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Sulfamethoxazole Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Confusional State, Inappropriate Antidiuretic Hormone Secretion, Hyponatraemia, Asthenia (8429697-6)
on May 23, 2012 Female from UNITED STATES , 79 years of age, was treated with Sulfamethoxazole And Trimethoprim. Directly after, patient experienced the unwanted or unexpected Sulfamethoxazole side effects: confusional state, inappropriate antidiuretic hormone secretion, hyponatraemia, asthenia. Sulfamethoxazole And Trimethoprim dosage: 3 Days Prior To Hospitalisation.
Associated medications used:
  • Citalopram Hydrobromide (7 Days Prior To Hospitalisation)
Patient was hospitalized.

Pain, Emotional Distress, Anxiety, Anhedonia, Fear Of Disease, Deep Vein Thrombosis (8429515-6)
Patient was taking Sulfamethoxazole And Trimethoprim Double Strength. Patient felt the following Sulfamethoxazole side effects: pain, emotional distress, anxiety, anhedonia, fear of disease, deep vein thrombosis on Jun 04, 2012 from UNITED STATES Additional patient health information: Female , 38 years of age, weighting 240.3 lb, . Sulfamethoxazole And Trimethoprim Double Strength dosage: 800-160.
Multiple prescriptions taken:
  • Hydrocodone Bitartrate And Acetaminophen (5-500)
  • Yasmin (Unk)
  • Drospirenone And Ethinyl Estradiol (Unk)
Patient was hospitalized.

Lung Neoplasm, Organising Pneumonia, Infection (8426819-8)
Adverse event was reported on Jun 01, 2012 by a Male taking Sulfamethoxazole And Trimethoprim (Dosage: N/A) was diagnosed with
  • prophylaxis
  • gastrooesophageal reflux disease
  • rheumatoid arthritis
  • pneumocystis jiroveci pneumonia
and. Location: JAPAN , weighting 171.7 lb, After Sulfamethoxazole was administered, patient encountered several Sulfamethoxazole side effects: lung neoplasm, organising pneumonia, infection.
Multiple concurrent drugs taken:
  • Rabeprazole Sodium
  • Humira
Patient was hospitalized.

Haemoptysis, Cardiac Arrest, Thrombosis, Feeling Abnormal (8423353-6)
on May 30, 2012 Male from JAPAN , weighting 120.8 lb, was treated with Sulfamethoxazole And Trimethoprim. Directly after, patient experienced the unwanted or unexpected Sulfamethoxazole side effects: haemoptysis, cardiac arrest, thrombosis, feeling abnormal. Sulfamethoxazole And Trimethoprim dosage: N/A.
Associated medications used:
  • Heparin Sodium
  • Alendronate Sodium
  • Oxygen
  • Tracleer (125 Mg, Bid)
  • Prednisolone
  • Tracleer (62.5 Mg, Qd)
  • Rabeprazole Sodium



Dehydration, Renal Failure Acute (8421282-5)
on Jun 04, 2012 Male from UNITED STATES , 87 years of age, weighting 165.3 lb, was diagnosed with
  • infection
and was treated with Sulfamethoxazole And Trimethoprim. Patient felt the following Sulfamethoxazole side effects: dehydration, renal failure acute. Sulfamethoxazole And Trimethoprim dosage: 1 Tab Bid Po. Patient was hospitalized.

Toxic Epidermal Necrolysis (8421183-2)
Patient was taking Sulfamethoxazole And Trimethoprim. After Sulfamethoxazole was administered, patient encountered several Sulfamethoxazole side effects: toxic epidermal necrolysis on Jun 04, 2012 from UNITED STATES Additional patient health information: Male , 70 years of age, weighting 261.5 lb, was diagnosed with
  • interstitial lung disease
and. Sulfamethoxazole And Trimethoprim dosage: 800/160 Mg Po. Patient was hospitalized.

Angioedema, Lip Swelling, Throat Tightness (8421177-7)
Adverse event was reported on Jun 04, 2012 by a Male taking Sulfamethoxazole And Trimethoprim (Dosage: 800/160 Mg Bid Po) was diagnosed with
  • infection
and. Location: UNITED STATES , 50 years of age, weighting 201.5 lb, Directly after, patient experienced the unwanted or unexpected Sulfamethoxazole side effects: angioedema, lip swelling, throat tightness.

