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Bactrim Side Effects

Common Bactrim Side Effects


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

Pyrexia (115)
Rash (109)
Nausea (99)
Stevens-johnson Syndrome (88)
Vomiting (71)
Renal Failure Acute (69)
Fatigue (62)
Headache (60)
Pruritus (58)
Asthenia (57)
Diarrhoea (53)
Pain (48)
Dyspnoea (48)
Chills (44)
Erythema (37)
Urticaria (37)
Hyperkalaemia (35)
Abdominal Pain (35)
Dizziness (34)
Alanine Aminotransferase Increased (32)

➢ 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.

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.

Bactrim Side Effects Reported to FDA

The following Bactrim 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.


The appearance of Bactrim 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.
Mental Status Changes, Asthenia, Hyponatraemia, Hallucinations, Mixed
This is a report of a 89-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: urinary tract infection, who was treated with Bactrim Ds (dosage: Recent, start time: NS), combined with:
  • Valium (Chronic)
  • Demerol
  • Valium
  • Prilosec
  • Caltrate
  • Lasix
  • Synthroid
  • Kombiglyze
and developed a serious reaction and side effect(s). The consumer presented with:
  • Mental Status Changes
  • Asthenia
  • Hyponatraemia
  • Hallucinations, Mixed
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bactrim Ds treatment in female patients, resulting in mental status changes side effect. The patient was hospitalized.

Jaundice, Pruritus, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased
This report suggests a potential Bactrim Jaundice, Pruritus, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased side effect(s) that can have serious consequences. A 73-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: foot ulcer and used Bactrim (dosage: NA) starting Jan 05, 2011. Soon after starting Bactrim the patient began experiencing various side effects, including:
  • Jaundice
  • Pruritus
  • Aspartate Aminotransferase Increased
  • Alanine Aminotransferase Increased
  • Blood Alkaline Phosphatase Increased
  • Blood Bilirubin Increased
Drugs used concurrently:
  • Hydralazine
  • Tigecycline
Although Bactrim demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as jaundice, may still occur.

Cholestasis
This Cholestasis problem was reported by a physician from US. A 62-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Sep 11, 2010 this consumer started treatment with Bactrim (dosage: NA). The following drugs were being taken at the same time:
  • Imuran
When commencing Bactrim, the patient experienced the following unwanted symptoms/side effects:
  • Cholestasis
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as cholestasis, may become evident only after a product is in use by the general population.

Thrombocytopenia, Presyncope, Cardiac Failure Acute, Septic Shock, Atrial Fibrillation
This is a report of a 75-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Bactrim (dosage: NA) starting Aug 22, 2012. Concurrently used drugs:
  • Saxagliptin
  • Metformin Hcl
Soon after that, the consumer experienced the following side effects:
  • Thrombocytopenia
  • Presyncope
  • Cardiac Failure Acute
  • Septic Shock
  • Atrial Fibrillation
The patient was hospitalized. This opens a possibility that Bactrim treatment could cause the above reactions, including thrombocytopenia, and some female subjects may be more susceptible.


Pharyngeal Oedema
A 60-year-old female patient (weight: NA) from US with the following symptoms/conditions: bronchitis started Bactrim Ds treatment (dosage: Ds, Bid, Po) on Oct 31, 2012. Soon after starting Bactrim Ds treatment, the subject experienced various side effects, including:
  • Pharyngeal Oedema
Concurrently used drugs:
  • Albuterol Mdi
This finding indicates that some female patients could be more vulnerable to Bactrim Ds.

Pyrexia, Rash, Nausea, Vomiting, Headache, Fatigue, Cholestasis, Hepatic Steatosis
A 40-year-old female patient from US (weight: NA) experienced symptoms, such as: NA and was treated with Bactrim(dosage: NA). The treatment was initiated on Jun 17, 2010. After that a consumer reported the following side effect(s):
  • Pyrexia
  • Rash
  • Nausea
  • Vomiting
  • Headache
  • Fatigue
  • Cholestasis
  • Hepatic Steatosis
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Bactrim efficacy:
  • Doxycycline


Arterial Rupture, Myocardial Infarction
In this report, Bactrim was administered for the following condition: prophylaxis urinary tract infection.A 30-year-old female consumer from US (weight: NA) started Bactrim treatment (dosage: NA) on Aug 24, 2011.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Arterial Rupture
  • Myocardial Infarction
A possible interaction with other drugs could have contributed to this reaction: NA.The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Bactrim treatment could be related to the listed above side effect(s).

