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Colace Side Effects

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.

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.

Colace Side Effects Reported to FDA

The following 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.


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.
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 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). The consumer presented with:
  • Anaphylactic Reaction
  • Rash
  • Throat Tightness
  • Dyspnoea
  • Reaction To Colouring
which developed 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.

Fall, Joint Injury, Medical Device Complication, Shoulder Operation, Shoulder Arthroplasty, Frequent Bowel Movements, Constipation
This report suggests a potential Colace Fall, Joint Injury, Medical Device Complication, Shoulder Operation, Shoulder Arthroplasty, Frequent Bowel Movements, Constipation 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. Soon after starting Colace the patient began experiencing various side effects, including:
  • Fall
  • Joint Injury
  • Medical Device Complication
  • Shoulder Operation
  • Shoulder Arthroplasty
  • Frequent Bowel Movements
  • Constipation
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.

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 commencing Colace, the patient experienced the following unwanted symptoms/side effects:
  • Granulocytopenia
Although 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.

Jaundice, Blood Bilirubin Increased, Transaminases Increased, Pain, Nausea, Malaise
This is a report of a 36-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: diarrhoea and was treated with Colace (dosage: 100 Mg, Bid) starting 201302. Concurrently used drugs:
  • Vicodin
  • Clindamycin
  • Keflex
Soon after that, the consumer experienced the following side effects:
  • Jaundice
  • Blood Bilirubin Increased
  • Transaminases Increased
  • Pain
  • Nausea
  • Malaise
This opens a possibility that Colace treatment could cause the above reactions, including jaundice, and some female subjects may be more susceptible.


Injury, Anxiety, Pain, Emotional Distress, Abdominal Pain, Pulmonary Embolism
A 19-year-old female patient (weight: NA) from US with the following symptoms/conditions: NA started Colace treatment (dosage: 100 Mg 1 Tablet By Mouth 2 Times A Day) on 2008. Soon after starting Colace treatment, the subject experienced various side effects, including:
  • Injury
  • Anxiety
  • Pain
  • Emotional Distress
  • Abdominal Pain
  • Pulmonary Embolism
Concurrently used drugs:
  • Ferrous Sulfate (325 Mg One Tablet By Mouth 2 Times A Day)
  • Yasmin (Unk)
  • Ocella (Unk)
  • Yaz (Unk)
  • Iron
  • Tylenol
  • Miralax (Daily As Needed)
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Colace.

Pneumothorax, Opportunistic Infection, Bronchial Fistula, Lymphopenia
A male patient from US (weight: NA) experienced symptoms, such as: NA and was treated with Colace(dosage: Unk). The treatment was initiated on Sep 11, 2009. After that a consumer reported the following side effect(s):
  • Pneumothorax
  • Opportunistic Infection
  • Bronchial Fistula
  • Lymphopenia
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Colace efficacy:
  • 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.

Syncope
In this report, Colace was administered for the following condition: constipation.A 84-year-old female consumer from US (weight: NA) started Colace treatment (dosage: 100 Mg, Daily) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Syncope
A possible interaction with other drugs could have contributed to this reaction:
  • 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)
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Colace treatment could be related to the listed above side effect(s).

Malaise
This is a report of the following Colace (docusate Sodium) side effect(s):
  • Malaise
A 38-year-old male patient from UNITED STATES (weight: NA) presented with the following condition: NA and received a treatment with Colace (docusate Sodium) (dosage: NA) starting: Feb 17, 2010.The following concurrently used drugs could have generated interactions:
  • Clozaril (12.5 Mg, Bid 300 Mg/day 100 Mg/day 300 Mg/day)
  • Prinivil
  • Glucotrol
  • Lamictal
  • Novolog
  • Lopid
  • Inderal La
  • Glucophage
The patient was hospitalized.This report suggests that a Colace (docusate Sodium) treatment could be associated with the listed above side effect(s).

Pain, Menstruation Irregular, Anaemia, Injury, Deep Vein Thrombosis, Emotional Distress, Pain In Extremity, Anxiety
This Colace report was submitted by a 36-year-old female consumer from UNITED STATES (weight: NA). The patient was diagnosed with: NA and Colace was administered (dosage: 100 Mg, Bid) starting: Nov 07, 2005. The consumer developed a set of symptoms:
  • Pain
  • Menstruation Irregular
  • Anaemia
  • Injury
  • Deep Vein Thrombosis
  • Emotional Distress
  • Pain In Extremity
  • Anxiety
Other drugs used simultaneously:
  • Feldene (Unk Unk, Bid)
  • Yasmin (Unk)
  • Acetaminophen (2 Tablets, Prn)
  • Doxycycline (100 Mg, Bid)
  • Ferrous Sulfate Tab (325 Mg, Tid)
The patient was hospitalized.Those unexpected symptoms could be linked to a Colace treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Deep Vein Thrombosis
This is a report of a possible correlation between Colace use and the following symptoms/side effect(s):
  • Deep Vein Thrombosis
which could contribute to an assessment of Colace risk profile.A 49-year-old female consumer from UNITED STATES (weight: NA) was suffering from NA and was treated with Colace (dosage: NA) starting Sep 17, 2007.Other concurrent medications:
  • Aspirin
  • Cymbalta (Unk)
  • Amerge (Unk)
  • Vitamin Tab
  • Yaz
The patient was hospitalized.

