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Sulfamethoxazole Side Effects

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Common Sulfamethoxazole Side Effects


The most commonly reported Sulfamethoxazole side effects (click to view or check a box to report):

Renal Failure Acute (166)
Rash (145)
Hyperkalaemia (112)
Nausea (103)
Pyrexia (96)
Pruritus (77)
Vomiting (67)
Urticaria (64)
Headache (61)
Asthenia (60)
Stevens-johnson Syndrome (58)
Fatigue (53)
Pain (52)
Dyspnoea (51)
Chills (50)
Diarrhoea (44)
Blood Creatinine Increased (43)
Angioedema (42)
Dizziness (41)
Arthralgia (38)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Sulfamethoxazole Side Effects Reported to FDA



Sulfamethoxazole Side Effect Report#9999560
Renal Failure, Hyperkalaemia
This is a report of a 75-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Sulfamethoxazole/trimethoprim (dosage: NA, start time:
Jul 01, 2013), combined with: NA. and developed a serious reaction and side effect(s): Renal Failure, Hyperkalaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfamethoxazole/trimethoprim treatment in male patients, resulting in Renal Failure side effect. The patient was hospitalized.
Sulfamethoxazole Side Effect Report#9981631
Stevens-johnson Syndrome, Toxic Epidermal Necrolysis, Rash
This report suggests a potential Sulfamethoxazole/trimethoprim 800 Mg/160 Stevens-johnson Syndrome side effect(s) that can have serious consequences. A 54-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: infection and used Sulfamethoxazole/trimethoprim 800 Mg/160 (dosage: 1 Bid Oral) starting NS. After starting Sulfamethoxazole/trimethoprim 800 Mg/160 the patient began experiencing various side effects, including: Stevens-johnson Syndrome, Toxic Epidermal Necrolysis, RashAdditional drugs used concurrently: NA. Although Sulfamethoxazole/trimethoprim 800 Mg/160 demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Stevens-johnson Syndrome, may still occur.
Sulfamethoxazole Side Effect Report#9981621
Stevens-johnson Syndrome, Wound
This Stevens-johnson Syndrome problem was reported by a health professional from US. A 34-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: cellulitis. On
Mar 02, 2014 this consumer started treatment with Sulfamethoxazole/trimethoprim (dosage: NA). The following drugs were being taken at the same time: NA. When using Sulfamethoxazole/trimethoprim, the patient experienced the following unwanted symptoms/side effects: Stevens-johnson Syndrome, WoundThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Stevens-johnson Syndrome, may become evident only after a product is in use by the general population.
Sulfamethoxazole Side Effect Report#9972324
Hyponatraemia, Hypokalaemia
This Hyponatraemia side effect was reported by a pharmacist from US. A 57-year-old male patient (weight:NA) experienced the following symptoms/conditions: pneumocystis jirovecii pneumonia.The patient was prescribed Sulfamethoxazole-trimethoprim, Ds (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Acetaminophen
  • Azithromycin
  • Budesonide
  • Dextrose
  • Emtricitabine/tenofovir
  • Etravirine
  • Heparin
  • Ipratropium/albuterol
.After starting to take Sulfamethoxazole-trimethoprim, Ds the consumer reported adverse symptoms, such as: Hyponatraemia, HypokalaemiaThese side effects may potentially be related to Sulfamethoxazole-trimethoprim, Ds. The patient was hospitalized.
Sulfamethoxazole Side Effect Report#9970468
Pharyngitis, Dysphagia, Odynophagia, Dysphonia, Oral Candidiasis, Agranulocytosis
This is a report of a 68-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: furuncle, who was treated with Sulfamethoxazole And Trimethorpim (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Pharyngitis, Dysphagia, Odynophagia, Dysphonia, Oral Candidiasis, Agranulocytosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfamethoxazole And Trimethorpim treatment in male patients, resulting in Pharyngitis side effect. The patient was hospitalized.
Sulfamethoxazole Side Effect Report#9961554
Nausea, Vomiting, Hyperkalaemia, Bradycardia, Dialysis
This report suggests a potential Sulfamethoxazole/trimethoprim Nausea side effect(s) that can have serious consequences. A 66-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: urinary tract infection,hypertension and used Sulfamethoxazole/trimethoprim (dosage: NA) starting
May 12, 2010. After starting Sulfamethoxazole/trimethoprim the patient began experiencing various side effects, including: Nausea, Vomiting, Hyperkalaemia, Bradycardia, DialysisAdditional drugs used concurrently:
  • Spironolactone
The patient was hospitalized. Although Sulfamethoxazole/trimethoprim demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nausea, may still occur.
Sulfamethoxazole Side Effect Report#9954451
Oral Mucosal Discolouration, Paraesthesia Oral, Lip Swelling
This Oral Mucosal Discolouration problem was reported by a consumer or non-health professional from US. A 35-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 201303 this consumer started treatment with Sulfamethoxazole/trimethoprim Tablets (dosage: 800 Mg/160 Mg). The following drugs were being taken at the same time: NA. When using Sulfamethoxazole/trimethoprim Tablets, the patient experienced the following unwanted symptoms/side effects: Oral Mucosal Discolouration, Paraesthesia Oral, Lip SwellingAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Oral Mucosal Discolouration, may become evident only after a product is in use by the general population.
Sulfamethoxazole Side Effect Report#9924832
Palpitations, Dizziness, Dyspnoea, Penile Blister, Burns Second Degree
This Palpitations side effect was reported by a consumer or non-health professional from US. A 46-year-old male patient (weight:NA) experienced the following symptoms/conditions: sinusitis.The patient was prescribed Sulfamethoxazole/trimethoprim 800/160 (drug dosage: One Table Twice Daily), which was initiated on
