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Septra (Trimethoprim / Sulfamethoxazole) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Septra (Trimethoprim / Sulfamethoxazole) 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 (79)
Death (13)
Life Threatening Events (6)

Reports by Reaction Type

Drug Hypersensitivity (28)Malaise (11)Pain (10)Hypersensitivity (9)Skin Exfoliation (8)Pneumonia (8)Rash (8)Sepsis (8)Confusional State (7)Osteomyelitis (7)Loss of Consciousness (7)Myalgia (7)

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

Possible Septra side effects in 59 year old

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

Patient: 59 year old

Reactions: Drug Hypersensitivity

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

Septra
    Dosage: unk

Phenylephrine Hydrochloride
    Dosage: unk

Chlorpheniramine Maleate
    Dosage: unk

Albuterol Sulfate
    Dosage: unk

Bactrim
    Dosage: unk

Tetracycline Hydrochloride
    Dosage: unk

Chlorpheniramine Maleate
    Dosage: unk

Triprolidine Hydrochloride
    Dosage: unk

Leflunomide
    Dosage: unk

Ceclor
    Dosage: unk

Amlodipine Besylate
    Dosage: unk

Celebrex
    Dosage: unk

Meclizine HCL
    Dosage: unk

Phenylpropanolamine HCL
    Dosage: unk

Naprosyn
    Dosage: unk

Gemifloxacin Mesylate
    Dosage: unk

Sulfanilamide
    Dosage: unk

Astemizole
    Dosage: unk

Lodine
    Dosage: unk

Morphine Sulfate
    Dosage: unk

Fosinopril Sodium
    Dosage: unk

Fluticasone Propionate
    Dosage: unk

Cefadroxil
    Dosage: unk

Cefuroxime
    Dosage: unk

Dexchlorpheniramine Maleate
    Dosage: unk

Moxifloxacin Hydrochloride
    Dosage: unk

Codeine Sulfate
    Dosage: unk

Theophylline
    Dosage: unk

Pseudoephedrine Hydrochloride
    Dosage: unk

Pseudoephedrine Sulfate
    Dosage: unk

Codeine Phosphate
    Dosage: unk

Demerol
    Dosage: unk

Acetaminophen
    Dosage: unk

Oxymetazoline HCL
    Dosage: unk

Methscopolamine Bromide
    Dosage: unk

Phenyltoloxamine
    Dosage: unk

Cromolyn Sodium
    Dosage: unk

Caffeine Citrate
    Dosage: unk

Aspirin
    Dosage: unk



Possible Septra side effects in 32 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-16

Patient: 32 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: Abortion Missed, Pregnancy

Adverse event resulted in: death

Drug(s) suspected as cause:
Efavirenz
    Dosage: 600 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2003-05-29

Septra
    Dosage: 480 mg, qd
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    Start date: 2003-04-29
    End date: 2009-08-04

Acyclovir
    Dosage: 800 mg
    Administration route: Oral
    Indication: Antiviral Prophylaxis
    Start date: 2003-04-29

Combivir
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2003-05-29



Possible Septra side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Septra



Possible Septra side effects in 59 year old

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: 59 year old

Reactions: Drug Hypersensitivity

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

Pseudoephedrine HCL
    Dosage: unk

Triprolidine HCL
    Dosage: unk

Cromolyn Sodium
    Dosage: unk

Fluticasone Propionate
    Dosage: unk

Cefadroxil
    Dosage: unk

Cefuroxime Axetil
    Dosage: unk

Tetracycline Hydrochloride
    Dosage: unk

Phenyltoloxamine
    Dosage: unk

Leflunomide
    Dosage: unk

Codeine Phosphate
    Dosage: unk

Codeine Sulfate
    Dosage: unk

Ceclor
    Dosage: unk

Amlodipine Besylate
    Dosage: unk

Septra
    Dosage: unk

Lodine
    Dosage: unk

Theophylline
    Dosage: unk

Fosinopril Sodium
    Dosage: unk

Phenylephrine Hydrochloride
    Dosage: unk

Morphine
    Dosage: unk

Methscopolamine Bromide
    Dosage: unk

Chlorpheniramine Maleate
    Dosage: unk

Demerol
    Dosage: unk

Naprosyn
    Dosage: unk

Pseudoephedrine Sulfate
    Dosage: unk

Methotrexate
    Dosage: unk

Aspirin
    Dosage: unk

Oxymetazoline HCL
    Dosage: unk

Celebrex
    Dosage: unk

Chlorpheniramine Maleate
    Dosage: unk

Dexchlorpheniramine Maleate
    Dosage: unk

Phenylpropanolamine HCL
    Dosage: unk

Gemifloxacin Mesylate
    Dosage: unk

Albuterol Sulfate
    Dosage: unk

Astemizole
    Dosage: unk

Meclizine
    Dosage: unk

Moxifloxacin Hydrochloride
    Dosage: unk

Caffeine Citrate
    Dosage: unk

Bactrim
    Dosage: unk

Acetaminophen
    Dosage: unk



Possible Septra side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient:

