PatientsVille.com Logo

Ketotifen Side Effects

PatientsVille

Common Ketotifen Side Effects


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

Eye Pruritus (3)
Vision Blurred (3)
Ocular Hyperaemia (3)
Eye Irritation (2)
Condition Aggravated (2)
Visual Impairment (2)
Hepatotoxicity (2)
Photophobia (1)
Parakeratosis (1)
Premature Labour (1)
Prurigo (1)
Nervousness (1)
Somnolence (1)
Loss Of Consciousness (1)
Lymphocytic Infiltration (1)
Multi-organ Failure (1)
Insomnia (1)
Hypotonia (1)
Hyperkeratosis (1)
Halo Vision (1)

➢ 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.

Ketotifen Side Effects Reported to FDA



Ketotifen Side Effect Report#8103451-7
Nervousness, Insomnia
This is a report of a 3-year-old male patient (weight: NA) from Spain, suffering from the following health symptoms/conditions: respiratory tract infection, who was treated with Ketotifen Fumarate (dosage: 7.5 Ml, Daily, start time:
May 05, 2011), combined with: NA. and developed a serious reaction and side effect(s): Nervousness, Insomnia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ketotifen Fumarate treatment in male patients, resulting in Nervousness side effect.
Ketotifen Side Effect Report#8051255-6
Hepatotoxicity
This report suggests a potential Ketotifen Fumarate Hepatotoxicity side effect(s) that can have serious consequences. A 70-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: off label use and used Ketotifen Fumarate (dosage: NA) starting NS. After starting Ketotifen Fumarate the patient began experiencing various side effects, including: HepatotoxicityAdditional drugs used concurrently: NA. Although Ketotifen Fumarate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatotoxicity, may still occur.
Ketotifen Side Effect Report#7965346-9
Loss Of Consciousness, Epilepsy, Glossoptosis
This Loss Of Consciousness problem was reported by a pharmacist from Japan. A 2-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Ketotifen Fumarate (dosage: Unk Ukn, Unk). The following drugs were being taken at the same time: NA. When using Ketotifen Fumarate, the patient experienced the following unwanted symptoms/side effects: Loss Of Consciousness, Epilepsy, GlossoptosisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Loss Of Consciousness, may become evident only after a product is in use by the general population.
Ketotifen Side Effect Report#7902065-9
Somnolence, Aggression
This Somnolence side effect was reported by a physician from Korea, Republic Of. A 4-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Ketotifen Fumarate (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Fluticasone Propionate
  • Loratadine
  • Levodropropizine
  • Montelukast Sodium
.After starting to take Ketotifen Fumarate the consumer reported adverse symptoms, such as: Somnolence, AggressionThese side effects may potentially be related to Ketotifen Fumarate.
Ketotifen Side Effect Report#7361610-5
Chalazion
This is a report of a 45-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: seasonal allergy, who was treated with Ketotifen Fumarate (dosage: ;qd;oph, start time:
Nov 22, 2010), combined with: NA. and developed a serious reaction and side effect(s): Chalazion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ketotifen Fumarate treatment in male patients, resulting in Chalazion side effect.
Ketotifen Side Effect Report#7115424-1
Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Hepatotoxicity
This report suggests a potential Ketotifen Fumarate Alanine Aminotransferase Increased side effect(s) that can have serious consequences. A 70-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: gastrointestinal disorder and used Ketotifen Fumarate (dosage: NA) starting NS. After starting Ketotifen Fumarate the patient began experiencing various side effects, including: Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, HepatotoxicityAdditional drugs used concurrently: NA. Although Ketotifen Fumarate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Alanine Aminotransferase Increased, may still occur.
Ketotifen Side Effect Report#7074168-5
Eye Irritation, Eye Pruritus, Visual Impairment
This Eye Irritation problem was reported by a consumer or non-health professional from United States. A 69-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: eye pruritus. On
Jan 01, 2010 this consumer started treatment with Ketotifen Fumarate (dosage: 1 Gtt;bid;oph). The following drugs were being taken at the same time:
  • Simvastatin
When using Ketotifen Fumarate, the patient experienced the following unwanted symptoms/side effects: Eye Irritation, Eye Pruritus, Visual ImpairmentAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Eye Irritation, may become evident only after a product is in use by the general population.
Ketotifen Side Effect Report#6945596-0
Eye Irritation, Eye Pruritus, Visual Impairment
This Eye Irritation side effect was reported by a consumer or non-health professional from United States. A 69-year-old female patient (weight:NA) experienced the following symptoms/conditions: eye pruritus.The patient was prescribed Ketotifen Fumarate (drug dosage: 1 Gtt; Bid; Oph), which was initiated on
Jan 01, 2010. Concurrently used drugs:
  • Simvastatin
.After starting to take Ketotifen Fumarate the consumer reported adverse symptoms, such as: Eye Irritation, Eye Pruritus, Visual ImpairmentThese side effects may potentially be related to Ketotifen Fumarate.
Ketotifen Side Effect Report#6755941-7
Acanthosis, Caesarean Section, Hyperkeratosis, Lymphocytic Infiltration, Parakeratosis, Premature Labour, Prurigo
This is a report of a 40-year-old female patient (weight: NA) from China, suffering from the following health symptoms/conditions: prurigo, who was treated with Ketotifen Fumarate (dosage: 1 Mg, Bid, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Acanthosis, Caesarean Section, Hyperkeratosis, Lymphocytic Infiltration, Parakeratosis, Premature Labour, Prurigo after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ketotifen Fumarate treatment in female patients, resulting in Acanthosis side effect. The patient was hospitalized.