Feb 13, 2014. Concurrently used drugs: NA..After starting to take Sulfamethoxazole/trimethoprim 800/160 the consumer reported adverse symptoms, such as: Palpitations, Dizziness, Dyspnoea, Penile Blister, Burns Second DegreeThese side effects may potentially be related to Sulfamethoxazole/trimethoprim 800/160.
Sulfamethoxazole Side Effect Report#9921286
Candida Infection, Agranulocytosis
This is a report of a 68-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: antibiotic prophylaxis, who was treated with Sulfamethoxazole And Trimethoprim Tablets, Usp 800 Mg/ 160 Mg (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Candida Infection, Agranulocytosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfamethoxazole And Trimethoprim Tablets, Usp 800 Mg/ 160 Mg treatment in male patients, resulting in Candida Infection side effect.
Sulfamethoxazole Side Effect Report#9913516
Renal Failure Acute, Hyperkalaemia
This report suggests a potential Sulfamethoxazole/trimethoprim Renal Failure Acute side effect(s) that can have serious consequences. A 94-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Sulfamethoxazole/trimethoprim (dosage: NA) starting
May 15, 2001. After starting Sulfamethoxazole/trimethoprim the patient began experiencing various side effects, including: Renal Failure Acute, HyperkalaemiaAdditional drugs used concurrently:
  • Lisinopril
The patient was hospitalized. Although Sulfamethoxazole/trimethoprim demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Failure Acute, may still occur.
Sulfamethoxazole Side Effect Report#9912531
Hyperkalaemia
This Hyperkalaemia problem was reported by a pharmacist from US. A 71-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Mar 11, 2013 this consumer started treatment with Sulfamethoxazole/trimethoprim (dosage: NA). The following drugs were being taken at the same time: NA. When using Sulfamethoxazole/trimethoprim, the patient experienced the following unwanted symptoms/side effects: HyperkalaemiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hyperkalaemia, may become evident only after a product is in use by the general population.
Sulfamethoxazole Side Effect Report#9908559
Hyperkalaemia, Blood Pressure Decreased, Heart Rate Decreased, Nodal Rhythm, Bundle Branch Block Left, Electrocardiogram Qrs Complex Prolonged, Electrocardiogram T Wave Peaked, Metabolic Acidosis, Haemodialysis
This Hyperkalaemia side effect was reported by a health professional from US. A 85-year-old female patient (weight:NA) experienced the following symptoms/conditions: urinary tract infection.The patient was prescribed Sulfamethoxazole And Trimethoprim (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Spironolactone
  • Valsartan
  • Sotalol
.After starting to take Sulfamethoxazole And Trimethoprim the consumer reported adverse symptoms, such as: Hyperkalaemia, Blood Pressure Decreased, Heart Rate Decreased, Nodal Rhythm, Bundle Branch Block Left, Electrocardiogram Qrs Complex Prolonged, Electrocardiogram T Wave Peaked, Metabolic Acidosis, HaemodialysisThese side effects may potentially be related to Sulfamethoxazole And Trimethoprim.
Sulfamethoxazole Side Effect Report#9893283
Polyarthritis
This is a report of a 63-year-old male patient (weight: NA) from AU, suffering from the following health symptoms/conditions: antifungal prophylaxis,immunosuppression, who was treated with Sulfamethoxazole/trimethoprim (dosage: NA, start time: NS), combined with:
  • Basiliximab (Pre-operatively And Again On Day 4.)
  • Mycophenolic Acid (Commenced Post-operatively)
  • Prednisolone (Commenced Post-operatively)
  • Tacrolimus (Commenced Post-operatively)
  • Methylprednisolone (Pre-operatively)
and developed a serious reaction and side effect(s): Polyarthritis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfamethoxazole/trimethoprim treatment in male patients, resulting in Polyarthritis side effect. The patient was hospitalized.
Sulfamethoxazole Side Effect Report#9891519
Renal Failure Acute, Hyponatraemia
This report suggests a potential Sulfamethoxazole/trimethoprim Renal Failure Acute side effect(s) that can have serious consequences. A 63-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: pneumocystis jirovecii pneumonia and used Sulfamethoxazole/trimethoprim (dosage: NA) starting
Aug 09, 2013. After starting Sulfamethoxazole/trimethoprim the patient began experiencing various side effects, including: Renal Failure Acute, HyponatraemiaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Sulfamethoxazole/trimethoprim demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Failure Acute, may still occur.
Sulfamethoxazole Side Effect Report#9888056
Renal Failure Acute, Rash Erythematous, Rhabdomyolysis, Diarrhoea, Dialysis
This Renal Failure Acute problem was reported by a pharmacist from US. A 67-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: urinary tract infection. On
Jul 04, 2012 this consumer started treatment with Sulfamethoxazole/trimethoprim (dosage: NA). The following drugs were being taken at the same time: NA. When using Sulfamethoxazole/trimethoprim, the patient experienced the following unwanted symptoms/side effects: Renal Failure Acute, Rash Erythematous, Rhabdomyolysis, Diarrhoea, DialysisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Renal Failure Acute, may become evident only after a product is in use by the general population.
Sulfamethoxazole Side Effect Report#9888052
Renal Failure Acute, Hyperkalaemia
This Renal Failure Acute side effect was reported by a pharmacist from US. A 55-year-old male patient (weight:NA) experienced the following symptoms/conditions: infection,hypertension.The patient was prescribed Sulfamethoxazole/trimethoprim (drug dosage: 1 Tab, Bid, Po), which was initiated on
Oct 04, 2002. Concurrently used drugs:
  • Lisinopril
.After starting to take Sulfamethoxazole/trimethoprim the consumer reported adverse symptoms, such as: Renal Failure Acute, HyperkalaemiaThese side effects may potentially be related to Sulfamethoxazole/trimethoprim. The patient was hospitalized.
Sulfamethoxazole Side Effect Report#9887886
Fatigue, Asthenia, Lethargy, Renal Failure Acute