Granulocytopenia
A 39-year-old male patient from UNITED STATES (weight: NA) presented with the following symptoms: NA and after a treatment with Colace (dosage: NA) experienced the following side effect(s):
  • Granulocytopenia
The treatment was started on NS. Colace was used in combination with the following drugs:
  • Lipitor
  • Clonazepam
  • Clozapine
  • Depakote
  • Synthroid
  • Invega
This report could alert potential Colace consumers.

Granulocytopenia, Leukopenia
In this report, a 16-year-old male patient from UNITED STATES (weight: NA) was affected by a possible Colace side effect.The patient was diagnosed with NA. After a treatment with Colace (dosage: NA, start date: NS), the patient experienced the following side effect(s):
  • Granulocytopenia
  • Leukopenia
The following simultaneously used drugs could have led to this reaction:
  • Haldol
  • Zyprexa
  • Clozapine
  • Seroquel
The findings here stress that side effects should be taken into consideration when evaluating a Colace treatment.

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 from UNITED STATES (weight: NA), who used Colace (dosage: NA) for a treatment of constipation,hypertension,pain,cardiovascular event prophylaxis,rheumatoid arthritis,vitamin supplementation. After starting a treatment on Jan 01, 2011, the patient experienced the following side effect(s):
  • Back Pain
  • Weight Decreased
  • Vision Blurred
  • Nerve Compression
  • Blood Pressure Increased
  • Spinal Column Stenosis
  • Osteoarthritis
  • Intervertebral Disc Protrusion
  • Osteoporosis
The following drugs could possibly have interacted with the Colace treatment
  • Enalapril Maleate
  • Gabapentin
  • Aspirin
  • Methotrexate
  • Vitamin D
  • Senna-mint Waf
  • Humira
  • Zantac
Taken together, these observations suggest that a Colace treatment could be related to side effect(s), such as Back Pain, Weight Decreased, Vision Blurred, Nerve Compression, Blood Pressure Increased, Spinal Column Stenosis, Osteoarthritis, Intervertebral Disc Protrusion, Osteoporosis.

Urosepsis, Lobar Pneumonia, Blood Creatinine Increased
This urosepsis side effect was reported by a physician from UNITED STATES. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: constipation prophylaxis,computerised tomogram,arthralgia,hypertension,pain. The patient was prescribed Colace (dosage: Unk), which was started on Jul 15, 2011. Concurrently used drugs:
  • Contrast Media (Unk)
  • Naproxen (Unk)
  • Amlodipine
  • Oxycodone Hcl
  • Miralax (Unk)
  • Finasteride (Unk)
  • Methyl Salicylate (Unk)
  • Sorafenib (raf Kinase Inhibitor) (200 Mg, Bid)
When starting to take Colace the consumer reported the following symptoms:
  • Urosepsis
  • Lobar Pneumonia
  • Blood Creatinine Increased
The patient was hospitalized. These side effects may potentially be related to Colace.

Pancytopenia, Multiple Myeloma
This is a Colace (docusate Sodium) side effect report of a 57-year-old male patient (weight:NA) from UNITED STATES, suffering from the following symptoms/conditions: NA, who was treated with Colace (docusate Sodium) (dosage:NA, start time: Jan 21, 2011), combined with:
  • Zofran
  • Acyclovir
  • Revlimid (5 Mg, 1 In 1 D, Po)
  • Velcade
  • Dexamethasone
  • Acetaminophen
  • Phenergan Hcl
  • Celexa
, and developed a serious reaction and a pancytopenia side effect. The patient presented with:
  • Pancytopenia
  • Multiple Myeloma
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Colace (docusate Sodium) treatment in male patients suffering from NA, resulting in pancytopenia.

Pneumonia, Bacteraemia
This report suggests a potential Colace pneumonia side effect(s) that can have serious consequences. A male patient from UNITED STATES (weight:NA) was diagnosed with the following health condition(s): NA and used Colace (dosage: NA) starting Aug 06, 2011. Soon after starting Colace the patient began experiencing various side effects, including:
  • Pneumonia
  • Bacteraemia
Drugs used concurrently:
  • Fluconazole
  • Oxycodone Hcl
  • Treanda
  • Gabapentin
  • Aspirin
  • Treanda
  • Famotidine
  • Valacyclovir Hydrochloride
The patient was hospitalized. Although Colace demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as pneumonia, may still occur.

