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Labetalol Side Effects

Common Labetalol Side Effects


The most commonly reported Labetalol side effects (click to view or check a box to report):

Death (16)
Bradycardia (16)
Blood Pressure Increased (15)
Hypotension (13)
Caesarean Section (11)
Dyspnoea (10)
Maternal Exposure During Pregnancy (10)
Completed Suicide (10)
Nausea (9)
Renal Failure (8)
Pain (8)
Heart Rate Decreased (7)
Headache (6)
Blood Glucose Increased (6)
Dizziness (6)
Cerebrovascular Accident (6)
Blood Pressure Decreased (6)
Anxiety (6)
Pain In Extremity (5)
Overdose (5)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Labetalol Side Effects Reported to FDA

The following Labetalol reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Labetalol on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Blood Pressure Increased
This is a report of a 63-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: hypertension, who was treated with Labetalol (dosage: 60 Twice A Day, start time: Nov 20, 2013), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Blood Pressure Increased
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Labetalol treatment in female patients, resulting in blood pressure increased side effect.

Night Sweats, Semen Analysis Abnormal, Fear
This report suggests a potential Labetalol Night Sweats, Semen Analysis Abnormal, Fear side effect(s) that can have serious consequences. A 73-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hypertension and used Labetalol (dosage: NA) starting Jan 17, 2014. Soon after starting Labetalol the patient began experiencing various side effects, including:
  • Night Sweats
  • Semen Analysis Abnormal
  • Fear
Drugs used concurrently: NA. Although Labetalol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as night sweats, may still occur.

Raynaud^s Phenomenon, Pain In Extremity, Nipple Pain, Skin Discolouration, Maternal Exposure During Pregnancy
This Raynaud^s Phenomenon, Pain In Extremity, Nipple Pain, Skin Discolouration, Maternal Exposure During Pregnancy problem was reported by a health professional from GB. A 37-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: blood pressure increased. On NS this consumer started treatment with Labetalol (dosage: 100 Mg, Bid). The following drugs were being taken at the same time: NA. When commencing Labetalol, the patient experienced the following unwanted symptoms/side effects:
  • Raynaud^s Phenomenon
  • Pain In Extremity
  • Nipple Pain
  • Skin Discolouration
  • Maternal Exposure During Pregnancy
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as raynaud^s phenomenon, may become evident only after a product is in use by the general population.

Completed Suicide
This is a report of a 50-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Labetalol (dosage: NA) starting NS. Concurrently used drugs:
  • Zolpidem Tartrate Er
  • Clonidine (Unk, Unk)
  • Lisinopril
  • Iron
  • Citalopram
Soon after that, the consumer experienced the following side effects:
  • Completed Suicide
This opens a possibility that Labetalol treatment could cause the above reactions, including death, and some female subjects may be more susceptible.


Cardio-respiratory Arrest
A 32-year-old male patient (weight: NA) from US with the following symptoms/conditions: NA started Labetalol treatment (dosage: NA) on NS. Soon after starting Labetalol treatment, the subject experienced various side effects, including:
  • Cardio-respiratory Arrest
Concurrently used drugs:
  • Doxycycline (Unk Unk, Ingst + Unk)
  • Cocaine
  • Thiazide
This finding indicates that some male patients could be more vulnerable to Labetalol.

Completed Suicide
A 51-year-old male patient from US (weight: NA) experienced symptoms, such as: NA and was treated with Labetalol(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Completed Suicide
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Labetalol efficacy:
  • Diltiazem Hcl


Supraventricular Extrasystoles, Product Substitution Issue, Blood Pressure Increased
In this report, Labetalol was administered for the following condition: hypertension.A 58-year-old male consumer from US (weight: NA) started Labetalol treatment (dosage: NA) on Nov 11, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Supraventricular Extrasystoles
  • Product Substitution Issue
  • Blood Pressure Increased
A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Labetalol treatment could be related to the listed above side effect(s).

Mental Status Changes, Renal Failure Acute, Hypotension, Heart Rate Decreased, Overdose
This is a report of the following Labetalol side effect(s):
  • Mental Status Changes
  • Renal Failure Acute
  • Hypotension
  • Heart Rate Decreased
  • Overdose
A 55-year-old male patient from US (weight: NA) presented with the following condition: NA and received a treatment with Labetalol (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions:
  • Amlodipine Besylate
The patient was hospitalized.This report suggests that a Labetalol treatment could be associated with the listed above side effect(s).

Diabetic Ketoacidosis
This Labetalol report was submitted by a 26-year-old female consumer from US (weight: NA). The patient was diagnosed with: supraventricular tachycardia and Labetalol was administered (dosage: 30feb2013) starting: NS. The consumer developed a set of symptoms:
  • Diabetic Ketoacidosis
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Labetalol treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Lichenoid Keratosis
This is a report of a possible correlation between Labetalol use and the following symptoms/side effect(s):
  • Lichenoid Keratosis
which could contribute to an assessment of Labetalol risk profile.A 45-year-old male consumer from AU (weight: NA) was suffering from hypertension and was treated with Labetalol (dosage: 800 Mg, Tid) starting NS.Other concurrent medications: NA.

