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Dafalgan Side Effects

Common Dafalgan Side Effects


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

Hepatitis (5)
Renal Failure Acute (5)
Blood Alkaline Phosphatase Increased (4)
Fall (4)
Gamma-glutamyltransferase Increased (4)
Vomiting (4)
Renal Failure (4)
Haematoma (4)
Alanine Aminotransferase Increased (3)
Agitation (3)
Aspartate Aminotransferase Increased (3)
Diarrhoea (3)
Cytolytic Hepatitis (3)
Overdose (3)
Hypotension (2)
Hypothyroidism (2)
Hypokalaemia (2)
Sepsis (2)
Pneumonia (2)
Hypocalcaemia (2)

➢ 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.

Dafalgan Side Effects Reported to FDA

The following Dafalgan 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 Dafalgan 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.
Pancreatic Carcinoma Metastatic
This is a report of a 72-year-old female patient (weight: NA) from FR, suffering from the following symptoms/conditions: NA, who was treated with Dafalgan Tabs 1 Gm (dosage: NA, start time: Jun 22, 2013), combined with:
  • Metformin Hcl
  • Janumet (Janumet 50mg/1000mg,film-coated Tab.)
  • Repaglinide
  • Loxen Lp (50 Mg, Extended-release Caps.?1df= 1 Caps.)
  • Diffu-k (Caps)
  • Lasilix
  • Celiprolol Hcl
  • Allopurinol
and developed a serious reaction and side effect(s). The consumer presented with:
  • Pancreatic Carcinoma Metastatic
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dafalgan Tabs 1 Gm treatment in female patients, resulting in pancreatic carcinoma metastatic side effect.

Vomiting, Abdominal Pain, Overdose
This report suggests a potential Dafalgan Oral Vomiting, Abdominal Pain, Overdose side effect(s) that can have serious consequences. A 26-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: toothache and used Dafalgan Oral (dosage: 1 Single Intake) starting Oct 05, 2013. Soon after starting Dafalgan Oral the patient began experiencing various side effects, including:
  • Vomiting
  • Abdominal Pain
  • Overdose
Drugs used concurrently:
  • Efferalgan (1 Single Intake)
  • Baraclude Tabs 1.0 Mg (1df= 1 Tablet.?1 Single Intake)
Although Dafalgan Oral demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as vomiting, may still occur.

Confusional State
This Confusional State problem was reported by a consumer or non-health professional from FR. A 88-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On May 12, 2013 this consumer started treatment with Dafalgan Codeine Tabs (dosage: 1df:1 Tabs? Film Coated Tabs). The following drugs were being taken at the same time:
  • Metformin Hcl
  • Zolpidem
  • Atacand (Scored Tablet)
  • Mono-tildiem
  • Januvia
  • Inexium (Gastro-resistant Tablet)
  • Furadantine
When commencing Dafalgan Codeine Tabs, the patient experienced the following unwanted symptoms/side effects:
  • Confusional State
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 confusional state, may become evident only after a product is in use by the general population.

Hepatic Enzyme Increased, Pneumonia
This is a report of a 59-year-old female patient (weight: NA) from CH. The patient developed the following symptoms/conditions: pain,psychotic disorder,tachycardia,pneumonia bacterial,hypothyroidism,embolism arterial,thrombosis,constipation and was treated with Dafalgan (dosage: NA) starting 201303. Concurrently used drugs:
  • Abilify
  • Beloc-zok
  • Co-amoxicillin
  • Euthyrox
  • Clexane
  • Clexane
  • Laxoberon
  • Quetiapine
Soon after that, the consumer experienced the following side effects:
  • Hepatic Enzyme Increased
  • Pneumonia
The patient was hospitalized. This opens a possibility that Dafalgan treatment could cause the above reactions, including hepatic enzyme increased, and some female subjects may be more susceptible.


