Trandate
- Generic Name: labetalol
- Brand Name: Trandate
- Drug Class: How Do Betablockers with Alpha Activity Work?
Trandate (Labetalol) side effects drug center
Trandate Side Effects Center
What Is Trandate?
Trandate (labetalol) is a beta-blocker used to treat hypertension (high blood pressure). Trandate is available in generic form.
What Are Side Effects of Trandate?
Common side effects of Trandate include:
- dizziness,
- spinning sensation,
- tiredness,
- nausea,
- upset stomach,
- stuffy nose,
- tired feeling, or
- difficulty having an orgasm.
- Scalp tingling may occur as your body adjusts to Trandate.
Dosage for Trandate
The recommended initial dosage of Trandate is 100 mg twice daily. The usual maintenance dose range is 200 - 400 mg twice daily.
What Drugs, Substances, or Supplements Interact with Trandate?
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 During Pregnancy and Breastfeeding
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 breastfeeding.
Additional Information
Our Trandate (labetalol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Trandate Consumer Information
Get emergency medical help if you have 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 light-headed feeling, like you might pass out;
- slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
- shortness of breath (even with mild exertion), swelling, rapid weight gain;
- severe headache, blurred vision, pounding in your neck or ears; or
- liver problems--loss of appetite, stomach pain (upper right side), flu-like symptoms, itching, dark urine, jaundice (yellowing of the skin or eyes).
Severe dizziness or fainting may be more likely in older adults.
Common side effects may include:
- dizziness, drowsiness, tiredness;
- nausea, vomiting;
- sudden warmth, skin redness, sweating;
- numbness; or
- tingly feeling in your scalp.
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)
Trandate Professional Information
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)
&Copy; Trandate Patient Information is supplied by Cerner Multum, Inc. and Trandate Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.