DrugLib.com — Drug Information Portal

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

Monopril (Fosinopril Sodium) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

MONOPRIL has been evaluated for safety in more than 2100 individuals in hypertension and heart failure trials, including approximately 530 patients treated for a year or more. Generally adverse events were mild and transient, and their frequency was not prominently related to dose within the recommended daily dosage range.

Hypertension

In placebo-controlled clinical trials (688 MONOPRIL-treated patients), the usual duration of therapy was two to three months. Discontinuations due to any clinical or laboratory adverse event were 4.1% and 1.1% in MONOPRIL-treated and placebo-treated patients, respectively. The most frequent reasons (0.4 to 0.9%) were headache, elevated transaminases, fatigue, cough (see PRECAUTIONS: General, Cough ), diarrhea, and nausea and vomiting.

During clinical trials with any MONOPRIL regimen, the incidence of adverse events in the elderly (≥65 years old) was similar to that seen in younger patients.

Clinical adverse events probably or possibly related or of uncertain relationship to therapy, occurring in at least 1% of patients treated with MONOPRIL alone and at least as frequent on MONOPRIL as on placebo in placebo-controlled clinical trials are shown in the table below.

Clinical Adverse Events in Placebo-Controlled Trials (Hypertension)
MONOPRIL
(N=688)
Incidence
(Discontinuation)
Placebo
(N=184)
Incidence
(Discontinuation)
Cough2.2 (0.4)0.0 (0.0)
Dizziness1.6 (0.0)0.0 (0.0)
Nausea/Vomiting1.2 (0.4)0.5 (0.0)

The following events were also seen at >1% on MONOPRIL but occurred in the placebo group at a greater rate: headache, diarrhea, fatigue, and sexual dysfunction. Other clinical events probably or possibly related, or of uncertain relationship to therapy occurring in 0.2 to 1.0% of patients (except as noted) treated with MONOPRIL in controlled or uncontrolled clinical trials (N=1479) and less frequent, clinically significant events include (listed by body system):

General: Chest pain, edema, weakness, excessive sweating.

Cardiovascular: Angina/myocardial infarction, cerebrovascular accident, hypertensive crisis, rhythm disturbances, palpitations, hypotension, syncope, flushing, claudication.

Orthostatic hypotension occurred in 1.4% of patients treated with fosinopril monotherapy. Hypotension or orthostatic hypotension was a cause for discontinuation of therapy in 0.1% of patients.

Dermatologic: Urticaria, rash, photosensitivity, pruritus.

Endocrine/Metabolic: Gout, decreased libido.

Gastrointestinal: Pancreatitis, hepatitis, dysphagia, abdominal distention, abdominal pain, flatulence, constipation, heartburn, appetite/weight change, dry mouth.

Hematologic: Lymphadenopathy.

Immunologic: Angioedema. (See WARNINGS: Head and Neck Angioedema and Intestinal Angioedema.)

Musculoskeletal: Arthralgia, musculoskeletal pain, myalgia/muscle cramp.

Nervous/Psychiatric: Memory disturbance, tremor, confusion, mood change, paresthesia, sleep disturbance, drowsiness, vertigo.

Respiratory: Bronchospasm, pharyngitis, sinusitis/rhinitis, laryngitis/hoarseness, epistaxis. A symptom-complex of cough, bronchospasm, and eosinophilia has been observed in two patients treated with fosinopril.

Special Senses: Tinnitus, vision disturbance, taste disturbance, eye irritation.

Urogenital: Renal insufficiency, urinary frequency.

Heart Failure

In placebo-controlled clinical trials (361 MONOPRIL-treated patients), the usual duration of therapy was 3-6 months. Discontinuations due to any clinical or laboratory adverse event, except for heart failure, were 8.0% and 7.5% in MONOPRIL-treated and placebo-treated patients, respectively. The most frequent reason for discontinuation of MONOPRIL was angina pectoris (1.1%). Significant hypotension after the first dose of MONOPRIL occurred in 14/590 (2.4%) of patients; 5/590 (0.8%) patients discontinued due to first dose hypotension.

Clinical adverse events probably or possibly related or of uncertain relationship to therapy, occurring in at least 1% of patients treated with MONOPRIL and at least as common as the placebo group, in placebo-controlled trials are shown in the table below.