Aphasia, Hyperhidrosis, Disorientation, Haemorrhagic Transformation Stroke, Movement Disorder
A 70-year-old male patient from US (weight: NA) presented with the following symptoms: cerebrovascular accident and after a treatment with Labetalol (dosage: NA) experienced the following side effect(s):
  • Aphasia
  • Hyperhidrosis
  • Disorientation
  • Haemorrhagic Transformation Stroke
  • Movement Disorder
The treatment was started on Mar 31, 2013. Labetalol was used in combination with the following drugs: NA.This report could alert potential Labetalol consumers.

Fall, Head Injury, Mobility Decreased, Syncope, Hypotension, Dizziness, Feeling Hot, Cold Sweat, Amnesia
In this report, a 67-year-old female patient from US (weight: NA) was affected by a possible Labetalol side effect.The patient was diagnosed with hypertension,multiple sclerosis. After a treatment with Labetalol (dosage: 2 X 200 Mg In The Am, start date: Sep 16, 2011), the patient experienced the following side effect(s):
  • Fall
  • Head Injury
  • Mobility Decreased
  • Syncope
  • Hypotension
  • Dizziness
  • Feeling Hot
  • Cold Sweat
  • Amnesia
The following simultaneously used drugs could have led to this reaction:
  • Copaxone (20 Milligram Daily;)
The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Labetalol treatment.

Renal Failure Acute
This is a report of a 47-year-old male patient from US (weight: NA), who used Labetalol (dosage: NA) for a treatment of cardiac failure congestive,cardiomyopathy,diabetic nephropathy. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Renal Failure Acute
The following drugs could possibly have interacted with the Labetalol treatment NA.The patient was hospitalized.Taken together, these observations suggest that a Labetalol treatment could be related to side effect(s), such as Renal Failure Acute.

Dyspnoea, Fatigue
This dyspnoea side effect was reported by a health professional from US. A 54-year-old male patient (weight:NA) experienced the following symptoms/conditions: essential hypertension. The patient was prescribed Labetalol (dosage: 100mg 2 Tabs Tid Po), which was started on Aug 01, 2012. Concurrently used drugs: NA. When starting to take Labetalol the consumer reported the following symptoms:
  • Dyspnoea
  • Fatigue
The patient was hospitalized. These side effects may potentially be related to Labetalol.

Reaction To Azo-dyes
This is a Labetalol side effect report of a 46-year-old female patient (weight:NA) from US, suffering from the following symptoms/conditions: phaeochromocytoma, who was treated with Labetalol (dosage:NA, start time: Apr 02, 2010), combined with: NA., and developed a serious reaction and a reaction to azo-dyes side effect. The patient presented with:
  • Reaction To Azo-dyes
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Labetalol treatment in female patients suffering from phaeochromocytoma, resulting in reaction to azo-dyes.

Raynaud^s Phenomenon, Maternal Exposure During Delivery, Caesarean Section, Nipple Pain
This report suggests a potential Labetalol raynaud^s phenomenon side effect(s) that can have serious consequences. A 37-year-old female patient from GB (weight:NA) was diagnosed with the following health condition(s): gestational hypertension and used Labetalol (dosage: Bd, Several Weeks) starting NS. Soon after starting Labetalol the patient began experiencing various side effects, including:
  • Raynaud^s Phenomenon
  • Maternal Exposure During Delivery
  • Caesarean Section
  • Nipple Pain
Drugs used concurrently:NA. Although Labetalol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as raynaud^s phenomenon, may still occur.

Completed Suicide
This death problem was reported by a physician from US. A 67-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): NA.On NS a consumer started treatment with Labetalol (dosage: NA). The following drugs/medications were being taken at the same time:
  • Amlodipine
  • Diltiazem Er
  • Metoprolol
  • Acetaminophen
  • Sertraline
When commencing Labetalol, the patient experienced the following unwanted symptoms /side effects:
  • Completed Suicide
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as death, may become evident only after a product is in use by the general population.

Dizziness, Heart Rate Decreased
This is a Labetalol side effect report of a 85-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Labetalol (dosage: 100 Mg Po Bid) starting May 01, 2012. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Dizziness
  • Heart Rate Decreased
The patient was hospitalized. This opens a possibility that Labetalol could cause dizziness and that some female patients may be more susceptible.

Dizziness, Dyspnoea, Product Substitution Issue, Product Quality Issue
A 65-year-old male patient (weight: NA) from US with the following symptoms: blood pressure high started Labetalol treatment (dosage: NA) on Nov 01, 2012. Soon after starting Labetalol treatment, the consumer experienced several side effects, including:
  • Dizziness
  • Dyspnoea
  • Product Substitution Issue
  • Product Quality Issue
. Concurrently used drugs: NA. This finding indicates that some patients can be more vulnerable to developing Labetalol side effects, such as dizziness.

