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Fatigue (11)
Night Sweats (8)
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Joint Pain (6)
Dizziness (4)
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Labetalol Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 177 

Injection Site Pain, Injection Site Reaction, Injection Site Erythema (8096035-0)
on Dec 28, 2011 Female from UNITED STATES , weighting 284.4 lb, was treated with Labetalol Hcl. Directly after, patient experienced the unwanted or unexpected Labetalol side effects: injection site pain, injection site reaction, injection site erythema. Labetalol Hcl dosage: N/A.
Associated medications used:
  • Venlafaxine
  • Humira
  • Prednisone Tab
  • Hydroxychloroquine Sulfate
  • Moxifloxacin
  • Levothyroxine Sodium
  • Salsalate
  • Prednisone Eye Drops


Rash Erythematous, Induration (8092867-3)
Patient was taking Labetalol Hcl. Patient felt the following Labetalol side effects: rash erythematous, induration on Jul 26, 2011 from UNITED STATES Additional patient health information: Female , 57 years of age, was diagnosed with
  • hypertension
  • vitamin supplementation
and. Labetalol Hcl dosage: N/A.
Multiple prescriptions taken:
  • Vit D3
  • Fish Oil
  • Humira


Ischaemic Hepatitis, Renal Failure Acute, Pneumonia, Hypotension, Thrombocytopenia, Treatment Noncompliance (8078257-8)
Adverse event was reported on Jan 09, 2012 by a Male taking Labetalol Hcl (Dosage: ;;iv) was diagnosed with
  • hypertension
and. Location: UNITED STATES , 55 years of age, After Labetalol was administered, patient encountered several Labetalol side effects: ischaemic hepatitis, renal failure acute, pneumonia, hypotension, thrombocytopenia, treatment noncompliance.
Multiple concurrent drugs taken:
  • Albumin (human) (5% Bolus;qd;iv)
  • Dobutamine Hcl (;prn;iv)
  • Norepinephrine Bitartrate (;prn;iv)
  • Lorazepam (Prn;iv)
  • Omeprazole
  • Vasopressin (;prn;iv)
  • Esomeprazole Sodium (40 Mg;bid;iv)
  • Hydrochlorothiazide
Patient was hospitalized.

Caesarean Section (8071272-X)
on Jan 23, 2012 Female from , 37 years of age, was treated with Labetalol Hydrochloride. Directly after, patient experienced the unwanted or unexpected Labetalol side effects: caesarean section. Labetalol Hydrochloride dosage: N/A.
Associated medications used:
  • Reyataz (300 Mg Daily)
  • Norvir (100 Mg Daily)
  • Metformin Hydrochloride
  • Aspirin
  • Atripla (1 Tablet Daily)
  • Ramipril
  • Zidovudine
  • Insulin



Induced Labour, Postpartum Haemorrhage, Delivery, Maternal Exposure During Pregnancy, Uterine Hypotonus (8066917-4)
on Jan 17, 2012 Female from JAPAN , 29 years of age, was diagnosed with
  • essential hypertension
and was treated with Labetalol Hcl. Patient felt the following Labetalol side effects: induced labour, postpartum haemorrhage, delivery, maternal exposure during pregnancy, uterine hypotonus. Labetalol Hcl dosage: 150 Mg, Unk.
Multiple prescriptions taken:
  • Adalat (40 Mg, Unk)


Angioedema (8060148-X)
Patient was taking Labetalol Hcl. After Labetalol was administered, patient encountered several Labetalol side effects: angioedema on Jan 19, 2012 from UNITED STATES Additional patient health information: Patient , 59 years of age, weighting 227.5 lb, . Labetalol Hcl dosage: N/A.
Multiple concurrent drugs taken:
  • Promethazine
  • Oxycodone Hcl And Acetaminophen
  • Advair Diskus 100/50
  • Ventolin
  • Norvasc (10 Mg Daily Po Chronic)
  • Fluticasone Propionate
  • Dexilant
  • Lantus
Patient was hospitalized.

Poisoning (8036071-3)
Adverse event was reported on Dec 21, 2011 by a Male taking Labetalol Hydrochloride (Dosage: Parenteral) . Location: UNITED STATES , 51 years of age, Directly after, patient experienced the unwanted or unexpected Labetalol side effects: poisoning.

