Note: This document contains side effect information about fosinopril / hydrochlorothiazide. Some dosage forms listed on this page may not apply to the brand name Monopril HCT.
Applies to fosinopril / hydrochlorothiazide: oral tablet.
Warning
Oral route (Tablet)
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue therapy as soon as possible when pregnancy is detected.
Serious side effects of Monopril HCT
Along with its needed effects, fosinopril/hydrochlorothiazide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking fosinopril / hydrochlorothiazide:
Less common
- Blurred vision
- chest pain or discomfort
- chills
- cold sweats
- confusion
- decreased urination
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- dry mouth
- fainting
- fast, slow, or irregular heartbeat
- muscle cramps or pain
- numbness, tingling, pain, or weakness in the hands or feet
- rapid breathing
- seizures
- sunken eyes
- sweating
- thirst
- trembling
- unusual tiredness or weakness
- weakness and heaviness of legs
- wrinkled skin
Incidence not known
- Persistent non-healing sore
- pink growth
- reddish patch or irritated area
- shiny bump
- white, yellow or waxy scar-like area
Other side effects of Monopril HCT
Some side effects of fosinopril / hydrochlorothiazide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Cough
Less common
- Body aches or pain
- diarrhea
- difficult breathing
- ear congestion
- fever
- headache
- loss of voice
- muscle or bone pain
- nausea and vomiting
- runny or stuffy nose
- sneezing
- sore throat
For Healthcare Professionals
Applies to fosinopril / hydrochlorothiazide: oral tablet.
General
The most common adverse reactions were cough, headache, upper respiratory infection, dizziness, weakness, musculoskeletal pain, pharyngitis, and fatigue.[Ref]
Respiratory
Common (1% to 10%): Cough, upper respiratory infection, pharyngitis, rhinitis, sinus abnormality, tracheobronchitis
Uncommon (0.1% to 1%): Congestion, dyspnea, epistaxis, sneezing
Frequency not reported: Sinus congestion
Fosinopril:
Common (1% to 10%): Cough, pharyngitis, rhinitis, upper respiratory infection
Uncommon (0.1% to 1%): Sinus abnormality, tracheobronchitis
Frequency not reported: Bronchospasm, laryngitis/hoarseness, epistaxis
Hydrochlorothiazide:
Frequency not reported: Respiratory distress, pneumonitis, pulmonary edema[Ref]
Gastrointestinal
Common (1% to 10%): Dyspepsia/heartburn, gastroenteritis, nausea/vomiting, epigastric pain
Uncommon (0.1% to 1%): Abnormal stool, constipation, diarrhea, abdominal distention, dry mouth, gastritis, oral lesion, intestinal obstruction, abdominal pain, eructation, halitosis
Frequency not reported: Esophagitis
Fosinopril:
Common (1% to 10%): Dyspepsia/heartburn, gastroenteritis, nausea/vomiting, epigastric pain
Frequency not reported: Pancreatitis, dysphagia, abdominal distention, flatulence, dry mouth
Hydrochlorothiazide:
Frequency not reported: Pancreatitis, sialadenitis, vomiting, diarrhea, cramping, nausea, gastric irritation, constipation[Ref]
Nervous system
Common (1% to 10%): Headache, dizziness, vertigo
Uncommon (0.1% to 1%): Syncope, neuropathy entrapment, memory impairment, numbness, somnolence, paresthesia
Frequency not reported: Tinnitus
Fosinopril:
Common (1% to 10%): Dizziness, headache
Frequency not reported: Cerebrovascular accident, memory disturbance, tremor, taste disturbance
Hydrochlorothiazide:
Frequency not reported: Vertigo, lightheadedness, headache, paresthesia[Ref]
Genitourinary