Cough, Pruritus
This cough side effect was reported by a health professional from UNITED STATES. A 40-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Labetalol Hcl (dosage: NA), which was started on Nov 23, 2011. Concurrently used drugs:
  • Synthroid
  • Magnevist (13 Ml, Once, Right Arm)
  • Amitriptyline Hcl
.When starting to take Labetalol Hcl the consumer reported symptoms, such as:
  • Cough
  • Pruritus
These side effects may potentially be related to Labetalol Hcl.

Hyperkeratosis, Skin Hyperpigmentation, Musculoskeletal Pain, Hypoaesthesia, Bone Pain, Skin Fibrosis, Oedema, Nephrogenic Systemic Fibrosis
This is a report of a male patient (weight: NA) from UNITED STATES, suffering from the following symptoms/conditions: NA, who was treated with Labetalol Hcl (dosage: 200 Mg, Bid, start time: Aug 12, 2002), combined with:
  • Procardia Xl (60 Mg, Qd)
  • Sucralfate (1 Pill Before Meals)
  • Accupril (40 Mg, Qd)
  • Divalproex Sodium
  • Carvedilol (25 Mg, Bid)
  • Magnevist
  • Norvasc (10 Mg, Qd)
  • Phenytoin (100 Mg, Unk)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Hyperkeratosis
  • Skin Hyperpigmentation
  • Musculoskeletal Pain
  • Hypoaesthesia
  • Bone Pain
  • Skin Fibrosis
  • Oedema
  • Nephrogenic Systemic Fibrosis
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Labetalol Hcl treatment in male patients, resulting in hyperkeratosis side effect.

Product Substitution Issue
This report suggests a potential Labetalol Hcl Product Substitution Issue side effect(s) that can have serious consequences. A female patient (weight: NA) from UNITED STATES was diagnosed with the following symptoms/conditions: NA and used Labetalol Hcl (dosage: 200mg Bid Oral) starting NS. Soon after starting Labetalol Hcl the patient began experiencing various side effects, including:
  • Product Substitution Issue
Drugs used concurrently: NA. Although Labetalol Hcl demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as product substitution issue, may still occur.

Cardiac Failure Congestive, Coronary Artery Disease
This Cardiac Failure Congestive, Coronary Artery Disease problem was reported by a consumer or non-health professional from UNITED STATES. A 49-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Jan 01, 1999 this consumer started treatment with Labetalol Hydrochloride (dosage: NA). The following drugs were being taken at the same time:
  • Lipitor
  • Insulin
  • Avandia (4mg Per Day)
When commencing Labetalol Hydrochloride, the patient experienced the following unwanted symptoms/side effects:
  • Cardiac Failure Congestive
  • Coronary Artery Disease
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as cardiac failure congestive, may become evident only after a product is in use by the general population.

Completed Suicide
This is a report of a 47-year-old male patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Labetalol Hydrochloride (dosage: NA) starting NS. Concurrently used drugs:
  • Clonidine
  • Propranolol
  • Verapamil Hcl
Soon after that, the consumer experienced the following side effects:
  • Completed Suicide
This opens a possibility that Labetalol Hydrochloride treatment could cause the above reactions, including completed suicide, and some male subjects may be more susceptible.

Therapeutic Response Decreased, White Blood Cell Count Increased, Weight Increased, Haemorrhage, Thrombotic Stroke
A 62-year-old male patient (weight: NA) from UNITED STATES with the following symptoms/conditions: NA started Labetalol Hcl treatment (dosage: NA) on May 04, 2011. Soon after starting Labetalol Hcl treatment, the subject experienced various side effects, including:
  • Therapeutic Response Decreased
  • White Blood Cell Count Increased
  • Weight Increased
  • Haemorrhage
  • Thrombotic Stroke
Concurrently used drugs:
  • Prazosin Hcl
  • Corticosteroids
  • Aspirin (1 Mg, Unk)
  • Lantus (Unk)
  • Nplate (10 Mug/kg, Unk)
  • Fentanyl-100
  • Docusate
  • Lipitor
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Labetalol Hcl.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    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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    Labetalol Safety Alerts, Active Ingredients, Usage Information

    NDC0172-4364
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameLabetalol Hydrochloride
    NameLabetalol Hydrochloride
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since19980803
    LabelerIVAX Pharmaceuticals, Inc.
    Active Ingredient(s)LABETALOL HYDROCHLORIDE
    Strength(s)100
    Unit(s)mg/1
    Pharma ClassAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]

    More About Labetalol

    Side Effects reported to FDA: 200

    Labetalol safety alerts: 2013

    Reported deaths: 17

    Reported hospitalizations: 64

    Latest Labetalol clinical trials