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Colace Side Effects

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Common Colace Side Effects


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

Chest Pain (12)
Pain (12)
Nausea (12)
Pneumonia (10)
Fall (10)
Dehydration (10)
Abdominal Pain (9)
Anxiety (9)
Diarrhoea (9)
Vomiting (8)
Dyspnoea (8)
Injury (8)
Asthenia (7)
Pyrexia (7)
Cough (6)
Constipation (6)
Deep Vein Thrombosis (6)
Palpitations (6)
Renal Failure (6)
Feeling Abnormal (6)

➢ 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.

Colace Side Effects Reported to FDA



Colace Side Effect Report#9910133
Anaphylactic Reaction, Rash, Throat Tightness, Dyspnoea, Reaction To Colouring
This is a report of a 19-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: constipation, who was treated with Colace (dosage: 100 Mg, Unk, start time:
Feb 09, 2014), combined with: NA. and developed a serious reaction and side effect(s): Anaphylactic Reaction, Rash, Throat Tightness, Dyspnoea, Reaction To Colouring after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Colace treatment in female patients, resulting in Anaphylactic Reaction side effect.
Colace Side Effect Report#9540382
Fall, Joint Injury, Medical Device Complication, Shoulder Operation, Shoulder Arthroplasty, Frequent Bowel Movements, Constipation
This report suggests a potential Colace Fall side effect(s) that can have serious consequences. A 69-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: constipation,thrombosis,pain and used Colace (dosage: 100 Mg, Tid) starting 201306. After starting Colace the patient began experiencing various side effects, including: Fall, Joint Injury, Medical Device Complication, Shoulder Operation, Shoulder Arthroplasty, Frequent Bowel Movements, ConstipationAdditional drugs used concurrently:
  • Plavix (75 Mg, Daily)
  • Hydrocodone (10/325 Mg, Tid)
  • Percocet /00446701/ (5/325 Mg, Tid)
The patient was hospitalized. Although Colace demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Fall, may still occur.
Colace Side Effect Report#9372281
Granulocytopenia
This Granulocytopenia problem was reported by a pharmacist from US. A 54-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Colace (dosage: NA). The following drugs were being taken at the same time:
  • Rozerem
  • Haldol
  • Multivitamines With Iron /02170101/
  • Clozapine Tablets
  • Clozapine Tablets
  • Tylenol
  • Clonazepam
  • Vitamin C
When using Colace, the patient experienced the following unwanted symptoms/side effects: GranulocytopeniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Granulocytopenia, may become evident only after a product is in use by the general population.
Colace Side Effect Report#9148739
Jaundice, Blood Bilirubin Increased, Transaminases Increased, Pain, Nausea, Malaise
This Jaundice side effect was reported by a physician from US. A 36-year-old female patient (weight:NA) experienced the following symptoms/conditions: diarrhoea.The patient was prescribed Colace (drug dosage: 100 Mg, Bid), which was initiated on 201302. Concurrently used drugs:
  • Vicodin
  • Clindamycin
  • Keflex
.After starting to take Colace the consumer reported adverse symptoms, such as: Jaundice, Blood Bilirubin Increased, Transaminases Increased, Pain, Nausea, MalaiseThese side effects may potentially be related to Colace.
Colace Side Effect Report#9100899
Injury, Anxiety, Pain, Emotional Distress, Pain, Abdominal Pain, Pulmonary Embolism
This is a report of a 19-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Colace (dosage: 100 Mg 1 Tablet By Mouth 2 Times A Day, start time: 2008), combined with:
  • Ferrous Sulfate (325 Mg One Tablet By Mouth 2 Times A Day)
  • Yasmin (Unk)
  • Ocella (Unk)
  • Yaz (Unk)
  • Iron
  • Tylenol
  • Miralax (Daily As Needed)
and developed a serious reaction and side effect(s): Injury, Anxiety, Pain, Emotional Distress, Pain, Abdominal Pain, Pulmonary Embolism after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Colace treatment in female patients, resulting in Injury side effect. The patient was hospitalized.
Colace Side Effect Report#8930264
Pneumothorax, Opportunistic Infection, Bronchial Fistula, Lymphopenia
This report suggests a potential Colace Pneumothorax side effect(s) that can have serious consequences. A male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Colace (dosage: Unk) starting
Sep 11, 2009. After starting Colace the patient began experiencing various side effects, including: Pneumothorax, Opportunistic Infection, Bronchial Fistula, LymphopeniaAdditional drugs used concurrently:
  • Bactrim Ds (Unk)
  • Diovan (Unk)
