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),
Death (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 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 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 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 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 2012-05-22
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 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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