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Trandate

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Trandate

Trandate Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Trandate (labetalol) is used to treat hypertension (high blood pressure). It is a beta-blocker. This medication is available in generic form. Common side effects include dizziness or tiredness. Scalp tingling may occur as your body adjusts to the medication.

The recommended initial dosage of Trandate is 100 mg twice daily. The usual maintenance dose range is 200 - 400 mg twice daily. Trandate may interact with allergy treatments, clonidine, guanabenz, MAO inhibitors, diabetes medication, heart medication, medicine for asthma or other breathing disorders, cold medicines, stimulant medicines, or diet pills. Tell your doctor all medications you use. Trandate may be used to treat high blood pressure in pregnant women. It is important to control high blood pressure for the health of the mother and fetus. Rarely, babies born to mothers who took Trandate during pregnancy have symptoms of low blood pressure, slow heartbeat, slow breathing, and low blood sugar (such as shaking, unusual sweating) for a few days after delivery. Tell the doctor if you notice symptoms in your newborn. This medication passes into breast milk, and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.

Our Trandate (labetalol) 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.

Trandate 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 a serious side effect such as:

  • slow or uneven heartbeats;
  • feeling like you might pass out;
  • feeling short of breath, even with mild exertion;
  • swelling or rapid weight gain; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • tingly feeling in your scalp;
  • dizziness, spinning sensation;
  • mild nausea, upset stomach;
  • tired feeling;
  • stuffy nose; or
  • difficulty having an orgasm.

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 Trandate (Labetalol) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Trandate Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning and Precautions sections.

Dizziness and tiredness may occur. Scalp tingling may also occur as your body adjusts to the medication. Decreased sexual ability has been reported infrequently. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This drug may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: very slow heartbeat, severe dizziness, fainting, blue fingers/toes, trouble breathing, new or worsening symptoms of heart failure (such as swelling ankles/feet, severe tiredness, shortness of breath, unexplained/sudden weight gain), mental/mood changes (such as confusion, mood swings, depression).

This drug may rarely cause serious (rarely fatal) liver disease. If you notice any of the following rare but serious side effects, seek immediate medical attention: persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Trandate (Labetalol)»

What is Prescribing information?

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

Trandate FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Most adverse effects are mild and transient and occur early in the course of treatment. In controlled clinical trials of 3 to 4 months' duration, discontinuation of Trandate (labetalol) Tablets due to one or more adverse effects was required in 7% of all patients. In these same trials, other agents with solely beta-blocking activity used in the control groups led to discontinuation in 8% to 10% of patients, and a centrally acting alpha-agonist led to discontinuation in 30% of patients.

The incidence rates of adverse reactions listed in the following table were derived from multicenter, controlled clinical trials comparing labetalol HCl, placebo, metoprolol, and propranolol over treatment periods of 3 and 4 months. Where the frequency of adverse effects for labetalol HCl and placebo is similar, causal relationship is uncertain. The rates are based on adverse reactions considered probably drug related by the investigator. If all reports are considered, the rates are somewhat higher (e.g., dizziness, 20%; nausea, 14%; fatigue, 11%), but the overall conclusions are unchanged.

  Labetalol HCI
(n = 227)
%
Placebo
(n = 98)
%
Propranolol
(n = 84)
%
Metoprolol
(n = 49)
%
Body as a whole
  Fatigue 5 0 12 12
  Asthenia 1 1 1 0
  Headache 2 1 1 2
Gastrointestinal
  Nausea 6 1 1 2
  Vomiting <1 0 0 0
  Dyspepsia 3 1 1 0
  Abdominal pain 0 0 1 2
  Diarrhea <1 0 2 0
  Taste distortion 1 0 0 0
Central and peripheral nervous systems
  Dizziness 11 3 4 4
  Paresthesia <1 0 0 0
  Drowsiness <1 2 2 2
Autonomic nervous system
  Nasal stuffiness 3 0 0 0
  Ejaculation failure 2 0 0 0
  Impotence 1 0 1 3
  Increased sweating <1 0 0 0
Cardiovascular
  Edema 1 0 0 0
  Postural hypotension 1 0 0 0
  Bradycardia 0 0 5 12
Respiratory
  Dyspnea 2 0 1 2
Skin
  Rash 1 0 0 0
Special senses
  Vision abnormality 1 0 0 0
  Vertigo 2 1 0 0