  • Minocycline (Unk)
  • Decadron (dexamethasone) (Unk)
  • Megace (Unk)
  • Temozolomide (200 Mg/m2, Qd)
  • Bevacizumab (10 Mg/kg 1 En 2 Week)
  • Erlotinib Hydrochloride (150 Mg/m2, Qd)
The patient was hospitalized. Although Colace demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pneumothorax, may still occur.
Colace Side Effect Report#8825865
Syncope
This Syncope problem was reported by a consumer or non-health professional from US. A 84-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: constipation. On NS this consumer started treatment with Colace (dosage: 100 Mg, Daily). The following drugs were being taken at the same time:
  • Omeprazole (20 Mg, Unk)
  • Centrum Silver (Unk Unk, Unk)
  • Spironolactone W/hydrochlorothiazide (25 Mg, Daily)
  • Omega 3 (Unk Capsl, Unk)
  • Super B Complex (Unk)
  • Biotin (5000 Mcg, Unk)
  • Caltrate With Vitamin D (600 Unk, Unk)
  • Colon Health Probiotic (Unk Capsl, Unk)
When using Colace, the patient experienced the following unwanted symptoms/side effects: SyncopeAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Syncope, may become evident only after a product is in use by the general population.
Colace Side Effect Report#8535590-0
Malaise
This Malaise side effect was reported by a physician from United States. A 38-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Colace (docusate Sodium) (drug dosage: NA), which was initiated on
Feb 17, 2010. Concurrently used drugs:
  • Clozaril (12.5 Mg, Bid 300 Mg/day 100 Mg/day 300 Mg/day)
  • Prinivil
  • Glucotrol
  • Lamictal
  • Novolog
  • Lopid
  • Inderal La
  • Glucophage
.After starting to take Colace (docusate Sodium) the consumer reported adverse symptoms, such as: MalaiseThese side effects may potentially be related to Colace (docusate Sodium). The patient was hospitalized.
Colace Side Effect Report#8475013-3
Pain, Menstruation Irregular, Anaemia, Injury, Deep Vein Thrombosis, Emotional Distress, Pain In Extremity, Anxiety
This is a report of a 36-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Colace (dosage: 100 Mg, Bid, start time:
Nov 07, 2005), combined with:
  • Feldene (Unk Unk, Bid)
  • Yasmin (Unk)
  • Acetaminophen (2 Tablets, Prn)
  • Doxycycline (100 Mg, Bid)
  • Ferrous Sulfate Tab (325 Mg, Tid)
and developed a serious reaction and side effect(s): Pain, Menstruation Irregular, Anaemia, Injury, Deep Vein Thrombosis, Emotional Distress, Pain In Extremity, Anxiety after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Colace treatment in female patients, resulting in Pain side effect. The patient was hospitalized.
Colace Side Effect Report#8474210-0
Deep Vein Thrombosis
This report suggests a potential Colace Deep Vein Thrombosis side effect(s) that can have serious consequences. A 49-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Colace (dosage: NA) starting
Sep 17, 2007. After starting Colace the patient began experiencing various side effects, including: Deep Vein ThrombosisAdditional drugs used concurrently:
  • Aspirin
  • Cymbalta (Unk)
  • Amerge (Unk)
  • Vitamin Tab
  • Yaz
The patient was hospitalized. Although Colace demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Deep Vein Thrombosis, may still occur.
Colace Side Effect Report#8474062-9
Granulocytopenia
This Granulocytopenia problem was reported by a pharmacist from United States. A 39-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Colace (dosage: NA). The following drugs were being taken at the same time:
  • Lipitor
  • Clonazepam
  • Clozapine
  • Depakote
  • Synthroid
  • Invega
When using Colace, the patient experienced the following unwanted symptoms/side effects: GranulocytopeniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Granulocytopenia, may become evident only after a product is in use by the general population.
Colace Side Effect Report#8473563-7
Granulocytopenia, Leukopenia
This Granulocytopenia side effect was reported by a pharmacist from United States. A 16-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Colace (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Haldol
  • Zyprexa
  • Clozapine
  • Seroquel
.After starting to take Colace the consumer reported adverse symptoms, such as: Granulocytopenia, LeukopeniaThese side effects may potentially be related to Colace.
Colace Side Effect Report#8473223-2
Back Pain, Weight Decreased, Vision Blurred, Nerve Compression, Blood Pressure Increased, Spinal Column Stenosis, Osteoarthritis, Intervertebral Disc Protrusion, Osteoporosis
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: constipation,hypertension,pain,cardiovascular event prophylaxis,rheumatoid arthritis,vitamin supplementation, who was treated with Colace (dosage: NA, start time:
Jan 01, 2011), combined with:
  • Enalapril Maleate
  • Gabapentin
  • Aspirin
  • Methotrexate
  • Vitamin D
  • Senna-mint Waf
  • Humira
  • Zantac
and developed a serious reaction and side effect(s): Back Pain, Weight Decreased, Vision Blurred, Nerve Compression, Blood Pressure Increased, Spinal Column Stenosis, Osteoarthritis, Intervertebral Disc Protrusion, Osteoporosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Colace treatment in female patients, resulting in Back Pain side effect.
Colace Side Effect Report#8471872-9
Urosepsis, Lobar Pneumonia, Blood Creatinine Increased
This report suggests a potential Colace Urosepsis side effect(s) that can have serious consequences. A 70-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: constipation prophylaxis,computerised tomogram,arthralgia,hypertension,pain and used Colace (dosage: Unk) starting
Jul 15, 2011. After starting Colace the patient began experiencing various side effects, including: Urosepsis, Lobar Pneumonia, Blood Creatinine IncreasedAdditional drugs used concurrently:
  • Contrast Media (Unk)
  • Naproxen (Unk)
  • Amlodipine
  • Oxycodone Hcl
  • Miralax (Unk)
  • Finasteride (Unk)
  • Methyl Salicylate (Unk)
  • Sorafenib (raf Kinase Inhibitor) (200 Mg, Bid)
The patient was hospitalized. Although Colace demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Urosepsis, may still occur.
Colace Side Effect Report#8444024-6
Pancytopenia, Multiple Myeloma
This Pancytopenia problem was reported by a physician from United States. A 57-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 21, 2011 this consumer started treatment with Colace (docusate Sodium) (dosage: NA). The following drugs were being taken at the same time:
  • Zofran
  • Acyclovir
  • Revlimid (5 Mg, 1 In 1 D, Po)
  • Velcade
  • Dexamethasone
  • Acetaminophen
  • Phenergan Hcl
  • Celexa
When using Colace (docusate Sodium), the patient experienced the following unwanted symptoms/side effects: Pancytopenia, Multiple MyelomaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pancytopenia, may become evident only after a product is in use by the general population.
Colace Side Effect Report#8443914-8
Pneumonia, Bacteraemia
This Pneumonia side effect was reported by a physician from United States. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Colace (drug dosage: NA), which was initiated on
Aug 06, 2011. Concurrently used drugs:
  • Fluconazole
  • Oxycodone Hcl
  • Treanda
  • Gabapentin
  • Aspirin
  • Treanda
  • Famotidine
  • Valacyclovir Hydrochloride
.After starting to take Colace the consumer reported adverse symptoms, such as: Pneumonia, BacteraemiaThese side effects may potentially be related to Colace. The patient was hospitalized.
Colace Side Effect Report#8431961-1
Nasal Septum Perforation, Nasal Inflammation, Cough, Wound Dehiscence, Sinusitis
This is a report of a 19-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Colace (dosage: NA, start time:
Sep 29, 2009), combined with:
  • Risperdal
  • Zinc Sulfate
  • Rhinocort (32 Mcg Two To Four Puffs Daily)
  • Clonidine
  • Singulair
and developed a serious reaction and side effect(s): Nasal Septum Perforation, Nasal Inflammation, Cough, Wound Dehiscence, Sinusitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Colace treatment in male patients, resulting in Nasal Septum Perforation side effect.
Colace Side Effect Report#8429933-6
Dehydration, Dizziness
This report suggests a potential Colace (docusate Sodium) Dehydration side effect(s) that can have serious consequences. A 76-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Colace (docusate Sodium) (dosage: NA) starting
Oct 19, 2011. After starting Colace (docusate Sodium) the patient began experiencing various side effects, including: Dehydration, DizzinessAdditional drugs used concurrently:
  • Revlimid (10 Mg, Qd X 28d, Po)
  • Emend
  • Pantoprazole
  • Aspirin
  • Azilect
  • Metoprolol Tartrate
  • Simvastatin
The patient was hospitalized. Although Colace (docusate Sodium) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dehydration, may still occur.
Colace Side Effect Report#8420056-9
Dehydration, Abdominal Pain, Asthenia, Gastrointestinal Motility Disorder, Diarrhoea
This Dehydration problem was reported by a consumer or non-health professional from United States. A 42-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: constipation. On
