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Colistin Side Effects

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Common Colistin Side Effects


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

Blood Creatinine Increased (6)
Renal Failure Acute (6)
Respiratory Failure (4)
Renal Impairment (4)
Paraesthesia (3)
Pseudomembranous Colitis (3)
Dyspnoea (3)
Pyrexia (3)
Tachycardia (3)
Sepsis (3)
Acute Respiratory Distress Syndrome (2)
Abdominal Distension (2)
Clostridium Difficile Colitis (2)
Condition Aggravated (2)
Renal Disorder (2)
Hypotension (2)
Overdose (1)
Operative Haemorrhage (1)
Neutropenic Colitis (1)
Ocular Vasculitis (1)

➢ 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.

Colistin Side Effects Reported to FDA



Colistin Side Effect Report#8419028-X
Distal Ileal Obstruction Syndrome, Constipation
This is a report of a 33-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Colistin (colistin) (dosage: NA, start time:
Jan 01, 2010), combined with:
  • Boniva
  • Albuterol
  • Cayston
  • Pulmozyme
  • Hypersol B (budesonide)
  • Mephyton (phytomenadione)
  • Spiriva
  • Vitamin D
and developed a serious reaction and side effect(s): Distal Ileal Obstruction Syndrome, Constipation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Colistin (colistin) treatment in male patients, resulting in Distal Ileal Obstruction Syndrome side effect. The patient was hospitalized.
Colistin Side Effect Report#8352005-6
Confusional State, Renal Failure, Acute Respiratory Distress Syndrome, Overdose, Condition Aggravated, Hypotension
This report suggests a potential Colistin Sulfate Confusional State side effect(s) that can have serious consequences. A 29-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: pseudomonas infection and used Colistin Sulfate (dosage: NA) starting
Apr 06, 2012. After starting Colistin Sulfate the patient began experiencing various side effects, including: Confusional State, Renal Failure, Acute Respiratory Distress Syndrome, Overdose, Condition Aggravated, HypotensionAdditional drugs used concurrently:
  • Pegzerepoetin Alfa
  • Na Polystyrene Sulfonate
  • Azithromycin
  • Posaconazole
  • Valaciclovir Hydrochlorid
  • Pancreatin Triple Strength Cap
  • Colecalciferol
  • Bisoprolol Fumarate
The patient was hospitalized. Although Colistin Sulfate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Confusional State, may still occur.
Colistin Side Effect Report#8294454-0
Respiratory Failure, Neutropenic Colitis, Sepsis
This Respiratory Failure problem was reported by a physician from Belgium. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: prophylaxis,haematological malignancy. On
Jan 10, 2012 this consumer started treatment with Colistin Sulfate (dosage: 100 Mg, Qid). The following drugs were being taken at the same time:
  • Evoltra (10 Mg/m2, Qod, On Days 2, 4, 6, 8, 10)
  • Allopurinol (300 Mg, Qd)
  • Valacyclovir Hydrochloride (500 Mg, Bid)
  • Cytarabine (100 Mg/m2, Qd)
  • Acyclovir (250 Mg, Qd)
  • Ceftazidime (1000 Mg, Qid)
  • Idarubicin Hcl (10 Mg/m2, Qod, On Days 1, 3, 5)
  • Acyclovir (500 Mg, Bid)
When using Colistin Sulfate, the patient experienced the following unwanted symptoms/side effects: Respiratory Failure, Neutropenic Colitis, SepsisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Respiratory Failure, may become evident only after a product is in use by the general population.
Colistin Side Effect Report#8266414-7
Anaphylactic Shock, Dyspnoea, Feeling Hot
This Anaphylactic Shock side effect was reported by a pharmacist from Germany. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Colistin Sulfate (drug dosage: Unk), which was initiated on
Feb 28, 2012. Concurrently used drugs:
  • Meropenem (Unk)
  • Ambisome (120 Mg, Uid/qd)
.After starting to take Colistin Sulfate the consumer reported adverse symptoms, such as: Anaphylactic Shock, Dyspnoea, Feeling HotThese side effects may potentially be related to Colistin Sulfate. The patient was hospitalized.