Ketotifen Side Effect Report#6506604-4
Vision Blurred
This report suggests a potential Ketotifen Fumarate Vision Blurred side effect(s) that can have serious consequences. A 44-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: eye pain,eye pruritus and used Ketotifen Fumarate (dosage: 1 Gtt; Qd; Oph) starting
Sep 01, 2009. After starting Ketotifen Fumarate the patient began experiencing various side effects, including: Vision BlurredAdditional drugs used concurrently: NA. Although Ketotifen Fumarate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Vision Blurred, may still occur.
Ketotifen Side Effect Report#6467290-5
Condition Aggravated, Eye Pain, Eye Pruritus, Ocular Hyperaemia, Vision Blurred
This Condition Aggravated problem was reported by a consumer or non-health professional from United States. A 44-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: eye pain,eye pruritus. On
Sep 01, 2009 this consumer started treatment with Ketotifen Fumarate (dosage: 1 Gtt;qd; Oph). The following drugs were being taken at the same time: NA. When using Ketotifen Fumarate, the patient experienced the following unwanted symptoms/side effects: Condition Aggravated, Eye Pain, Eye Pruritus, Ocular Hyperaemia, Vision BlurredAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Condition Aggravated, may become evident only after a product is in use by the general population.
Ketotifen Side Effect Report#6094616-7
Diarrhoea, Endoscopy Upper Gastrointestinal Tract, Flushing, Hypotonia
This Diarrhoea side effect was reported by a health professional from United Kingdom. A 3-year-old patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Ketotifen Hydrogen Fumarate (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Cetrizine
  • Trimeprazine Tab
  • Cimetidine
  • Chlorphentermine 65mg Tab
  • Cromolyn Sodium
  • Adrenaline
  • Midazolam Hcl
  • Hydrocortisone
.After starting to take Ketotifen Hydrogen Fumarate the consumer reported adverse symptoms, such as: Diarrhoea, Endoscopy Upper Gastrointestinal Tract, Flushing, HypotoniaThese side effects may potentially be related to Ketotifen Hydrogen Fumarate.
Ketotifen Side Effect Report#6087190-2
Condition Aggravated, Eye Disorder, Ocular Hyperaemia
This is a report of a 21-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: conjunctivitis allergic, who was treated with Ketotifen Fumarate (dosage: 1 Drop Each Eye Every 8hours Ophthalmic, start time:
Feb 16, 2009), combined with: NA. and developed a serious reaction and side effect(s): Condition Aggravated, Eye Disorder, Ocular Hyperaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ketotifen Fumarate treatment in male patients, resulting in Condition Aggravated side effect.
Ketotifen Side Effect Report#5610724-6
Convulsion, Vomiting
This report suggests a potential Ketotifen Fumarate Convulsion side effect(s) that can have serious consequences. A 8-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Ketotifen Fumarate (dosage: NA) starting NS. After starting Ketotifen Fumarate the patient began experiencing various side effects, including: Convulsion, VomitingAdditional drugs used concurrently:
  • Onon
Although Ketotifen Fumarate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Convulsion, may still occur.
Ketotifen Side Effect Report#4920972-6
Depressed Level Of Consciousness, Disseminated Intravascular Coagulation, Multi-organ Failure, Staphylococcal Infection, Urinary Tract Infection
This Depressed Level Of Consciousness problem was reported by a physician from Japan. A 82-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Mar 20, 2005 this consumer started treatment with Ketotifen Fumarate (dosage: NA). The following drugs were being taken at the same time:
  • Sodium Gualenate
  • Magnesium Oxide
  • Stromectol
  • Bucillamine
  • Prednisolone
  • Acecol
  • Atelec
  • Loxonin
When using Ketotifen Fumarate, the patient experienced the following unwanted symptoms/side effects: Depressed Level Of Consciousness, Disseminated Intravascular Coagulation, Multi-organ Failure, Staphylococcal Infection, Urinary Tract InfectionThe 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 Depressed Level Of Consciousness, may become evident only after a product is in use by the general population.
Ketotifen Side Effect Report#10050023
Vision Blurred, Eye Inflammation, Ocular Hyperaemia, Photophobia, Halo Vision
This Vision Blurred side effect was reported by a consumer or non-health professional from US. A 36-year-old female patient (weight:NA) experienced the following symptoms/conditions: eye allergy.The patient was prescribed Ketotifen (drug dosage: 1 Drop, Twice Daily, Into The Eye), which was initiated on
Mar 26, 2014. Concurrently used drugs: NA..After starting to take Ketotifen the consumer reported adverse symptoms, such as: Vision Blurred, Eye Inflammation, Ocular Hyperaemia, Photophobia, Halo VisionThese side effects may potentially be related to Ketotifen.



The appearance of Ketotifen 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.

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.

    Ketotifen 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.

    Discuss Ketotifen Side Effects

    Did You Have a Ketotifen Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Ketotifen for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Ketotifen Safety Alerts, Active Ingredients, Usage Information

    NDC0363-9060
    TypeHUMAN OTC DRUG
    Proprietary NameKetotifen Fumarate
    NameKetotifen Fumarate
    Dosage FormSOLUTION/ DROPS
    RouteOPHTHALMIC
    On market since20130125
    LabelerWalgreens
    Active Ingredient(s)KETOTIFEN FUMARATE
    Strength(s)0.25
    Unit(s)mg/mL
    Pharma Class

    More About Ketotifen

    Side Effects reported to FDA: 16

    Ketotifen safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 3

    Latest Ketotifen clinical trials