Apr 20, 2012 this consumer started treatment with Colace Capsules (dosage: 1 Capsule, One Time). The following drugs were being taken at the same time: NA. When using Colace Capsules, the patient experienced the following unwanted symptoms/side effects: Dehydration, Abdominal Pain, Asthenia, Gastrointestinal Motility Disorder, DiarrhoeaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dehydration, may become evident only after a product is in use by the general population.
Colace Side Effect Report#8412360-5
Colon Cancer
This Colon Cancer side effect was reported by a consumer or non-health professional from United States. A 58-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Colace (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Dexamethasone
  • Hydrochlorothiazide
  • Compazine
  • Cymbalta (60 Mg, Qd)
  • Benadryl
  • Prilosec
  • Clonazepam
  • Remeron
.After starting to take Colace the consumer reported adverse symptoms, such as: Colon CancerThese side effects may potentially be related to Colace.
Colace Side Effect Report#8398218-9
Palpitations, Dyspnoea, Anxiety
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Colace (dosage: NA, start time:
Jun 20, 2011), combined with:
  • Senokot
  • Gilenya (5 Mg, Qd)
  • Lotrel
  • Detrol
  • Rebif
  • Zofran
  • Dulcolax
  • Keflex
and developed a serious reaction and side effect(s): Palpitations, Dyspnoea, Anxiety after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Colace treatment in female patients, resulting in Palpitations side effect. The patient was hospitalized.
Colace Side Effect Report#8392940-6
Pneumonia, Pyrexia
This report suggests a potential Colace (docusate Sodium) Pneumonia side effect(s) that can have serious consequences. A 85-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Colace (docusate Sodium) (dosage: NA) starting
Jun 15, 2009. After starting Colace (docusate Sodium) the patient began experiencing various side effects, including: Pneumonia, PyrexiaAdditional drugs used concurrently:
  • Potassium Chloride
  • Aranesp
  • Calcium Carbonate
  • Glipizide
  • Revlimid (25 Mg, X 21 Days/7 Days Off, Po ; 10 Mg, Daily X 21 Days/7 Dyas Off)
  • Revlimid (25 Mg, X 21 Days/7 Days Off, Po ; 10 Mg, Daily X 21 Days/7 Dyas Off)
  • Prilosec
  • Lipitor
The patient was hospitalized. Although Colace (docusate Sodium) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pneumonia, may still occur.
Colace Side Effect Report#8390341-8
Hypotension, Lobar Pneumonia, Pleural Effusion, Chest Pain, Pain
This Hypotension problem was reported by a physician from United States. A 44-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Colace (dosage: NA). The following drugs were being taken at the same time:
  • Zofran
  • Guaifenesin
  • Vidaza
  • Acetaminophen And Oxycodone Hcl
  • Ibuprofen
  • Enoxaparin
  • Morphine Sulfate
  • Senna-mint Waf
When using Colace, the patient experienced the following unwanted symptoms/side effects: Hypotension, Lobar Pneumonia, Pleural Effusion, Chest Pain, PainThe 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 Hypotension, may become evident only after a product is in use by the general population.
Colace Side Effect Report#8381928-7
Hyperhidrosis, Dyspnoea, Withdrawal Syndrome, Muscle Twitching, Chest Pain, Infusion Related Reaction
This Hyperhidrosis side effect was reported by a health professional from Canada. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Colace (drug dosage: NA), which was initiated on
May 09, 2012. Concurrently used drugs:
  • Imovane
  • Diovan
  • Remicade (7.5 Mg/kg)
  • Fentanyl-100
  • Narcotic Analgesics, Nos
  • Remicade
  • Pantoprazole
  • Tylenol W/ Codeine No. 3
.After starting to take Colace the consumer reported adverse symptoms, such as: Hyperhidrosis, Dyspnoea, Withdrawal Syndrome, Muscle Twitching, Chest Pain, Infusion Related ReactionThese side effects may potentially be related to Colace. The patient was hospitalized.
Colace Side Effect Report#8381047-X
Arthralgia, Headache, Blood Pressure Increased, Pulmonary Embolism, Haematoma, Nerve Injury, Deep Vein Thrombosis, Fall, Influenza Immunisation
This is a report of a 53-year-old female patient (weight: NA) from Canada, suffering from the following health symptoms/conditions: NA, who was treated with Colace (dosage: NA, start time:
Jul 13, 2011), combined with:
  • Symicort
  • Daxas
  • Euro-senna
  • Pantoloc /01263201/
  • Ativan
  • Lasix
  • Effexor
  • Coumadin
and developed a serious reaction and side effect(s): Arthralgia, Headache, Blood Pressure Increased, Pulmonary Embolism, Haematoma, Nerve Injury, Deep Vein Thrombosis, Fall, Influenza Immunisation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Colace treatment in female patients, resulting in Arthralgia side effect. The patient was hospitalized and became disabled.