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Niacin

Corgard

Vytorin
    Administration route: Oral

Septra

Rocephin

Niaspan



Possible Septra side effects in 40 year old male

Reported by a pharmacist from United States on 2012-07-27

Patient: 40 year old male, weighing 87.7 kg (192.9 pounds)

Reactions: Vomiting, Nausea, Drug Hypersensitivity, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Septra

Other drugs received by patient: Advil; Atripla; Ibuprofen; Allegra



Possible Septra side effects in female

Reported by a physician from United States on 2012-07-26

Patient: female

Reactions: Drug Hypersensitivity, Rash

Drug(s) suspected as cause:
Depo-Medrol
    Dosage: unk

Septra
    Dosage: unk



Possible Septra side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-24

Patient: female, weighing 66.7 kg (146.7 pounds)

Reactions: Speech Disorder, Blood Potassium Decreased, Swollen Tongue, Hypertension, Feeling Cold, Tremor

Drug(s) suspected as cause:
Septra
    Dosage: unk
    Indication: Cystitis
    Start date: 2012-07-11
    End date: 2012-07-01

Hydrochlorothiazide
    Dosage: 25 mg, daily
    Indication: Hypertension

Lisinopril
    Dosage: 20 mg, daily
    Indication: Hypertension
    Start date: 2012-07-01

Other drugs received by patient: Pramipexole



Possible Septra side effects in 64 year old female

Reported by a individual with unspecified qualification from United States on 2012-07-20

Patient: 64 year old female, weighing 76.2 kg (167.6 pounds)

Reactions: Productive Cough, Type 2 Diabetes Mellitus, Hepatitis C, Diabetes Mellitus, Chills, Pyrexia, Hyperhidrosis, Dizziness, Bronchitis, Diabetes Mellitus Inadequate Control, Cough

Drug(s) suspected as cause:
Seroquel
    Dosage: 200-750 mg
    Administration route: Oral
    Indication: Depression
    Start date: 2004-12-12

Seroquel
    Administration route: Oral
    Start date: 2012-06-26

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Start date: 2012-06-26

Septra

Seroquel
    Administration route: Oral

Seroquel
    Dosage: 200-750 mg
    Administration route: Oral
    Indication: Insomnia
    Start date: 2004-12-12

Bupivacaine HCL

Other drugs received by patient: Metformin Hydrochloride; Risperdal; Percocet; Metformin Hydrochloride; Zyprexa; Prozac; Prozac; Ambien; Xanax; Prozac; Metformin Hydrochloride; Vantin; Medrol; Metformin Hydrochloride; Tamoxifen Citrate; Zyprexa; Gemfibrozil; Lortab; Restoril; Lisinopril; Vitamin D



Possible Septra side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Septra



Possible Septra side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: female

Reactions: Neck Pain, Arthralgia, Musculoskeletal Pain, Pain, Rash, Carpal Tunnel Syndrome

Drug(s) suspected as cause:
Septra



Possible Septra side effects in

Reported by a physician from United States on 2012-07-06

Patient:

Reactions: Drug Hypersensitivity

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

Septra
    Dosage: unk

Keflex
    Dosage: unk



Possible Septra side effects in

Reported by a physician from United States on 2012-06-26

Patient:

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Septra



Possible Septra side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-25

Patient: male, weighing 92.1 kg (202.6 pounds)

Reactions: Hypersensitivity, Urticaria

Drug(s) suspected as cause:
Extra Strength Tylenol
    Administration route: Oral

Extra Strength Tylenol
    Dosage: 1/2 ounce and 8 hours later 1/2 oz.
    Administration route: Oral
    Indication: Pain
    Start date: 2012-04-18
    End date: 2012-04-01

Valacyclovir Hydrochloride
    Indication: Infection
    Start date: 2012-04-16
    End date: 2012-04-19

Septra
    Dosage: 800-160mg
    Administration route: Oral
    Indication: Infection
    Start date: 2012-04-16

Other drugs received by patient: Septra DS; Celexa; Ambien



Possible Septra side effects in 66 year old female

Reported by a physician from United States on 2012-06-19

Patient: 66 year old female

Reactions: Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Pioglitazone
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Septra
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Metformin HCL
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Quetiapine
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Venlafaxine Hydrocholride
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Clonazepam
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide



