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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
on Jun 07, 2012 Female from CHINA , 51 years of age, weighting 114.6 lb, was diagnosed with and was treated with Ambroxol Hydrochloride. Directly after, patient experienced the unwanted or unexpected Ambroxol side effects: injection site abscess. Ambroxol Hydrochloride dosage: 120 Mg, 1x/day.
Associated medications used:
  • Zithromax (0.5g, Once Daily)


Pathogen Resistance
Patient was taking Ambroxol Hydrochloride. Patient felt the following Ambroxol side effects: pathogen resistance on Mar 28, 2012 from GERMANY Additional patient health information: Female , 63 years of age, . Ambroxol Hydrochloride dosage: N/A.
Multiple prescriptions taken:
  • Cancidas
  • Dihydralazine Mesylate
  • Enoxaparin Sodium
  • Hydrochlorothiazide
  • Levothyroxine Sodium


Convulsion, Hyponatraemia, Vomiting
Adverse event was reported on Mar 22, 2012 by a Female taking Ambroxol Hydrochloride (Dosage: N/A) . Location: JAPAN , 77 years of age, weighting 145.5 lb, After Ambroxol was administered, patient encountered several Ambroxol side effects: convulsion, hyponatraemia, vomiting.
Multiple concurrent drugs taken:
  • Calblock
  • Merislon
  • Codeine Phosphate
  • Magnesium Oxide
  • Emend (Dose:125-80)
  • Olmesartan Medoxomil
  • Dexamethasone
  • Depas


Gingival Bleeding, Dyspnoea
on Feb 08, 2012 Female from KOREA, REPUBLIC OF , 74 years of age, weighting 114.6 lb, was treated with Ambroxol. Directly after, patient experienced the unwanted or unexpected Ambroxol side effects: gingival bleeding, dyspnoea. Ambroxol dosage: N/A.
Associated medications used:
  • Aspirin
  • Tenormin
  • Aldactone(spinololactone)
  • Dioban(valsartan)
  • Niacin
  • Lasix
  • Pradaxa (300 Mg)
Patient was hospitalized.


Left Ventricular Dysfunction, Hypovolaemic Shock, Renal Failure Acute
on Dec 22, 2011 Male from TAIWAN, PROVINCE OF CHINA , weighting 143.3 lb, was diagnosed with and was treated with Ambroxol. Patient felt the following Ambroxol side effects: left ventricular dysfunction, hypovolaemic shock, renal failure acute. Ambroxol dosage: 30 Mg, Bid.
Multiple prescriptions taken:
  • Acetaminophen
  • Diclofenac
  • Valsartan
  • Combivent
  • Valsartan
  • Furosemide (40 Mg, Qd)
  • Carvedilol (25 Mg, Bid)
  • Clopidogrel
Patient was hospitalized.

Tubulointerstitial Nephritis, C-reactive Protein Increased, Blood Creatinine Increased, Constipation, Hyperhidrosis
Patient was taking Ambroxol Hydrochloride. After Ambroxol was administered, patient encountered several Ambroxol side effects: tubulointerstitial nephritis, c-reactive protein increased, blood creatinine increased, constipation, hyperhidrosis on Dec 16, 2011 from JAPAN Additional patient health information: Female , 14 years of age, . Ambroxol Hydrochloride dosage: N/A.
Multiple concurrent drugs taken:
  • 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
Adverse event was reported on Nov 04, 2011 by a Female taking Ambroxol (Dosage: N/A) . Location: GERMANY , 49 years of age, Directly after, patient experienced the unwanted or unexpected Ambroxol side effects: restlessness, respiratory distress, cough, decreased appetite, speech disorder, weight decreased, dysphonia, headache.
Associated medications used:
  • Lithium Carbonate
  • Budesonide
  • Bupropion Hydrochloride (150 Mg Qd Oral)


Altered State Of Consciousness
on Oct 11, 2011 Female from JAPAN , 95 years of age, was treated with Ambroxol Hydrochloride. Patient felt the following Ambroxol side effects: altered state of consciousness. Ambroxol Hydrochloride dosage: N/A.
Multiple prescriptions taken:
  • Gasmotin
  • Histablock
  • Aricept
  • Clarithromycin
  • Acetaminophen
  • Aricept
  • Mevatorte
Patient was hospitalized.

