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Sulfadiazine (Sulfadiazine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Sulfadiazine 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 (50)
Death (4)
Life Threatening Events (11)

Reports by Reaction Type

Fall (10)Stevens-Johnson Syndrome (10)Drug Rash With Eosinophilia and Systemic Symptoms (10)Hyperhidrosis (9)Loss of Consciousness (9)Gastric Ulcer Haemorrhage (9)Drug Hypersensitivity (6)Renal Failure (6)Cytolytic Hepatitis (5)Myocarditis (4)Pyrexia (3)Blood Creatinine Increased (3)

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

Possible Sulfadiazine side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27

Patient: male

Reactions: Haemoglobin Decreased, Drug Rash With Eosinophilia and Systemic Symptoms, Blood Sodium Decreased, Myocarditis, Blood Creatinine Increased, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    Start date: 2012-06-12
    End date: 2012-07-05

Combivir
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Fluconazole
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: Oesophageal Candidiasis
    Start date: 2012-06-08
    End date: 2012-06-30

Norvir
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Prezista
    Dosage: 2 tablets at 400 mg a day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Sulfadiazine
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: Cerebral Toxoplasmosis
    Start date: 2012-06-18
    End date: 2012-07-09



Possible Sulfadiazine side effects in male

Reported by a physician from France on 2012-08-27

Patient: male

Reactions: Eyelid Oedema, Lymphadenopathy, Skin Exfoliation, Conjunctivitis, Tachycardia, Scab, Pyrexia, Cheilitis, Penile Ulceration, Face Oedema, Scrotal Oedema, Optic Disc Haemorrhage, Myocarditis, Stevens-Johnson Syndrome, Dysphagia, N-Terminal Prohormone Brain Natriuretic Peptide Increased, Troponin Increased, LIP Haemorrhage, Drug Rash With Eosinophilia and Systemic Symptoms, Anal Erosion, Mucosal Erosion, Cardiac Failure, Cytomegalovirus Chorioretinitis, Epidermal Necrosis, Electrocardiogram Abnormal, Oedema Genital, Rash Maculo-Papular

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim
    Dosage: 1unit per day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    Start date: 2012-06-12
    End date: 2012-07-05

Combivir
    Dosage: 1tab twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Fluconazole
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Oesophageal Candidiasis
    Start date: 2012-06-08
    End date: 2012-06-30

Norvir
    Dosage: 100mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Prezista
    Dosage: 400mg twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Sulfadiazine
    Dosage: 6g per day
    Administration route: Oral
    Indication: Cerebral Toxoplasmosis
    Start date: 2012-06-18
    End date: 2012-07-09

Other drugs received by patient: Malocide; Folinate



Possible Sulfadiazine side effects in 39 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-24

Patient: 39 year old male

Reactions: Cytolytic Hepatitis, Blood Creatinine Increased, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Keppra
    Indication: Epilepsy
    Start date: 2012-05-15
    End date: 2012-05-25

Malocide
    Dosage: 50 mg tablet
    Administration route: Oral
    Indication: Cerebral Toxoplasmosis
    Start date: 2012-05-15
    End date: 2012-05-25

Sulfadiazine
    Dosage: 500 mg
    Administration route: Oral
    Indication: Cerebral Toxoplasmosis
    Start date: 2012-05-15
    End date: 2012-05-25



Possible Sulfadiazine side effects in male

Reported by a physician from France on 2012-08-24

Patient: male

Reactions: Dysphagia, Cytomegalovirus Chorioretinitis, Drug Hypersensitivity, Conjunctivitis, Drug Rash With Eosinophilia and Systemic Symptoms, Myocarditis, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim
    Administration route: Oral
    Indication: Pneumocystis Jiroveci Pneumonia
    Start date: 2012-06-12
    End date: 2012-07-05

Bactrim
    Indication: Prophylaxis

Combivir
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Fluconazole
    Administration route: Oral
    Indication: Oesophageal Candidiasis
    Start date: 2012-06-08
    End date: 2012-06-30

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Sulfadiazine
    Administration route: Oral
    Indication: Cerebral Toxoplasmosis
    Start date: 2012-06-18
    End date: 2012-07-09



Possible Sulfadiazine side effects in 58 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23

