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Nystatin (Nystatin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Nystatin and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (39)
Death (3)
Life Threatening Events (1)

Reports by Reaction Type

Hypersensitivity (7)Erythema (5)Pruritus (4)Drug Ineffective (4)Developmental Delay (4)DRY Mouth (4)Duane's Syndrome (4)Cleft LIP and Palate (4)Torticollis (4)Craniosynostosis (4)Feeding Disorder (4)Hydrocele (4)

Below are a few examples of reports where side effects / adverse reactions may be related to Nystatin. For a complete list or a specific selection of reports, please use the links above.

Possible Nystatin side effects in

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient:

Reactions: Hypersensitivity, Candidiasis

Drug(s) suspected as cause:
Nystatin

Fluconazole

Dulera
    Dosage: 2 puffs by mouth daily in the morning and evening

Other drugs received by patient: Meticorten; Prilosec; Furosemide



Possible Nystatin side effects in 63 year old female

Reported by a individual with unspecified qualification from Germany on 2012-07-25

Patient: 63 year old female

Reactions: Osteoarthritis, Tendon Disorder

Drug(s) suspected as cause:
Ciprofloxacin
    Indication: Diverticulitis

Nystatin
    Indication: Product Used FOR Unknown Indication



Possible Nystatin side effects in male

Reported by a lawyer from United States on 2012-07-12

Patient: male

Reactions: Cleft LIP and Palate, Cerebral Palsy, Torticollis, Craniosynostosis, Lacrimal Disorder, Developmental Delay, Plagiocephaly, Feeding Disorder, Hydrocele, Duane's Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen

Oxycodone / Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Nystatin
    Indication: Foetal Exposure During Pregnancy

Vicodin
    Indication: Foetal Exposure During Pregnancy

Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Oxycontin
    Indication: Foetal Exposure During Pregnancy

Ovcon-35
    Indication: Foetal Exposure During Pregnancy

Ultram
    Indication: Foetal Exposure During Pregnancy

Soma
    Indication: Foetal Exposure During Pregnancy

Feldene
    Indication: Foetal Exposure During Pregnancy

Crestor
    Indication: Foetal Exposure During Pregnancy

Effexor
    Indication: Foetal Exposure During Pregnancy

Selective Serotonin Reuptake Inhibitor
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Folic Acid; Fish OIL



Possible Nystatin side effects in 72 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-12

Patient: 72 year old male, weighing 81.0 kg (178.2 pounds)

Reactions: Tendon Rupture

Drug(s) suspected as cause:
Nystatin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Simvastatin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-09

Other drugs received by patient: Aspirin; Bendroflumethiazide; Acetaminophen; Bisoprolol Fumarate; Amlodipine; Ramipril; Colchicine



Possible Nystatin side effects in

Reported by a individual with unspecified qualification from United States on 2012-07-09

Patient:

Reactions: Product Packaging Issue, Medication Error

Drug(s) suspected as cause:
Hydrocortisone Valerate
    Dosage: 0.2% topical cream 15 gram
    Administration route: Topical

Nystatin
    Dosage: topical cream 100,000 units per gr 15 gram
    Administration route: Topical



Possible Nystatin side effects in male

Reported by a health professional (non-physician/pharmacist) from Serbia on 2012-06-18

Patient: male

Reactions: Haemorrhage, International Normalised Ratio Increased

Drug(s) suspected as cause:
Nystatin
    Dosage: top
    Administration route: Topical

Warfarin Sodium
    Dosage: po
    Administration route: Oral



Possible Nystatin side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-15

Patient: male

Reactions: Cerebral Palsy, Cleft LIP and Palate, Maternal Drugs Affecting Foetus, Ear Infection, Torticollis, Craniosynostosis, Lacrimal Disorder, Developmental Delay, Plagiocephaly, Dacryostenosis Congenital, Hypermetropia, Feeding Disorder, Hydrocele, Duane's Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Oxycontin
    Indication: Foetal Exposure During Pregnancy

Effexor
    Indication: Foetal Exposure During Pregnancy

Vicodin
    Indication: Foetal Exposure During Pregnancy

Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Crestor
    Indication: Foetal Exposure During Pregnancy