This is a report of a 69-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: cellulitis,hypertension, who was treated with Sulfamethoxazole/trimethoprim (dosage: 2 Tab, Bid, Po, start time:
Jan 18, 2006), combined with:
  • Losartan
and developed a serious reaction and side effect(s): Fatigue, Asthenia, Lethargy, Renal Failure Acute after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfamethoxazole/trimethoprim treatment in male patients, resulting in Fatigue side effect. The patient was hospitalized.
Sulfamethoxazole Side Effect Report#9887779
Dehydration, Hypotension, Eosinophilia, Renal Failure Acute
This report suggests a potential Sulfamethoxazole\trimethoprim Dehydration side effect(s) that can have serious consequences. A 58-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: urinary tract infection and used Sulfamethoxazole\trimethoprim (dosage: NA) starting
Oct 18, 2010. After starting Sulfamethoxazole\trimethoprim the patient began experiencing various side effects, including: Dehydration, Hypotension, Eosinophilia, Renal Failure AcuteAdditional drugs used concurrently: NA.The patient was hospitalized. Although Sulfamethoxazole\trimethoprim demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dehydration, may still occur.
Sulfamethoxazole Side Effect Report#9887745
Asthenia, Upper Respiratory Tract Infection, Cough, Respiratory Tract Congestion, Nephropathy Toxic, Renal Failure Acute
This Asthenia problem was reported by a pharmacist from US. A 58-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: infection. On
Feb 20, 2013 this consumer started treatment with Sulfamethoxazole/trimethoprim (dosage: NA). The following drugs were being taken at the same time: NA. When using Sulfamethoxazole/trimethoprim, the patient experienced the following unwanted symptoms/side effects: Asthenia, Upper Respiratory Tract Infection, Cough, Respiratory Tract Congestion, Nephropathy Toxic, Renal Failure AcuteThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Asthenia, may become evident only after a product is in use by the general population.
Sulfamethoxazole Side Effect Report#9858774
Diarrhoea, Panic Attack, Anxiety
This Diarrhoea side effect was reported by a pharmacist from US. A 41-year-old female patient (weight:NA) experienced the following symptoms/conditions: infection.The patient was prescribed Sulfamethoxazole/trimethoprim (drug dosage: NA), which was initiated on
Jan 24, 2014. Concurrently used drugs: NA..After starting to take Sulfamethoxazole/trimethoprim the consumer reported adverse symptoms, such as: Diarrhoea, Panic Attack, AnxietyThese side effects may potentially be related to Sulfamethoxazole/trimethoprim. The patient was hospitalized.
Sulfamethoxazole Side Effect Report#9858701
Hypotension, Diarrhoea, Asthenia, Fatigue, Dizziness, Renal Failure Acute, Melaena
This is a report of a 67-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Sulfamethoxazole/trimethoprim (dosage: NA, start time:
Oct 13, 2013), combined with: NA. and developed a serious reaction and side effect(s): Hypotension, Diarrhoea, Asthenia, Fatigue, Dizziness, Renal Failure Acute, Melaena after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfamethoxazole/trimethoprim treatment in male patients, resulting in Hypotension side effect.
Sulfamethoxazole Side Effect Report#9852645
Nerve Injury
This report suggests a potential Sulfamethoxazole/tmp Ds Nerve Injury side effect(s) that can have serious consequences. A 25-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: staphylococcal infection and used Sulfamethoxazole/tmp Ds (dosage: 20, Twice Daily, Mouth) starting
May 18, 2013. After starting Sulfamethoxazole/tmp Ds the patient began experiencing various side effects, including: Nerve InjuryAdditional drugs used concurrently:
  • Thyroid
  • Adderall
Although Sulfamethoxazole/tmp Ds demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nerve Injury, may still occur.
Sulfamethoxazole Side Effect Report#9850490
Pseudomembranous Colitis, Megacolon
This Pseudomembranous Colitis problem was reported by a physician from US. A 32-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: prophylaxis,leukaemia cutis. On NS this consumer started treatment with Sulfamethoxazole/trimethoprim (dosage: Unk). The following drugs were being taken at the same time:
  • Carbenicillin (Unk)
  • Ticarcillin (Unk)
  • Allopurinol (Unk)
  • Cytosine Arabinoside ((100 Mg/m2 ) On Days 1 Through 7)
  • Doxorubicin (Doxorubicin (35 Mg/m2 ) On Days 1 Through 3)
  • Gentamicin (Unk)
  • Cephalothin (Unk)
When using Sulfamethoxazole/trimethoprim, the patient experienced the following unwanted symptoms/side effects: Pseudomembranous Colitis, MegacolonThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pseudomembranous Colitis, may become evident only after a product is in use by the general population.
Sulfamethoxazole Side Effect Report#9850096
Meningitis
This Meningitis side effect was reported by a consumer or non-health professional from US. A 77-year-old female patient (weight:NA) experienced the following symptoms/conditions: urinary tract infection.The patient was prescribed Sulfamethoxazole/tmp Ds (drug dosage: 1 Tablet, Twice A Day, By Mouth), which was initiated on NS. Concurrently used drugs:
  • Donepezil
  • Risperidone
  • Lorazepam
  • Sertraline
  • Metoprolol Tartrate
  • Amlodipine Besylate
  • Sucralfate
  • Viactiv Calcium Plus D
.After starting to take Sulfamethoxazole/tmp Ds the consumer reported adverse symptoms, such as: MeningitisThese side effects may potentially be related to Sulfamethoxazole/tmp Ds. The patient was hospitalized and became disabled.
Sulfamethoxazole Side Effect Report#9849439
Neutropenia, Rash, Pyrexia
This is a report of a 73-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: prostatitis, who was treated with Sulfamethoxazole/trimethoprim (dosage: NA, start time:
Sep 09, 2013), combined with: NA. and developed a serious reaction and side effect(s): Neutropenia, Rash, Pyrexia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfamethoxazole/trimethoprim treatment in male patients, resulting in Neutropenia side effect. The patient was hospitalized.


