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side effects patient, 51 years of age, weighting 114.6 lb, was diagnosed with upper respiratory tract infection and took Ambroxol hydrochloride 120 Mg, 1x/day . View more Serious Adverse Events reported to FDA.

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List of Ambroxol Hydrochloride Adverse Effects reported to US Food and Drug Administration (FDA)

Injection Site Abscess (8447650-3)
on Jun 07, 2012 Female patient from CHINA , 51 years of age, weighting 114.6 lb, was diagnosed with
  • upper respiratory tract infection
and was treated with Ambroxol Hydrochloride. Patient experienced the following unwanted or unexpected effects: injection site abscess. Ambroxol Hydrochloride dosage: 120 Mg, 1x/day.
Patient also using the following medications:
  • Zithromax (0.5g, Once Daily)


Pathogen Resistance (8259542-3)
Patient was taking Ambroxol Hydrochloride. Patient had the following side effects: pathogen resistance on Mar 28, 2012 from GERMANY Additional patient health information: Female patient , 63 years of age, . Ambroxol Hydrochloride dosage: N/A.
Patient also using the following medications:
  • Cancidas
  • Dihydralazine Mesylate
  • Enoxaparin Sodium
  • Hydrochlorothiazide
  • Levothyroxine Sodium


Convulsion, Hyponatraemia, Vomiting (8234308-9)
Adverse event was reported on Mar 22, 2012 by a Female patient taking Ambroxol Hydrochloride (Dosage: N/A) . Location: JAPAN , 77 years of age, weighting 145.5 lb, After Ambroxol Hydrochloride was administered, patient had the following side effects: convulsion, hyponatraemia, vomiting.
Patient also using the following medications:
  • Calblock
  • Merislon
  • Codeine Phosphate
  • Magnesium Oxide
  • Emend (Dose:125-80)
  • Olmesartan Medoxomil
  • Dexamethasone
  • Depas


Tubulointerstitial Nephritis, C-reactive Protein Increased, Blood Creatinine Increased, Constipation, Hyperhidrosis (8001494-5)
on Dec 16, 2011 Female patient from JAPAN , 14 years of age, was treated with Ambroxol Hydrochloride. Patient experienced the following unwanted or unexpected effects: tubulointerstitial nephritis, c-reactive protein increased, blood creatinine increased, constipation, hyperhidrosis. Ambroxol Hydrochloride dosage: N/A.
Patient also using the following medications:
  • Isosorbide Dinitrate
  • Pregabalin
  • Etizolam
  • Alendronate Sodium
  • Tramadol Hydrochloride/acetaminophen (1 Df 2 Per Day)
  • Lactulose
  • Tramadol Hydrochloride/acetaminophen (2 Doses 2 Times A Day)



Altered State Of Consciousness (7828650-0)
on Oct 11, 2011 Female patient from JAPAN , 95 years of age, was treated with Ambroxol Hydrochloride. Patient had the following side effects: altered state of consciousness. Ambroxol Hydrochloride dosage: N/A.
Patient also using the following medications:
  • Gasmotin
  • Histablock
  • Aricept
  • Clarithromycin
  • Acetaminophen
  • Aricept
  • Mevatorte
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 (7458001-5)
Patient was taking Ambroxol Hydrochloride. After Ambroxol Hydrochloride was administered, patient had the following 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 on Apr 20, 2011 from JAPAN Additional patient health information: Female patient , child 3 years of age, was diagnosed with
  • productive cough
  • urinary tract infection
  • constipation
and. Ambroxol Hydrochloride dosage: N/A.
Patient also using the following medications:
  • 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 (7328608-4)
Adverse event was reported on Feb 25, 2011 by a Male patient taking Ambroxol Hydrochloride (Dosage: N/A) . Location: JAPAN , child 5 years of age, Patient experienced the following unwanted or unexpected effects: respiratory disorder, toxic epidermal necrolysis.
Patient also using the following medications:
  • Polbonol
  • Clarith Dry Syrup
  • Lanoxin


Hypertension (7325673-5)
on Feb 23, 2011 Female patient from BRAZIL , 70 years of age, was treated with Ambroxol Hydrochloride. Patient had the following side effects: hypertension. Ambroxol Hydrochloride dosage: Unk.
Patient also using the following medications:
  • Lyrica (75 Mg, 1x/day)


Hypertension (7316216-0)
on Feb 17, 2011 Female patient from , 70 years of age, was treated with Ambroxol Hydrochloride. After Ambroxol Hydrochloride was administered, patient had the following side effects: hypertension. Ambroxol Hydrochloride dosage: Unk.
Patient also using the following medications:
  • Lyrica (75 Mg, 1x/day)


Blood Alkaline Phosphatase Increased, Bundle Branch Block Right, Bundle Branch Block Bilateral, Tachycardia, Hyperglycaemia (7307345-6)
Patient was taking Ambroxol Hydrochloride. Patient experienced the following unwanted or unexpected effects: blood alkaline phosphatase increased, bundle branch block right, bundle branch block bilateral, tachycardia, hyperglycaemia on Feb 16, 2011 from JAPAN Additional patient health information: Male patient , 68 years of age, weighting 79.59 lb, . Ambroxol Hydrochloride dosage: N/A.
Patient also using the following medications:
  • Vfend (150 Mg, 1x/day)
  • Marzulene S
  • Mucodyne
  • Vfend (150 Mg, 2x/day)
Patient was hospitalized.

Rhabdomyolysis (4568661-4)
Adverse event was reported on Jan 12, 2005 by a Female patient taking Ambroxol Hydrochloride (Dosage: N/A) . Location: , child 10 years of age, Patient had the following side effects: rhabdomyolysis.
Patient also using the following medications:
  • Hokunalin
  • Diazepam
  • Pepcid
  • Pepcid
  • Pepcid
  • Pepcid
  • Rocephin
  • Rocephin
Patient was hospitalized.

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Ambroxol Hydrochloride Information

More About Ambroxol hydrochloride

Side Effects reported to FDA: 11. View FDA Adverse Reports

Ambroxol Hydrochloride safety alerts: No

Reported deaths: 2

Reported hospitalizations: 3

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Ambroxol Hydrochloride Adverse Reactions

Blood Creatinine Increased ( 2 Reports)

Hypertension ( 2 Reports)

Alanine Aminotransferase ( 1 Reports)

Altered State Of Consciousness ( 1 Reports)

Aspartate Aminotransferase ( 1 Reports)

Blood Alkaline Phosphatase Increased ( 1 Reports)

Bundle Branch Block Bilateral ( 1 Reports)

Bundle Branch Block Right ( 1 Reports)

C-reactive Protein Increased ( 1 Reports)

Cardiac Failure ( 1 Reports)

Constipation ( 1 Reports)

Convulsion ( 1 Reports)

Frequent Bowel Movements ( 1 Reports)

Hepatic Function Abnormal ( 1 Reports)

Hyperglycaemia ( 1 Reports)

Hyperhidrosis ( 1 Reports)

Hyponatraemia ( 1 Reports)

Injection Site Abscess ( 1 Reports)

Pathogen Resistance ( 1 Reports)

Renal Failure ( 1 Reports)

Respiratory Disorder ( 1 Reports)

Rhabdomyolysis ( 1 Reports)

Tachycardia ( 1 Reports)

Toxic Epidermal Necrolysis ( 1 Reports)

Tubulointerstitial Nephritis ( 1 Reports)

Urine Output Decreased ( 1 Reports)

Vomiting ( 1 Reports)

White Blood Cell Count Increased ( 1 Reports)

side effects
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