Poisoning (8036069-5)
on Dec 21, 2011 Female from UNITED STATES , 80 years of age, was treated with Labetalol Hydrochloride. Patient felt the following Labetalol side effects: poisoning. Labetalol Hydrochloride dosage: N/A.

Headache, Blood Pressure Increased, Dyspnoea, Overdose, Atrioventricular Block First Degree, Urinary Incontinence, Hypertensive Crisis, Labile Hypertension (8031632-X)
on Jan 03, 2012 Female from UNITED STATES , weighting 144.2 lb, was treated with Labetalol Hcl. After Labetalol was administered, patient encountered several Labetalol side effects: headache, blood pressure increased, dyspnoea, overdose, atrioventricular block first degree, urinary incontinence, hypertensive crisis, labile hypertension. Labetalol Hcl dosage: 1 Df, Qid.
Multiple concurrent drugs taken:
  • Synthroid (2 Df, Qd)
  • Valium (5000 U, Qd)
  • Prilosec (1 Df, Qd)
  • Lopressor (50 Mg, Tid)
Patient was hospitalized and became disabled.

Chromaturia, Bile Duct Stone, Emotional Distress, Anxiety, Cholelithiasis, Pain, Injury, Coordination Abnormal (8011630-2)
Patient was taking Labetalol Hcl. Directly after, patient experienced the unwanted or unexpected Labetalol side effects: chromaturia, bile duct stone, emotional distress, anxiety, cholelithiasis, pain, injury, coordination abnormal on Dec 19, 2011 from UNITED STATES Additional patient health information: Female , 21 years of age, weighting 275.6 lb, . Labetalol Hcl dosage: Unk.
Associated medications used:
  • Micronor (Unk)
  • Macrobid (100 Mg, Unk)
  • Iron Sulfatethiamin Compound Tab (Unk)
  • Claritin
  • Fioricet (Unk)
  • Ampicillin (250 Mg, Unk)
  • Acetaminophen
  • Monistat
Patient was hospitalized.

Speech Disorder (7999450-6)
Adverse event was reported on Dec 12, 2011 by a Male taking Labetalol Hcl (Dosage: N/A) . Location: UNITED STATES , 65 years of age, Patient felt the following Labetalol side effects: speech disorder.
Multiple prescriptions taken:
  • Lipitor
  • Actos
  • Starlix
  • Seroquel
  • Phenobarbital Tab


Maternal Exposure During Pregnancy (7998124-5)
on Feb 11, 2011 Female from UNITED STATES , 38 years of age, was treated with Labetalol Hcl. After Labetalol was administered, patient encountered several Labetalol side effects: maternal exposure during pregnancy. Labetalol Hcl dosage: N/A.
Multiple concurrent drugs taken:
  • Aldomet
  • Lovaza (2cap Twice Per Day)
  • Vitamin And Mineral Prenatal Supplement W/ Folic Acid Cap
  • Folic Acid


Pregnancy With Contraceptive Device, Device Dislocation, Menstruation Delayed, Device Breakage (7979296-5)
on Dec 06, 2011 Female from UNITED STATES , 26 years of age, weighting 192.0 lb, was diagnosed with
  • hypertension
  • contraception
and was treated with Labetalol Hcl. Directly after, patient experienced the unwanted or unexpected Labetalol side effects: pregnancy with contraceptive device, device dislocation, menstruation delayed, device breakage. Labetalol Hcl dosage: 400 Mg, Bid.
Associated medications used:
  • Mirena (Unk)
Patient was hospitalized.

Stress, Anxiety, Unevaluable Event, Fear, Multi-organ Failure, Renal Impairment, Renal Injury, Renal Failure, Emotional Distress (7963460-5)
Patient was taking Labetalol Hcl. Patient felt the following Labetalol side effects: stress, anxiety, unevaluable event, fear, multi-organ failure, renal impairment, renal injury, renal failure, emotional distress on Nov 29, 2011 from UNITED STATES Additional patient health information: Male , 63 years of age, weighting 196.2 lb, . Labetalol Hcl dosage: 100 Mg, Unk.
Multiple prescriptions taken:
  • Fentanyl-100 (Unk)
  • Bumex (Unk)
  • Red Blood Cells, Concentrated (Unk)
  • Cardioplegia
  • Contrast Media
  • Levaquin (200 Mg, Qd)
  • Aspirin (325 Mg)
  • Cordarone (200 Mg, Bid)
Patient was hospitalized.