Common (1% to 10%): Sexual dysfunction, urinary tract infection
Uncommon (0.1% to 1%): Menstrual disorder, urination abnormality, prostate disorder, vaginal bleeding
Frequency not reported: Urinary frequency, dysuria
Fosinopril:
Uncommon (0.1% to 1%): Sexual dysfunction, urinary tract infection
Hydrochlorothiazide:
Frequency not reported: Glycosuria[Ref]
Immunologic
Common (1% to 10%): Viral infection, influenza
Uncommon (0.1% to 1%): Allergy
Fosinopril:
Common (1% to 10%): Viral infection, influenza
Hydrochlorothiazide:
Frequency not reported: Anaphylactic reactions[Ref]
Other
Common (1% to 10%): Fatigue, weakness
Uncommon (0.1% to 1%): Edema, breast disorder, chest pain, chills, fever, cold sensation, malaise, extremity swelling, ear abnormality, ear infection, hearing abnormality
Frequency not reported: Breast mass, edema lower extremity
Fosinopril:
Common (1% to 10%): Fatigue, weakness
Hydrochlorothiazide:
Frequency not reported: Weakness[Ref]
Musculoskeletal
Common (1% to 10%): Musculoskeletal pain
Uncommon (0.1% to 1%): Limitation of movement, muscle cramp, musculoskeletal trauma, musculoskeletal chest pain, tendonitis, extremity weakness
Frequency not reported: Myalgia
Fosinopril:
Common (1% to 10%): Musculoskeletal pain
Frequency not reported: Arthralgia
Hydrochlorothiazide:
Frequency not reported: Muscle spasm[Ref]
Cardiovascular
Common (1% to 10%): Orthostatic hypotension
Uncommon (0.1% to 1%): Rhythm disturbance, flushing, hypertension, non-angina cardiac chest pain, hot flashes
Fosinopril:
Frequency not reported: Angina, myocardial infarction, hypertensive crisis, hypotension, claudication
Hydrochlorothiazide:
Frequency not reported: Orthostatic hypotension, necrotizing angiitis[Ref]
Dermatologic
Uncommon (0.1% to 1%): Acne, dermatitis, ecchymosis, extremity erythema, bacterial skin infection, pruritus, rash, skin discomfort, hyperhidrosis, angioedema
Fosinopril:
Frequency not reported: Urticaria, photosensitivity
Hydrochlorothiazide:
Frequency not reported: Stevens-Johnson syndrome, purpura, urticaria, rash, photosensitivity[Ref]
Psychiatric
Uncommon (0.1% to 1%): Libido change, depression, emotional lability/disturbance, insomnia
Fosinopril:
Frequency not reported: Confusion, mood change, sleep disturbance
Hydrochlorothiazide:
Frequency not reported: Restlessness[Ref]
Metabolic
Uncommon (0.1% to 1%): Polydipsia, appetite decreased, appetite increased, weight loss
Fosinopril:
Frequency not reported: Gout, appetite/weight change
Hydrochlorothiazide:
Frequency not reported: Anorexia, hyperglycemia, hyperuricemia[Ref]
Hepatic
Uncommon (0.1% to 1%): Hepatitis
Fosinopril:
Frequency not reported: Hepatitis, transaminases elevated, lactate dehydrogenase elevated, alkaline phosphatase elevated, serum bilirubin elevated
Hydrochlorothiazide:
Frequency not reported: Intrahepatic cholestatic jaundice[Ref]
Hematologic
Frequency not reported: Neutropenia, hematocrit decreased, hemoglobin decreased, eosinophilia
Fosinopril:
Frequency not reported: Lymphadenopathy, eosinophilia, hemoglobin decreased, leukopenia
Hydrochlorothiazide:
Frequency not reported: Aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia, hemolytic anemia[Ref]
Renal
Frequency not reported: BUN elevated, creatinine elevated
Fosinopril:
Frequency not reported: Renal insufficiency, BUN elevated, creatinine elevated[Ref]
Ocular
Fosinopril:
Frequency not reported: Vision disturbance, eye irritation
Hydrochlorothiazide:
Frequency not reported: Transient blurred vision, xanthopsia[Ref]