Hypotension, Swelling Face, Swollen Tongue, Anaphylactic Reaction, Rash, Pyrexia
This is a report of the following Bactrim side effect(s):
  • Hypotension
  • Swelling Face
  • Swollen Tongue
  • Anaphylactic Reaction
  • Rash
  • Pyrexia
A female patient from US (weight: NA) presented with the following condition: infection,pulmonary arterial hypertension and received a treatment with Bactrim (dosage: NA) starting: May 01, 2011.The following concurrently used drugs could have generated interactions:
  • Adcirca
  • Remodulin
  • Furosemide
  • Aspirin
  • Naproxen
  • Calcium With Vitamin D
The patient was hospitalized.This report suggests that a Bactrim treatment could be associated with the listed above side effect(s).

Angioedema, Diarrhoea
This Bactrim report was submitted by a 68-year-old female consumer from US (weight: NA). The patient was diagnosed with: insect bite nos and Bactrim was administered (dosage: 1 Pill 2x) starting: Sep 26, 2012. The consumer developed a set of symptoms:
  • Angioedema
  • Diarrhoea
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Bactrim treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Thrombocytopenia, White Blood Cell Count Increased, Haemoglobin Increased, Haematocrit Increased, Hypovolaemia, Haemoconcentration, Lymphoproliferative Disorder, Autoimmune Disorder, Infection
This is a report of a possible correlation between Bactrim use and the following symptoms/side effect(s):
  • Thrombocytopenia
  • White Blood Cell Count Increased
  • Haemoglobin Increased
  • Haematocrit Increased
  • Hypovolaemia
  • Haemoconcentration
  • Lymphoproliferative Disorder
  • Autoimmune Disorder
  • Infection
which could contribute to an assessment of Bactrim risk profile.A 78-year-old female consumer from US (weight: NA) was suffering from NA and was treated with Bactrim (dosage: NA) starting NS.Other concurrent medications:
  • Glucovance (1 Tablet Once Daily Po)
The patient was hospitalized.

Dermatitis Infected
A 27-year-old female patient from US (weight: NA) presented with the following symptoms: uti,skin swelling and after a treatment with Bactrim Ds (dosage: 1 Tablet 2 Times Daily Po) experienced the following side effect(s):
  • Dermatitis Infected
The treatment was started on Oct 18, 2012. Bactrim Ds was used in combination with the following drugs: NA.This report could alert potential Bactrim Ds consumers.

Rash Erythematous
In this report, a 49-year-old female patient from US (weight: NA) was affected by a possible Bactrim side effect.The patient was diagnosed with NA. After a treatment with Bactrim (dosage: NA, start date: Apr 23, 2012), the patient experienced the following side effect(s):
  • Rash Erythematous
The following simultaneously used drugs could have led to this reaction: NA.The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Bactrim treatment.

Alanine Aminotransferase Increased, Abdominal Pain, Nausea, Fatigue, Blood Bilirubin Increased, Blood Alkaline Phosphatase Increased, Ascites, Hepatic Steatosis
This is a report of a 43-year-old female patient from US (weight: NA), who used Bactrim (dosage: NA) for a treatment of NA. After starting a treatment on Nov 05, 2010, the patient experienced the following side effect(s):
  • Alanine Aminotransferase Increased
  • Abdominal Pain
  • Nausea
  • Fatigue
  • Blood Bilirubin Increased
  • Blood Alkaline Phosphatase Increased
  • Ascites
  • Hepatic Steatosis
The following drugs could possibly have interacted with the Bactrim treatment NA.The patient was hospitalized.Taken together, these observations suggest that a Bactrim treatment could be related to side effect(s), such as Alanine Aminotransferase Increased, Abdominal Pain, Nausea, Fatigue, Blood Bilirubin Increased, Blood Alkaline Phosphatase Increased, Ascites, Hepatic Steatosis.