The adverse effects were reported spontaneously and are representative of the incidence of adverse effects that may be observed in a properly selected hypertensive patient population, i.e., a group excluding patients with bronchospastic disease, overt congestive heart failure, or other contraindications to beta-blocker therapy.

Clinical trials also included studies utilizing daily doses up to 2,400 mg in more severely hypertensive patients. Certain of the side effects increased with increasing dose, as shown in the following table that depicts the entire US therapeutic trials data base for adverse reactions that are clearly or possibly dose related.

Labetalol HCl Daily Dose (mg) 200 300 400 600 800 900 1,200 1,600 2,400
Number of patients 522 181 606 608 503 117 411 242 175
Dizziness (%) 2 3 3 3 5 1 9 13 16
Fatigue 2 1 4 4 5 3 7 6 10
Nausea < 1 0 1 2 4 0 7 11 19
Vomiting 0 0 < 1 < 1 < 1 0 1 2 3
Dyspepsia 1 0 2 1 1 0 2 2 4
Paresthesia 2 0 2 2 1 1 2 5 5
Nasal stuffiness 1 1 2 2 2 2 4 5 6
Ejaculation failure 0 2 1 2 3 0 4 3 5
Impotence 1 1 1 1 2 4 3 4 3
Edema 1 0 1 1 1 0 1 2 2

In addition, a number of other less common adverse events have been reported:

Body as a Whole: Fever.

Cardiovascular: Hypotension, and rarely, syncope, bradycardia, heart block.

Central and Peripheral Nervous Systems: Paresthesia, most frequently described as scalp tingling. In most cases, it was mild and transient and usually occurred at the beginning of treatment.

Collagen Disorders: Systemic lupus erythematosus, positive antinuclear factor.

Eyes: Dry eyes.

Immunological System: Antimitochondrial antibodies.

Liver and Biliary System: Hepatic necrosis, hepatitis, cholestatic jaundice, elevated liver function tests.

Musculoskeletal System: Muscle cramps, toxic myopathy.

Respiratory System: Bronchospasm.

Skin and Appendages: Rashes of various types, such as generalized maculopapular, lichenoid, urticarial, bullous lichen planus, psoriaform, and facial erythema; Peyronie's disease; reversible alopecia.

Urinary System: Difficulty in micturition, including acute urinary bladder retention.

Hypersensitivity: Rare reports of hypersensitivity (e.g., rash, urticaria, pruritus, angioedema, dyspnea) and anaphylactoid reactions.

Following approval for marketing in the United Kingdom, a monitored release survey involving approximately 6,800 patients was conducted for further safety and efficacy evaluation of this product. Results of this survey indicate that the type, severity, and incidence of adverse effects were comparable to those cited above.

Potential Adverse Effects

In addition, other adverse effects not listed above have been reported with other beta-adrenergic blocking agents.

Central Nervous System

Reversible mental depression progressing to catatonia, an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on psychometrics.

Cardiovascular

Intensification of A-V block (see CONTRAINDICATIONS).

Allergic

Fever combined with aching and sore throat, laryngospasm, respiratory distress.

Hematologic

Agranulocytosis, thrombocytopenic or nonthrombocytopenic purpura.

Gastrointestinal

Mesenteric artery thrombosis, ischemic colitis.

The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with labetalol HCl.

Clinical Laboratory Tests

There have been reversible increases of serum transaminases in 4% of patients treated with labetalol HCl and tested and, more rarely, reversible increases in blood urea.

Read the entire FDA prescribing information for Trandate (Labetalol) »

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Trandate - User Reviews

Trandate User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Trandate sorted by most helpful. Patient Discussions FAQs

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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