Patient: 58 year old male

Reactions: Tachycardia, Transferrin Decreased, Cerebral Toxoplasmosis, Transferrin Saturation Decreased, Eye Haemorrhage, Gamma-Glutamyltransferase Increased, Blood Sodium Decreased, Myocarditis, Electrocardiogram Repolarisation Abnormality, Stevens-Johnson Syndrome, Blood Iron Decreased, Blood Lactate Dehydrogenase Increased, Renal Cyst, Drug Rash With Eosinophilia and Systemic Symptoms, Nephrotic Syndrome, Renal Failure, Cytomegalovirus Chorioretinitis, Electrocardiogram ST Segment Elevation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim
    Dosage: 1 tablet, 1x/day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    Start date: 2012-06-12
    End date: 2012-07-05

Combivir
    Dosage: 1 df, 2x/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Fluconazole
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Indication: Oesophageal Candidiasis
    Start date: 2012-06-08
    End date: 2012-06-30

Norvir
    Dosage: 100 mg, 1x/day (1 df)
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Prezista
    Dosage: 400 mg, 1x/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Sulfadiazine
    Dosage: 6 g, 1x/day
    Administration route: Oral
    Indication: Cerebral Toxoplasmosis
    Start date: 2012-06-18
    End date: 2012-07-09

Other drugs received by patient: Malocide; Malocide; Calcium Folinate; Malocide



Possible Sulfadiazine side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: male

Reactions: Confusional State, Renal Haemorrhage, Fall, Renal Failure, Dysstasia, Activities of Daily Living Impaired, Memory Impairment, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sulfadiazine



Possible Sulfadiazine side effects in 44 year old female

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

Patient: 44 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Rash Generalised, Hypophagia, Dehydration, Drug Hypersensitivity, Influenza Like Illness

Drug(s) suspected as cause:
Daraprim
    Dosage: 100 mg;x1;po 25 mg;qd;po
    Administration route: Oral
    Indication: Toxoplasmosis
    Start date: 2012-06-30
    End date: 2012-06-30

Daraprim
    Dosage: 100 mg;x1;po 25 mg;qd;po
    Administration route: Oral
    Indication: Toxoplasmosis
    Start date: 2012-07-01
    End date: 2012-07-11

Sulfadiazine
    Dosage: 2000 mg;qd;
    Indication: Toxoplasmosis
    Start date: 2012-06-30
    End date: 2012-07-11

Other drugs received by patient: Synthroid; Simvastatin



Possible Sulfadiazine side effects in 55 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-17

Patient: 55 year old male

Reactions: Nephrolithiasis, Renal Failure, Hydronephrosis, Calculus Urinary

Drug(s) suspected as cause:
Sulfadiazine

Other drugs received by patient: Pyrimethamine TAB



Possible Sulfadiazine side effects in

Reported by a pharmacist from United States on 2012-07-09

Patient:

Reactions: Circumstance or Information Capable of Leading To Medication Error, Intercepted Drug Dispensing Error

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azulfidine
    Dosage: tablet oral 500 mg
    Administration route: Oral

Sulfadiazine
    Dosage: tablet oral 500 mg
    Administration route: Oral



Possible Sulfadiazine side effects in female

Reported by a physician from Germany on 2012-07-04

Patient: female, weighing 66.0 kg (145.2 pounds)

Reactions: Movement Disorder, Tubulointerstitial Nephritis, Brain Mass, Abasia, Central Nervous System Lesion, Aphasia, Optic Neuritis, Hemiparesis, Multiple Sclerosis Relapse, Oscillopsia, Brain Oedema, Blood Creatinine Increased, Renal Failure Acute, Hypertonia, Back Pain, Scotoma, Hypoaesthesia, Renal Hypertrophy, Paraesthesia, Epstein-Barr Virus Infection, Myoclonus, Hyperaesthesia, Vertigo, Dysaesthesia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Gilenya
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Multiple Sclerosis
    Start date: 2010-09-20
    End date: 2010-12-20

Sulfadiazine

Other drugs received by patient: Nebivolol; Levothyroxine Sodium; Diovan; Keppra



Possible Sulfadiazine side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-07-02

Patient: 68 year old female

Reactions: Drug Intolerance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Itraconazole
    Administration route: Oral
    Indication: Paracoccidioides Infection

Sulfadiazine
    Indication: Paracoccidioides Infection



Possible Sulfadiazine side effects in 42 year old male

Reported by a health professional (non-physician/pharmacist) from China on 2012-06-26

