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Lexxel Side Effects Center
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Lexxel in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- feeling like you might pass out;
- chest pain;
- swelling in your hands or feet;
- fast, pounding, or uneven heartbeats;
- fever, chills, body aches, flu symptoms; or
- nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
- swelling in your gums;
- feeling tired or weak;
- warmth, redness, or tingling under your skin;
- dry mouth, sore throat; or
- diarrhea, constipation, upset stomach.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
Read the entire detailed patient monograph for Lexxel (Enalapril Maleate-Felodipine) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Lexxel FDA Prescribing Information: Side Effects
In a factorial study, combinations of enalapril at doses of 0, 5, and 20 mg and felodipine ER at doses of 0, 2.5, 5, and 10 mg were evaluated for safety in more than 700 patients with hypertension. In addition more than 500 patients received various combinations of enalapril (5 or 10 mg) and felodipine ER (2.5, 5, or 10 mg) with or without hydrochlorothiazide (12.5 mg) in an open-labeled study up to 52 weeks (mean 33 weeks). Adverse events were similar to those described with the individual components.
In general, treatment with enalapril maleate-felodipine ER was well tolerated and adverse events were mild and transient in nature. In the placebo-controlled, double-blind trial, discontinuation of therapy due to adverse events considered related (possibly, probably or definitely) occurred in 2.8% vs 1.3% of patients treated with the combination or placebo, respectively. The most frequently observed clinical adverse events considered related to treatment with the combination were headache, edema or swelling, and dizziness.
Clinical adverse events considered related (possibly, probably, or definitely) to treatment with enalapril-felodipine ER that occurred with an incidence of 1% or greater with the combination during the placebo-controlled, double-blind trial are compared to individual components and placebo in the table below:
|Percent of Patients with Adverse Events in the Double-Blind Trial (Percent discontinuation shown in parentheses)|
|Body System Adverse Event|| Enalaprila Felodipine ERb
| Felodipine ERb
|Body as a Whole|
| aCombination of dose of 5 and 20 mg daily
bCombination of dose 2.5, 5 and 10 mg daily
Other clinical adverse events considered related (possibly, probably, or definitely) to treatment with enalapril-felodipine ER that occurred with an incidence of less than 1% in the placebo-controlled, double-blind trial are listed below. These events are listed in order of decreasing frequency within each category. Body as a Whole: Syncope, facial edema, orthostatic effects, chest pain; Cardiovascular: Palpitation, hypotension, bradycardia, premature ventricular contraction, increased blood pressure; Digestive: Dry mouth, constipation, dyspepsia, flatulence, acid regurgitation, vomiting, diarrhea, nausea, anal/rectal pain; Metabolic: Gout; Musculoskeletal: Neck pain, joint swelling; Nervous/Psychiatric: Insomnia, nervousness, somnolence, ataxia, agitation, paresthesia, tremor; Respiratory: Dyspnea, respiratory congestion, pharyngeal discomfort, dry throat; Skin: Rash, angioedema, pruritus, alopecia, dry skin; Special Senses: Increased intraocular pressure; Urogenital: Impotence, hot flashes.
Other infrequently reported adverse events were seen in clinical trials with enalapril-felodipine ER (causal relationship unknown). These included: Body as a Whole: Abdominal pain, fever; Digestive: Dental pain; Metabolic: Increased ALT and AST, hyperglycemia; Musculoskeletal: Back pain, myalgia, foot pain, knee pain, shoulder pain, tendinitis; Respiratory: Upper respiratory infection, sinusitis, pharyngitis, bronchitis, nasal congestion, influenza, sinus disorder; Special Senses: Conjunctivitis; Urogenital: Proteinuria, pyuria, urinary tract infection.