Colistin Side Effect Report#7998704-7
Quadriparesis, Rhabdomyolysis, Hypernatraemia
This is a report of a 62-year-old male patient (weight: NA) from Italy, suffering from the following health symptoms/conditions: NA, who was treated with Colistin (dosage: Unk, start time:
Nov 21, 2011), combined with:
  • Amikacin (1g Daily)
  • Tygacil (50 Mg, 2x/day)
  • Tygacil (100 Mg, 2x/day)
and developed a serious reaction and side effect(s): Quadriparesis, Rhabdomyolysis, Hypernatraemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Colistin treatment in male patients, resulting in Quadriparesis side effect.
Colistin Side Effect Report#7746107-2
Dehydration, Hypotension, Tachycardia, Pseudomembranous Colitis, Abdominal Distension
This report suggests a potential Colistin Sulfate Dehydration side effect(s) that can have serious consequences. A 34-year-old male patient (weight: NA) from United Kingdom was diagnosed with the following symptoms/conditions: NA and used Colistin Sulfate (dosage: Intravenous) starting NS. After starting Colistin Sulfate the patient began experiencing various side effects, including: Dehydration, Hypotension, Tachycardia, Pseudomembranous Colitis, Abdominal DistensionAdditional drugs used concurrently:
  • Meropenem (Intravenous)
  • Clarithromycin
  • Tobramycin
  • Omeprazole
  • Interferon Gamma Nos (Subcutaneous)
  • Minocycline Hcl
  • Ciprofloxacin
The patient was hospitalized. Although Colistin Sulfate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dehydration, may still occur.
Colistin Side Effect Report#7734905-0
Jugular Vein Thrombosis, Chills, Pyrexia
This Jugular Vein Thrombosis problem was reported by a health professional from Italy. A 59-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
May 29, 2009 this consumer started treatment with Colistin (dosage: NA). The following drugs were being taken at the same time:
  • Cubicin
  • Immunoglobulins
  • Meropenem
  • Cubicin
When using Colistin, the patient experienced the following unwanted symptoms/side effects: Jugular Vein Thrombosis, Chills, PyrexiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Jugular Vein Thrombosis, may become evident only after a product is in use by the general population.
Colistin Side Effect Report#7717396-5
Hypoxic-ischaemic Encephalopathy, Metabolic Encephalopathy
This Hypoxic-ischaemic Encephalopathy side effect was reported by a physician from Brazil. A 21-year-old female patient (weight:NA) experienced the following symptoms/conditions: convulsion.The patient was prescribed Colistin (drug dosage: NA), which was initiated on
Sep 01, 2010. Concurrently used drugs:
  • Imipenem
  • Amlodipine
  • Atenolol
  • Ranitidine
  • Clonazine
  • Cubicin
  • Clonidine Hydrochloride
  • Solutions For Parenteral Nutrition
.After starting to take Colistin the consumer reported adverse symptoms, such as: Hypoxic-ischaemic Encephalopathy, Metabolic EncephalopathyThese side effects may potentially be related to Colistin.
Colistin Side Effect Report#7717107-3
Pseudomembranous Colitis, Clostridium Difficile Colitis
This is a report of a 34-year-old male patient (weight: NA) from United Kingdom, suffering from the following health symptoms/conditions: NA, who was treated with Colistin Sulfate (dosage: NA, start time: NS), combined with:
  • Interferon Gamma Nos
  • Clarithromycin
  • Tobi (Unk)
  • Omeprazole (Unk)
  • Meropenem (Unk)
  • Minocycline Hcl (Unk)
  • Tobramycin (Unk)
  • Azithromycin (Unk)
and developed a serious reaction and side effect(s): Pseudomembranous Colitis, Clostridium Difficile Colitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Colistin Sulfate treatment in male patients, resulting in Pseudomembranous Colitis side effect. The patient was hospitalized.
Colistin Side Effect Report#7683774-6
Liver Disorder
This report suggests a potential Colistin Liver Disorder side effect(s) that can have serious consequences. A female patient (weight: NA) from Hungary was diagnosed with the following symptoms/conditions: sepsis and used Colistin (dosage: Unk Iu, Unk) starting