Haematoma, International Normalised Ratio Increased, Fall, Pain, Atrial Fibrillation
A 85-year-old male patient (weight: NA) from FRANCE with the following symptoms/conditions: pain started Dafalgan Codeine (panadeine Co) (coated Tablet) (paracetamol, Codeine) treatment (dosage: 6 Df (6 Df, 1 In 1 D)) on Jan 31, 2012. Soon after starting Dafalgan Codeine (panadeine Co) (coated Tablet) (paracetamol, Codeine) treatment, the subject experienced various side effects, including:
  • Haematoma
  • International Normalised Ratio Increased
  • Fall
  • Pain
  • Atrial Fibrillation
Concurrently used drugs:
  • Nitriderm (lyceryl Trinitrate)
  • Levothyroxine Sodium (1 Df (1 Df, 1 In 1 D))
  • Furosemide
  • Gaviscon
  • Previscan (fluindione) (fluindione) (1.25 Or 1.5 One In Two Days)
  • Crestor (1 Df (1 Df, 1 In 1 D))
  • Bisoprolol Fumarate
  • Repaglinide
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Dafalgan Codeine (panadeine Co) (coated Tablet) (paracetamol, Codeine).

Fall, Skull Fractured Base, Haemorrhage, International Normalised Ratio Increased
A 94-year-old male patient from FRANCE (weight: NA) experienced symptoms, such as: NA and was treated with Dafalgan Caps 500 Mg(dosage: 1 Df: 2 Capsules). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Fall
  • Skull Fractured Base
  • Haemorrhage
  • International Normalised Ratio Increased
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Dafalgan Caps 500 Mg efficacy:
  • Rabeprazole Sodium (Gastro-resistant Tablet)
  • Bisoprolol Fumarate (Film-coated Tablet)
  • Coumadin (1df: 0.5 Df)
The patient was hospitalized.

Lumbar Spinal Stenosis, Haematoma
In this report, Dafalgan Codeine was administered for the following condition: NA.A male consumer from BELGIUM (weight: NA) started Dafalgan Codeine treatment (dosage: NA) on Nov 01, 2006.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Lumbar Spinal Stenosis
  • Haematoma
A possible interaction with other drugs could have contributed to this reaction:
  • Diclofenac Sodium
  • Lipitor
  • Tramadol Hcl
  • Methotrexate
  • Golimumab
  • Methotrexate
  • Golimumab
  • Xenical
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 Dafalgan Codeine treatment could be related to the listed above side effect(s).

Hyperhidrosis, Tachycardia, Pain In Extremity, Loss Of Consciousness, Hypotension, Hyperthermia
This is a report of the following Dafalgan Codein (panadeine Co) (tablets) (panadeine Co) side effect(s):
  • Hyperhidrosis
  • Tachycardia
  • Pain In Extremity
  • Loss Of Consciousness
  • Hypotension
  • Hyperthermia
A 45-year-old male patient from DENMARK (weight: NA) presented with the following condition: NA and received a treatment with Dafalgan Codein (panadeine Co) (tablets) (panadeine Co) (dosage: NA) starting: May 11, 2011.The following concurrently used drugs could have generated interactions:
  • Escitalopram (20 Mg (10 Mg, 2 In 1 D), Oral)
  • Lexomil (bromazepam) (tablets) (bromazepam)
  • Tercian (cyamemazine) (cyamemazine)
  • Tramadol Hydrochloride (300 Mg (150 Mg, 2 In 1 D), Oral)
  • Xylocaine Visqueus (xylocain Viscos /02029501/) (gel) (xylocain Viscos
This report suggests that a Dafalgan Codein (panadeine Co) (tablets) (panadeine Co) treatment could be associated with the listed above side effect(s).

Fall, Dermatitis Allergic, Femoral Neck Fracture, Renal Failure Acute, Rash Erythematous
This Dafalgan (paracetamol, Codeine Phosphate) (tablets) (paracetamol, Code report was submitted by a 94-year-old female consumer from GERMANY (weight: NA). The patient was diagnosed with: NA and Dafalgan (paracetamol, Codeine Phosphate) (tablets) (paracetamol, Code was administered (dosage: NA) starting: Dec 23, 2010. The consumer developed a set of symptoms:
  • Fall
  • Dermatitis Allergic
  • Femoral Neck Fracture
  • Renal Failure Acute
  • Rash Erythematous
Other drugs used simultaneously:
  • Furosemide
  • Memantine
  • Memantine (10 Mg (10 Mg, 1 In 1 D), Oral; 5 Mg (5 Mg, 1 In 1 D), Oral)
  • Memantine (10 Mg (10 Mg, 1 In 1 D), Oral; 5 Mg (5 Mg, 1 In 1 D), Oral)
  • Cefuroxime (3000 Mg (1500 Mg, 2 In 1 D), Intravenous (not Otherwise Specified))
  • Levothyroxine Sodium (100 Microgram (100 Mcg, 1 In 1 D) Long Term Treatment-)
  • Aspirin Cardio (acetylsalicylic Acid) (tablets) (acetylsalicylic Acid)
  • Torsemide (10 Mg (10 Mg, 1 In 1 D); 25 Mg (25 Mg, 1 In 1 D))
The patient was hospitalized.Those unexpected symptoms could be linked to a Dafalgan (paracetamol, Codeine Phosphate) (tablets) (paracetamol, Code treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Chest Discomfort
This is a report of a possible correlation between Dafalgan use and the following symptoms/side effect(s):
  • Chest Discomfort
which could contribute to an assessment of Dafalgan risk profile.A 48-year-old female consumer from FRANCE (weight: NA) was suffering from pain,spondylitis and was treated with Dafalgan (dosage: 1 G, As Needed) starting Jul 01, 2007.Other concurrent medications:
  • Sulfasalazine (1000 Mg, 2x/day)
  • Trileptal (150 Mg, 3x/day)
  • Laroxyl (25 Mg (1 Df), 1x/day)
  • Levothyroxine Sodium (25 Ug (1 Df), 1x/day)


