Summary

More frequently reported side effects include: cough. Continue reading for a comprehensive list of adverse effects.

Applies to fosinopril / hydrochlorothiazide: oral tablet.

Serious side effects

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

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]