Disease Progression (7963119-4)
Adverse event was reported on Dec 05, 2011 by a Male taking Labetalol Hcl (Dosage: N/A) . Location: CANADA , weighting 225.2 lb, After Labetalol was administered, patient encountered several Labetalol side effects: disease progression.
Multiple concurrent drugs taken:
  • Avastin
  • Zantac
  • Lorazepam
  • Avastin
  • Amlodipine


Blood Pressure Increased (7939296-8)
on Nov 17, 2011 Male from UNITED STATES , 57 years of age, was treated with Labetalol Hcl. Directly after, patient experienced the unwanted or unexpected Labetalol side effects: blood pressure increased. Labetalol Hcl dosage: N/A.
Associated medications used:
  • Pravastatin
  • Lisinopril
  • Mucinex Dm
  • Amlodipine Besylate
  • Januvia
  • Lantus


Cerebrovascular Accident, Cardiac Failure Congestive, Pulmonary Oedema, Coronary Artery Disease (7930764-1)
on Nov 15, 2011 Female from UNITED STATES , weighting 240.5 lb, was treated with Labetalol Hcl. Patient felt the following Labetalol side effects: cerebrovascular accident, cardiac failure congestive, pulmonary oedema, coronary artery disease. Labetalol Hcl dosage: N/A.
Multiple prescriptions taken:
  • Elavil
  • Prinivil
  • Provera
  • Avandia (8mg Per Day)
  • Glucophage
Patient was hospitalized.

Acne, Rash (7925757-4)
Patient was taking Labetalol Hcl. After Labetalol was administered, patient encountered several Labetalol side effects: acne, rash on Apr 12, 2011 from UNITED STATES Additional patient health information: Female , 40 years of age, weighting 175.0 lb, . Labetalol Hcl dosage: 100 Mg, Unk.
Multiple concurrent drugs taken:
  • Methylprednisolone (4 Mg, Unk)
  • Enbrel (50 Mg, Qwk)
  • Prenatal /00231801/


Cerebrovascular Accident (7914258-5)
Adverse event was reported on Nov 03, 2011 by a Female taking Labetalol Hcl (Dosage: N/A) was diagnosed with
  • blood pressure increased
  • vitamin supplementation
  • peritoneal dialysis
  • contraception
  • anaemia
  • electrolyte imbalance
  • blood parathyroid hormone increased
and. Location: UNITED STATES , 36 years of age, Directly after, patient experienced the unwanted or unexpected Labetalol side effects: cerebrovascular accident.
Associated medications used:
  • Nephro-vite Rx
  • Dianeal
  • Ethinyl Estradiol
  • Epogen
  • Phoslo
  • Rocaltrol
Patient was hospitalized.

Inflammatory Bowel Disease, Arthritis, Bipolar Disorder, Neck Injury, Abdominal Hernia, Osteoarthritis, Anxiety, Flight Of Ideas, Obsessive-compulsive Disorder (7910195-0)
on Nov 08, 2011 Female from UNITED STATES , weighting 175.0 lb, was treated with Labetalol Hcl. Patient felt the following Labetalol side effects: inflammatory bowel disease, arthritis, bipolar disorder, neck injury, abdominal hernia, osteoarthritis, anxiety, flight of ideas, obsessive-compulsive disorder. Labetalol Hcl dosage: Reported As Labetolol..
Multiple prescriptions taken:
  • Zoloft
  • Accutane
  • Seroquel
  • Ativan
  • Prednisone Tab
  • Colazal
  • Valium
  • Accutane
Patient was hospitalized and became disabled.