Nausea, Vomiting, Abdominal Pain, Fatigue, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Blood Alkaline Phosphatase, White Blood Cell Count Increased
This nausea side effect was reported by a physician from US. A 39-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Bactrim (dosage: NA), which was started on Jun 07, 2011. Concurrently used drugs: NA. When starting to take Bactrim the consumer reported the following symptoms:
  • Nausea
  • Vomiting
  • Abdominal Pain
  • Fatigue
  • Aspartate Aminotransferase Increased
  • Alanine Aminotransferase Increased
  • Blood Alkaline Phosphatase
  • White Blood Cell Count Increased
These side effects may potentially be related to Bactrim.

Cholestasis
This is a Bactrim side effect report of a 51-year-old male patient (weight:NA) from US, suffering from the following symptoms/conditions: stenotrophomonas infection, who was treated with Bactrim (dosage:NA, start time: Sep 26, 2012), combined with: NA., and developed a serious reaction and a cholestasis side effect. The patient presented with:
  • Cholestasis
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Bactrim treatment in male patients suffering from stenotrophomonas infection, resulting in cholestasis.

Stevens-johnson Syndrome
This report suggests a potential Bactrim stevens-johnson syndrome side effect(s) that can have serious consequences. A 21-year-old female patient from US (weight:NA) was diagnosed with the following health condition(s): rash face and used Bactrim (dosage: 2/day Po) starting Sep 18, 2012. Soon after starting Bactrim the patient began experiencing various side effects, including:
  • Stevens-johnson Syndrome
Drugs used concurrently:NA. The patient was hospitalized. Although Bactrim demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as stevens-johnson syndrome, may still occur.

Fatigue, Cerebrovascular Accident, Lung Infection, Dyspnoea, Red Blood Cell Count Decreased, White Blood Cell Count Decreased
This fatigue problem was reported by a consumer or non-health professional from US. A 76-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): nose infection nos,staphylococcal infection.On Aug 06, 2012 a consumer started treatment with Bactrim (dosage: 20 Tabs). The following drugs/medications were being taken at the same time: NA. When commencing Bactrim, the patient experienced the following unwanted symptoms /side effects:
  • Fatigue
  • Cerebrovascular Accident
  • Lung Infection
  • Dyspnoea
  • Red Blood Cell Count Decreased
  • White Blood Cell Count Decreased
The patient was hospitalized and became disabled. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as fatigue, may become evident only after a product is in use by the general population.

Stomatitis, Glossitis, Glossodynia, Skin Exfoliation, Influenza Like Illness, Mouth Haemorrhage, Rash, Oral Pain
This is a Bactrim side effect report of a female patient (weight: NA) from US. The patient developed the following symptoms/conditions: uti and was treated with Bactrim (dosage: NA) starting May 16, 2012. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Stomatitis
  • Glossitis
  • Glossodynia
  • Skin Exfoliation
  • Influenza Like Illness
  • Mouth Haemorrhage
  • Rash
  • Oral Pain
The patient was hospitalized. This opens a possibility that Bactrim could cause stomatitis and that some female patients may be more susceptible.

Blood Potassium Increased, Renal Failure Acute, Renal Tubular Necrosis
A 57-year-old male patient (weight: NA) from US with the following symptoms: haematoma infection started Bactrim treatment (dosage: Recent) on NS. Soon after starting Bactrim treatment, the consumer experienced several side effects, including:
  • Blood Potassium Increased
  • Renal Failure Acute
  • Renal Tubular Necrosis
. Concurrently used drugs:
  • Keflex
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Bactrim side effects, such as blood potassium increased.

Gingival Swelling, Pyrexia, Flushing, Nausea
This gingival swelling side effect was reported by a consumer or non-health professional from US. A 9-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Bactrim (dosage: NA), which was started on Jan 26, 2012. Concurrently used drugs:
  • Allegra
.When starting to take Bactrim the consumer reported symptoms, such as:
  • Gingival Swelling
  • Pyrexia
  • Flushing
  • Nausea
These side effects may potentially be related to Bactrim.