Demyelinating Polyneuropathy, Gait Disturbance (8418305-6)
on Jun 05, 2012 Male from JAPAN , weighting 90.39 lb, was diagnosed with
  • prophylaxis
and was treated with Sulfamethoxazole And Trimethoprim. Patient felt the following Sulfamethoxazole side effects: demyelinating polyneuropathy, gait disturbance. Sulfamethoxazole And Trimethoprim dosage: N/A.
Multiple prescriptions taken:
  • Humira
  • Mesalamine (1.5g Daily)
  • Lansoprazole (15mg Daily)
Patient was hospitalized.

Fungal Skin Infection, Metabolic Acidosis, Hypotension, Systemic Inflammatory Response Syndrome, Respiratory Acidosis, Multi-organ Failure, Pulmonary Sepsis, Renal Failure Acute, Rhabdomyolysis (8417458-3)
on Jan 26, 2011 Female from UNITED STATES , 28 years of age, was treated with Sulfamethoxazole And Trimethoprim. After Sulfamethoxazole was administered, patient encountered several Sulfamethoxazole side effects: fungal skin infection, metabolic acidosis, hypotension, systemic inflammatory response syndrome, respiratory acidosis, multi-organ failure, pulmonary sepsis, renal failure acute, rhabdomyolysis. Sulfamethoxazole And Trimethoprim dosage: 550 Mg, Unk.
Multiple concurrent drugs taken:
  • Sirolimus
  • Methylprednisolone
  • Tacrolimus


Dizziness, Feeling Abnormal, Vaginal Haemorrhage, Fatigue, Muscle Spasms (8409619-4)
Patient was taking Sulfamethoxazole And Trimethoprim. Directly after, patient experienced the unwanted or unexpected Sulfamethoxazole side effects: dizziness, feeling abnormal, vaginal haemorrhage, fatigue, muscle spasms on May 31, 2012 from UNITED STATES Additional patient health information: Female , 77 years of age, was diagnosed with
  • arthritis infective
  • post procedural infection
and. Sulfamethoxazole And Trimethoprim dosage: 1 Tablet 2 X Day-10 Days.

Pancreatitis (8409519-X)
Adverse event was reported on May 31, 2012 by a Male taking Sulfamethoxazole And Trimethoprim (Dosage: 1 Tab Bid Po) was diagnosed with
  • urinary tract infection
and. Location: UNITED STATES , 60 years of age, weighting 162.7 lb, Patient felt the following Sulfamethoxazole side effects: pancreatitis. Patient was hospitalized.

Glioblastoma, Aphasia, Incoherent (8409203-2)
on May 30, 2012 Female from JAPAN , weighting 97.00 lb, was diagnosed with
  • prophylaxis
  • rheumatoid arthritis
and was treated with Sulfamethoxazole + Trimethoprim. After Sulfamethoxazole was administered, patient encountered several Sulfamethoxazole side effects: glioblastoma, aphasia, incoherent. Sulfamethoxazole + Trimethoprim dosage: N/A.
Multiple concurrent drugs taken:
  • Tacrolimus
  • Tacrolimus
  • Loxoprofen Sodium Hydrate (Q.s.)
  • Tacrolimus
  • Zopiclone
  • Tacrolimus
  • Ursodiol
  • Flunitrazepam
Patient was hospitalized.

Renal Failure, Hepatic Failure, Toxic Epidermal Necrolysis, Pyrexia (8404326-6)
on Aug 17, 2011 Female from GERMANY , 83 years of age, weighting 176.4 lb, was diagnosed with
  • urinary tract infection
and was treated with Sulfamethoxazole And Trimethoprim. Directly after, patient experienced the unwanted or unexpected Sulfamethoxazole side effects: renal failure, hepatic failure, toxic epidermal necrolysis, pyrexia. Sulfamethoxazole And Trimethoprim dosage: N/A. Patient was hospitalized.

Vomiting Projectile, Arthralgia, Skin Warm, Headache, Arthropathy, Joint Crepitation, Erythema, Rash, Skin Burning Sensation (8397441-7)
Patient was taking Sulfamethoxazole And Trimethoprim. Patient felt the following Sulfamethoxazole side effects: vomiting projectile, arthralgia, skin warm, headache, arthropathy, joint crepitation, erythema, rash, skin burning sensation on May 29, 2012 from UNITED STATES Additional patient health information: Female , 52 years of age, weighting 220.0 lb, was diagnosed with
  • sinusitis
  • ear infection
and. Sulfamethoxazole And Trimethoprim dosage: 1 Tablet Twice Daily Po One Dose.