Nasal Septum Perforation, Nasal Inflammation, Cough, Wound Dehiscence, Sinusitis
This nasal septum perforation problem was reported by a consumer or non-health professional from UNITED STATES. A 19-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): NA.On Sep 29, 2009 a consumer started treatment with Colace (dosage: NA). The following drugs/medications were being taken at the same time:
  • Risperdal
  • Zinc Sulfate
  • Rhinocort (32 Mcg Two To Four Puffs Daily)
  • Clonidine
  • Singulair
When commencing Colace, the patient experienced the following unwanted symptoms /side effects:
  • Nasal Septum Perforation
  • Nasal Inflammation
  • Cough
  • Wound Dehiscence
  • Sinusitis
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as nasal septum perforation, may become evident only after a product is in use by the general population.

Dehydration, Dizziness
This is a Colace (docusate Sodium) side effect report of a 76-year-old male patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Colace (docusate Sodium) (dosage: NA) starting Oct 19, 2011. Concurrently used drugs:
  • Revlimid (10 Mg, Qd X 28d, Po)
  • Emend
  • Pantoprazole
  • Aspirin
  • Azilect
  • Metoprolol Tartrate
  • Simvastatin
Soon after that, the consumer experienced the following of symptoms:
  • Dehydration
  • Dizziness
The patient was hospitalized. This opens a possibility that Colace (docusate Sodium) could cause dehydration and that some male patients may be more susceptible.

Dehydration, Abdominal Pain, Asthenia, Gastrointestinal Motility Disorder, Diarrhoea
A 42-year-old female patient (weight: NA) from UNITED STATES with the following symptoms: constipation started Colace Capsules treatment (dosage: 1 Capsule, One Time) on Apr 20, 2012. Soon after starting Colace Capsules treatment, the consumer experienced several side effects, including:
  • Dehydration
  • Abdominal Pain
  • Asthenia
  • Gastrointestinal Motility Disorder
  • Diarrhoea
. Concurrently used drugs: NA. This finding indicates that some patients can be more vulnerable to developing Colace Capsules side effects, such as dehydration.

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 (dosage: NA), which was started on NS. Concurrently used drugs:
  • Dexamethasone
  • Hydrochlorothiazide
  • Compazine
  • Cymbalta (60 Mg, Qd)
  • Benadryl
  • Prilosec
  • Clonazepam
  • Remeron
.When starting to take Colace the consumer reported symptoms, such as:
  • Colon Cancer
These side effects may potentially be related to Colace.

Palpitations, Dyspnoea, Anxiety
This is a report of a female patient (weight: NA) from UNITED STATES, suffering from the following 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). The consumer presented with:
  • Palpitations
  • Dyspnoea
  • Anxiety
which developed 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.

Pneumonia, Pyrexia
This report suggests a potential Colace (docusate Sodium) Pneumonia, Pyrexia 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. Soon after starting Colace (docusate Sodium) the patient began experiencing various side effects, including:
  • Pneumonia
  • Pyrexia
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.

Hypotension, Lobar Pneumonia, Pleural Effusion, Chest Pain
This Hypotension, Lobar Pneumonia, Pleural Effusion, Chest Pain 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 commencing Colace, the patient experienced the following unwanted symptoms/side effects:
  • Hypotension
  • Lobar Pneumonia
  • Pleural Effusion
  • Chest Pain
The 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.

Hyperhidrosis, Dyspnoea, Withdrawal Syndrome, Muscle Twitching, Chest Pain, Infusion Related Reaction
This is a report of a male patient (weight: NA) from CANADA. The patient developed the following symptoms/conditions: NA and was treated with Colace (dosage: NA) starting 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
Soon after that, the consumer experienced the following side effects:
  • Hyperhidrosis
  • Dyspnoea
  • Withdrawal Syndrome
  • Muscle Twitching
  • Chest Pain
  • Infusion Related Reaction
The patient was hospitalized. This opens a possibility that Colace treatment could cause the above reactions, including hyperhidrosis, and some male subjects may be more susceptible.

Arthralgia, Headache, Blood Pressure Increased, Pulmonary Embolism, Haematoma, Nerve Injury, Deep Vein Thrombosis, Fall, Influenza Immunisation
A 53-year-old female patient (weight: NA) from CANADA with the following symptoms/conditions: NA started Colace treatment (dosage: NA) on Jul 13, 2011. Soon after starting Colace treatment, the subject experienced various side effects, including:
  • Arthralgia
  • Headache
  • Blood Pressure Increased
  • Pulmonary Embolism
  • Haematoma
  • Nerve Injury
  • Deep Vein Thrombosis
  • Fall
  • Influenza Immunisation
Concurrently used drugs:
  • Symicort
  • Daxas
  • Euro-senna
  • Pantoloc /01263201/
  • Ativan
  • Lasix
  • Effexor
  • Coumadin
The patient was hospitalized and became disabled. This finding indicates that some female patients could be more vulnerable to Colace.

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Top 10 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

Top 10 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

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 Colace Side Effects

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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