Ovcon-35
    Indication: Foetal Exposure During Pregnancy

Nystatin
    Indication: Foetal Exposure During Pregnancy

Selective Serotonin Reuptake Inhibitor
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Soma
    Indication: Foetal Exposure During Pregnancy

Feldene
    Indication: Foetal Exposure During Pregnancy

Acetaminophen

Ultram
    Indication: Foetal Exposure During Pregnancy

Oxycodone / Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Leucovorin Calcium; Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Fish OIL



Possible Nystatin side effects in female

Reported by a physician from United States on 2012-06-14

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Talwin
    Dosage: unk

Vibramycin
    Dosage: unk

Percodan
    Dosage: unk

Nystatin
    Dosage: unk

Clonidine HCL
    Dosage: unk

Biaxin
    Dosage: unk

Demerol
    Dosage: unk

Bexxar
    Dosage: unk



Possible Nystatin side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14

Patient: male

Reactions: Cleft LIP and Palate, Torticollis, Craniosynostosis, Lacrimal Disorder, Developmental Delay, Feeding Disorder, Duane's Syndrome, Hydrocele

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ovcon-35
    Indication: Foetal Exposure During Pregnancy

Soma
    Indication: Foetal Exposure During Pregnancy

Vicodin
    Indication: Foetal Exposure During Pregnancy

Effexor
    Indication: Foetal Exposure During Pregnancy

Acetaminophen

Feldene
    Indication: Foetal Exposure During Pregnancy

Selective Serotonin Reuptake Inhibitor
    Indication: Foetal Exposure During Pregnancy

Ultram
    Indication: Foetal Exposure During Pregnancy

Oxycontin
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Oxycodone / Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Crestor
    Indication: Foetal Exposure During Pregnancy

Nystatin
    Indication: Foetal Exposure During Pregnancy

Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Leucovorin Calcium; Fish OIL; Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP



Possible Nystatin side effects in

Reported by a health professional (non-physician/pharmacist) from Serbia on 2012-06-12

Patient:

Reactions: International Normalised Ratio Increased, Haematuria

Drug(s) suspected as cause:
Nystatin
    Indication: Oropharyngeal Pain

Nystatin
    Indication: Oesophageal Candidiasis

Warfarin Sodium
    Indication: Heart Valve Replacement

Warfarin Sodium
    Indication: Embolism Venous



Possible Nystatin side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-06

Patient: male

Reactions: Cleft LIP and Palate, Craniosynostosis, Developmental Delay, Torticollis, Feeding Disorder, Hydrocele, Duane's Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Crestor
    Indication: Foetal Exposure During Pregnancy

Feldene
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Oxycodone / Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Acetaminophen

Selective Serotonin Reuptake Inhibitor
    Indication: Foetal Exposure During Pregnancy

Ovcon-35
    Indication: Foetal Exposure During Pregnancy

Oxycontin
    Indication: Foetal Exposure During Pregnancy

Vicodin
    Indication: Foetal Exposure During Pregnancy

Ultram
    Indication: Foetal Exposure During Pregnancy

Soma
    Indication: Foetal Exposure During Pregnancy

Nystatin
    Indication: Foetal Exposure During Pregnancy

Effexor
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Folic Acid; Fish OIL



Possible Nystatin side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-04-04

Patient: 36 year old female

Reactions: Agitation, Restlessness, Drug Interaction, Feeling Abnormal

Drug(s) suspected as cause:
Escitalopram
    Dosage: changing dosages
    Indication: Depression
    Start date: 2005-01-01
    End date: 2011-12-14

Nystatin
    Start date: 2011-12-01
    End date: 2011-12-01

Escitalopram
    Dosage: 20 mg
    Start date: 2011-12-15
    End date: 2012-01-03

Escitalopram
    Dosage: decreased dosage (nos)
    Start date: 2012-01-04



Possible Nystatin side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: 65 year old female, weighing 50.8 kg (111.8 pounds)

Reactions: Application Site Erythema, Product Odour Abnormal

Drug(s) suspected as cause:
Nystatin



Possible Nystatin side effects in 73 year old female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: 73 year old female, weighing 90.7 kg (199.6 pounds)

Reactions: Product Substitution Issue, Burning Sensation, Pruritus, Fungal Infection, Drug Ineffective, Condition Aggravated, Rash