Rash, Respiratory Disorder, Nonspecific Reaction, Product Quality Issue, Flushing (8395695-4)
Adverse event was reported on Mar 08, 2012 by a Female taking Sulfamethoxazole And Trimethoprim (Dosage: N/A) . Location: UNITED STATES , child 7 years of age, After Sulfamethoxazole was administered, patient encountered several Sulfamethoxazole side effects: rash, respiratory disorder, nonspecific reaction, product quality issue, flushing.
Multiple concurrent drugs taken:
  • Novolog
  • Singulair
  • Ventolin (2puff Four Times Per Day)


Pruritus (8395433-5)
on May 25, 2012 Female from UNITED STATES , weighting 187.0 lb, was treated with Sulfamethoxazole. Directly after, patient experienced the unwanted or unexpected Sulfamethoxazole side effects: pruritus. Sulfamethoxazole dosage: N/A.

Acute Graft Versus Host Disease, Engraft Failure, Haemorrhage Intracranial, Skin Infection, Respiratory Tract Infection, Neutropenia, Hypomagnesaemia, Diarrhoea (8394328-0)
on May 23, 2012 Female from JAPAN , weighting 112.4 lb, was diagnosed with
  • antifungal prophylaxis
and was treated with Sulfamethoxazole W. Patient felt the following Sulfamethoxazole side effects: acute graft versus host disease, engraft failure, haemorrhage intracranial, skin infection, respiratory tract infection, neutropenia, hypomagnesaemia, diarrhoea. Sulfamethoxazole W dosage: Unk.
Multiple prescriptions taken:
  • Ursodesoxycholic Acid (Unk)
  • Tacrolimus (Unk)
  • Leucovorin Calcium (Unk)
  • Hydrocortisone Sodium Succinate (Unk)
  • Fludarabine Phosphate (Unk)
  • Methylprednisolone Sodium Succinate (Unk)
  • Dexamethasone (Unk)
  • Haptoglobins (Unk)
Patient was hospitalized.

Neutrophil Count Decreased, Herpes Zoster, Lymphocyte Count Decreased, Bronchitis Chronic, C-reactive Protein Increased, White Blood Cell Count Decreased (8388318-1)
Patient was taking Sulfamethoxazole And Trimethoprim. After Sulfamethoxazole was administered, patient encountered several Sulfamethoxazole side effects: neutrophil count decreased, herpes zoster, lymphocyte count decreased, bronchitis chronic, c-reactive protein increased, white blood cell count decreased on May 16, 2012 from JAPAN Additional patient health information: Male , 62 years of age, weighting 151.6 lb, . Sulfamethoxazole And Trimethoprim dosage: N/A.
Multiple concurrent drugs taken:
  • Itraconazole
  • Treanda
  • Carbocisteine
  • Entecavir Hydrate
  • Omeprazole
  • Naftopidil
  • Ambroxol Hydrochloride
Patient was hospitalized.

Abdominal Tenderness, Cardiac Murmur, Staphylococcal Infection, Neutrophil Count Increased, Pyrexia, Iron Deficiency Anaemia, Mean Cell Volume Decreased, Thrombocytosis, Urinary Tract Infection (8384068-6)
Adverse event was reported on May 15, 2012 by a Female taking Sulfamethoxazole And Trimethoprim (Dosage: N/A) was diagnosed with
  • urinary tract infection
and. Location: UNITED KINGDOM , 36 years of age, Directly after, patient experienced the unwanted or unexpected Sulfamethoxazole side effects: abdominal tenderness, cardiac murmur, staphylococcal infection, neutrophil count increased, pyrexia, iron deficiency anaemia, mean cell volume decreased, thrombocytosis, urinary tract infection.
Associated medications used:
  • Lansoprazole (30 Mg Every Day)
  • Bendroflumethiazide
  • Clozapine (250 Mg, Qd)
  • Perindopril Erbumine (2 Mg, Bid)
  • Zopiclone (Unk Df, Qd)
  • Atorvastatin Calcium
  • Clozapine (Unk)
  • Lactulose


