed dose combination: The most common adverse reactions include dizziness and peripheral edema. Serious syncope may occur rarely (less than 1 case per 1,000 patients).
Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Adverse reactions reported with telmisartan plus amlodipine are shown below according to system organ class: see table.


Click on icon to see table/diagram/image


Additional information on the combination: Peripheral edema, a recognized dose dependent adverse reaction of amlodipine, was generally observed at a lower incidence in patients who received the telmisartan/amlodipine combination than in those who received amlodipine alone.
Additional information on individual components: Adverse reactions previously reported with one of the individual components (amlodipine or telmisartan) may be potential adverse reactions with TELSAT AM as well.
Telmisartan: Infections and infestations: Uncommon: urinary tract infections, upper respiratory tract infections.
Rare: sepsis including fatal outcome.
Blood and lymphatic system disorders: Uncommon: anemia.
Rare: eosinophilia, thrombocytopenia.
Immune system disorders: Rare: anaphylactic reaction, hypersensitivity.
Metabolism and nutrition disorders: Uncommon: hyperkalemia.
Rare: hypoglycemia (in diabetic patients).
Eye disorders: Rare: visual disturbance.
Cardiac disorders: Rare: tachycardia.
Respiratory, thoracic, and mediastinal disorders: Uncommon: dyspnea.
Gastrointestinal disorders: Uncommon: flatulence.
Rare: stomach discomfort.
Hepatobiliary disorders: Rare: hepatic function abnormal, liver disorder.
*Most cases of hepatic function abnormal/liver disorder from postmarketing experience with telmisartan occurred in patients in Japan, who are more likely to experience these adverse reactions.
Skin and subcutaneous tissue disorders: Uncommon: hyperhidrosis.
Rare: angioedema (with fatal outcome), urticaria, drug eruption, toxic skin eruption.
Musculoskeletal and connective tissue disorders: Rare: tendon pain (tendinitis like symptoms).
Renal and urinary disorders: Uncommon: renal impairment including acute renal failure.
General disorders: Rare: influenza-like illness.
Investigations: Uncommon: blood creatinine increased.
Very rare: blood creatine phosphokinase (CPK) increased, hemoglobin decreased.
Amlodipine: Blood and lymphatic system disorders: Very rare: thrombocytopenia, leukopenia.
Immune system disorders: Very rare: hypersensitivity.
Metabolism and nutrition disorders: Very rare: hyperglycemia.
Psychiatric disorders: Uncommon: mood change.
Rare: confusional state.
Nervous system disorders: Very rare: extrapyramidal disorder.
Eye disorders: Uncommon: visual impairment.
Ear and labyrinth disorders: Uncommon: tinnitus.
Cardiac disorders: Very rare: myocardial infarction, arrhythmia, ventricular tachycardia, atrial fibrillation.
Vascular disorders: Very rare: vasculitis.
Respiratory, thoracic, and mediastinal disorders: Uncommon: dyspnea, rhinitis.
Gastrointestinal disorders: Uncommon: change of bowel habit.
Very rare: pancreatitis, gastritis.
Hepatobiliary disorders: Very rare: hepatitis, jaundice, hepatic enzyme elevations (mostly consistent with cholestasis).
Skin and subcutaneous tissue disorders: Uncommon: alopecia, purpura, skin discoloration, hyperhidrosis.
Very rare: angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, photosensitivity reaction.
Renal and urinary disorders: Uncommon: micturition disorder, pollakiuria.
Reproductive system and breast disorders: Uncommon: gynecomastia.
General disorders: Uncommon: pain.
Investigations: Uncommon: weight increased, weight decreased.