Labetalol Side Effects
Brand Names: Normodyne, Trandate
Please note - some side effects for Labetalol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Labetalol - for the consumer
Labetalol
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Labetalol:
Seek medical attention right away if any of these SEVERE side effects occur when using Labetalol:Dizziness; indigestion; lightheadedness; nausea; pain, swelling, or redness at the injection site; stuffy nose; temporary tingling of the scalp; unusual tiredness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine; decreased sexual ability; fever, chills, or persistent sore throat; mental or mood changes; muscle pain or tenderness; persistent loss of appetite; right upper stomach pain; shortness of breath; slow heartbeat; swelling of the hands or feet; unusual bruising or bleeding; vision changes; yellowing of the skin or eyes.
Labetalol Tablets
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Labetalol Tablets:
Seek medical attention right away if any of these SEVERE side effects occur when using Labetalol Tablets:Dizziness; indigestion; lightheadedness; nausea; stuffy nose; temporary tingling of the scalp; unusual tiredness.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine; decreased sexual ability; fever, chills, or persistent sore throat; mental or mood changes; muscle pain or tenderness; persistent loss of appetite; right upper stomach pain; shortness of breath; slow heartbeat; swelling of the hands or feet; unusual bruising or bleeding; yellowing of the skin or eyes.
For the professional
Labetalol
Labetalol injection is usually well tolerated. Most adverse effects have been mild and transient and in controlled trials involving 92 patients did not require Labetalol withdrawal. Symptomatic postural hypotension (incidence 58%) is likely to occur if patients are tilted or allowed to assume the upright position within 3 hours of receiving Labetalol injection. Moderate hypotension occurred in 1 of 100 patients while supine. Increased sweating was noted in 4 of 100 patients, and flushing occurred in 1 of 100 patients.
The following also were reported with Labetalol injection with the incidence per 100 patients as noted:
Cardiovascular System Ventricular arrhythmia in 1.
Central and Peripheral Nervous Systems Dizziness in 9; tingling of the scalp/skin 7; hypoesthesia (numbness) and vertigo, 1 each.
Gastrointestinal System Nausea in 13; vomiting 4; dyspepsia and taste distortion, 1 each.
Metabolic Disorders Transient increases in blood urea nitrogen and serum creatinine levels occurred in 8 of 100 patients; these were associated with drops in blood pressure, generally in patients with prior renal insufficiency.
Psychiatric Disorders Somnolence/yawning in 3.
Respiratory System Wheezing in 1.
Skin Pruritus in 1.
The incidence of adverse reactions depends upon the dose of Labetalol. The largest experience is with oral Labetalol. Certain of the side effects increased with increasing oral dose as shown in the table below which depicts the entire U.S. therapeutic trials data base for adverse reactions that are clearly or possibly dose related.
Labetalol Daily Dose (mg) |
200 |
300 |
400 |
600 |
800 |
900 |
1200 |
1600 |
2400 |
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 |
Paresthesias |
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:
Cardiovascular Hypotension, and rarely, syncope, bradycardia, heart block.
Liver and BiliarySystem Hepatic necrosis, hepatitis, cholestatic jaundice, elevated liver function tests.
Hypersensitivity Rare reports of hypersensitivity (e.g., rash, urticaria, pruritus, angioedema, dyspnea) and anaphylactoid reactions.
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with Labetalol during investigational use and extensive foreign marketing experience.
Clinical Laboratory Tests: Among patients dosed with Labetalol tablets, there have been reversible increases of serum transaminases in 4% of patients tested, and more rarely, reversible increases in blood urea.
TopLabetalol Injection
Labetalol HCl Injection is usually well tolerated. Most adverse effects have been mild and transient and, in controlled trials involving 92 patients, did not require Labetalol withdrawal. Symptomatic postural hypotension (incidence 58%) is likely to occur if patients are tilted or allowed to assume the upright position within 3 hours of receiving Labetalol HCl injection. Moderate hypotension occurred in 1 of 100 patients while supine. Increased sweating was noted in 4 of 100 patients, and flushing occurred in 1 of 100 patients.
The following also were reported with Labetalol HCl injection with the incidence per 100 patients as noted:
Cardiovascular System -Ventricular arrhythmia in 1.
Central and Peripheral Nervous Systems -Dizziness in 9; tingling of the scalp/skin 7; hypoesthesia (numbness) and vertigo, 1 each.
Gastrointestinal System -Nausea in 13; vomiting 4; dyspepsia and taste distortion, 1 each.
Metabolic Disorders -Transient increases in blood urea nitrogen and serum creatinine levels occurred in 8 of 100 patients; these were associated with drops in blood pressure, generally in patients with prior renal insufficiency.
Psychiatric Disorders -Somnolence/yawning in 3.