Sep 27, 2010. After starting Colistin the patient began experiencing various side effects, including: Liver DisorderAdditional drugs used concurrently:
  • Solu-medrol
  • Furosemide (Unk)
  • Amikacin (1 G, Uid/qd)
  • Propofol (Unk)
  • Pantoprazole Sodium (40 Mg, Bid)
  • Tobramycin (80 Mg, Tid)
  • Fluconazole (200 Mg, Bid)
  • Vancomycin (0.5 G, Tid)
Although Colistin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Liver Disorder, may still occur.
Colistin Side Effect Report#7620761-8
Macular Oedema, Retinal Artery Occlusion, Ocular Vasculitis, Vision Blurred, Visual Acuity Reduced, Diabetic Retinopathy, Venous Occlusion
This Macular Oedema problem was reported by a health professional from United Kingdom. A 21-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: respiratory tract infection,immunosuppression. On NS this consumer started treatment with Colistin Sulfate (dosage: NA). The following drugs were being taken at the same time:
  • Tacrolimus (Unk)
  • Tobramycin
  • Creon (Unk)
  • Cotrim (Unk)
  • Meropenem
  • Ranitidine
When using Colistin Sulfate, the patient experienced the following unwanted symptoms/side effects: Macular Oedema, Retinal Artery Occlusion, Ocular Vasculitis, Vision Blurred, Visual Acuity Reduced, Diabetic Retinopathy, Venous OcclusionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Macular Oedema, may become evident only after a product is in use by the general population.
Colistin Side Effect Report#7605196-6
Dyspnoea, Flushing, Paraesthesia, Body Temperature Increased, Hypersensitivity
This Dyspnoea side effect was reported by a pharmacist from United Kingdom. A 45-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Colistin Sulfate (drug dosage: NA), which was initiated on
May 25, 2011. Concurrently used drugs:
  • Adcal D3
  • Meropenem (2 Grams, 1 Day, Intravenous Bolus)
  • Meropenem (2 Grams, 1 Day, Intravenous Bolus)
  • Creon
  • Megestrol Acetate
  • Carbocisteine
  • Pulmozyme
  • Symbicort
.After starting to take Colistin Sulfate the consumer reported adverse symptoms, such as: Dyspnoea, Flushing, Paraesthesia, Body Temperature Increased, HypersensitivityThese side effects may potentially be related to Colistin Sulfate. The patient was hospitalized.
Colistin Side Effect Report#7595276-6
C-reactive Protein Increased, Pyrexia, Abdominal Pain, Clostridium Difficile Colitis, Colitis, Nausea, Abdominal Distension, Pseudomembranous Colitis, Tachycardia
This is a report of a 34-year-old male patient (weight: NA) from United Kingdom, suffering from the following health symptoms/conditions: mycobacterium abscessus infection, who was treated with Colistin Sulfate (dosage: NA, start time: NS), combined with:
  • Azithromycin (Not Reported)
  • Tobramycin (Not Reported)
  • Interferon Gamma-1a (Not Reported)
and developed a serious reaction and side effect(s): C-reactive Protein Increased, Pyrexia, Abdominal Pain, Clostridium Difficile Colitis, Colitis, Nausea, Abdominal Distension, Pseudomembranous Colitis, Tachycardia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Colistin Sulfate treatment in male patients, resulting in C-reactive Protein Increased side effect. The patient was hospitalized.
Colistin Side Effect Report#7557740-5
Pneumonia Klebsiella, Sepsis, Febrile Infection, Urinary Tract Infection
This report suggests a potential Colistin Pneumonia Klebsiella side effect(s) that can have serious consequences. A 60-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Colistin (dosage: NA) starting NS. After starting Colistin the patient began experiencing various side effects, including: Pneumonia Klebsiella, Sepsis, Febrile Infection, Urinary Tract InfectionAdditional drugs used concurrently:
  • Primaxin
  • Amikacin
  • Teicoplanin
The patient was hospitalized. Although Colistin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pneumonia Klebsiella, may still occur.
