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Ambroxol Side Effects

Common Ambroxol Side Effects


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

Blood Creatinine Increased (2)
Renal Failure (2)
Hypertension (2)
Restlessness (1)
Respiratory Distress (1)
White Blood Cell Count Increased (1)
Vomiting (1)
Tubulointerstitial Nephritis (1)
Urine Output Decreased (1)
Respiratory Disorder (1)
Weight Decreased (1)
Hypovolaemic Shock (1)
Pathogen Resistance (1)
Renal Colic (1)
Renal Failure Acute (1)
Nephrolithiasis (1)
Left Ventricular Dysfunction (1)
Hyponatraemia (1)
Injection Site Abscess (1)
Hyperhidrosis (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.

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.

Ambroxol Side Effects Reported to FDA

The following Ambroxol 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 Ambroxol 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.
Injection Site Abscess
This is a report of a 51-year-old female patient (weight: NA) from CHINA, suffering from the following symptoms/conditions: upper respiratory tract infection, who was treated with Ambroxol Hydrochloride (dosage: 120 Mg, 1x/day, start time: Sep 16, 2008), combined with:
  • Zithromax (0.5g, Once Daily)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Injection Site Abscess
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ambroxol Hydrochloride treatment in female patients, resulting in injection site abscess side effect.

Pathogen Resistance
This report suggests a potential Ambroxol Hydrochloride Pathogen Resistance side effect(s) that can have serious consequences. A 63-year-old female patient (weight: NA) from GERMANY was diagnosed with the following symptoms/conditions: NA and used Ambroxol Hydrochloride (dosage: NA) starting Mar 02, 2012. Soon after starting Ambroxol Hydrochloride the patient began experiencing various side effects, including:
  • Pathogen Resistance
Drugs used concurrently:
  • Cancidas
  • Dihydralazine Mesylate
  • Enoxaparin Sodium
  • Hydrochlorothiazide
  • Levothyroxine Sodium
Although Ambroxol Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as pathogen resistance, may still occur.

Convulsion, Hyponatraemia, Vomiting
This Convulsion, Hyponatraemia, Vomiting problem was reported by a consumer or non-health professional from JAPAN. A 77-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Jun 02, 2011 this consumer started treatment with Ambroxol Hydrochloride (dosage: NA). The following drugs were being taken at the same time:
  • Calblock
  • Merislon
  • Codeine Phosphate
  • Magnesium Oxide
  • Emend (Dose:125-80)
  • Olmesartan Medoxomil
  • Dexamethasone
  • Depas
When commencing Ambroxol Hydrochloride, the patient experienced the following unwanted symptoms/side effects:
  • Convulsion
  • Hyponatraemia
  • Vomiting
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as convulsion, may become evident only after a product is in use by the general population.

Gingival Bleeding, Dyspnoea
This is a report of a 74-year-old female patient (weight: NA) from KOREA, REPUBLIC OF. The patient developed the following symptoms/conditions: NA and was treated with Ambroxol (dosage: NA) starting Jan 26, 2012. Concurrently used drugs:
  • Aspirin
  • Tenormin
  • Aldactone(spinololactone)
  • Dioban(valsartan)
  • Niacin
  • Lasix
  • Pradaxa (300 Mg)
Soon after that, the consumer experienced the following side effects:
  • Gingival Bleeding
  • Dyspnoea
The patient was hospitalized. This opens a possibility that Ambroxol treatment could cause the above reactions, including gingival bleeding, and some female subjects may be more susceptible.


Left Ventricular Dysfunction, Hypovolaemic Shock, Renal Failure Acute
A male patient (weight: NA) from TAIWAN, PROVINCE OF CHINA with the following symptoms/conditions: asthma started Ambroxol treatment (dosage: 30 Mg, Bid) on Jun 04, 2010. Soon after starting Ambroxol treatment, the subject experienced various side effects, including:
  • Left Ventricular Dysfunction
  • Hypovolaemic Shock
  • Renal Failure Acute
Concurrently used drugs:
  • Acetaminophen
  • Diclofenac
  • Valsartan
  • Combivent
  • Valsartan
  • Furosemide (40 Mg, Qd)
  • Carvedilol (25 Mg, Bid)
  • Clopidogrel
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Ambroxol.