Respiratory System -Wheezing in 1.
Skin -Pruritus in 1.
The incidence of adverse reactions depends upon the dose of Labetalol HCl. The largest experience is with oral Labetalol HCl.
Certain of the side effects increased with increasing oral dose as shown in the table below which depicts the entire U.S. therapeutic trials data base for adverse reactions that are clearly or possibly dose related.
Labetalol HCl
In addition, a number of other less common adverse events have been reported:
Cardiovascular -Hypotension, and rarely, syncope, bradycardia, heart block.
Liver and Biliary System -Hepatic necrosis, hepatitis, cholestatic jaundice, elevated liver function tests.
Hypersensitivity -Rare reports of hypersensitivity (e.g. rash, urticaria, pruritus, angioedema, dyspnea) and anaphylactoid reactions.
The oculomucocutaneous syndrome associated with the betablocker practolol has not been reported with Labetalol HCl during investigational use and extensive foreign marketing experience.
TopLabetalol Injection USP
Labetalol HCl injection is usually well tolerated. Most adverse effects have been mild and transient and, in controlled trials involving 92 patients, did not require Labetalol withdrawal. Symptomatic postural hypotension (incidence, 58%) is likely to occur if patients are tilted or allowed to assume the upright position within 3 hours of receiving Labetalol HCl. Moderate hypotension occurred in 1 of 100 patients while supine. Increased sweating was noted in 4 of 100 patients, and flushing occurred in 1 of 100 patients.
The following also were reported with Labetalol HCl with the incidence per 100 patients as noted:
Cardiovascular System:Ventricular arrhythmia in 1.
Central and Peripheral Nervous Systems: Dizziness in 9, tingling of the scalp/skin in 7, hypoesthesia (numbness) and vertigo in 1 each.
Gastrointestinal System: Nausea in 13, vomiting in 4, dyspepsia and taste distortion in 1 each.
Metabolic Disorders: Transient increases in blood urea nitrogen and serum creatinine levels occurred in 8 of 100 patients; these were associated with drops in blood pressure, generally in patients with prior renal insufficiency.
Psychiatric Disorders: Somnolence/yawning in 3.
Respiratory System: Wheezing in 1.
Skin: Pruritus in 1.
The incidence of adverse reactions depends upon the dose of Labetalol HCl. The largest experience is with oral Labetalol HCl. Certain of the side effects increased with increasing oral 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. In addition, a number of other less common adverse events have been reported:
| Labetalol HCl Daily Dose (mg) |
200 | 300 | 400 | 600 | 800 | 900 | 1200 | 1600 | 2400 |
| 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 |
Cardiovascular: Hypotension, and rarely, syncope, bradycardia, heart block.
Liver and Biliary System: Hepatic necrosis, hepatitis, cholestatic jaundice, elevated liver function tests.
Hypersensitivity: Rare reports of hypersensitivity (e.g., rash, urticaria, pruritus, angioedema, dyspnea) and anaphylactoid reactions.
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with Labetalol HCl during investigational use and extensive foreign marketing experience.
Clinical Laboratory Tests
Among patients dosed with Labetalol, there have been reversible increases of serum transaminases in 4% of patients tested and, more rarely, reversible increases in blood urea.
TopLabetalol Tablets
Most adverse effects are mild, transient and occur early in the course of treatment. In controlled clinical trials of 3 to 4 months duration, discontinuation of Labetalol tablets due to one or more adverse effects was required in 7% of all patients. In these same trials, beta-blocker control agents led to discontinuation in 8% to 10% of patients, and a centrally acting alpha-agonist in 30% of patients.
The incidence rates of adverse reactions listed in the following table were derived from multicenter controlled clinical trials, comparing Labetalol, placebo, metoprolol, and propranolol, over treatment periods of 3 and 4 months. Where the frequency of adverse effects for Labetalol 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 (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 |
| paresthesias | <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 2400 mg in more severely hypertensive patients. Certain of the side effects increased with increasing dose as shown in the table below which depicts the entire U.S. therapeutic trials data base for adverse reactions that are clearly or possibly drug related.
| Labetalol HCl Daily Dose (mg) |
200 | 300 | 400 | 600 | 800 | 900 | 1200 | 1600 | 2400 |
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| Paresthesias | 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: Paresthesias, most frequently described as scalp tingling. In most cases, it was mild, transient and usually occurred at the beginning of treatment
Collagen Disorders: Systemic lupus erythematosus; positive antinuclear factor (ANF).
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; 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 neuropsychometrics.
Cardiovascular: Intensification of AV block.
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.
Clinical Laboratory Tests
There have been reversible increases of serum transaminases in 4% of patients treated with Labetalol and tested, and more rarely, reversible increases in blood urea.
TopMore resources:
Labetalol - Includes detailed dosage instructions.
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