Colistin Side Effect Report#7536178-0
Acidosis, Blood Creatine Increased, Haemodialysis, Azotaemia, Tubulointerstitial Nephritis
This Acidosis problem was reported by a pharmacist from United States. A 93-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: cellulitis. On
Feb 27, 2011 this consumer started treatment with Colistin Sulfate (dosage: 200 Mg Q12h Iv). The following drugs were being taken at the same time: NA. When using Colistin Sulfate, the patient experienced the following unwanted symptoms/side effects: Acidosis, Blood Creatine Increased, Haemodialysis, Azotaemia, Tubulointerstitial NephritisThe 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 Acidosis, may become evident only after a product is in use by the general population.
Colistin Side Effect Report#7279668-0
Tracheal Haemorrhage
This Tracheal Haemorrhage side effect was reported by a pharmacist from United States. A 32-year-old female patient (weight:NA) experienced the following symptoms/conditions: lung infection pseudomonal.The patient was prescribed Colistin Sulfate (drug dosage: 75 Mg Q 12 Hours Inhal), which was initiated on
Jan 18, 2011. Concurrently used drugs:
  • Amikacin
.After starting to take Colistin Sulfate the consumer reported adverse symptoms, such as: Tracheal HaemorrhageThese side effects may potentially be related to Colistin Sulfate. The patient was hospitalized.
Colistin Side Effect Report#6731718-3
Renal Failure Acute
This is a report of a 84-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: pneumonia,sepsis,urinary tract infection, who was treated with Colistin Sulfate (dosage: 150 Mg Q12h Iv Bolus, start time:
Feb 06, 2010), combined with: NA. and developed a serious reaction and side effect(s): Renal Failure Acute after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Colistin Sulfate treatment in male patients, resulting in Renal Failure Acute side effect. The patient was hospitalized.
Colistin Side Effect Report#6519730-0
Acinetobacter Infection, Blood Creatinine Increased, Extradural Abscess
This report suggests a potential Colistin 150mg Acinetobacter Infection side effect(s) that can have serious consequences. A 31-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: osteomyelitis and used Colistin 150mg (dosage: 100mg Q8h Po) starting NS. After starting Colistin 150mg the patient began experiencing various side effects, including: Acinetobacter Infection, Blood Creatinine Increased, Extradural AbscessAdditional drugs used concurrently:
  • Vancomycin (1000mg Q12h Po)
Although Colistin 150mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Acinetobacter Infection, may still occur.
Colistin Side Effect Report#6160514-3
Blood Creatinine Increased, Paraesthesia, Paraesthesia Oral
This Blood Creatinine Increased problem was reported by a physician from United States. A 25-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: cystic fibrosis lung,condition aggravated. On
Mar 31, 2009 this consumer started treatment with Colistin Sulfate (dosage: 150 Mg Q12 Hours Iv Bolus). The following drugs were being taken at the same time:
  • Trimethoprim-sulfamethoxazole (1 Tablet Bid Po)
When using Colistin Sulfate, the patient experienced the following unwanted symptoms/side effects: Blood Creatinine Increased, Paraesthesia, Paraesthesia OralThe patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Blood Creatinine Increased, may become evident only after a product is in use by the general population.
Colistin Side Effect Report#5573376-X
Pneumothorax
This Pneumothorax side effect was reported by a pharmacist from United States. A 55-year-old female patient (weight:NA) experienced the following symptoms/conditions: pneumonia.The patient was prescribed Colistin 150 Mg Parke-davis (drug dosage: 75mg 8 Endotracheal), which was initiated on
Oct 10, 2007. Concurrently used drugs: NA..After starting to take Colistin 150 Mg Parke-davis the consumer reported adverse symptoms, such as: PneumothoraxThese side effects may potentially be related to Colistin 150 Mg Parke-davis.
