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Xyzal Side Effects

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Common Xyzal Side Effects


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

Loss Of Consciousness (22)
Somnolence (21)
Fatigue (18)
Urticaria (16)
Headache (16)
Dyspnoea (16)
Asthenia (15)
Nausea (14)
Pruritus (13)
Rash (12)
Convulsion (12)
Pyrexia (11)
Dizziness (11)
Abdominal Pain Upper (11)
Malaise (11)
Erythema (11)
Diarrhoea (10)
Platelet Count Decreased (9)
Insomnia (8)
Oedema Peripheral (8)

➢ 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.

Xyzal Side Effects Reported to FDA



Xyzal Side Effect Report#9961297
Overdose
This is a report of a 6-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: NA, who was treated with Xyzal (dosage: Strength: 5mg/ml, 32 Drops After Having Taken Other 7 Drops, start time:
May 02, 2013), combined with: NA. and developed a serious reaction and side effect(s): Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xyzal treatment in female patients, resulting in Overdose side effect. The patient was hospitalized.
Xyzal Side Effect Report#9916743
Respiratory Tract Infection, Pyrexia
This report suggests a potential Xyzal Respiratory Tract Infection side effect(s) that can have serious consequences. A 40-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: urticaria chronic,asthma and used Xyzal (dosage: NA) starting 201311. After starting Xyzal the patient began experiencing various side effects, including: Respiratory Tract Infection, PyrexiaAdditional drugs used concurrently:
  • Theodur
  • Symbicort
Although Xyzal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Respiratory Tract Infection, may still occur.
Xyzal Side Effect Report#9906277
Somnolence, Stupor, Fall, Dry Mouth, Thirst
This Somnolence problem was reported by a physician from JP. A 85-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: urticaria,hypertension,dyslipidaemia. On
Jan 24, 2014 this consumer started treatment with Xyzal (dosage: NA). The following drugs were being taken at the same time:
  • Adalat-cr
  • Crestor
  • Dexamethasone
  • Zithromac
When using Xyzal, the patient experienced the following unwanted symptoms/side effects: Somnolence, Stupor, Fall, Dry Mouth, ThirstAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Somnolence, may become evident only after a product is in use by the general population.
Xyzal Side Effect Report#9899856
Toxic Skin Eruption
This Toxic Skin Eruption side effect was reported by a physician from JP. A 82-year-old male patient (weight:NA) experienced the following symptoms/conditions: rhinitis allergic.The patient was prescribed Xyzal (drug dosage: NA), which was initiated on
Dec 16, 2013. Concurrently used drugs: NA..After starting to take Xyzal the consumer reported adverse symptoms, such as: Toxic Skin EruptionThese side effects may potentially be related to Xyzal.
Xyzal Side Effect Report#9894398
Palmar-plantar Erythrodysaesthesia Syndrome, Convulsion
This is a report of a 70-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: NA, who was treated with Xyzal (dosage: NA, start time:
Nov 21, 2013), combined with:
  • Zyloric
  • Nexavar
  • Furosemide
  • Aldactone A
  • Norvasc Od
  • Urso
  • Glakay
  • Lactulose
and developed a serious reaction and side effect(s): Palmar-plantar Erythrodysaesthesia Syndrome, Convulsion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xyzal treatment in male patients, resulting in Palmar-plantar Erythrodysaesthesia Syndrome side effect. The patient was hospitalized.
Xyzal Side Effect Report#9851240
Erythema Multiforme
This report suggests a potential Xyzal Erythema Multiforme side effect(s) that can have serious consequences. A 80-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: eczema and used Xyzal (dosage: NA) starting
Dec 24, 2013. After starting Xyzal the patient began experiencing various side effects, including: Erythema MultiformeAdditional drugs used concurrently:
  • Tramcet
  • Betanis
  • Alendronate
  • Lyrica
  • Calfina
  • Tryptanol
  • Domperidone
  • Myorelark
Although Xyzal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Erythema Multiforme, may still occur.
Xyzal Side Effect Report#9847171
Anaphylactic Shock, Palpitations, Convulsion, Dizziness
This Anaphylactic Shock problem was reported by a consumer or non-health professional from NL. A 20-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: dermatitis. On
Nov 11, 2013 this consumer started treatment with Xyzal (dosage: At Start 2/day, Later 4/day). The following drugs were being taken at the same time: NA. When using Xyzal, the patient experienced the following unwanted symptoms/side effects: Anaphylactic Shock, Palpitations, Convulsion, DizzinessAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anaphylactic Shock, may become evident only after a product is in use by the general population.
Xyzal Side Effect Report#9814296
Eczema
This Eczema side effect was reported by a health professional from FR. A 61-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Xyzall (drug dosage: NA), which was initiated on 201307. Concurrently used drugs:
  • Crestor
  • Dexeryl
  • Mianserine Arrow
  • Lamotrigine Arrow (Dose :250 Mg/day Dosage Strength :25 Mg And 100 Mg 2 Per Day)
  • Alprazolam
  • Duphalac
  • Nebivolol
  • Paroxetine
.After starting to take Xyzall the consumer reported adverse symptoms, such as: EczemaThese side effects may potentially be related to Xyzall. The patient was hospitalized.
Xyzal Side Effect Report#9790220
Overdose
This is a report of a 6-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: NA, who was treated with Xyzal (dosage: 5 Mg/ml Oral Drops, 20 Ml Glass Bottle; 32 Drops, start time:
May 02, 2013), combined with: NA. and developed a serious reaction and side effect(s): Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xyzal treatment in female patients, resulting in Overdose side effect. The patient was hospitalized.
Xyzal Side Effect Report#9761285
Pneumonia Aspiration, Somnolence, Overdose
This report suggests a potential Xyzal Pneumonia Aspiration side effect(s) that can have serious consequences. A 89-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: pruritus and used Xyzal (dosage: NA) starting NS. After starting Xyzal the patient began experiencing various side effects, including: Pneumonia Aspiration, Somnolence, OverdoseAdditional drugs used concurrently: NA. Although Xyzal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pneumonia Aspiration, may still occur.
Xyzal Side Effect Report#9741066
Road Traffic Accident, Somnolence
This Road Traffic Accident problem was reported by a physician from NL. A 71-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: rhinitis allergic,hypersensitivity. On
Oct 16, 2013 this consumer started treatment with Xyzal (dosage: NA). The following drugs were being taken at the same time:
  • Fluticasone Propionate (50 Ug/dose 1 Times Per Day)
When using Xyzal, the patient experienced the following unwanted symptoms/side effects: Road Traffic Accident, SomnolenceAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Road Traffic Accident, may become evident only after a product is in use by the general population.
Xyzal Side Effect Report#9708909
Agranulocytosis
This Agranulocytosis side effect was reported by a health professional from JP. A 46-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Xyzal (drug dosage: NA), which was initiated on 201301. Concurrently used drugs: NA..After starting to take Xyzal the consumer reported adverse symptoms, such as: AgranulocytosisThese side effects may potentially be related to Xyzal.
Xyzal Side Effect Report#9666000
Somnolence, Asthenia, Abdominal Distension
This is a report of a 30-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: urticaria, who was treated with Xyzall (dosage: 1 Unit Daily, start time:
Jul 06, 2013), combined with: NA. and developed a serious reaction and side effect(s): Somnolence, Asthenia, Abdominal Distension after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xyzall treatment in female patients, resulting in Somnolence side effect.
Xyzal Side Effect Report#9657797
Anaemia
This report suggests a potential Xyzall Anaemia side effect(s) that can have serious consequences. A 91-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Xyzall (dosage: 5 Mg) starting 201111. After starting Xyzall the patient began experiencing various side effects, including: AnaemiaAdditional drugs used concurrently:
  • Chloraminophene (2 Mg From 8 To 12 Of Each Month)
  • Risperdal (1 Mg)
  • Seresta (10 Mg)
The patient was hospitalized. Although Xyzall demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anaemia, may still occur.
Xyzal Side Effect Report#9620069
Liver Disorder, Cholestasis, Anomalous Arrangement Of Pancreaticobiliary Duct, Gallbladder Polyp, Hepatic Cyst, Renal Cyst, Hepatic Necrosis
This Liver Disorder problem was reported by a physician from JP. A 69-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jul 12, 2005 this consumer started treatment with Xyzal (dosage: NA). The following drugs were being taken at the same time:
  • Pursennid
  • Tamsulosin Hydrochloride
  • Allelock
  • Primperan
  • Magmitt
  • Amlodin
  • Solanax
  • Hirnamin
When using Xyzal, the patient experienced the following unwanted symptoms/side effects: Liver Disorder, Cholestasis, Anomalous Arrangement Of Pancreaticobiliary Duct, Gallbladder Polyp, Hepatic Cyst, Renal Cyst, Hepatic NecrosisThe 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 Liver Disorder, may become evident only after a product is in use by the general population.
Xyzal Side Effect Report#9606943
Pericarditis
This Pericarditis side effect was reported by a pharmacist from FR. A female patient (weight:NA) experienced the following symptoms/conditions: hypersensitivity.The patient was prescribed Xyzall (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Xyzall the consumer reported adverse symptoms, such as: PericarditisThese side effects may potentially be related to Xyzall.
Xyzal Side Effect Report#9604403
Exposure During Pregnancy
This is a report of a 40-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: pruritus, who was treated with Xyzal (dosage: NA, start time:
Dec 17, 2012), combined with:
  • Protopic