Drug(s) suspected as cause:
Nystatin

Nystatin
    Dosage: bid; top
    Administration route: Topical
    Indication: Fungal Infection
    Start date: 2012-01-16
    End date: 2012-01-20

Other drugs received by patient: Glipizide; Lipitor; Indapamide; Calcium + Vitamin D; Multi-Vitamins; Fish OIL



Possible Nystatin side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: 62 year old female, weighing 117.9 kg (259.5 pounds)

Reactions: Dysgeusia, Product Quality Issue

Drug(s) suspected as cause:
Nystatin
    Dosage: x1; top
    Administration route: Topical
    Indication: Seborrhoea
    Start date: 2010-08-01
    End date: 2010-08-01

Nystatin
    Dosage: x1; top
    Administration route: Topical
    Indication: Erythema
    Start date: 2010-08-01
    End date: 2010-08-01

Nystatin
    Dosage: x1; top
    Administration route: Topical
    Indication: Parosmia
    Start date: 2010-08-01
    End date: 2010-08-01

Other drugs received by patient: Hydrochlorothiazide; Glimepiride; Lisinopril; Coumadin; Amlodipine



Possible Nystatin side effects in 79 year old female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: 79 year old female, weighing 62.1 kg (136.7 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Drug Effect Decreased, Erythema

Drug(s) suspected as cause:
Nystatin

Other drugs received by patient: Ativan; Hydrochlorothiazide; Verelan



Possible Nystatin side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Nystatin



Possible Nystatin side effects in 61 year old male

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: 61 year old male, weighing 86.6 kg (190.6 pounds)

Reactions: Conjunctivitis Infective, Ocular Hyperaemia, Ear Pain, Sinusitis, Accidental Exposure

Drug(s) suspected as cause:
Nystatin

Other drugs received by patient: Inhalers



Possible Nystatin side effects in 69 year old male

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: 69 year old male, weighing 67.6 kg (148.7 pounds)

Reactions: Application Site Reaction, Urticaria

Drug(s) suspected as cause:
Nystatin



Possible Nystatin side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-26

Patient: female

Reactions: Discomfort

Drug(s) suspected as cause:
Nystatin



Possible Nystatin side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-03-23

Patient: female

Reactions: Hypersensitivity, DRY Mouth, Swollen Tongue, Erythema

Drug(s) suspected as cause:
Nystatin



Possible Nystatin side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-03-20

Patient: female

Reactions: Hypersensitivity, DRY Mouth, Swollen Tongue, Erythema

Drug(s) suspected as cause:
Nystatin



Possible Nystatin side effects in female

Reported by a pharmacist from United States on 2012-03-12

Patient: female

Reactions: Vulvovaginal Mycotic Infection

Drug(s) suspected as cause:
Nystatin



Possible Nystatin side effects in male

Reported by a pharmacist from Canada on 2012-03-08

Patient: male

Reactions: Hypersensitivity, Swollen Tongue, Erythema

Drug(s) suspected as cause:
Nystatin



Possible Nystatin side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-23

Patient: female

Reactions: Rash Generalised, Chills, Dizziness, Fall, Faeces Discoloured, Loss of Consciousness, Infection

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Nystatin



Possible Nystatin side effects in female

Reported by a pharmacist from Denmark on 2012-02-02

Patient: female

Reactions: Anxiety Disorder, Condition Aggravated, Drug Interaction, Serotonin Syndrome, Gastrointestinal Infection, Stress AT Work, Feeling Abnormal, Depressed Mood

Drug(s) suspected as cause:
Nystatin
    Indication: Gastrointestinal Fungal Infection

Escitalopram Oxalate
    Dosage: 15 mg (15 mg, 1 in 1 d)
    Indication: Anxiety Disorder

Escitalopram Oxalate
    Dosage: 20 mg (20 mg, 1 in 1 d) 15 mg (15 mg, 1 in 1 d)
    Indication: Anxiety Disorder

Escitalopram Oxalate
    Dosage: 20 mg (20 mg, 1 in 1 d) tapered down from 20 mg to 5 mg in steps of 2.5 mg
    Indication: Anxiety Disorder



Possible Nystatin side effects in 20 year old female

Reported by a consumer/non-health professional from United States on 2012-01-29

Patient: 20 year old female, weighing 47.7 kg (104.9 pounds)