Clinical Adverse Events in Placebo-Controlled Trials (Heart Failure)
MONOPRIL
(N=361)
Incidence
(Discontinuation)
Placebo
(N=373)
Incidence
(Discontinuation)
Dizziness11.9 (0.6)5.4 (0.3)
Cough9.7 (0.8)5.1 (0.0)
Hypotension4.4 (0.8)0.8 (0.0)
Musculoskeletal Pain3.3 (0.0)2.7 (0.0)
Nausea/Vomiting2.2 (0.6)1.6 (0.3)
Diarrhea2.2 (0.0)1.3 (0.0)
Chest Pain (non-cardiac)2.2 (0.0)1.6 (0.0)
Upper Respiratory Infection2.2 (0.0)1.3 (0.0)
Orthostatic Hypotension1.9 (0.0)0.8 (0.0)
Subjective Cardiac Rhythm Disturbance1.4 (0.6)0.8 (0.3)
Weakness1.4 (0.3)0.5 (0.0)

The following events also occurred at a rate of 1% or more on MONOPRIL (fosinopril sodium tablets) but occurred on placebo more often: fatigue, dyspnea, headache, rash, abdominal pain, muscle cramp, angina pectoris, edema, and insomnia.

The incidence of adverse events in the elderly (≥65 years old) was similar to that seen in younger patients.

Other clinical events probably or possibly related, or of uncertain relationship to therapy occurring in 0.4 to 1.0% of patients (except as noted) treated with MONOPRIL in controlled clinical trials (N=516) and less frequent, clinically significant events include (listed by body system):

General: Fever, influenza, weight gain, hyperhidrosis, sensation of cold, fall, pain.

Cardiovascular: Sudden death, cardiorespiratory arrest, shock (0.2%), atrial rhythm disturbance, cardiac rhythm disturbances, non-anginal chest pain, edema lower extremity, hypertension, syncope, conduction disorder, bradycardia, tachycardia.

Dermatologic: Pruritus.

Endocrine/Metabolic: Gout, sexual dysfunction.

Gastrointestinal: Hepatomegaly, abdominal distension, decreased appetite, dry mouth, constipation, flatulence.

Immunologic: Angioedema (0.2%).

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

Nervous/Psychiatric: 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, pancytopenia, 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: arthralgia/arthritis, vasculitis, serositis, myalgia, fever, rash or other dermatologic manifestations, a positive ANA, leukocytosis, eosinophilia, or an elevated ESR.

Laboratory Test Abnormalities

Serum Electrolytes: Hyperkalemia, (see PRECAUTIONS); hyponatremia, (see PRECAUTIONS: 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.)

Hematology: In controlled trials, a mean hemoglobin decrease of 0.1 g/dL was observed in fosinopril-treated patients. In individual patients decreases in hemoglobin or hematocrit were usually transient, small, and not associated with symptoms. No patient was discontinued from therapy due to the development of anemia. Other: Neutropenia (see WARNINGS), leukopenia and eosinophilia.

Liver Function Tests: Elevations of transaminases, LDH, alkaline phosphatase and serum bilirubin have been reported. Fosinopril therapy was discontinued because of serum transaminase elevations in 0.7% of patients. In the majority of cases, the abnormalities were either present at baseline or were associated with other etiologic factors. In those cases which were possibly related to fosinopril therapy, the elevations were generally mild and transient and resolved after discontinuation of therapy.

Pediatric Patients

The adverse experience profile for pediatric patients is similar to that seen in adult patients with hypertension. The long-term effects of MONOPRIL on growth and development have not been studied.



REPORTS OF SUSPECTED MONOPRIL SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Monopril side effects / adverse reactions in 53 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-17

Patient: 53 year old female weighing 96.6 kg (212.6 pounds)

Reactions: Renal Impairment, Drug Effect Decreased, Road Traffic Accident, Diabetes Mellitus, Pain, Dyscalculia, Feeling Abnormal

Suspect drug(s):
Lyrica
    Dosage: 150 mg/bid/po
    Administration route: Oral
    Indication: Neuropathy Peripheral
    Start date: 2010-01-01
    End date: 2010-01-01

Lyrica
    Dosage: 150 mg/bid/po
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2010-01-01
    End date: 2010-01-01

Monopril

Prinivil
    Dosage: //po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Atacand

Atenolol
    Dosage: / / po ; 150 mg/tid po ; 175 mg tid/po ; 100 mg/bid/po
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2010-01-01
    End date: 2010-01-01

Atenolol
    Dosage: / / po ; 150 mg/tid po ; 175 mg tid/po ; 100 mg/bid/po
    Administration route: Oral
    Indication: Neuropathy Peripheral
    Start date: 2010-01-01
    End date: 2010-01-01