Chest Discomfort
A 48-year-old female patient from FRANCE (weight: NA) presented with the following symptoms: pain and after a treatment with Dafalgan (dosage: 1 G, As Needed) experienced the following side effect(s):
  • Chest Discomfort
The treatment was started on Jul 01, 2007. Dafalgan was used in combination with the following drugs:
  • Laroxyl (25 Mg (1 Df), 1x/day)
  • Trileptal (150 Mg, 3x/day)
  • Salazopyrine (1000 Mg, 2x/day)
  • Levothyrox (25 Ug (1 Df), 1x/day)
This report could alert potential Dafalgan consumers.

Haemoglobin Decreased
In this report, a female patient from FRANCE (weight: NA) was affected by a possible Dafalgan side effect.The patient was diagnosed with arthralgia,hypertension. After a treatment with Dafalgan (dosage: 3 G, start date: Feb 22, 2011), the patient experienced the following side effect(s):
  • Haemoglobin Decreased
The following simultaneously used drugs could have led to this reaction:
  • Eupressyl (120 Mg)
  • Xyzal (10 Mg)
  • Pradaxa (220 Mg)
  • Lovenox (4000 U)
  • Topalgic (300 Mg)
  • Hydergine (4.5 Mg)
  • Nisisco (160 Mg/25 Mg)
  • Tardyferon
The findings here stress that side effects should be taken into consideration when evaluating a Dafalgan treatment.

Obsessive-compulsive Disorder, Depressed Mood, Anxiety
This is a report of a male patient from SWITZERLAND (weight: NA), who used Dafalgan (dosage: NA) for a treatment of headache,multiple sclerosis. After starting a treatment on Apr 01, 2009, the patient experienced the following side effect(s):
  • Obsessive-compulsive Disorder
  • Depressed Mood
  • Anxiety
The following drugs could possibly have interacted with the Dafalgan treatment
  • Rebif
Taken together, these observations suggest that a Dafalgan treatment could be related to side effect(s), such as Obsessive-compulsive Disorder, Depressed Mood, Anxiety.

Liver Injury, Rash Maculo-papular
This liver injury side effect was reported by a health professional from FRANCE. A 81-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Dafalgan (dosage: Unk), which was started on Jan 21, 2011. Concurrently used drugs:
  • Celebrex (Unk)
  • Lyrica (Unk)
  • Amlodipine Besylate (Unk)
  • Amlodipine Besylate (Unk)
  • Acupan (Unk)
  • Pradaxa (Unk)
  • Kardegic (Unk)
  • Acupan (Unk)
When starting to take Dafalgan the consumer reported the following symptoms:
  • Liver Injury
  • Rash Maculo-papular
The patient was hospitalized. These side effects may potentially be related to Dafalgan.


This is a Dafalgan side effect report of a 61-year-old male patient (weight:NA) from SWITZERLAND, suffering from the following symptoms/conditions: NA, who was treated with Dafalgan (dosage:NA, start time: Feb 05, 2011), combined with:
  • Prazine
  • Temesta
  • Seroquel (400 Mg Twice A Day In The Evening)
  • Seroquel
  • Depakene (1000-0-500 Mg Daily)
  • Buscopan
  • Seroquel
  • Seroquel
, and developed a serious reaction and a sudden cardiac death side effect. The patient presented with:
    which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Dafalgan treatment in male patients suffering from NA, resulting in sudden cardiac death.