Reactions: Fungal Test Positive, Rash

Drug(s) suspected as cause:
Nystatin
    Dosage: approximately one month
    Indication: Fungal Infection
    Start date: 2011-08-01
    End date: 2011-09-01

Humira
    Indication: Colitis Ulcerative
    Start date: 2011-05-07

Other drugs received by patient: Mercaptopurine; Oxycontin; Lyrica; Lexapro



Possible Nystatin side effects in 76 year old female

Reported by a individual with unspecified qualification from United States on 2012-01-27

Patient: 76 year old female, weighing 55.3 kg (121.7 pounds)

Reactions: Tinnitus, Head Discomfort, Hypersensitivity, Pain in Extremity, Nasal Discomfort, Drug Ineffective, Upper-Airway Cough Syndrome, Oropharyngeal Pain, Dyspepsia, DRY Throat, DRY Mouth, Musculoskeletal Stiffness, DRY Eye, Transient Ischaemic Attack

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Unspecified Medication
    Start date: 2011-01-01
    End date: 2011-01-01

Claritin-D
    Administration route: Oral
    Indication: Oropharyngeal Pain
    Start date: 2011-01-01

Nystatin
    Dosage: one teaspoon every six hours
    Administration route: Oral
    Indication: Oropharyngeal Pain
    Start date: 2011-01-01

Unspecified Allergy Tablet
    Administration route: Oral
    Indication: Oropharyngeal Pain
    Start date: 2011-01-01

Centrum Silver Ultra Women's
    Dosage: daily
    Administration route: Oral
    Indication: Vitamin Supplementation
    Start date: 2011-04-01
    End date: 2011-11-01

Claritin
    Administration route: Oral
    Indication: Oropharyngeal Pain
    Start date: 2011-01-01

Unspecified Nose Spray
    Indication: Oropharyngeal Pain
    Start date: 2011-01-01

Prilosec
    Dosage: two times a day
    Administration route: Oral
    Start date: 2011-01-01
    End date: 2011-01-01

Hydrogen Peroxide Solution
    Administration route: Oral
    Indication: Oropharyngeal Pain
    Start date: 2011-01-01

Other drugs received by patient: Lunesta



Possible Nystatin side effects in 56 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-10

Patient: 56 year old female, weighing 39.9 kg (87.8 pounds)

Reactions: Pruritus, Swelling, Reaction To Drug Excipients, Skin Reaction, Erythema, Feeling Abnormal

Drug(s) suspected as cause:
Nystatin

Other drugs received by patient: Fluconazole; Prednisone TAB; Monistat Vagina Cream



Possible Nystatin side effects in 76 year old female

Reported by a individual with unspecified qualification from United States on 2012-01-03

Patient: 76 year old female, weighing 55.3 kg (121.7 pounds)

Reactions: Head Discomfort, Tinnitus, Hypersensitivity, Drug Ineffective, Pain in Extremity, Oropharyngeal Pain, Dyspepsia, DRY Throat, DRY Mouth, Musculoskeletal Stiffness, Transient Ischaemic Attack

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Centrum Silver Ultra Women's
    Dosage: daily
    Administration route: Oral
    Indication: Medical Diet
    Start date: 2011-04-01
    End date: 2011-11-01

Hydrogen Peroxide Solution
    Administration route: Oral
    Indication: Oropharyngeal Pain
    Start date: 2011-01-01

Nystatin
    Dosage: one teaspoon every six hours
    Administration route: Oral
    Indication: Oropharyngeal Pain
    Start date: 2011-01-01

Unspecified Nose Spray
    Indication: Oropharyngeal Pain
    Start date: 2011-01-01

Unspecified Medication
    Start date: 2011-01-01
    End date: 2011-01-01

Claritin
    Administration route: Oral
    Indication: Oropharyngeal Pain
    Start date: 2011-01-01

Prilosec
    Dosage: two times a day
    Administration route: Oral
    Start date: 2011-01-01
    End date: 2011-01-01

Unspecified Allergy Tablet
    Administration route: Oral
    Indication: Oropharyngeal Pain
    Start date: 2011-01-01

Claritin-D
    Administration route: Oral
    Indication: Oropharyngeal Pain
    Start date: 2011-01-01

Other drugs received by patient: Lunesta

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