Neutrophil Count Decreased, Bronchitis Chronic, C-reactive Protein Increased, Herpes Zoster, White Blood Cell Count Decreased, Lymphocyte Count Decreased (8381517-4)
on May 16, 2012 Male from JAPAN , 62 years of age, weighting 151.6 lb, was treated with Sulfamethoxazole And Trimethoprim. Patient felt the following Sulfamethoxazole side effects: neutrophil count decreased, bronchitis chronic, c-reactive protein increased, herpes zoster, white blood cell count decreased, lymphocyte count decreased. Sulfamethoxazole And Trimethoprim dosage: N/A.
Multiple prescriptions taken:
  • Entecavir Hydrate
  • Carbocisteine
  • Treanda
  • Itraconazole
  • Omeprazole
  • Ambroxol Hydrochloride
  • Naftopidil
Patient was hospitalized.

White Blood Cell Count Decreased, Petechiae, Platelet Count Decreased, Pyrexia, Coagulation Time Abnormal (8369624-3)
on May 16, 2012 Male from UNITED STATES , 15 years of age, weighting 116.0 lb, was treated with Sulfamethoxazole And Trimethoprim. After Sulfamethoxazole was administered, patient encountered several Sulfamethoxazole side effects: white blood cell count decreased, petechiae, platelet count decreased, pyrexia, coagulation time abnormal. Sulfamethoxazole And Trimethoprim dosage: N/A.

Stevens-johnson Syndrome, Pyrexia, Pruritus, Arthralgia, Rash Maculo-papular, Hypotension, Burning Sensation (8365897-1)
Patient was taking Sulfamethoxazole And Trimethoprim. Directly after, patient experienced the unwanted or unexpected Sulfamethoxazole side effects: stevens-johnson syndrome, pyrexia, pruritus, arthralgia, rash maculo-papular, hypotension, burning sensation on May 15, 2012 from UNITED STATES Additional patient health information: Female , 43 years of age, weighting 207.5 lb, was diagnosed with
  • urinary tract infection
and. Sulfamethoxazole And Trimethoprim dosage: 1 Tab Bid Po. Patient was hospitalized.

Chronic Obstructive Pulmonary Disease, Renal Failure Acute (8359683-6)
Adverse event was reported on May 14, 2012 by a Male taking Sulfamethoxazole And Trimethoprim (Dosage: 1 Tab Bid Po) was diagnosed with
  • upper respiratory tract infection
and. Location: UNITED STATES , 89 years of age, weighting 155.0 lb, Patient felt the following Sulfamethoxazole side effects: chronic obstructive pulmonary disease, renal failure acute. Patient was hospitalized.

Tremor, Hyperhidrosis, Asthenia, Pyrexia (8352017-2)
on May 10, 2012 Male from UNITED STATES , 71 years of age, weighting 247.1 lb, was diagnosed with
  • sinusitis
and was treated with Sulfamethoxazole And Trimethoprim. After Sulfamethoxazole was administered, patient encountered several Sulfamethoxazole side effects: tremor, hyperhidrosis, asthenia, pyrexia. Sulfamethoxazole And Trimethoprim dosage: 1 Tab Bid Po. Patient was hospitalized.

Gingivitis, Meningioma (8341297-5)
on Apr 23, 2012 Male from JAPAN , weighting 125.7 lb, was treated with Sulfamethoxazole And Trimethoprim. Directly after, patient experienced the unwanted or unexpected Sulfamethoxazole side effects: gingivitis, meningioma. Sulfamethoxazole And Trimethoprim dosage: N/A.
Associated medications used:
  • Amoxicillin (Form: Per Oral Agent)
  • Prednisolone And Prednisolone Acetate And Prednisolone Sodium Succinat
  • Prednisolone And Prednisolone Acetate And Prednisolone Sodium Succinat
  • Prednisolone And Prednisolone Acetate And Prednisolone Sodium Succinat
  • Prednisolone And Prednisolone Acetate And Prednisolone Sodium Succinat
  • Prednisolone And Prednisolone (Form: Peroral Agent)
  • Actemra
  • Actemra (Action Taken: Continued)
Patient was hospitalized.

Showing 1-25 of 956 

Sulfamethoxazole Health Episodes

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Sulfamethoxazole Information

Alternative SULFAMETHOXAZOLE Names:SULFAMETH

Active Ingredient: SULFAMETH

More About Sulfamethoxazole

Side Effects reported to FDA: 956. View Sulfamethoxazole Adverse Reports

Sulfamethoxazole safety alerts: No

Reported deaths: 28

Reported hospitalizations: 477

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