Tubulointerstitial Nephritis, C-reactive Protein Increased, Blood Creatinine Increased, Constipation, Hyperhidrosis
A 14-year-old female patient from JAPAN (weight: NA) experienced symptoms, such as: NA and was treated with Ambroxol Hydrochloride(dosage: NA). The treatment was initiated on Nov 28, 2011. After that a consumer reported the following side effect(s):
  • Tubulointerstitial Nephritis
  • C-reactive Protein Increased
  • Blood Creatinine Increased
  • Constipation
  • Hyperhidrosis
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Ambroxol Hydrochloride efficacy:
  • Isosorbide Dinitrate
  • Pregabalin
  • Etizolam
  • Alendronate Sodium
  • Tramadol Hydrochloride/acetaminophen (1 Df 2 Per Day)
  • Lactulose
  • Tramadol Hydrochloride/acetaminophen (2 Doses 2 Times A Day)


Restlessness, Respiratory Distress, Cough, Decreased Appetite, Speech Disorder, Weight Decreased, Dysphonia, Headache
In this report, Ambroxol was administered for the following condition: NA.A 49-year-old female consumer from GERMANY (weight: NA) started Ambroxol treatment (dosage: NA) on Jan 01, 2011.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Restlessness
  • Respiratory Distress
  • Cough
  • Decreased Appetite
  • Speech Disorder
  • Weight Decreased
  • Dysphonia
  • Headache
A possible interaction with other drugs could have contributed to this reaction:
  • Lithium Carbonate
  • Budesonide
  • Bupropion Hydrochloride (150 Mg Qd Oral)
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Ambroxol treatment could be related to the listed above side effect(s).

Altered State Of Consciousness
This is a report of the following Ambroxol Hydrochloride side effect(s):
  • Altered State Of Consciousness
A 95-year-old female patient from JAPAN (weight: NA) presented with the following condition: NA and received a treatment with Ambroxol Hydrochloride (dosage: NA) starting: May 19, 2011.The following concurrently used drugs could have generated interactions:
  • Gasmotin
  • Histablock
  • Aricept
  • Clarithromycin
  • Acetaminophen
  • Aricept
  • Mevatorte
The patient was hospitalized.This report suggests that a Ambroxol Hydrochloride treatment could be associated with the listed above side effect(s).

Fatigue
This Ambroxol report was submitted by a male consumer from GERMANY (weight: NA). The patient was diagnosed with: bone graft lysis,chronic obstructive pulmonary disease and Ambroxol was administered (dosage: 2x1/d) starting: Nov 01, 2010. The consumer developed a set of symptoms:
  • Fatigue
Other drugs used simultaneously:
  • Onbrez (300ug (1 Df),qd)
  • Onbrez (150 Ug (1 Df), Qd)
Those unexpected symptoms could be linked to a Ambroxol treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Nephrolithiasis, Renal Colic
This is a report of a possible correlation between Ambroxol use and the following symptoms/side effect(s):
  • Nephrolithiasis
  • Renal Colic
which could contribute to an assessment of Ambroxol risk profile.A 72-year-old male consumer from UNITED STATES (weight: NA) was suffering from NA and was treated with Ambroxol (dosage: Unk) starting Apr 01, 2009.Other concurrent medications:
  • Foradil (10 Ug, Bid)
  • Acetylsalicylic Acid Srt (Unk)
  • Diclofenac Sodium (75mg Qd)
The patient was hospitalized.

Cardiac Failure, Aspartate Aminotransferase, Frequent Bowel Movements, Alanine Aminotransferase, Blood Creatinine Increased, White Blood Cell Count Increased, Renal Failure, Hepatic Function Abnormal, Urine Output Decreased
A 3-year-old female patient from JAPAN (weight: NA) presented with the following symptoms: productive cough,urinary tract infection,constipation and after a treatment with Ambroxol Hydrochloride (dosage: NA) experienced the following side effect(s):
  • Cardiac Failure
  • Aspartate Aminotransferase
  • Frequent Bowel Movements
  • Alanine Aminotransferase
  • Blood Creatinine Increased
  • White Blood Cell Count Increased
  • Renal Failure
  • Hepatic Function Abnormal
  • Urine Output Decreased
The treatment was started on Jan 07, 2011. Ambroxol Hydrochloride was used in combination with the following drugs:
  • Orapenem Fine Granules (tebipenem Pivoxil)
  • Sodium Picosulfate Hydrate ([0-20 Drops])
  • Hydrocortisone (Df)
  • Levothyroxine Sodium Hydrate (Df)
  • Antibiotics-resistant Lactic Acid Bacteriae (Df)
  • Cotrim ([wednesday, Thursday, Friday, 3 Days On And 4 Days Off, Every Week])
  • Cotrim ([wednesday, Thursday, Friday, 3 Days On And 4 Days Off, Every Week])
  • L-carbocisteine
This report could alert potential Ambroxol Hydrochloride consumers.