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The appearance of Colace 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 Colace Side Effects for Women?

Women Side EffectsReports
Pain 10
Fall 9
Nausea 9
Diarrhoea 8
Pneumonia 8
Chest Pain 7
Dyspnoea 7
Abdominal Pain 6
Anxiety 6
Deep Vein Thrombosis 6

What are common Colace Side Effects for Men?

Men Side EffectsReports
Chest Pain 5
Dehydration 5
Renal Failure 5
Confusional State 4
Granulocytopenia 4
Vomiting 4
Abdominal Pain 3
Anaemia 3
Anxiety 3
Asthenia 3

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Why Your Notes are Important

Your notes could be helpful in several ways:

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  • 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.

    Colace 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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    Colace Safety Alerts, Active Ingredients, Usage Information

    NDC54868-2337
    TypeHUMAN OTC DRUG
    Proprietary NameColace
    Namedocusate sodium
    Dosage FormCAPSULE
    RouteORAL
    On market since20111108
    LabelerPhysicians Total Care, Inc.
    Active Ingredient(s)DOCUSATE SODIUM
    Strength(s)100
    Unit(s)mg/1
    Pharma Class

    More About Colace

    Side Effects reported to FDA: 179

    Colace safety alerts: No

    Reported deaths: 18

    Reported hospitalizations: 83

    Latest Colace clinical trials