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Monopril HCT Side Effects

Generic Name: fosinopril / hydrochlorothiazide

Note: This document contains side effect information about fosinopril / hydrochlorothiazide. Some of the dosage forms listed on this page may not apply to the brand name Monopril HCT.

For the Consumer

Applies to fosinopril / hydrochlorothiazide: oral tablet

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 hands or feet
  • rapid breathing
  • seizures
  • sunken eyes
  • sweating
  • thirst
  • trembling
  • unusual tiredness or weakness
  • weakness and heaviness of legs
  • wrinkled skin

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
  • nasal congestion
  • nausea and vomiting
  • runny nose
  • sneezing
  • sore throat
  • weakness

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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Monopril HCT (fosinopril-hydrochlorothiazide)." Bristol-Myers Squibb, Princeton, NJ.

Some side effects of Monopril HCT may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

More about Monopril HCT (fosinopril / hydrochlorothiazide)

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