Monopril

[Fosinopril]

Musculoskeletal

Muscle ache, swelling of an extremity, weakness of an extremity.

Nervous/ Psychiatric

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Cerebral infarction, TIA, depression, numbness, paresthesia, vertigo, behavior change, tremor. Respiratory: Abnormal vocalization, rhinitis, sinus abnormality, tracheobronchitis, abnormal breathing, pleuritic chest pain.

Special Senses

Vision disturbance, taste disturbance.

Urogenital

Abnormal urination, kidney pain.
Fetal/ Neonatal Morbidity and Mortality See WARNINGS: Fetal/ Neonatal Morbidity and Mortality.

Potential Adverse Effects Reported with ACE Inhibitors

Body as a whole:

Anaphylactoid reactions (see WARNINGS: Anaphylactoid and possible related reactions and PRECAUTIONS: Hemodialysis).

Other medically important adverse effects reported with ACE inhibitors include:
Cardiac arrest; eosinophilic pneumonitis; neutropenia/ agranulocytosis, pancytope-nia, anemia (including hemolytic and aplastic), thrombocytopenia; acute renal failure; hepatic failure, jaundice (hepatocellular or cholestatic); symptomatic hyponatremia; bullous pemphigus, exfoliative dermatitis; a syndrome which may include: arthral-gia/ arthritis, vasculitis, serositis, myalgia, fever, rash or other dermatologic manifes-tations, a positive ANA, leukocytosis, eosinophilia, or an elevated ESR.

Laboratory Test Abnormalities Serum Electrolytes:

Hyperkalemia, (see PRECAUTIONS); hyponatremia, (see PRE-CAUTIONS:
Drug Interactions, With diuretics).

BUN/ Serum Creatinine:

Elevations, usually transient and minor, of BUN or serum creatinine have been observed. In placebo-controlled clinical trials, there were no significant differences in the number of patients experiencing increases in serum creatinine (outside the normal range or 1.33 times the pre-treatment value) between the fosinopril and placebo treatment groups. Rapid reduction of longstanding or markedly elevated blood pressure by any antihypertensive therapy can result in decreases in the glomerular filtration rate and, in turn, lead to increases in BUN or serum creatinine. (See PRECAUTIONS: General.)

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