Possible Septra side effects in male

Reported by a physician from United States on 2012-06-19

Patient: male

Reactions: Drug Hypersensitivity

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

Ambien
    Dosage: unk

Septra
    Dosage: unk

Vicodin
    Dosage: unk

Wellbutrin
    Dosage: unk

Vioxx
    Dosage: unk



Possible Septra side effects in 56 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-06-15

Patient: 56 year old female

Reactions: Jaundice, Faeces Pale, Fatigue, Malaise, Drug Ineffective, Hepatotoxicity, Liver Function Test Abnormal, Chromaturia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Macrobid
    Administration route: Oral
    Indication: Urinary Tract Infection
    Start date: 2010-06-09
    End date: 2010-06-19

Azathioprine
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-06-30
    End date: 2010-08-03

Septra
    Administration route: Oral
    Indication: Urinary Tract Infection
    Start date: 2010-06-30
    End date: 2010-07-06

Other drugs received by patient: Calcium Carbonate; Aspirin; Prednisone TAB; Oxycodone and Acetaminophen; Lyrica



Possible Septra side effects in female

Reported by a physician from United States on 2012-06-13

Patient: female

Reactions: Drug Hypersensitivity

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

Vytorin
    Dosage: unk

Niacin
    Dosage: unk

Niaspan
    Dosage: unk

Rocephin
    Dosage: unk

Septra
    Dosage: unk



Possible Septra side effects in 66 year old female

Reported by a physician from United States on 2012-06-11

Patient: 66 year old female

Reactions: Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Septra
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Clonazepam
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Pioglitazone
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Metformin
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Quetiapine
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Venlafaxine HCL
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide



Possible Septra side effects in 66 year old female

Reported by a physician from United States on 2012-06-08

Patient: 66 year old female

Reactions: Completed Suicide, Intentional Drug Misuse, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Septra
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Pioglitazone Hydrochloride
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide
    Start date: 2008-01-01
    End date: 2008-01-01

Clonazepam
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide
    Start date: 2008-01-01
    End date: 2008-01-01

Quetiapine
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide
    Start date: 2008-01-01
    End date: 2008-01-01

Metformin HCL
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide
    Start date: 2008-01-01
    End date: 2008-01-01

Venlafaxine HCL
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide
    Start date: 2008-01-01
    End date: 2008-01-01



Possible Septra side effects in 38 year old male

Reported by a pharmacist from Spain on 2012-06-07

Patient: 38 year old male

Reactions: Generalised Erythema, Malaise, Diarrhoea, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Septra
    Dosage: 4 df, q1wk
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    Start date: 2011-05-19

Atripla
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-26
    End date: 2011-06-11

Other drugs received by patient: Zolpidem; Esertia; Lorazepam



Possible Septra side effects in female

Reported by a physician from United States on 2012-06-04

Patient: female

Reactions: Drug Hypersensitivity

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

Ampicillin
    Dosage: unk

Septra
    Dosage: unk



Possible Septra side effects in female

Reported by a physician from United States on 2012-06-01

Patient: female

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Septra



Possible Septra side effects in female

Reported by a physician from United States on 2012-05-29

Patient: female

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Septra



Possible Septra side effects in female

Reported by a physician from United States on 2012-05-22

Patient: female

Reactions: Drug Hypersensitivity

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

Codeine Sulfate
    Dosage: unk

Septra
    Dosage: unk



Possible Septra side effects in 60 year old female

Reported by a pharmacist from United States on 2012-05-22

Patient: 60 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Ventricular Extrasystoles, Nodal Arrhythmia, Blood Urea Increased, Dyspnoea, Hyperkalaemia, Dialysis, Chest Pain, Blood Creatinine Increased, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Septra



Possible Septra side effects in female

Reported by a physician from United States on 2012-05-09

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Septra



Possible Septra side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-02

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Penicillin G Potassium
    Dosage: unk

Paxil
    Dosage: unk

Septra
    Dosage: unk

Wellbutrin
    Dosage: unk

Demerol
    Dosage: unk



Possible Septra side effects in female

Reported by a physician from United States on 2012-04-27

Patient: female

Reactions: Drug Hypersensitivity

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

Ampicillin
    Dosage: unk

Codeine
    Dosage: unk



Possible Septra side effects in 62 year old male

Reported by a physician from Spain on 2012-04-25

Patient: 62 year old male

Reactions: Retinal Degeneration, Retinal Neovascularisation

Drug(s) suspected as cause:
Mycostatin
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2009-04-17

Adalat
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2009-04-17

Atenolol
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2009-04-17

Septra
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2009-04-17

Prednisone
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2009-04-17

Tacrolimus
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2009-04-17

Mycophenolate Mofetil (Cellcept)
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2009-04-17

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