Atenolol
    Dosage: / / po ; 150 mg/tid po ; 175 mg tid/po ; 100 mg/bid/po
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2010-01-01

Atenolol
    Dosage: / / po ; 150 mg/tid po ; 175 mg tid/po ; 100 mg/bid/po
    Administration route: Oral
    Indication: Neuropathy Peripheral
    Start date: 2010-01-01

Atenolol
    Dosage: / / po ; 150 mg/tid po ; 175 mg tid/po ; 100 mg/bid/po
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2010-08-01
    End date: 2010-08-29

Atenolol
    Dosage: / / po ; 150 mg/tid po ; 175 mg tid/po ; 100 mg/bid/po
    Administration route: Oral
    Indication: Neuropathy Peripheral
    Start date: 2010-08-01
    End date: 2010-08-29

Other drugs received by patient: Valium; Soma; Hydrochlorothiazide; Potassium; Metformin HCL; Percocet; Cymbalta



Possible Monopril side effects / adverse reactions in 53 year old female

Reported by a consumer/non-health professional from United States on 2011-10-19

Patient: 53 year old female weighing 97.5 kg (214.5 pounds)

Reactions: Mental Impairment, Neuropathy Peripheral, Renal Impairment, Road Traffic Accident, Fibromyalgia, Blood Cholesterol Increased, Back Disorder, Neuralgia

Suspect drug(s):
Atenolol

Lyrica
    Administration route: Oral
    Start date: 2010-01-01
    End date: 2010-01-01

Lyrica
    Start date: 2010-01-01
    End date: 2010-01-01

Lyrica
    Start date: 2010-01-01
    End date: 2010-01-01

Lyrica
    Administration route: Oral
    Indication: Fibromyalgia

Lyrica
    Administration route: Oral
    Start date: 2010-01-01
    End date: 2010-01-01

Lyrica
    Start date: 2010-01-01
    End date: 2010-01-01

Lyrica
    Start date: 2010-08-01
    End date: 2010-08-29

Lyrica
    Start date: 2010-01-01
    End date: 2010-01-01

Lyrica
    Start date: 2010-01-01
    End date: 2010-01-01

Lyrica
    Start date: 2010-08-01
    End date: 2010-08-29

Lisinopril
    Administration route: Oral

Monopril

Lyrica
    Administration route: Oral
    Start date: 2010-01-01
    End date: 2010-01-01

Lyrica
    Administration route: Oral
    Indication: Back Disorder

Lyrica
    Administration route: Oral
    Indication: Neuralgia

Lyrica
    Administration route: Oral
    Start date: 2010-01-01
    End date: 2010-01-01

Lyrica
    Start date: 2010-01-01
    End date: 2010-01-01

Atacand
    Administration route: Oral

Lyrica
    Administration route: Oral
    Indication: Neuropathy Peripheral

Lyrica
    Start date: 2010-01-01
    End date: 2010-01-01

Lyrica
    Start date: 2010-01-01
    End date: 2010-01-01

Lyrica
    Start date: 2010-08-01
    End date: 2010-08-29

Lyrica
    Start date: 2010-08-01
    End date: 2010-08-29

Other drugs received by patient: Soma; Potassium; Percocet; Cymbalta; Metformin HCL; Hydrochlorothiazide; Valium



Possible Monopril side effects / adverse reactions in 53 year old female

Reported by a consumer/non-health professional from United States on 2011-10-21

Patient: 53 year old female

Reactions: Mental Impairment, Neuropathy Peripheral, Renal Impairment, Road Traffic Accident, Fibromyalgia, Blood Cholesterol Increased, Back Disorder, Neuralgia

Suspect drug(s):
Atenolol

Atacand
    Administration route: Oral

Lyrica
    Dosage: 150 mg, 2x/day
    Indication: Back Pain

Lisinopril
    Administration route: Oral

Monopril

Lyrica
    Dosage: 175 mg, 3x/day

Lyrica
    Dosage: 150 mg, 3x/day
    Indication: Fibromyalgia

Lyrica
    Dosage: 100 mg, 2x/day
    Start date: 2010-08-01
    End date: 2010-08-29

Lyrica
    Dosage: 200 mg, 3x/day
    Administration route: Oral
    Indication: Neuropathy Peripheral

Other drugs received by patient: Potassium; Percocet; Soma; Valium; Cymbalta; Hydrochlorothiazide; Metformin



See index of all Monopril side effect reports >>

Drug label data at the top of this Page last updated: 2006-07-10

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

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