Ambroxol Hydrochloride Side Effects

Common Ambroxol Hydrochloride Side Effects

The most commonly reported Ambroxol Hydrochloride side effects are:
Ambroxol (3)
Head Spinning (2)
Dizzy And Head Spinning (2)
Tummy Pain (1)
Dizzy (1)
Chest Painst (1)
Dizziness (1)

If you have experienced a side effect listed above, you can check a box to report it.

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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 Hydrochloride Side Effects Reported to FDA

The following Ambroxol Hydrochloride 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 Hydrochloride 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.

Tubulointerstitial Nephritis, C-reactive Protein Increased, Blood Creatinine Increased, Constipation, Hyperhidrosis
This is a report of a 14-year-old female patient (weight: NA) from JAPAN. The patient developed the following symptoms/conditions: NA and was treated with Ambroxol Hydrochloride (dosage: NA) starting Nov 28, 2011. Concurrently used drugs:
  • Isosorbide Dinitrate
  • Pregabalin
  • Etizolam
  • Alendronate Sodium
  • Tramadol Hydrochloride/acetaminophen (1 Df 2 Per Day)
  • Lactulose
  • Tramadol Hydrochloride/acetaminophen (2 Doses 2 Times A Day)
Soon after that, the consumer experienced the following side effects:
  • Tubulointerstitial Nephritis
  • C-reactive Protein Increased
  • Blood Creatinine Increased
  • Constipation
  • Hyperhidrosis
This opens a possibility that Ambroxol Hydrochloride treatment could cause the above reactions, including tubulointerstitial nephritis, and some female subjects may be more susceptible.

Altered State Of Consciousness
A 95-year-old female patient (weight: NA) from JAPAN with the following symptoms/conditions: NA started Ambroxol Hydrochloride treatment (dosage: NA) on May 19, 2011. Soon after starting Ambroxol Hydrochloride treatment, the subject experienced various side effects, including:
  • Altered State Of Consciousness
Concurrently used drugs:
  • Gasmotin
  • Histablock
  • Aricept
  • Clarithromycin
  • Acetaminophen
  • Aricept
  • Mevatorte
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Ambroxol Hydrochloride.

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) experienced symptoms, such as: productive cough,urinary tract infection,constipation and was treated with Ambroxol Hydrochloride(dosage: NA). The treatment was initiated on Jan 07, 2011. After that a consumer reported 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
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Ambroxol Hydrochloride efficacy:
  • 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

Respiratory Disorder, Toxic Epidermal Necrolysis
In this report, Ambroxol Hydrochloride was administered for the following condition: NA.A 5-year-old male consumer from JAPAN (weight: NA) started Ambroxol Hydrochloride treatment (dosage: NA) on Jun 12, 2009.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Respiratory Disorder
  • Toxic Epidermal Necrolysis
A possible interaction with other drugs could have contributed to this reaction:
  • Polbonol
  • Clarith Dry Syrup
  • Lanoxin
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Ambroxol Hydrochloride treatment could be related to the listed above side effect(s).

This is a report of the following Ambroxol Hydrochloride side effect(s):
  • Hypertension
A 70-year-old female patient from BRAZIL (weight: NA) presented with the following condition: NA and received a treatment with Ambroxol Hydrochloride (dosage: Unk) starting: Nov 01, 2010.The following concurrently used drugs could have generated interactions:
  • Lyrica (75 Mg, 1x/day)
This report suggests that a Ambroxol Hydrochloride treatment could be associated with the listed above side effect(s).

This Ambroxol Hydrochloride report was submitted by a 70-year-old female consumer from (weight: NA). The patient was diagnosed with: NA and Ambroxol Hydrochloride was administered (dosage: Unk) starting: Nov 01, 2010. The consumer developed a set of symptoms:
  • Hypertension
Other drugs used simultaneously:
  • Lyrica (75 Mg, 1x/day)
Those unexpected symptoms could be linked to a Ambroxol Hydrochloride treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Blood Alkaline Phosphatase Increased, Bundle Branch Block Right, Bundle Branch Block Bilateral, Tachycardia, Hyperglycaemia
This is a report of a possible correlation between Ambroxol Hydrochloride use and the following symptoms/side effect(s):
  • Blood Alkaline Phosphatase Increased
  • Bundle Branch Block Right
  • Bundle Branch Block Bilateral
  • Tachycardia
  • Hyperglycaemia
which could contribute to an assessment of Ambroxol Hydrochloride risk profile.A 68-year-old male consumer from JAPAN (weight: NA) was suffering from NA and was treated with Ambroxol Hydrochloride (dosage: NA) starting Sep 10, 2010.Other concurrent medications:
  • Vfend (150 Mg, 1x/day)
  • Marzulene S
  • Mucodyne
  • Vfend (150 Mg, 2x/day)
The patient was hospitalized.

A 10-year-old female patient from (weight: NA) presented with the following symptoms: NA and after a treatment with Ambroxol Hydrochloride (dosage: NA) experienced the following side effect(s):
  • Rhabdomyolysis
The treatment was started on Dec 22, 2004. Ambroxol Hydrochloride was used in combination with the following drugs:
  • Hokunalin
  • Diazepam
  • Pepcid
  • Pepcid
  • Pepcid
  • Pepcid
  • Rocephin
  • Rocephin
The patient was hospitalized.This report could alert potential Ambroxol Hydrochloride consumers.

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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    Ambroxol Hydrochloride Safety Alerts, Active Ingredients, Usage Information

    More About Ambroxol hydrochloride

    Side Effects reported to FDA: 11

    Ambroxol Hydrochloride safety alerts: No

    Reported deaths: 2

    Reported hospitalizations: 3

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