Other adverse events that have been reported with enalapril, without regard to causality, are listed (in decreasing severity) below:
Angioedema- Angioedema has been reported in patients receiving enalapril maleate, with an incidence higher in black than in non-black patients. Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis and/or larynx occurs, treatment with LEXXEL (enalapril maleate-felodipine) should be discontinued and appropriate therapy instituted immediately. (See WARNINGS.)
Body as a Whole: Anaphylactoid reactions (see WARNINGS, Anaphylactoid and Possibly Related Reactions); Cardiovascular: Cardiac arrest, myocardial infarction or cerebrovascular accident, possibly secondary to excessive hypotension in high risk patients (see WARNINGS, Hypotension), orthostatic hypotension, pulmonary embolism and infarction, pulmonary edema, rhythm disturbances including atrial tachycardia and bradycardia, atrial fibrillation, angina pectoris; Digestive: Ileus, pancreatitis, hepatic failure, hepatitis (hepatocellular [proven on rechallenge] or cholestatic jaundice) (see WARNINGS, Hepatic Failure), melena, anorexia, glossitis, stomatitis; Hematologic: Rare cases of neutropenia, thrombocytopenia and bone marrow depression; Musculoskeletal: Muscle cramps; Nervous/Psychiatric: Depression, confusion, peripheral neuropathy (eg paresthesia, dysesthesia), vertigo; Respiratory: Bronchospasm, rhinorrhea, sore throat and hoarseness, asthma, pneumonia, pulmonary infiltrates, eosinophilic pneumonitis; Skin: Exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, pemphigus, herpes zoster, erythema multiforme, urticaria, diaphoresis, photosensitivity; Special Senses: Blurred vision, taste alteration, anosmia, tinnitus, dry eyes, tearing; Urogenital: Renal failure, oliguria, renal dysfunction (see PRECAUTIONS), flank pain, gynecomastia; Miscellaneous: A symptom complex has been reported which may include a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia/myositis, fever, serositis, vasculitis, leukocytosis, eosinophilia, photosensitivity rash and other dermatologic manifestations; Fetal/Neonatal Morbidity and Mortality: See WARNINGS, Fetal/Neonatal Morbidity and Mortality.
Felodipine as an Extended-Release Formulation
Other adverse events that have been reported with felodipine ER, without regard to causality, are listed (in decreasing severity) below:
Body as a Whole: Flu-like illness; Cardiovascular: Myocardial infarction, angina pectoris, arrhythmia, tachycardia, premature beats; Digestive: Gingival hyperplasia; Endocrine: Gynecomastia; Hematologic: Anemia; Musculoskeletal: Arthralgia, leg pain, muscle cramps, arm pain, hip pain; Nervous/Psychiatric: Depression, anxiety disorders, irritability, decreased libido; Respiratory: Upper respiratory infection, rhinorrhea, sneezing, pharyngitis, influenza, epistaxis, respiratory infection; Skin: Angioedema, contusion, erythema, urticaria, leukocytoclastic vasculitis; Special Senses: Visual disturbances; Urogenital: Urinary frequency, urinary urgency, dysuria, polyuria.
Laboratory Test Findings
In controlled clinical trials with enalapril-felodipine ER, clinically important changes in standard laboratory parameters associated with administration of LEXXEL (enalapril maleate-felodipine) were rare. No changes peculiar to the combination treatment were observed.
Serum Electrolytes- See PRECAUTIONS.
Creatinine- Minor reversible increases in serum creatinine were observed in patients treated with LEXXEL (enalapril maleate-felodipine) . Increases in creatinine are more likely to occur in patients with renal insufficiency or those pretreated with a diuretic and based on experience with other ACE inhibitors, would be expected to be especially likely in patients with renal artery stenosis (see PRECAUTIONS).
Other- Minor reversible increases or decreases in serum potassium were infrequently observed in patients treated with LEXXEL (enalapril maleate-felodipine) ; rarely were these measurements outside the normal range.
Read the entire FDA prescribing information for Lexxel (Enalapril Maleate-Felodipine) »
Additional Lexxel Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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