    Gastroenteritis, Hypokalaemia, Blood Sodium Increased, Electrolyte Imbalance, Renal Failure Acute, Acidosis Hyperchloraemic
    This report suggests a potential Dafalgan gastroenteritis side effect(s) that can have serious consequences. A 62-year-old male patient from SWITZERLAND (weight:NA) was diagnosed with the following health condition(s): NA and used Dafalgan (dosage: NA) starting NS. Soon after starting Dafalgan the patient began experiencing various side effects, including:
    • Gastroenteritis
    • Hypokalaemia
    • Blood Sodium Increased
    • Electrolyte Imbalance
    • Renal Failure Acute
    • Acidosis Hyperchloraemic
    Drugs used concurrently:
    • Zestril
    • Calcium D3-mepha (1200mg/800 Iu Daily)
    • Spiralgin
    • Condrosulf
    • Neurontin
    • Seroquel Xr
    • Citalopram
    The patient was hospitalized. Although Dafalgan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as gastroenteritis, may still occur.

    Systemic Sclerosis, Hepatic Steatosis, Gastritis Erosive
    This systemic sclerosis problem was reported by a physician from SWITZERLAND. A 59-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): NA.On Apr 30, 2010 a consumer started treatment with Dafalgan /00020001/ (dosage: Unk). The following drugs/medications were being taken at the same time:
    • Etanercept
    • Pantozol /01263202/ (Unk)
    • Fraxiparin /00889603/ (Unk)
    • Fraxiparin /00889603/ (Unk)
    • Dafalgan /00020001/ (Unk)
    • Etanercept (50 Mg, Qwk)
    • Methotrexate Sodium (10-25 Mg Once Weekly)
    When commencing Dafalgan /00020001/, the patient experienced the following unwanted symptoms /side effects:
    • Systemic Sclerosis
    • Hepatic Steatosis
    • Gastritis Erosive
    The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as systemic sclerosis, may become evident only after a product is in use by the general population.

    Decreased Appetite, Rash Pruritic, Escherichia Urinary Tract Infection, Weight Decreased, Shift To The Left, Constipation, Abdominal Pain Upper, Hypokalaemia, Cytolytic Hepatitis
    This is a Dafalgan side effect report of a 86-year-old female patient (weight: NA) from SWITZERLAND. The patient developed the following symptoms/conditions: NA and was treated with Dafalgan (dosage: 1 G, 4x/day) starting Jan 07, 2011. Concurrently used drugs:
    • Fentanyl (1 Df, 2x/week Every 3 Days)
    • Tolterodine Tartrate (4 Mg, 1x/day)
    • Januvia (100 Mg, 1x/day)
    • Motilium (10 Mg, 3x/day)
    • Zolpidem (5 Mg, 1x/day)
    • Remeron (30 Mg, 1x/day)
    Soon after that, the consumer experienced the following of symptoms:
    • Decreased Appetite
    • Rash Pruritic
    • Escherichia Urinary Tract Infection
    • Weight Decreased
    • Shift To The Left
    • Constipation
    • Abdominal Pain Upper
    • Hypokalaemia
    • Cytolytic Hepatitis
    The patient was hospitalized. This opens a possibility that Dafalgan could cause decreased appetite and that some female patients may be more susceptible.

    Hypoglycaemia
    A 58-year-old female patient (weight: NA) from SWITZERLAND with the following symptoms: NA started Dafalgan treatment (dosage: NA) on NS. Soon after starting Dafalgan treatment, the consumer experienced several side effects, including:
    • Hypoglycaemia
    . Concurrently used drugs:
    • Tramadol Hydrochloride
    • Irfen
    • Physiotens
    • Singulair
    • Nasonex
    • Duspatalin
    • Seretide
    • Coaprovel
    This finding indicates that some patients can be more vulnerable to developing Dafalgan side effects, such as hypoglycaemia.

    Abortion Missed
    This abortion missed side effect was reported by a physician from SWITZERLAND. A 36-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Dafalgan (dosage: NA), which was started on Dec 24, 2005. Concurrently used drugs:
    • Relpax (40 Mg, Single)
    • Pantozol (40 Mg, 1x/day)
    .When starting to take Dafalgan the consumer reported symptoms, such as:
    • Abortion Missed
    These side effects may potentially be related to Dafalgan.