Cerebral Infarction
In this report, a 75-year-old female patient from CHINA (weight: NA) was affected by a possible Ambroxol side effect.The patient was diagnosed with NA. After a treatment with Ambroxol (dosage: NA, start date: Apr 07, 2011), the patient experienced the following side effect(s):
  • Cerebral Infarction
The following simultaneously used drugs could have led to this reaction:
  • Levofloxacin
  • Sulperazon (1.5)
The findings here stress that side effects should be taken into consideration when evaluating a Ambroxol treatment.

Respiratory Disorder, Toxic Epidermal Necrolysis
This is a report of a 5-year-old male patient from JAPAN (weight: NA), who used Ambroxol Hydrochloride (dosage: NA) for a treatment of NA. After starting a treatment on Jun 12, 2009, the patient experienced the following side effect(s):
  • Respiratory Disorder
  • Toxic Epidermal Necrolysis
The following drugs could possibly have interacted with the Ambroxol Hydrochloride treatment
  • Polbonol
  • Clarith Dry Syrup
  • Lanoxin
Taken together, these observations suggest that a Ambroxol Hydrochloride treatment could be related to side effect(s), such as Respiratory Disorder, Toxic Epidermal Necrolysis.

Hypertension
This hypertension side effect was reported by a consumer or non-health professional from BRAZIL. A 70-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Ambroxol Hydrochloride (dosage: Unk), which was started on Nov 01, 2010. Concurrently used drugs:
  • Lyrica (75 Mg, 1x/day)
When starting to take Ambroxol Hydrochloride the consumer reported the following symptoms:
  • Hypertension
These side effects may potentially be related to Ambroxol Hydrochloride.

Hypertension
This is a Ambroxol Hydrochloride side effect report of a 70-year-old female patient (weight:NA) from , suffering from the following symptoms/conditions: NA, who was treated with Ambroxol Hydrochloride (dosage:Unk, start time: Nov 01, 2010), combined with:
  • Lyrica (75 Mg, 1x/day)
, and developed a serious reaction and a hypertension side effect. The patient presented with:
  • Hypertension
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Ambroxol Hydrochloride treatment in female patients suffering from NA, resulting in hypertension.

Blood Alkaline Phosphatase Increased, Bundle Branch Block Right, Bundle Branch Block Bilateral, Tachycardia, Hyperglycaemia
This report suggests a potential Ambroxol Hydrochloride blood alkaline phosphatase increased side effect(s) that can have serious consequences. A 68-year-old male patient from JAPAN (weight:NA) was diagnosed with the following health condition(s): NA and used Ambroxol Hydrochloride (dosage: NA) starting Sep 10, 2010. Soon after starting Ambroxol Hydrochloride the patient began experiencing various side effects, including:
  • Blood Alkaline Phosphatase Increased
  • Bundle Branch Block Right
  • Bundle Branch Block Bilateral
  • Tachycardia
  • Hyperglycaemia
Drugs used concurrently:
  • Vfend (150 Mg, 1x/day)
  • Marzulene S
  • Mucodyne
  • Vfend (150 Mg, 2x/day)
The patient was hospitalized. Although Ambroxol Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as blood alkaline phosphatase increased, may still occur.

Cholestasis, Renal Failure, Cytolytic Hepatitis
This cholestasis problem was reported by a health professional from FRANCE. A 77-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): NA.On Nov 30, 2010 a consumer started treatment with Ambroxol (dosage: Unk). The following drugs/medications were being taken at the same time:
  • Zoladex (Unk)
  • Multaq (Unk)
  • Tahor (Unk)
  • Androcur (Unk)
When commencing Ambroxol, the patient experienced the following unwanted symptoms /side effects:
  • Cholestasis
  • Renal Failure
  • Cytolytic Hepatitis
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 cholestasis, may become evident only after a product is in use by the general population.

Rhabdomyolysis
This is a Ambroxol Hydrochloride side effect report of a 10-year-old female patient (weight: NA) from . The patient developed the following symptoms/conditions: NA and was treated with Ambroxol Hydrochloride (dosage: NA) starting Dec 22, 2004. Concurrently used drugs:
  • Hokunalin
  • Diazepam
  • Pepcid
  • Pepcid
  • Pepcid
  • Pepcid
  • Rocephin
  • Rocephin
Soon after that, the consumer experienced the following of symptoms:
  • Rhabdomyolysis
The patient was hospitalized. This opens a possibility that Ambroxol Hydrochloride could cause rhabdomyolysis and that some female patients may be more susceptible.



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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    Side Effects reported to FDA: 18

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    Reported deaths: 2

    Reported hospitalizations: 4

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