Amtrel Adverse Reactions

International studies have revealed that, in over 1600 hypertensive patients >500 received treatment with the formula of the same ingredients for at least 6 months and >400 received treatment for >1 year. Reports on side effects were mild and temporary, and these side effects had no correlation with age, gender, race and treatment duration. Approximately 4% of patients that received the combined formula and 3% of patients that received placebo stopped treatment due to side effects. Most common side effects were coughs and edema*. The following table indicates the more common side effects associated with the formula with the same ingredients as reported in the placebo-controlled clinical study from the United States. See Table 1.

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Patients that received only amlodipine had a higher rate of edema compared to patients taking the combination therapy and the difference has reached statistical significance. Edema and other side effects are related with the dosage of amlodipine, and are more common in females. The addition of benazepril decreased the rate of side effects and was uncorrelated with race (within the range of tested dosage). See Table 2.

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The following list depicts the possible side effects associated with the combination formula reported by the placebo-controlled clinical trials involving the formula with identical ingredients performed in the United States and side effects reported after Amtrel has been marketed: Vascular Edema: Including the lips or face (see Vascular Edema under Warnings).
Systemic: Weakness, fatigue.
Central and Peripheral Nervous System: Insomnia, anxiety, shaking, decreased libido.
Skin: Facial hot flushes, rashes, skin nodules, dermatitis.
Gastrointestinal System: Dry mouth, nausea, abdominal pain, constipation, diarrhea, indigestion, esophagitis.
Metabolic and Nutrition: Hypokalemia.
Musculoskeletal System: Back pain, musculoskeletal pain, spasm.
Respiratory System: Laryngitis.
Urinary and Reproductive System: Impotence, frequent urination.
Other rare adverse effects not necessarily associated with Amtrel include chest pain, premature ventricular contraction, gout, neuritis, tinnitus and alopecia.
Fetus/Newborn Disease Incidence and Death Rate: See Warnings.