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 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 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
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 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 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 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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