  • Myser
  • Voalla
  • Lidomex
  • Hirudoid
  • Propeto
and developed a serious reaction and side effect(s): Exposure During Pregnancy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xyzal treatment in female patients, resulting in Exposure During Pregnancy side effect.
Xyzal Side Effect Report#9586249
Renal Impairment, Hepatic Function Abnormal, Oedema Peripheral, Face Oedema
This report suggests a potential Xyzal Renal Impairment side effect(s) that can have serious consequences. A 33-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: urticaria and used Xyzal (dosage: NA) starting
Sep 09, 2013. After starting Xyzal the patient began experiencing various side effects, including: Renal Impairment, Hepatic Function Abnormal, Oedema Peripheral, Face OedemaAdditional drugs used concurrently: NA. Although Xyzal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Impairment, may still occur.
Xyzal Side Effect Report#9581398
Malaise, Hypotension, Pruritus, Erythema
This Malaise problem was reported by a health professional from FR. A 74-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Feb 26, 2013 this consumer started treatment with Xyzall (dosage: Scored Film Coated Tablets). The following drugs were being taken at the same time:
  • Polaramine (5 Mg/1ml In One Cycle)
  • Mylan (40 Mg In One Cycle)
  • Azantac (50 Mg (50 Mg In One Cycle))
When using Xyzall, the patient experienced the following unwanted symptoms/side effects: Malaise, Hypotension, Pruritus, ErythemaThe 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 Malaise, may become evident only after a product is in use by the general population.
Xyzal Side Effect Report#9553340
Disturbance In Attention, Somnolence
This Disturbance In Attention side effect was reported by a consumer or non-health professional from GB. A 51-year-old female patient (weight:NA) experienced the following symptoms/conditions: multiple allergies.The patient was prescribed Xyzal (drug dosage: NA), which was initiated on
Aug 01, 2013. Concurrently used drugs:
  • Buscopan
  • Co-dydramol
  • Mebeverine
  • Oramorph
  • Seretide
.After starting to take Xyzal the consumer reported adverse symptoms, such as: Disturbance In Attention, SomnolenceThese side effects may potentially be related to Xyzal.
Xyzal Side Effect Report#9551339
Fatigue, Depression, Suicidal Ideation
This is a report of a 12-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: multiple allergies, who was treated with Xyzal (dosage: NA, start time: NS), combined with:
  • Albuterol
  • Nasonex
and developed a serious reaction and side effect(s): Fatigue, Depression, Suicidal Ideation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xyzal treatment in male patients, resulting in Fatigue side effect.
Xyzal Side Effect Report#9513260
Hepatocellular Injury, Cholestasis, Lymphadenopathy, Influenza
This report suggests a potential Xyzall Hepatocellular Injury side effect(s) that can have serious consequences. A 28-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Xyzall (dosage: NA) starting 2013. After starting Xyzall the patient began experiencing various side effects, including: Hepatocellular Injury, Cholestasis, Lymphadenopathy, InfluenzaAdditional drugs used concurrently:
  • Imurel
  • Augmentin (2 Units Daily, 1g/125 Mg)
  • Tramadol Hydrochloride (2 Units Daily)
  • Paracetamol
  • Nasonex
  • Multicrom
  • Myolastan
The patient was hospitalized. Although Xyzall demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatocellular Injury, may still occur.
Xyzal Side Effect Report#9507783
Diarrhoea, Muscle Spasms
This Diarrhoea problem was reported by a physician from US. A 43-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: sinusitis. On
Apr 06, 2010 this consumer started treatment with Xyzal (dosage: 5mg Daily By Mouth). The following drugs were being taken at the same time: NA. When using Xyzal, the patient experienced the following unwanted symptoms/side effects: Diarrhoea, Muscle SpasmsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Diarrhoea, may become evident only after a product is in use by the general population.
Xyzal Side Effect Report#9495206
Platelet Count Decreased, Herpes Zoster
This Platelet Count Decreased side effect was reported by a physician from JP. A 72-year-old male patient (weight:NA) experienced the following symptoms/conditions: dermatitis atopic,herpes zoster.The patient was prescribed Xyzal (drug dosage: NA), which was initiated on
Jul 18, 2013. Concurrently used drugs:
  • Famvir
  • Loxonin
  • Methycobal
.After starting to take Xyzal the consumer reported adverse symptoms, such as: Platelet Count Decreased, Herpes ZosterThese side effects may potentially be related to Xyzal. The patient was hospitalized.
Xyzal Side Effect Report#9458678
Arrhythmia
This is a report of a 61-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: eczema, who was treated with Xyzal (dosage: NA, start time:
Mar 21, 2013), combined with: NA. and developed a serious reaction and side effect(s): Arrhythmia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xyzal treatment in male patients, resulting in Arrhythmia side effect.


