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Ambroxol Side Effects

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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.

Ambroxol Side Effects Reported to FDA



Ambroxol Side Effect Report#8447650-3
Injection Site Abscess
This is a report of a 51-year-old female patient (weight: NA) from China, suffering from the following health 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): Injection Site Abscess 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.
Ambroxol Side Effect Report#8259542-3
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. After starting Ambroxol Hydrochloride the patient began experiencing various side effects, including: Pathogen ResistanceAdditional 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.
Ambroxol Side Effect Report#8234308-9
Convulsion, Hyponatraemia, Vomiting
This Convulsion 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 using Ambroxol Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Convulsion, Hyponatraemia, VomitingAlthough 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.
Ambroxol Side Effect Report#8138429-0
Gingival Bleeding, Dyspnoea
This Gingival Bleeding side effect was reported by a physician from Korea, Republic Of. A 74-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Ambroxol (drug dosage: NA), which was initiated on
Jan 26, 2012. Concurrently used drugs:
  • Aspirin
  • Tenormin
  • Aldactone(spinololactone)
  • Dioban(valsartan)
  • Niacin
  • Lasix
  • Pradaxa (300 Mg)
.After starting to take Ambroxol the consumer reported adverse symptoms, such as: Gingival Bleeding, DyspnoeaThese side effects may potentially be related to Ambroxol. The patient was hospitalized.
Ambroxol Side Effect Report#8014469-7
Left Ventricular Dysfunction, Hypovolaemic Shock, Renal Failure Acute
This is a report of a male patient (weight: NA) from Taiwan, Province Of China, suffering from the following health symptoms/conditions: asthma, who was treated with Ambroxol (dosage: 30 Mg, Bid, start time:
Jun 04, 2010), combined with:
  • Acetaminophen
  • Diclofenac
  • Valsartan
  • Combivent
  • Valsartan
  • Furosemide (40 Mg, Qd)
  • Carvedilol (25 Mg, Bid)
  • Clopidogrel
and developed a serious reaction and side effect(s): Left Ventricular Dysfunction, Hypovolaemic Shock, Renal Failure Acute after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ambroxol treatment in male patients, resulting in Left Ventricular Dysfunction side effect. The patient was hospitalized.
Ambroxol Side Effect Report#8001494-5
Tubulointerstitial Nephritis, C-reactive Protein Increased, Blood Creatinine Increased, Constipation, Hyperhidrosis
This report suggests a potential Ambroxol Hydrochloride Tubulointerstitial Nephritis side effect(s) that can have serious consequences. A 14-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Ambroxol Hydrochloride (dosage: NA) starting
Nov 28, 2011. After starting Ambroxol Hydrochloride the patient began experiencing various side effects, including: Tubulointerstitial Nephritis, C-reactive Protein Increased, Blood Creatinine Increased, Constipation, HyperhidrosisAdditional drugs used concurrently:
  • Isosorbide Dinitrate
  • Pregabalin
  • Etizolam
  • Alendronate Sodium
  • Tramadol Hydrochloride/acetaminophen (1 Df 2 Per Day)
  • Lactulose
  • Tramadol Hydrochloride/acetaminophen (2 Doses 2 Times A Day)
Although Ambroxol Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Tubulointerstitial Nephritis, may still occur.
Ambroxol Side Effect Report#7920283-0
Restlessness, Respiratory Distress, Cough, Decreased Appetite, Speech Disorder, Weight Decreased, Dysphonia, Headache
This Restlessness problem was reported by a pharmacist from Germany. A 49-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 01, 2011 this consumer started treatment with Ambroxol (dosage: NA). The following drugs were being taken at the same time:
  • Lithium Carbonate
  • Budesonide
  • Bupropion Hydrochloride (150 Mg Qd Oral)
When using Ambroxol, the patient experienced the following unwanted symptoms/side effects: Restlessness, Respiratory Distress, Cough, Decreased Appetite, Speech Disorder, Weight Decreased, Dysphonia, HeadacheAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Restlessness, may become evident only after a product is in use by the general population.
Ambroxol Side Effect Report#7828650-0
Altered State Of Consciousness
This Altered State Of Consciousness side effect was reported by a physician from Japan. A 95-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Ambroxol Hydrochloride (drug dosage: NA), which was initiated on
May 19, 2011. Concurrently used drugs:
  • Gasmotin
  • Histablock
  • Aricept
  • Clarithromycin
  • Acetaminophen
  • Aricept
  • Mevatorte
.After starting to take Ambroxol Hydrochloride the consumer reported adverse symptoms, such as: Altered State Of ConsciousnessThese side effects may potentially be related to Ambroxol Hydrochloride. The patient was hospitalized.
Ambroxol Side Effect Report#7802646-7
Fatigue
This is a report of a male patient (weight: NA) from Germany, suffering from the following health symptoms/conditions: bone graft lysis,chronic obstructive pulmonary disease, who was treated with Ambroxol (dosage: 2x1/d, start time:
Nov 01, 2010), combined with:
  • Onbrez (300ug (1 Df),qd)
  • Onbrez (150 Ug (1 Df), Qd)
and developed a serious reaction and side effect(s): Fatigue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ambroxol treatment in male patients, resulting in Fatigue side effect.
Ambroxol Side Effect Report#7506041-X
Nephrolithiasis, Renal Colic
This report suggests a potential Ambroxol Nephrolithiasis side effect(s) that can have serious consequences. A 72-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Ambroxol (dosage: Unk) starting
Apr 01, 2009. After starting Ambroxol the patient began experiencing various side effects, including: Nephrolithiasis, Renal ColicAdditional drugs used concurrently:
