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Labetalol Side Effects

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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.

Labetalol Side Effects Reported to FDA



Labetalol Side Effect Report#9925274
Blood Pressure Increased
This is a report of a 63-year-old female patient (weight: NA) from US, suffering from the following health 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): Blood Pressure Increased 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.
Labetalol Side Effect Report#9915960
Night Sweats, Semen Analysis Abnormal, Fear
This report suggests a potential Labetalol Night Sweats 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. After starting Labetalol the patient began experiencing various side effects, including: Night Sweats, Semen Analysis Abnormal, FearAdditional 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.
Labetalol Side Effect Report#9856816
Raynaud^s Phenomenon, Pain In Extremity, Nipple Pain, Skin Discolouration, Maternal Exposure During Pregnancy
This Raynaud^s Phenomenon 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 using Labetalol, the patient experienced the following unwanted symptoms/side effects: Raynaud^s Phenomenon, Pain In Extremity, Nipple Pain, Skin Discolouration, Maternal Exposure During PregnancyThe 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.
Labetalol Side Effect Report#9817279
Completed Suicide
This Death side effect was reported by a pharmacist from US. A 50-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Labetalol (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Zolpidem Tartrate Er
  • Clonidine (Unk, Unk)
  • Lisinopril
  • Iron
  • Citalopram
.After starting to take Labetalol the consumer reported adverse symptoms, such as: Completed SuicideThese side effects may potentially be related to Labetalol.
Labetalol Side Effect Report#9817277
Cardio-respiratory Arrest
This is a report of a 32-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Labetalol (dosage: NA, start time: NS), combined with:
  • Doxycycline (Unk Unk, Ingst + Unk)
  • Cocaine
  • Thiazide
and developed a serious reaction and side effect(s): Cardio-respiratory Arrest after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Labetalol treatment in male patients, resulting in Death side effect.
Labetalol Side Effect Report#9817274
Completed Suicide
This report suggests a potential Labetalol Death side effect(s) that can have serious consequences. A 51-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Labetalol (dosage: NA) starting NS. After starting Labetalol the patient began experiencing various side effects, including: Completed SuicideAdditional drugs used concurrently:
  • Diltiazem Hcl
Although Labetalol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Labetalol Side Effect Report#9731468
Supraventricular Extrasystoles, Product Substitution Issue, Blood Pressure Increased
This Supraventricular Extrasystoles problem was reported by a consumer or non-health professional from US. A 58-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension. On
Nov 11, 2013 this consumer started treatment with Labetalol (dosage: NA). The following drugs were being taken at the same time: NA. When using Labetalol, the patient experienced the following unwanted symptoms/side effects: Supraventricular Extrasystoles, Product Substitution Issue, Blood Pressure IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Supraventricular Extrasystoles, may become evident only after a product is in use by the general population.
Labetalol Side Effect Report#9671685
Mental Status Changes, Renal Failure Acute, Hypotension, Heart Rate Decreased, Overdose
This Mental Status Changes side effect was reported by a health professional from US. A 55-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Labetalol (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Amlodipine Besylate
.After starting to take Labetalol the consumer reported adverse symptoms, such as: Mental Status Changes, Renal Failure Acute, Hypotension, Heart Rate Decreased, OverdoseThese side effects may potentially be related to Labetalol. The patient was hospitalized.
Labetalol Side Effect Report#9392824
Diabetic Ketoacidosis
This is a report of a 26-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: supraventricular tachycardia, who was treated with Labetalol (dosage: 30feb2013, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Diabetic Ketoacidosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Labetalol treatment in female patients, resulting in Diabetic Ketoacidosis side effect.
Labetalol Side Effect Report#9364464
Lichenoid Keratosis
