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Combaren Side Effects

Common Combaren Side Effects


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

Anorexia (5)
Dyspnoea (5)
Dysphagia (5)
Cardio-respiratory Arrest (5)
Brain Oedema (4)
Acute Myocardial Infarction (4)
Lethargy (4)
Hydrothorax (3)
Rectal Cancer (2)
Decreased Appetite (1)
Feeling Abnormal (1)
Vomiting (1)
Gait Disturbance (1)
Brain Herniation (1)
Thrombosis (1)
Respiratory Rate Decreased (1)
Rapid Correction Of Hyponatraemia (1)
Pain (1)
Joint Swelling (1)


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.

Combaren Side Effects Reported to FDA

The following Combaren 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 Combaren 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.
Rectal Cancer
This is a report of a 67-year-old male patient (weight: NA) from VENEZUELA, suffering from the following symptoms/conditions: NA, who was treated with Combaren (dosage: 50 Mg, 3x/day, start time: Jan 01, 2004), combined with:
  • Sitagliptin (100 Mg, 1x/day)
  • Morphine (5 Ml, 3x/day)
  • Hyperlipen (100 Mg, 1x/day)
  • Lipitor (40 Mg, 1x/day)
  • Glafornil (500 Mg, 1x/day)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Rectal Cancer
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Combaren treatment in male patients, resulting in rectal cancer side effect.

Rectal Cancer
This report suggests a potential Combaren Rectal Cancer side effect(s) that can have serious consequences. A 67-year-old male patient (weight: NA) from VENEZUELA was diagnosed with the following symptoms/conditions: NA and used Combaren (dosage: 50 Mg, 3x/day) starting Jan 01, 2008. Soon after starting Combaren the patient began experiencing various side effects, including:
  • Rectal Cancer
Drugs used concurrently:
  • Morphine (5 Ml, 3x/day)
  • Glafornil (500 Mg, 1x/day)
  • Hyperlipen (100 Mg, 1x/day)
  • Sitagliptin (100 Mg, 1x/day)
  • Lipitor (40 Mg, 1x/day)
Although Combaren demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as rectal cancer, may still occur.

Rapid Correction Of Hyponatraemia
This Rapid Correction Of Hyponatraemia problem was reported by a physician from GERMANY. A 66-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Feb 10, 2011 this consumer started treatment with Combaren (codeine Phosphate, Diclofenac Sodium) (dosage: NA). The following drugs were being taken at the same time:
  • Remergil (mirtazapine)
  • Samsca (15 Mg Milligram(s), Single, Oral)
When commencing Combaren (codeine Phosphate, Diclofenac Sodium), the patient experienced the following unwanted symptoms/side effects:
  • Rapid Correction Of Hyponatraemia
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 rapid correction of hyponatraemia, may become evident only after a product is in use by the general population.

Feeling Abnormal, Gait Disturbance, Joint Swelling, Pain, Thrombosis, Vomiting
This is a report of a 50-year-old male patient (weight: NA) from BRAZIL. The patient developed the following symptoms/conditions: oedema peripheral,pain and was treated with Combaren T30087+fctab (dosage: 50 Mg, Q8h) starting Oct 28, 2007. Concurrently used drugs:
  • Dipyrone (Unk, Once/single)
Soon after that, the consumer experienced the following side effects:
  • Feeling Abnormal
  • Gait Disturbance
  • Joint Swelling
  • Pain
  • Thrombosis
  • Vomiting
This opens a possibility that Combaren T30087+fctab treatment could cause the above reactions, including feeling abnormal, and some male subjects may be more susceptible.


Acute Myocardial Infarction, Anorexia, Brain Oedema, Cardio-respiratory Arrest, Dysphagia, Dyspnoea, Hydrothorax, Lethargy
A 73-year-old male patient (weight: NA) from VENEZUELA with the following symptoms/conditions: procedural pain,postoperative care started Combaren treatment (dosage: 1 Df, Q8h) on May 09, 2006. Soon after starting Combaren treatment, the subject experienced various side effects, including:
  • Acute Myocardial Infarction
  • Anorexia
  • Brain Oedema
  • Cardio-respiratory Arrest
  • Dysphagia
  • Dyspnoea
  • Hydrothorax
  • Lethargy
Concurrently used drugs:
  • Cepotril
  • Cefadroxil
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Combaren.

Acute Myocardial Infarction, Anorexia, Brain Oedema, Cardio-respiratory Arrest, Dysphagia, Dyspnoea, Hydrothorax, Lethargy
A 73-year-old male patient from VENEZUELA (weight: NA) experienced symptoms, such as: procedural pain,postoperative care and was treated with Combaren(dosage: 1 Df, Q8h). The treatment was initiated on May 09, 2006. After that a consumer reported the following side effect(s):
  • Acute Myocardial Infarction
  • Anorexia
  • Brain Oedema
  • Cardio-respiratory Arrest
  • Dysphagia
  • Dyspnoea
  • Hydrothorax
  • Lethargy
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Combaren efficacy:
  • Cepotril
  • Cefadroxil
The patient was hospitalized.

Acute Myocardial Infarction, Anorexia, Brain Oedema, Cardio-respiratory Arrest, Dysphagia, Dyspnoea, Hydrothorax, Lethargy
In this report, Combaren was administered for the following condition: procedural pain,postoperative care.A 73-year-old male consumer from VENEZUELA (weight: NA) started Combaren treatment (dosage: 1 Df, Q8h) on May 09, 2006.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Acute Myocardial Infarction
  • Anorexia
  • Brain Oedema
  • Cardio-respiratory Arrest
  • Dysphagia
  • Dyspnoea
  • Hydrothorax
  • Lethargy
A possible interaction with other drugs could have contributed to this reaction:
  • Cepotril
  • Cefadroxil
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 Combaren treatment could be related to the listed above side effect(s).

Acute Myocardial Infarction, Anorexia, Brain Herniation, Brain Oedema, Cardio-respiratory Arrest, Decreased Appetite, Dysphagia, Dyspnoea
This is a report of the following Combaren side effect(s):
  • Acute Myocardial Infarction
  • Anorexia
  • Brain Herniation
  • Brain Oedema
  • Cardio-respiratory Arrest
  • Decreased Appetite
  • Dysphagia
  • Dyspnoea
A 73-year-old male patient from VENEZUELA (weight: NA) presented with the following condition: procedural pain,postoperative care and received a treatment with Combaren (dosage: 1 Df, Q8h) starting: May 09, 2006.The following concurrently used drugs could have generated interactions:
  • Cepotril
  • Cefadroxil
The patient was hospitalized.This report suggests that a Combaren treatment could be associated with the listed above side effect(s).

Anorexia, Cardio-respiratory Arrest, Dysphagia, Dyspnoea, Lethargy, Respiratory Rate Decreased
This Combaren report was submitted by a 73-year-old male consumer from VENEZUELA (weight: NA). The patient was diagnosed with: procedural pain,postoperative care and Combaren was administered (dosage: 1 Df, Q8h) starting: May 09, 2006. The consumer developed a set of symptoms:
  • Anorexia
  • Cardio-respiratory Arrest
  • Dysphagia
  • Dyspnoea
  • Lethargy
  • Respiratory Rate Decreased
Other drugs used simultaneously:
  • Cepotril
The patient was hospitalized.Those unexpected symptoms could be linked to a Combaren treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.



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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.


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    Combaren Safety Alerts, Active Ingredients, Usage Information

    More About Combaren

    Side Effects reported to FDA: 9

    Combaren safety alerts: No

    Reported deaths: 5

    Reported hospitalizations: 5

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