  • Foradil (10 Ug, Bid)
  • Acetylsalicylic Acid Srt (Unk)
  • Diclofenac Sodium (75mg Qd)
The patient was hospitalized. Although Ambroxol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nephrolithiasis, may still occur.
Ambroxol Side Effect Report#7458001-5
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
This Cardiac Failure problem was reported by a physician from Japan. A 3-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: productive cough,urinary tract infection,constipation. On
Jan 07, 2011 this consumer started treatment with Ambroxol Hydrochloride (dosage: NA). The following drugs were being taken at the same time:
  • 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
When using Ambroxol Hydrochloride, the patient experienced the following unwanted symptoms/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 DecreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardiac Failure, may become evident only after a product is in use by the general population.
Ambroxol Side Effect Report#7413181-2
Cerebral Infarction
This Cerebral Infarction side effect was reported by a physician from China. A 75-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Ambroxol (drug dosage: NA), which was initiated on
Apr 07, 2011. Concurrently used drugs:
  • Levofloxacin
  • Sulperazon (1.5)
.After starting to take Ambroxol the consumer reported adverse symptoms, such as: Cerebral InfarctionThese side effects may potentially be related to Ambroxol.
Ambroxol Side Effect Report#7328608-4
Respiratory Disorder, Toxic Epidermal Necrolysis
This is a report of a 5-year-old male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Ambroxol Hydrochloride (dosage: NA, start time:
Jun 12, 2009), combined with:
  • Polbonol
  • Clarith Dry Syrup
  • Lanoxin
and developed a serious reaction and side effect(s): Respiratory Disorder, Toxic Epidermal Necrolysis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ambroxol Hydrochloride treatment in male patients, resulting in Respiratory Disorder side effect.
Ambroxol Side Effect Report#7325673-5
Hypertension
This report suggests a potential Ambroxol Hydrochloride Hypertension side effect(s) that can have serious consequences. A 70-year-old female patient (weight: NA) from Brazil was diagnosed with the following symptoms/conditions: NA and used Ambroxol Hydrochloride (dosage: Unk) starting
Nov 01, 2010. After starting Ambroxol Hydrochloride the patient began experiencing various side effects, including: HypertensionAdditional drugs used concurrently:
  • Lyrica (75 Mg, 1x/day)
Although Ambroxol Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypertension, may still occur.
Ambroxol Side Effect Report#7316216-0
Hypertension
This Hypertension problem was reported by a consumer or non-health professional from . A 70-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Nov 01, 2010 this consumer started treatment with Ambroxol Hydrochloride (dosage: Unk). The following drugs were being taken at the same time:
  • Lyrica (75 Mg, 1x/day)
When using Ambroxol Hydrochloride, the patient experienced the following unwanted symptoms/side effects: HypertensionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypertension, may become evident only after a product is in use by the general population.
Ambroxol Side Effect Report#7307345-6
Blood Alkaline Phosphatase Increased, Bundle Branch Block Right, Bundle Branch Block Bilateral, Tachycardia, Hyperglycaemia
This Blood Alkaline Phosphatase Increased side effect was reported by a pharmacist from Japan. A 68-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Ambroxol Hydrochloride (drug dosage: NA), which was initiated on
Sep 10, 2010. Concurrently used drugs:
  • Vfend (150 Mg, 1x/day)
  • Marzulene S
  • Mucodyne
  • Vfend (150 Mg, 2x/day)
.After starting to take Ambroxol Hydrochloride the consumer reported adverse symptoms, such as: Blood Alkaline Phosphatase Increased, Bundle Branch Block Right, Bundle Branch Block Bilateral, Tachycardia, HyperglycaemiaThese side effects may potentially be related to Ambroxol Hydrochloride. The patient was hospitalized.
Ambroxol Side Effect Report#7289390-2
Cholestasis, Renal Failure, Cytolytic Hepatitis
This is a report of a 77-year-old male patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Ambroxol (dosage: Unk, start time:
Nov 30, 2010), combined with:
  • Zoladex (Unk)
  • Multaq (Unk)
  • Tahor (Unk)
  • Androcur (Unk)
and developed a serious reaction and side effect(s): Cholestasis, Renal Failure, Cytolytic Hepatitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ambroxol treatment in male patients, resulting in Cholestasis side effect. The patient was hospitalized.
Ambroxol Side Effect Report#4568661-4
Rhabdomyolysis
This report suggests a potential Ambroxol Hydrochloride Rhabdomyolysis side effect(s) that can have serious consequences. A 10-year-old female patient (weight: NA) from was diagnosed with the following symptoms/conditions: NA and used Ambroxol Hydrochloride (dosage: NA) starting
Dec 22, 2004. After starting Ambroxol Hydrochloride the patient began experiencing various side effects, including: RhabdomyolysisAdditional drugs used concurrently:
  • Hokunalin
  • Diazepam
  • Pepcid
  • Pepcid
  • Pepcid
  • Pepcid
  • Rocephin
  • Rocephin
The patient was hospitalized. Although Ambroxol Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rhabdomyolysis, may still occur.



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.


Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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.

    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.

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    More About Ambroxol

    Side Effects reported to FDA: 18

    Ambroxol safety alerts: No

    Reported deaths: 2

    Reported hospitalizations: 4

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