This report suggests a potential Labetalol Lichenoid Keratosis side effect(s) that can have serious consequences. A 45-year-old male patient (weight: NA) from AU was diagnosed with the following symptoms/conditions: hypertension and used Labetalol (dosage: 800 Mg, Tid) starting NS. After starting Labetalol the patient began experiencing various side effects, including: Lichenoid KeratosisAdditional drugs used concurrently: NA. Although Labetalol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Lichenoid Keratosis, may still occur.
Labetalol Side Effect Report#9358394
Aphasia, Hyperhidrosis, Disorientation, Haemorrhagic Transformation Stroke, Movement Disorder
This Aphasia problem was reported by a pharmacist from US. A 70-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: cerebrovascular accident. On
Mar 31, 2013 this consumer started treatment with Labetalol (dosage: NA). The following drugs were being taken at the same time: NA. When using Labetalol, the patient experienced the following unwanted symptoms/side effects: Aphasia, Hyperhidrosis, Disorientation, Haemorrhagic Transformation Stroke, Movement DisorderAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Aphasia, may become evident only after a product is in use by the general population.
Labetalol Side Effect Report#9312509
Fall, Head Injury, Mobility Decreased, Syncope, Hypotension, Dizziness, Feeling Hot, Cold Sweat, Amnesia
This Fall side effect was reported by a consumer or non-health professional from US. A 67-year-old female patient (weight:NA) experienced the following symptoms/conditions: hypertension,multiple sclerosis.The patient was prescribed Labetalol (drug dosage: 2 X 200 Mg In The Am), which was initiated on
Sep 16, 2011. Concurrently used drugs:
  • Copaxone (20 Milligram Daily;)
.After starting to take Labetalol the consumer reported adverse symptoms, such as: Fall, Head Injury, Mobility Decreased, Syncope, Hypotension, Dizziness, Feeling Hot, Cold Sweat, AmnesiaThese side effects may potentially be related to Labetalol. The patient was hospitalized.
Labetalol Side Effect Report#9290364
Renal Failure Acute
This is a report of a 47-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: cardiac failure congestive,cardiomyopathy,diabetic nephropathy, who was treated with Labetalol (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Renal Failure Acute after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Labetalol treatment in male patients, resulting in Renal Failure Acute side effect. The patient was hospitalized.
Labetalol Side Effect Report#9288390
Dyspnoea, Fatigue
This report suggests a potential Labetalol Dyspnoea side effect(s) that can have serious consequences. A 54-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: essential hypertension and used Labetalol (dosage: 100mg 2 Tabs Tid Po) starting
Aug 01, 2012. After starting Labetalol the patient began experiencing various side effects, including: Dyspnoea, FatigueAdditional drugs used concurrently: NA.The patient was hospitalized. Although Labetalol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dyspnoea, may still occur.
Labetalol Side Effect Report#9192101
Reaction To Azo-dyes
This Reaction To Azo-dyes problem was reported by a health professional from US. A 46-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: phaeochromocytoma. On
Apr 02, 2010 this consumer started treatment with Labetalol (dosage: NA). The following drugs were being taken at the same time: NA. When using Labetalol, the patient experienced the following unwanted symptoms/side effects: Reaction To Azo-dyesAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Reaction To Azo-dyes, may become evident only after a product is in use by the general population.
Labetalol Side Effect Report#9167613
Raynaud^s Phenomenon, Maternal Exposure During Delivery, Caesarean Section, Nipple Pain
This Raynaud^s Phenomenon side effect was reported by a physician from GB. A 37-year-old female patient (weight:NA) experienced the following symptoms/conditions: gestational hypertension.The patient was prescribed Labetalol (drug dosage: Bd, Several Weeks), which was initiated on NS. Concurrently used drugs: NA..After starting to take Labetalol the consumer reported adverse symptoms, such as: Raynaud^s Phenomenon, Maternal Exposure During Delivery, Caesarean Section, Nipple PainThese side effects may potentially be related to Labetalol.
Labetalol Side Effect Report#9007515
Completed Suicide
This is a report of a 67-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Labetalol (dosage: NA, start time: NS), combined with:
  • Amlodipine
  • Diltiazem Er
  • Metoprolol
  • Acetaminophen
  • Sertraline
and developed a serious reaction and side effect(s): Completed Suicide after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Labetalol treatment in male patients, resulting in Death side effect.
