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Covera-HS

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Covera-HS

Covera-HS Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Covera HS (verapamil) is an oral drug belonging to the class known as calcium channel blockers (CCBs), which are used for treating and preventing chest pain (angina) resulting from spasm (contraction) of the coronary arteries that reduces the flow of blood to the heart. Covera HS is available in a generic form, Verapamil. Common side effects of Covera HS include dizziness, weakness, or fainting.

Concurrent use of Covera HS with a beta blocker can occasionally cause profound and dangerous heart slowing. Covera HS can raise the levels of some drugs in blood including digoxin (Lanoxin), theophylline (Slo-Bid), and carbamazepine (Tegretol). Safety during pregnancy has not been established. Covera HS crosses the placenta and enters the fetus. Covera HS is known to be excreted in human breast milk.

Our Covera HS Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Covera-HS in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have any of these serious side effects:

  • fast or slow heartbeats;
  • feeling like you might pass out;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • constipation, nausea;
  • skin rash or itching;
  • dizziness, headache, tired feeling; or
  • warmth, itching, redness, or tingly feeling under your skin.

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 Covera-HS (Verapamil) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Covera-HS FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Serious adverse reactions are uncommon when verapamil therapy is initiated with upward dose titration within the recommended single and total daily dose. See WARNINGS for discussion of heart failure, hypotension, elevated liver enzymes, AV block, and rapid ventricular response. Reversible (upon discontinuation of verapamil) non-obstructive, paralytic ileus has been infrequently reported in association with the use of verapamil. The following reactions to orally administered COVERA-HS occurred at rates greater than 2.0% or occurred at lower rates but appeared drug-related in clinical trials in hypertension and angina:

  Placebo
n=261
%
All doses studied
n=572
%
Constipation 2.7 11.7*
Headache 7.3 6.6
Upper respiratory infection 4.6 5.4
Dizziness 2.7 4.7
Fatigue 3.8 4.5
Edema 3.1 3.0
Nausea 1.9 2.1
AV block (1°) 0.0 1.7
Elevated liver enzymes (see WARNINGS) 0.8 1.4
Bradycardia 0.4 1.4
Paresthesia 0.0 1.0
Flushing 0.3 0.8
Hypotension 0.0 0.7
Postural hypotension 0.3 0.4
* Constipation was typically mild, easily manageable, and the incidence usually diminished within about one week. At a typical once-daily dose of 240 mg, the observed incidence was 7.2%.

In previous experience with other formulations of verapamil, the following reactions occurred at rates greater than 1.0% or occurred at lower rates but appeared clearly drug related in clinical trials in 4,954 patients.

Constipation 7.3% Dyspnea 1.4%
Dizziness 3.3% Bradycardia (HR < 50/min) 1.4%
Nausea 2.7% AV Block total (1°,2°,3°) 1.2%
Hypotension 2.5% AV Block 2° and 3° 0.8%
Headache 2.2% Rash 1.2%
Edema 1.9% Flushing 0.6%
CHF/Pulmonary Edema 1.8%    
Fatigue 1.7%    
Elevated liver enzymes (see WARNINGS)

The following reactions, reported with orally administered verapamil in 2% or less of patients, occurred under conditions (open trials, marketing experience) where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:

Cardiovascular: angina pectoris, AV block (2° & 3°), atrioventricular dissociation, CHF, pulmonary edema, chest pain, claudication, myocardial infarction, palpitations, purpura (vasculitis), syncope.

Digestive system: diarrhea, dry mouth, gastrointestinal distress, gingival hyperplasia.

Hemic and lymphatic: ecchymosis or bruising.

Nervous system: cerebrovascular accident, confusion, equilibrium disorders, insomnia, muscle cramps, psychotic symptoms, shakiness, somnolence, extrapyramidal symptoms.

Skin: arthralgia and rash, exanthema, hair loss, hyperkeratosis, macules, sweating, urticaria, Stevens-Johnson syndrome, erythema multiforme.

Special senses: blurred vision, tinnitus.

Urogenital: gynecomastia, galactorrhea/hyperprolactinemia, increased urination, spotty menstruation, impotence.

Other: allergy aggravated, dyspnea.

Treatment of acute cardiovascular adverse reactions

The frequency of cardiovascular adverse reactions that require therapy is rare; hence, experience with their treatment is limited. Whenever severe hypotension or complete AV block occurs following oral administration of verapamil, the appropriate emergency measures should be applied immediately; e.g., intravenously administered norepinephrine bitartrate, atropine sulfate, isoproterenol HCl (all in usual doses), or calcium gluconate (10% solution). In patients with hypertrophic cardiomyopathy (IHSS), alpha-adrenergic agents (phenylephrine HCl, metaraminol bitartrate, or methoxamine HCl) should be used to maintain blood pressure, and isoproterenol and norepinephrine should be avoided. If further support is necessary, dopamine HCl or dobutamine HCl may be administered. Actual treatment and dosage should depend on the severity of the clinical situation and the judgement and experience of the treating physician.

Read the entire FDA prescribing information for Covera-HS (Verapamil) »

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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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