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The appearance of Sulfamethoxazole on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.


What are common Sulfamethoxazole Side Effects for Women?

Women Side EffectsReports
Rash 50
Pyrexia 46
Pruritus 42
Headache 40
Nausea 40
Pain 40
Vomiting 29
Fatigue 28
Arthralgia 27
Dyspnoea 27

What are common Sulfamethoxazole Side Effects for Men?

Men Side EffectsReports
Renal Failure Acute 157
Hyperkalaemia 107
Rash 94
Nausea 63
Pyrexia 48
Asthenia 45
Urticaria 40
Vomiting 38
Stevens-johnson Syndrome 37
Blood Creatinine Increased 35

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    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 reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Sulfamethoxazole Safety Alerts, Active Ingredients, Usage Information

    NDC0093-0088
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameSulfamethoxazole and Trimethoprim
    NameSulfamethoxazole and Trimethoprim
    Dosage FormTABLET
    RouteORAL
    On market since19900930
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)SULFAMETHOXAZOLE; TRIMETHOPRIM
    Strength(s)400; 80
    Unit(s)mg/1; mg/1
    Pharma ClassSulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [M

    More About Sulfamethoxazole

    Side Effects reported to FDA: 1252

    Sulfamethoxazole safety alerts: No

    Reported deaths: 31

    Reported hospitalizations: 496

    Latest Sulfamethoxazole clinical trials