Fatigue
on Sep 30, 2011 Male from GERMANY , weighting 145.5 lb, was diagnosed with and was treated with Ambroxol. After Ambroxol was administered, patient encountered several Ambroxol side effects: fatigue. Ambroxol dosage: 2x1/d.
Multiple concurrent drugs taken:
  • Onbrez (300ug (1 Df),qd)
  • Onbrez (150 Ug (1 Df), Qd)


Nephrolithiasis, Renal Colic
Patient was taking Ambroxol. Directly after, patient experienced the unwanted or unexpected Ambroxol side effects: nephrolithiasis, renal colic on May 26, 2011 from UNITED STATES Additional patient health information: Male , 72 years of age, . Ambroxol dosage: Unk.
Associated medications used:
  • Foradil (10 Ug, Bid)
  • Acetylsalicylic Acid Srt (Unk)
  • Diclofenac Sodium (75mg Qd)
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
Adverse event was reported on Apr 20, 2011 by a Female taking Ambroxol Hydrochloride (Dosage: N/A) was diagnosed with and. Location: JAPAN , child 3 years of age, Patient felt the following Ambroxol side effects: 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.
Multiple prescriptions taken:
  • 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


Cerebral Infarction
on Apr 08, 2011 Female from CHINA , 75 years of age, was treated with Ambroxol. After Ambroxol was administered, patient encountered several Ambroxol side effects: cerebral infarction. Ambroxol dosage: N/A.
Multiple concurrent drugs taken:
  • Levofloxacin
  • Sulperazon (1.5)


Respiratory Disorder, Toxic Epidermal Necrolysis
on Feb 25, 2011 Male from JAPAN , child 5 years of age, was treated with Ambroxol Hydrochloride. Directly after, patient experienced the unwanted or unexpected Ambroxol side effects: respiratory disorder, toxic epidermal necrolysis. Ambroxol Hydrochloride dosage: N/A.
Associated medications used:
  • Polbonol
  • Clarith Dry Syrup
  • Lanoxin


Hypertension
Patient was taking Ambroxol Hydrochloride. Patient felt the following Ambroxol side effects: hypertension on Feb 23, 2011 from BRAZIL Additional patient health information: Female , 70 years of age, . Ambroxol Hydrochloride dosage: Unk.
Multiple prescriptions taken:
  • Lyrica (75 Mg, 1x/day)


Hypertension
Adverse event was reported on Feb 17, 2011 by a Female taking Ambroxol Hydrochloride (Dosage: Unk) . Location: , 70 years of age, After Ambroxol was administered, patient encountered several Ambroxol side effects: hypertension.
Multiple concurrent drugs taken:
  • Lyrica (75 Mg, 1x/day)


Blood Alkaline Phosphatase Increased, Bundle Branch Block Right, Bundle Branch Block Bilateral, Tachycardia, Hyperglycaemia
on Feb 16, 2011 Male from JAPAN , 68 years of age, weighting 79.59 lb, was treated with Ambroxol Hydrochloride. Directly after, patient experienced the unwanted or unexpected Ambroxol side effects: blood alkaline phosphatase increased, bundle branch block right, bundle branch block bilateral, tachycardia, hyperglycaemia. Ambroxol Hydrochloride dosage: N/A.
Associated medications used:
  • Vfend (150 Mg, 1x/day)
  • Marzulene S
  • Mucodyne
  • Vfend (150 Mg, 2x/day)
Patient was hospitalized.

Cholestasis, Renal Failure, Cytolytic Hepatitis
on Feb 04, 2011 Male from FRANCE , 77 years of age, was treated with Ambroxol. Patient felt the following Ambroxol side effects: cholestasis, renal failure, cytolytic hepatitis. Ambroxol dosage: Unk.
Multiple prescriptions taken:
  • Zoladex (Unk)
  • Multaq (Unk)
  • Tahor (Unk)
  • Androcur (Unk)
Patient was hospitalized.

Rhabdomyolysis
Patient was taking Ambroxol Hydrochloride. After Ambroxol was administered, patient encountered several Ambroxol side effects: rhabdomyolysis on Jan 12, 2005 from Additional patient health information: Female , child 10 years of age, . Ambroxol Hydrochloride dosage: N/A.
Multiple concurrent drugs taken:
  • Hokunalin
  • Diazepam
  • Pepcid
  • Pepcid
  • Pepcid
  • Pepcid
  • Rocephin
  • Rocephin
Patient was hospitalized.



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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


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    Safety Alerts, Active Ingredients, Usage Information

    More About Ambroxol

    Side Effects reported to FDA: 18

    Ambroxol safety alerts: No

    Reported deaths: 2

    Reported hospitalizations: 4

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