Labetalol Side Effect Report#8974135
Dizziness, Heart Rate Decreased
This report suggests a potential Labetalol Dizziness side effect(s) that can have serious consequences. A 85-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Labetalol (dosage: 100 Mg Po Bid) starting
May 01, 2012. After starting Labetalol the patient began experiencing various side effects, including: Dizziness, Heart Rate DecreasedAdditional drugs used concurrently: NA.The patient was hospitalized. Although Labetalol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dizziness, may still occur.
Labetalol Side Effect Report#8927949
Dizziness, Dyspnoea, Product Substitution Issue, Product Quality Issue
This Dizziness problem was reported by a consumer or non-health professional from US. A 65-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: blood pressure high. On
Nov 01, 2012 this consumer started treatment with Labetalol (dosage: NA). The following drugs were being taken at the same time: NA. When using Labetalol, the patient experienced the following unwanted symptoms/side effects: Dizziness, Dyspnoea, Product Substitution Issue, Product Quality IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dizziness, may become evident only after a product is in use by the general population.
Labetalol Side Effect Report#8457636-0
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 (drug dosage: NA), which was initiated on
Nov 23, 2011. Concurrently used drugs:
  • Synthroid
  • Magnevist (13 Ml, Once, Right Arm)
  • Amitriptyline Hcl
.After starting to take Labetalol Hcl the consumer reported adverse symptoms, such as: Cough, PruritusThese side effects may potentially be related to Labetalol Hcl.
Labetalol Side Effect Report#8452251-7
Hyperkeratosis, Skin Hyperpigmentation, Musculoskeletal Pain, Hypoaesthesia, Bone Pain, Skin Fibrosis, Oedema, Pain, Nephrogenic Systemic Fibrosis
This is a report of a male patient (weight: NA) from United States, suffering from the following health 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): Hyperkeratosis, Skin Hyperpigmentation, Musculoskeletal Pain, Hypoaesthesia, Bone Pain, Skin Fibrosis, Oedema, Pain, Nephrogenic Systemic Fibrosis 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.
Labetalol Side Effect Report#8428595-1
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. After starting Labetalol Hcl the patient began experiencing various side effects, including: Product Substitution IssueAdditional 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.
Labetalol Side Effect Report#8422859-3
Cardiac Failure Congestive, Coronary Artery Disease
This Cardiac Failure Congestive 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 using Labetalol Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Cardiac Failure Congestive, Coronary Artery DiseaseThe 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.
Labetalol Side Effect Report#8416966-9
Completed Suicide
This Completed Suicide side effect was reported by a physician from United States. A 47-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Labetalol Hydrochloride (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Clonidine
  • Propranolol
  • Verapamil Hcl
.After starting to take Labetalol Hydrochloride the consumer reported adverse symptoms, such as: Completed SuicideThese side effects may potentially be related to Labetalol Hydrochloride.
Labetalol Side Effect Report#8409425-0
Therapeutic Response Decreased, White Blood Cell Count Increased, Weight Increased, Haemorrhage, Thrombotic Stroke
This is a report of a 62-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Labetalol Hcl (dosage: NA, start time:
May 04, 2011), combined with:
  • Prazosin Hcl
  • Corticosteroids
  • Aspirin (1 Mg, Unk)
  • Lantus (Unk)
  • Nplate (10 Mug/kg, Unk)
  • Fentanyl-100
  • Docusate
  • Lipitor
and developed a serious reaction and side effect(s): Therapeutic Response Decreased, White Blood Cell Count Increased, Weight Increased, Haemorrhage, Thrombotic Stroke after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Labetalol Hcl treatment in male patients, resulting in Therapeutic Response Decreased side effect. The patient was hospitalized.


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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.

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Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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.

    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.

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    Discuss Labetalol Side Effects

    Did You Have a Labetalol Side Effect?

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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