Slideshows Images Quizzes

Verelan PM

Last reviewed on RxList: 7/12/2017
Verelan PM Side Effects Center

Last reviewed on RxList 7/12/2017

Verelan PM (verapamil hydrochloride) Extended-Release Capsules are a calcium channel blocker used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. Verelan PM is available in generic form. Common side effects of Verelan PM include dizziness, slow heartbeat, constipation, stomach upset, nausea, headache, tiredness, skin rash or itching, or flushing (warmth, itching, redness, or tingly feeling under your skin).

The usual daily dose of extended-release Verelan PM is 200 mg given by mouth once daily at bedtime. Verelan PM may interact with buspirone, cimetidine, clonidine, other blood pressure medications, cyclosporine, digoxin, lithium, lovastatin or simvastatin, theophylline, antibiotics, antifungals, beta-blockers, cancer medicines, heart rhythm medications, HIV/AIDS medicines, sedatives, or seizure medications. Tell your doctor all medications and supplements you use. During pregnancy, Verelan PM should be used only when prescribed. This medication passes into breast milk, but it is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.

Our Verelan PM (verapamil hydrochloride) 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.

Verelan PM Consumer Information

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 Verelan PM (Verapamil Hydrochloride)

Verelan PM Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Serious adverse reactions are uncommon when verapamil therapy is initiated with upward dose titration within the recommended single and total daily dose. See WARNINGS AND PRECAUTIONS 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 (Table 1) to orally administered Verelan PM occurred at rates of 2.0% or greater or occurred at lower rates but appeared to be drug-related in clinical trials in hypertension.

Table 1: Adverse Events Occurring in 2% of Verelan PM Patients in Placebo-Controlled Clinical Trials

  All Doses Studied
N = 297 %
Placebo
N = 116 %
  All Doses Studied
N = 297 %
Placebo
N = 116%
Headache 12.1 11.2 Dyspepsia 2.7 1.7
Infection 12.1* 6.9 Rhinitis 2.7 2.6
Constipation 8.8* 0.9 Diarrhea 2.4 1.7
Flu Syndrome 3.7 2.6 Pain 2.4 1.7
Peripheral edema 3.7 0.9 Edema 1.7 0.0
Dizziness 3.0 0.9 Nausea 1.7 0.0
Pharyngitis 3.0 2.6 Accidental Injury 1.5 0.0
Sinusitis 3.0 2.6      
*Infection, primarily upper respiratory infection (URI) and unrelated to study medication. Constipation was typically mild and easily manageable. At the usual once-daily dose of 200 mg, the observed incidence of constipation was 3.9%.

In previous experience with other formulations of verapamil (N=4,954) the following reactions (Table 2) have occurred at rates greater than 1.0% or occurred at lower rates but appeared clearly drug related in clinical trials in 4,954 patients.

Table 2: Adverse Events Occurring in > 1% (or lower rates and clearly drug related) of Patients with Other Verapamil Formulations

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

In clinical trials related to the control of ventricular response in patients taking digoxin who had atrial fibrillation or atrial flutter, ventricular rate below 50/min at rest occurred in 15% of patients and asymptomatic hypotension occurred in 5% of patients.

Open Trials / Postmarketing Experience

The following reactions, reported with orally administered verapamil in 2.0% or less of patients, occurred under conditions (open verapamil trials, postmarketing experience [reactions added since the initial US approval of Verelan PM in 1998 are marked with an asterisk]) where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:

Cardiovascular: angina pectoris, atrioventricular dissociation, ECG Abnormal*, chest pain, claudication, hypertension*, myocardial infarction, palpitations, purpura (vasculitis), syncope.

Digestive System: diarrhea, dry mouth, elevated liver enzymes* [see WARNINGS AND PRECAUTIONS], gastrointestinal distress, gingival hyperplasia.

Hemic and Lymphatic: ecchymosis or bruising.

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

Respiratory: dyspnea.

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, impotence, increased urination, spotty menstruation.

Other: allergy aggravated, asthenia*.

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, apply the appropriate emergency measures immediately; e.g., intravenously administered norepinephrine bitartrate, atropine sulfate, isoproterenol HCl (all in the usual doses), or calcium gluconate (10% solution). In patients with hypertrophic cardiomyopathy, use alphaadrenergic agents (phenylephrine HCl, metaraminol bitartrate, or methoxamine HCl) to maintain blood pressure, and isoproterenol and avoid norepinephrine. If further support is necessary, inotropic agents (dopamine HCl or dobutamine HCl) may be administered. Actual treatment and dosage depends on the severity of the clinical situation and the judgment and experience of the treating physician.

Read the entire FDA prescribing information for Verelan PM (Verapamil Hydrochloride)

Related Resources for Verelan PM

Health Solutions From Our Sponsors