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Zestril

Last reviewed on RxList: 8/3/2017
Zestril Side Effects Center

Last reviewed on RxList 8/03/2017

Zestril (lisinopril) is an angiotensin-converting enzyme (ACE) inhibitor used to treat high blood pressure (hypertension), congestive heart failure, and to improve survival after a heart attack. Side effects of Zestril include:

  • cough,
  • dizziness,
  • drowsiness,
  • headache,
  • depression,
  • nausea,
  • vomiting,
  • diarrhea,
  • upset stomach, and
  • mild skin itching or rash.

Tell your doctor if you have unlikely but serious side effects of Zestril including:

  • fainting,
  • symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat, weak pulse, tingly feeling),
  • signs of infection (such as fever, chills, persistent sore throat, body aches, flu symptoms),
  • changes in the amount of urine,
  • swelling,
  • rapid weight gain,
  • tired feeling,
  • pounding or uneven heartbeats,
  • psoriasis (raised, silvery flaking of the skin), or
  • chest pain.

The recommended initial dose of Zestril is 10 mg once a day. Zestril is taken orally in tablet form. Zestril may interact with other blood pressure medications, gold injections, lithium potassium supplements, salt substitutes that contain potassium, insulin or oral diabetes medications, aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs), or diuretics (water pills). Tell your doctor all medications and supplements you use. ACE inhibitors can cause fetal and neonatal morbidity and death when administered to pregnant women. When pregnancy is detected, ACE inhibitors should be discontinued as soon as possible. It is not known whether this drug is excreted in human milk. Consult your doctor before breastfeeding.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Zestril Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • urinating less than usual or not at all;
  • swelling, rapid weight gain;
  • fever, chills, body aches, flu symptoms;
  • tired feeling, muscle weakness, and pounding or uneven heartbeats;
  • psoriasis (raised, silvery flaking of the skin);
  • chest pain; or
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);

Less serious side effects may include:

  • cough;
  • dizziness, drowsiness, headache;
  • depressed mood;
  • nausea, vomiting, diarrhea, upset stomach; or
  • mild skin itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Zestril (Lisinopril)

Zestril Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Hypertension

In clinical trials in patients with hypertension treated with Zestril, 5.7% of patients on Zestril discontinued with adverse reactions.

The following adverse reactions (events 2% greater on Zestril than on placebo) were observed with Zestril alone: headache (by 3.8%), dizziness (by 3.5%), cough (by 2.5%).

Heart Failure

In patients with systolic heart failure treated with Zestril for up to four years, 11% discontinued therapy with adverse reactions. In controlled studies in patients with heart failure, therapy was discontinued in 8.1% of patients treated with Zestril for 12 weeks, compared to 7.7% of patients treated with placebo for 12 weeks.

The following adverse reactions (events 2% greater on Zestril than on placebo) were observed with Zestril: hypotension (by 3.8%), chest pain (by 2.1%).

In the two-dose ATLAS trial [see Clinical Studies] in heart failure patients, withdrawals due to adverse reactions were not different between the low and high groups, either in total number of discontinuation (17-18%) or in rare specific reactions ( < 1%). The following adverse reactions, mostly related to ACE inhibition, were reported more commonly in the high dose group:

Table 1 : Dose-related Adverse Drug Reactions : ATLAS trial

  High Dose
(n=1568)
Low Dose
(n=1596)
Dizziness 19% 12%
Hypotension 11% 7%
Creatinine increased 10% 7%
Hyperkalemia 6% 4%
Syncope 7% 5%

Acute Myocardial Infarction

Patients treated with Zestril had a higher incidence of hypotension (by 5.3%) and renal dysfunction (by 1.3%) compared with patients not taking Zestril.

Other clinical adverse reactions occurring in 1% or higher of patients with hypertension or heart failure treated with Zestril in controlled clinical trials and do not appear in other sections of labeling are listed below:

Body as a whole: Fatigue, asthenia, orthostatic effects.

Digestive: Pancreatitis, constipation, flatulence, dry mouth, diarrhea.

Hematologic: Rare cases of bone marrow depression, hemolytic anemia, leukopenia/neutropenia and thrombocytopenia.

Endocrine: Diabetes mellitus, inappropriate antidiuretic hormone secretion.

Metabolic: Gout.

Skin: Urticaria, alopecia, photosensitivity, erythema, flushing, diaphoresis, cutaneous pseudolymphoma, toxic epidermal necrolysis, Stevens - Johnson syndrome, and pruritus.

Special Senses: Visual loss, diplopia, blurred vision, tinnitus, photophobia, taste disturbances, olfactory disturbance.

Urogenital: Impotence.

Miscellaneous: A symptom complex has been reported which may include a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia, fever, vasculitis, eosinophilia, leukocytosis, paresthesia and vertigo. Rash, photosensitivity or other dermatological manifestations may occur alone or in combination with these symptoms.

Clinical Laboratory Test Findings

Serum Potassium: In clinical trials hyperkalemia (serum potassium greater than 5.7 mEq/L) occurred in 2.2% and 4.8% of Zestril-treated patients with hypertension and heart failure, respectively [see WARNINGS AND PRECAUTIONS].

Creatinine, Blood Urea Nitrogen: Minor increases in blood urea nitrogen and serum creatinine, reversible upon discontinuation of therapy, were observed in about 2% of patients with hypertension treated with Zestril alone. Increases were more common in patients receiving concomitant diuretics and in patients with renal artery stenosis [see WARNINGS AND PRECAUTIONS]. Reversible minor increases in blood urea nitrogen and serum creatinine were observed in 11.6% of patients with heart failure on concomitant diuretic therapy. Frequently, these abnormalities resolved when the dosage of the diuretic was decreased.

Patients with acute myocardial infarction in the GISSI-3 trial treated with Zestril had a higher (2.4% versus 1.1% in placebo) incidence of renal dysfunction in-hospital and at six weeks (increasing creatinine concentration to over 3 mg/dL or a doubling or more of the baseline serum creatinine concentration).

Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.4 g% and 1.3 vol%, respectively) occurred frequently in patients treated with Zestril but were rarely of clinical importance in patients without some other cause of anemia. In clinical trials, less than 0.1% of patients discontinued therapy due to anemia.

Post-marketing Experience

The following adverse reactions have been identified during post-approval use of Zestril that are not included in other sections of labeling. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Other reactions include:

Metabolism and Nutrition Disorders

Hyponatremia [see WARNINGS AND PRECAUTIONS], cases of hypoglycemia in diabetic patients on oral antidiabetic agents or insulin [see DRUG INTERACTIONS]

Nervous System and Psychiatric Disorders

Mood alterations (including depressive symptoms), mental confusion, hallucinations

Skin and Subcutaneous Tissue Disorders

Psoriasis

Read the entire FDA prescribing information for Zestril (Lisinopril)

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