White Blood Cell Count Decreased, Pruritus, Swelling Face
This is a report of a 37-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Bactrim Ds Tablets (dosage: NA, start time: NS), combined with:
  • Clozapine
and developed a serious reaction and side effect(s). The consumer presented with:
  • White Blood Cell Count Decreased
  • Pruritus
  • Swelling Face
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bactrim Ds Tablets treatment in female patients, resulting in white blood cell count decreased side effect. The patient was hospitalized.

Pruritus, Dyspnoea, Exposure Via Body Fluid
This report suggests a potential Bactrim Tablets Pruritus, Dyspnoea, Exposure Via Body Fluid side effect(s) that can have serious consequences. A 45-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: exposure via semen,hypothyroidism and used Bactrim Tablets (dosage: NA) starting NS. Soon after starting Bactrim Tablets the patient began experiencing various side effects, including:
  • Pruritus
  • Dyspnoea
  • Exposure Via Body Fluid
Drugs used concurrently:
  • Levoxyl
The patient was hospitalized. Although Bactrim Tablets demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as pruritus, may still occur.

Mood Swings, Ovarian Mass, Pregnancy With Implant Contraceptive
This Mood Swings, Ovarian Mass, Pregnancy With Implant Contraceptive problem was reported by a consumer or non-health professional from US. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Aug 04, 2010 this consumer started treatment with Bactrim Tablets (dosage: NA). The following drugs were being taken at the same time:
  • Implanon
  • Azithromycin
When commencing Bactrim Tablets, the patient experienced the following unwanted symptoms/side effects:
  • Mood Swings
  • Ovarian Mass
  • Pregnancy With Implant Contraceptive
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as mood swings, may become evident only after a product is in use by the general population.

Rash, Anaphylactic Reaction, Night Sweats, Pyrexia
This is a report of a male patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Bactrim Tablets (dosage: NA) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Rash
  • Anaphylactic Reaction
  • Night Sweats
  • Pyrexia
This opens a possibility that Bactrim Tablets treatment could cause the above reactions, including rash, and some male subjects may be more susceptible.

Angioedema
A 78-year-old male patient (weight: NA) from US with the following symptoms/conditions: NA started Bactrim treatment (dosage: NA) on Jun 09, 2011. Soon after starting Bactrim treatment, the subject experienced various side effects, including:
  • Angioedema
Concurrently used drugs:
  • Aspirin
  • Percocet
  • Flomax 0.4 Mg Wolkoff Capsule Er
  • Namenda
  • Spiriva Handihaler
  • Triamterene/hctz 37.5 Mg/ 25 Mg Tablet
  • Xanax Demangone Tablet
  • Sennagen 8.6 Mg Otc Tablet
This finding indicates that some male patients could be more vulnerable to Bactrim.

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Top 10 Bactrim Side Effects for Women

Women Side EffectsReports
Nausea 65
Pyrexia 63
Rash 51
Stevens-johnson Syndrome 47
Headache 44
Vomiting 42
Diarrhoea 38
Fatigue 37
Pain 36
Pruritus 36

Top 10 Bactrim Side Effects for Men

Men Side EffectsReports
Rash 54
Pyrexia 51
Stevens-johnson Syndrome 41
Renal Failure Acute 37
Nausea 34
Asthenia 31
Vomiting 29
Dyspnoea 28
Fatigue 25
Hyperkalaemia 24

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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.


    Discuss Bactrim Side Effects

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    Bactrim Safety Alerts, Active Ingredients, Usage Information

    NDC13310-145
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameBactrim
    NameSulfamethoxazole and Trimethoprim
    Dosage FormTABLET
    RouteORAL
    On market since20041101
    LabelerAR Scientific, 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 Bactrim

    Side Effects reported to FDA: 1112

    Bactrim safety alerts: No

    Reported deaths: 58

    Reported hospitalizations: 404

    Latest Bactrim clinical trials