Patient: 42 year old male

Reactions: Multi-Organ Failure, Drug Ineffective

Adverse event resulted in: death

Drug(s) suspected as cause:
Amikacin Sulfate

Ciprofloxacin

Sulfadiazine

Other drugs received by patient: Imipenem; Prednisone TAB; Vancomycin Hychloride



Possible Sulfadiazine side effects in 46 year old male

Reported by a physician from France on 2012-06-21

Patient: 46 year old male

Reactions: Rash, Drug Rash With Eosinophilia and Systemic Symptoms, Eosinophilia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atripla
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-10
    End date: 2012-05-07

Sulfadiazine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-19
    End date: 2012-05-18

Valganciclovir
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-17
    End date: 2012-05-18



Possible Sulfadiazine side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-21

Patient: male

Reactions: Product Quality Issue, Product Friable, Haemorrhage, Tablet Physical Issue, Gastric Ulcer Haemorrhage, Product Tampering, Product Commingling, Fall, Hyperhidrosis, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Excedrin Extra Strength Tablets
    Dosage: 2 df, once a week
    Administration route: Oral
    Indication: Pain
    End date: 2011-10-01

Sulfadiazine
    Dosage: unk, everyday
    Administration route: Oral
    Indication: Functional Gastrointestinal Disorder

Other drugs received by patient: Vitamins NOS; Thiamine



Possible Sulfadiazine side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-21

Patient: male

Reactions: Gastric Ulcer Haemorrhage, Fall, Hyperhidrosis, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Excedrin Extra Strength Tablets
    Dosage: 2 df, once a week
    Administration route: Oral
    Indication: Pain
    End date: 2011-10-01

Sulfadiazine
    Dosage: unk, everyday
    Administration route: Oral
    Indication: Functional Gastrointestinal Disorder

Other drugs received by patient: Vitamins NOS; Thiamine



Possible Sulfadiazine side effects in male

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

Patient: male

Reactions: Rash, Drug Rash With Eosinophilia and Systemic Symptoms, Eosinophilia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atripla
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-04-10
    End date: 2012-05-07

Sulfadiazine
    Dosage: unk unk, qid
    Administration route: Oral
    Start date: 2012-03-19
    End date: 2012-05-18

Valganciclovir
    Dosage: unk
    Administration route: Oral
    Start date: 2012-04-17
    End date: 2012-05-18

Other drugs received by patient: Prezista; Truvada; Norvir



Possible Sulfadiazine side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-05

Patient: male

Reactions: Gastric Ulcer Haemorrhage, Fall, Hyperhidrosis, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Excedrin (Migraine)
    Dosage: 2 df, once a week
    Administration route: Oral
    Indication: Pain
    End date: 2011-10-01

Sulfadiazine
    Dosage: unk, everyday
    Administration route: Oral
    Indication: Functional Gastrointestinal Disorder

Other drugs received by patient: Vitamins NOS; Thiamine



Possible Sulfadiazine side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-29

Patient: male

Reactions: Gastric Ulcer Haemorrhage, Fall, Hyperhidrosis, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Excedrin (Migraine)
    Dosage: 2 df, once a week
    Administration route: Oral
    Indication: Pain
    End date: 2011-10-01

Sulfadiazine
    Dosage: unk, everyday
    Administration route: Oral
    Indication: Functional Gastrointestinal Disorder

Other drugs received by patient: Vitamins NOS; Thiamine



Possible Sulfadiazine side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-18

Patient: male

Reactions: Gastric Ulcer Haemorrhage, Hyperhidrosis, Fall, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Excedrin (Migraine)
    Dosage: 2 df, once a week
    Administration route: Oral
    Indication: Pain
    End date: 2011-10-01

Sulfadiazine
    Dosage: unk, everyday
    Administration route: Oral
    Indication: Functional Gastrointestinal Disorder

Other drugs received by patient: Vitamins NOS; Thiamine



Possible Sulfadiazine side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-18

Patient: male

Reactions: Gastric Ulcer Haemorrhage, Fall, Hyperhidrosis, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Excedrin (Migraine)
    Dosage: 2 df, once a week
    Administration route: Oral
    Indication: Pain
    End date: 2011-10-01

Sulfadiazine
    Dosage: unk, everyday
    Administration route: Oral
    Indication: Functional Gastrointestinal Disorder

Other drugs received by patient: Thiamine; Vitamins NOS



Possible Sulfadiazine side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-16

Patient: female

Reactions: Burning Sensation

Drug(s) suspected as cause:
Sulfadiazine



Possible Sulfadiazine side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-08