Colistin Side Effect Report#5527850-2
Paraesthesia, Renal Failure Acute
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: cystic fibrosis, who was treated with Colistin Sulfate (dosage: 500 Mg Q 8 Hr Iv, start time:
Nov 16, 2007), combined with: NA. and developed a serious reaction and side effect(s): Paraesthesia, Renal Failure Acute after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Colistin Sulfate treatment in female patients, resulting in Paraesthesia side effect.
Colistin Side Effect Report#5402786-6
Condition Aggravated, Cystic Fibrosis, Dyspnoea, Lobar Pneumonia, Lung Infiltration, Oxygen Saturation Decreased, Pyrexia, Tachycardia
This report suggests a potential Colistin Sulfate Condition Aggravated side effect(s) that can have serious consequences. A 37-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Colistin Sulfate (dosage: NA) starting NS. After starting Colistin Sulfate the patient began experiencing various side effects, including: Condition Aggravated, Cystic Fibrosis, Dyspnoea, Lobar Pneumonia, Lung Infiltration, Oxygen Saturation Decreased, Pyrexia, TachycardiaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Colistin Sulfate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Condition Aggravated, may still occur.
Colistin Side Effect Report#5378660-0
Renal Failure Acute
This Renal Failure Acute problem was reported by a pharmacist from United States. A 54-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: pancreatitis. On
Jun 21, 2007 this consumer started treatment with Colistin Sulfate (dosage: 160mg Q12h Iv). The following drugs were being taken at the same time: NA. When using Colistin Sulfate, the patient experienced the following unwanted symptoms/side effects: 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 Renal Failure Acute, may become evident only after a product is in use by the general population.
Colistin Side Effect Report#5361970-0
Acute Respiratory Distress Syndrome, Multi-organ Failure, Respiratory Failure
This Acute Respiratory Distress Syndrome side effect was reported by a consumer or non-health professional from United States. A 29-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Colistin Aerosol 75 Mg Bid Compounding (drug dosage: 75 Mg Bid), which was initiated on
Apr 26, 2007. Concurrently used drugs: NA..After starting to take Colistin Aerosol 75 Mg Bid Compounding the consumer reported adverse symptoms, such as: Acute Respiratory Distress Syndrome, Multi-organ Failure, Respiratory FailureThese side effects may potentially be related to Colistin Aerosol 75 Mg Bid Compounding.
Colistin Side Effect Report#5341508-4
Acute Respiratory Failure, Pancreatitis, Renal Failure Acute
This is a report of a 45-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Colistin Sulfate (dosage: 250mg Q12h Iv, start time:
Jun 19, 2006), combined with:
  • Clonidine
  • Lisinopril
  • Premix
  • M.v.i.
  • Docusate
  • Baclofen
  • Tegretol
  • Nsaid
and developed a serious reaction and side effect(s): Acute Respiratory Failure, Pancreatitis, Renal Failure Acute after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Colistin Sulfate treatment in male patients, resulting in Acute Respiratory Failure side effect. The patient was hospitalized.


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The appearance of Colistin 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.

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    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.

    Colistin 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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    Colistin Safety Alerts, Active Ingredients, Usage Information

    More About Colistin

    Side Effects reported to FDA: 35

    Colistin safety alerts: No

    Reported deaths: 4

    Reported hospitalizations: 14

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