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The appearance of Xyzal 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.

What are common Xyzal Side Effects for Women?

Women Side EffectsReports
Somnolence 15
Fatigue 11
Loss Of Consciousness 11
Urticaria 11
Headache 10
Nausea 10
Asthenia 9
Dizziness 9
Pruritus 9
Rash 9

What are common Xyzal Side Effects for Men?

Men Side EffectsReports
Loss Of Consciousness 11
Dyspnoea 8
Fatigue 7
Pyrexia 7
Asthenia 6
Headache 6
Somnolence 5
Urticaria 5
Abdominal Pain Upper 4
Aggression 4

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.

    Xyzal 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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    How Effective is Xyzal for You?

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    Xyzal Safety Alerts, Active Ingredients, Usage Information

    NDC0024-5800
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameXyzal
    Namelevocetirizine dihydrochloride
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since20070809
    LabelerSanofi-Aventis U.S. LLC
    Active Ingredient(s)LEVOCETIRIZINE DIHYDROCHLORIDE
    Strength(s)5
    Unit(s)mg/1
    Pharma ClassHistamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]

    Xyzal Dosage, Warnings, Usage.

    Side Effects reported to FDA: 369

    Xyzal safety alerts: No

    Reported deaths: 10

    Reported hospitalizations: 110

    Latest Xyzal clinical trials