Hyperlipidaemia, Cytomegalovirus Viraemia, Cerebral Ischaemia, Transient Ischaemic Attack (7898936-2)
on Oct 28, 2011 Male from UNITED STATES , weighting 249.1 lb, was treated with Labetalol Hcl. After Labetalol was administered, patient encountered several Labetalol side effects: hyperlipidaemia, cytomegalovirus viraemia, cerebral ischaemia, transient ischaemic attack. Labetalol Hcl dosage: Unk.
Multiple concurrent drugs taken:
  • Myfortic (360 Mg Am, 180 Mg Hs)
  • Multi-vitamin (1 Df, Uid/qd)
  • Amevive (7.5 Mg, Doses X 2)
  • Amevive (15 Mg, Weekly)
  • Amevive (15 Mg, Monthly)
  • Prograf (5 Mg, Bid)
  • Amlodipine (Unk)
Patient was hospitalized.

Gestational Hypertension, Caesarean Section, Premature Delivery, Maternal Exposure During Pregnancy (7864463-1)
Patient was taking Labetalol Hcl. Directly after, patient experienced the unwanted or unexpected Labetalol side effects: gestational hypertension, caesarean section, premature delivery, maternal exposure during pregnancy on Oct 18, 2011 from UNITED STATES Additional patient health information: Female , weighting 134.0 lb, was diagnosed with
  • hypertension
  • pregnancy
  • psoriatic arthropathy
and. Labetalol Hcl dosage: N/A.
Associated medications used:
  • Multi-vitamins
  • Remicade
Patient was hospitalized.

Glaucoma, Pollakiuria, Diverticulum, Cerebrovascular Accident, Chronic Obstructive Pulmonary Disease, Impaired Gastric Emptying, Pain In Extremity, Hiatus Hernia, Carotid Artery Stenosis (7838150-X)
Adverse event was reported on Oct 13, 2011 by a Female taking Labetalol Hcl (Dosage: N/A) . Location: UNITED STATES , weighting 132.9 lb, Patient felt the following Labetalol side effects: glaucoma, pollakiuria, diverticulum, cerebrovascular accident, chronic obstructive pulmonary disease, impaired gastric emptying, pain in extremity, hiatus hernia, carotid artery stenosis.
Multiple prescriptions taken:
  • Paxil
  • Pepcid (Q 12 H As Needed)
  • Tylenol-500
  • Amlodipine
  • Nitroglycerin (Dissolve One Tablet Under The Toungue May Repeat Every 5 Minutes. Maximum Of 3 Doses In 15 Minutes)
  • Aspirin
  • Multi-vitamin
  • Carbamazepine
Patient was hospitalized.

Loss Of Consciousness, Phaeochromocytoma, Ventricular Fibrillation, Circulatory Collapse, Tachycardia, Hypertensive Crisis, Maternal Exposure During Pregnancy (7799333-0)
on Sep 26, 2011 Female from JAPAN , 35 years of age, weighting 141.1 lb, was diagnosed with
  • hypertensive crisis
and was treated with Labetalol Hcl. After Labetalol was administered, patient encountered several Labetalol side effects: loss of consciousness, phaeochromocytoma, ventricular fibrillation, circulatory collapse, tachycardia, hypertensive crisis, maternal exposure during pregnancy. Labetalol Hcl dosage: 35 Mg, Unk.
Multiple concurrent drugs taken:
  • Apresoline (10 Mg, Unk)
  • Dopamine Hcl (Unk Ukn, Unk)
  • Apresoline (5 Mg, Unk)
  • Nicardipine Hcl (1 Mg, Unk)
  • Nicardipine Hcl (2 Mg, Unk)


Loss Of Consciousness, Ventricular Fibrillation, Circulatory Collapse, Phaeochromocytoma (7793267-3)
on Sep 23, 2011 Female from TAIWAN, PROVINCE OF CHINA , 35 years of age, was diagnosed with
  • hypertension
and was treated with Labetalol Hcl. Directly after, patient experienced the unwanted or unexpected Labetalol side effects: loss of consciousness, ventricular fibrillation, circulatory collapse, phaeochromocytoma. Labetalol Hcl dosage: 35mg/iv. Patient was hospitalized.

Showing 1-25 of 177 

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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 Information

Alternative LABETALOL Names:TRANDATE

Active Ingredient: LABETALOL

More About Labetalol

Side Effects reported to FDA: 177. View Labetalol Adverse Reports

Labetalol safety alerts: No

Reported deaths: 17

Reported hospitalizations: 59

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