    Dyspnoea, Dysphonia, Face Oedema, Dysphagia, Hypersensitivity, Angioedema, Lip Oedema
    This is a report of a 27-year-old female patient (weight: NA) from FRANCE, suffering from the following symptoms/conditions: tonsillitis, who was treated with Dafalgan (dosage: 2tab Single Dose, start time: Sep 20, 2010), combined with:
    • Derinox
    • Domperidone (1tab Single Dose)
    • Augmentin (1g Single Dose)
    and developed a serious reaction and side effect(s). The consumer presented with:
    • Dyspnoea
    • Dysphonia
    • Face Oedema
    • Dysphagia
    • Hypersensitivity
    • Angioedema
    • Lip Oedema
    which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dafalgan treatment in female patients, resulting in dyspnoea side effect. The patient was hospitalized.

    Bile Duct Stone, Gastritis, Hepatitis Acute, Abdominal Pain Upper
    This report suggests a potential Dafalgan Bile Duct Stone, Gastritis, Hepatitis Acute, Abdominal Pain Upper side effect(s) that can have serious consequences. A 51-year-old female patient (weight: NA) from SWITZERLAND was diagnosed with the following symptoms/conditions: back pain and used Dafalgan (dosage: 1 G, Qid) starting Dec 11, 2010. Soon after starting Dafalgan the patient began experiencing various side effects, including:
    • Bile Duct Stone
    • Gastritis
    • Hepatitis Acute
    • Abdominal Pain Upper
    Drugs used concurrently:
    • Sirdalud (2 Mg, Bid)
    • Bi-profenid (150 Mg, Qd)
    • Nexium (40 Mg, Qd)
    • Prednisone (Unk)
    • Ecofenac (75 Mg, Bid)
    The patient was hospitalized. Although Dafalgan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as bile duct stone, may still occur.

    Multi-organ Failure, Cardiac Arrest, Coma, Neoplasm Malignant, Renal Impairment, Hepatic Function Abnormal, Malaise
    This Multi-organ Failure, Cardiac Arrest, Coma, Neoplasm Malignant, Renal Impairment, Hepatic Function Abnormal, Malaise problem was reported by a physician from BELGIUM. A 69-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: bone pain,prostate cancer. On Dec 27, 2010 this consumer started treatment with Dafalgan (dosage: 1 G, Tid). The following drugs were being taken at the same time:
    • Androcur (50 Mg, Tid)
    • Zometa (5 Mg, Unk)
    When commencing Dafalgan, the patient experienced the following unwanted symptoms/side effects:
    • Multi-organ Failure
    • Cardiac Arrest
    • Coma
    • Neoplasm Malignant
    • Renal Impairment
    • Hepatic Function Abnormal
    • Malaise
    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 multi-organ failure, may become evident only after a product is in use by the general population.

    Metabolic Acidosis, Hyperkalaemia, Ventricular Tachycardia, Renal Failure Acute
    This is a report of a 83-year-old female patient (weight: NA) from FRANCE. The patient developed the following symptoms/conditions: pain and was treated with Dafalgan (dosage: Unk 6x/days) starting Jan 24, 2011. Concurrently used drugs:
    • Celebrex (200 Mg, 1x/day)
    • Lovenox (4000 Iu, 1x/day)
    • Mopral (20 Mg, 1x/day)
    Soon after that, the consumer experienced the following side effects:
    • Metabolic Acidosis
    • Hyperkalaemia
    • Ventricular Tachycardia
    • Renal Failure Acute
    This opens a possibility that Dafalgan treatment could cause the above reactions, including metabolic acidosis, and some female subjects may be more susceptible.

    Mucosal Induration
    A 63-year-old female patient (weight: NA) from SWITZERLAND with the following symptoms/conditions: arthralgia,hypopituitarism started Dafalgan treatment (dosage: NA) on NS. Soon after starting Dafalgan treatment, the subject experienced various side effects, including:
    • Mucosal Induration
    Concurrently used drugs:
    • Eltroxin
    • Hydrocortisone
    • Golimumab
    • Methotrexate
    • Tambocor
    • Golimumab
    The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Dafalgan.

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    More About Dafalgan

    Side Effects reported to FDA: 49

    Dafalgan safety alerts: No

    Reported deaths: 5

    Reported hospitalizations: 20

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