Patient: female

Reactions: Drug Hypersensitivity, Skin Reaction

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

Sulfadiazine
    Dosage: unk

Sulfasalazine
    Dosage: unk



Possible Sulfadiazine side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-07

Patient: female

Reactions: Drug Hypersensitivity

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

Sulfadiazine
    Dosage: unk



Possible Sulfadiazine side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-25

Patient: male

Reactions: Gastric Ulcer Haemorrhage, Hyperhidrosis, Fall, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Excedrin Extra Strength Tablets
    Dosage: 2 df, once a week
    Administration route: Oral
    Indication: Pain
    End date: 2011-10-01

Sulfadiazine
    Dosage: unk, everyday
    Administration route: Oral
    Indication: Functional Gastrointestinal Disorder

Other drugs received by patient: Thiamine HCL; Vitamins NOS



Possible Sulfadiazine side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-20

Patient: male

Reactions: Gastric Ulcer Haemorrhage, Fall, Hyperhidrosis, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Excedrin Extra Strength Tablets
    Dosage: 2 df, once a week
    Administration route: Oral
    Indication: Pain
    End date: 2011-10-01

Sulfadiazine
    Dosage: unk, everyday
    Administration route: Oral
    Indication: Functional Gastrointestinal Disorder

Other drugs received by patient: Thiamine HCL; Vitamins NOS



Possible Sulfadiazine side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-20

Patient: female

Reactions: Drug Hypersensitivity

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

Sulfadiazine
    Dosage: unk



Possible Sulfadiazine side effects in male

Reported by a physician from United States on 2012-03-26

Patient: male, weighing 90.8 kg (199.8 pounds)

Reactions: Bedridden, Abdominal Pain, Vomiting, Chills, Pain, Furuncle, Pyrexia, Headache, Glucose Tolerance Impaired, Epiploic Appendagitis, Staphylococcal Infection, Impaired Healing, Hypersomnia, Influenza Like Illness

Drug(s) suspected as cause:
Humira
    Indication: Psoriatic Arthropathy
    Start date: 2007-01-01
    End date: 2011-12-01

Sulfadiazine
    Indication: Staphylococcal Infection
    Start date: 2011-12-01
    End date: 2011-12-01

Other drugs received by patient: Urso 250; Oxaprozin



Possible Sulfadiazine side effects in 26 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-19

Patient: 26 year old male

Reactions: Neutropenia, Leukopenia, Toxic Skin Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clindamycin HCL
    Dosage: 600 mg, 4x/day
    Administration route: Oral
    Indication: Eye Infection Toxoplasmal
    Start date: 2011-11-04
    End date: 2011-11-06

Clindamycin HCL
    Dosage: unk
    Start date: 2011-11-08
    End date: 2011-11-19

Penicillin G
    Dosage: 3 million iu 3x/day, unk
    Indication: Eye Infection Syphilitic
    Start date: 2011-10-22
    End date: 2011-11-11

Pyrimethamine TAB
    Dosage: unk
    Administration route: Oral
    Indication: Eye Infection Toxoplasmal
    Start date: 2011-10-26
    End date: 2011-11-04

Pyrimethamine TAB
    Dosage: unk
    End date: 2011-11-19

Sulfadiazine
    Dosage: unk
    Administration route: Oral
    Indication: Eye Infection Toxoplasmal
    Start date: 2011-10-26
    End date: 2011-11-04

Other drugs received by patient: Tropicamide; Chibro-Cadron; Indomethacin; Atropine; Phenylephrine HCL



Possible Sulfadiazine side effects in 38 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-14

Patient: 38 year old female

Reactions: Cytolytic Hepatitis, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clindamycin HCL
    Dosage: unk
    Administration route: Oral
    Start date: 2011-12-23
    End date: 2012-01-02

Keppra
    Dosage: unk
    Administration route: Oral
    Start date: 2011-12-23
    End date: 2012-01-23

Sulfadiazine
    Dosage: unk
    Administration route: Oral
    Start date: 2011-12-23
    End date: 2012-01-15



Possible Sulfadiazine side effects in 38 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-13

Patient: 38 year old female

Reactions: Renal Failure, Cytolytic Hepatitis, Toxic Skin Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clindamycin HCL
    Administration route: Oral
    Start date: 2011-12-23
    End date: 2012-01-02

Keppra
    Administration route: Oral
    Start date: 2011-12-23
    End date: 2012-01-23

Sulfadiazine
    Dosage: 500 mg
    Administration route: Oral
    Start date: 2011-12-23
    End date: 2012-01-15

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