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Death (2)
Drowsiness (1)
Mouth Gets Very Bitter After Taking It (1)
Mouth Very Bitter (1)
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Ambroxol Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Injection Site Abscess (8447650-3)
on Jun 07, 2012 Female from CHINA , 51 years of age, weighting 114.6 lb, was diagnosed with
  • upper respiratory tract infection
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 (8259542-3)
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 (8234308-9)
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 (8138429-0)
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 (8014469-7)
on Dec 22, 2011 Male from TAIWAN, PROVINCE OF CHINA , weighting 143.3 lb, was diagnosed with
  • asthma
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 (8001494-5)
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 (7920283-0)
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 (7828650-0)
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 (7802646-7)
on Sep 30, 2011 Male from GERMANY , weighting 145.5 lb, was diagnosed with
  • bone graft lysis
  • chronic obstructive pulmonary disease
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 (7506041-X)
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 (7458001-5)
Adverse event was reported on Apr 20, 2011 by a Female taking Ambroxol Hydrochloride (Dosage: N/A) was diagnosed with
  • productive cough
  • urinary tract infection
  • constipation
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 (7413181-2)
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 (7328608-4)
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 (7325673-5)
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 (7316216-0)
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 (7307345-6)
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 (7289390-2)
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 (4568661-4)
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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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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 Information

More About Ambroxol

Side Effects reported to FDA: 18. View Ambroxol Adverse Reports

Ambroxol safety alerts: No

Reported deaths: 2

Reported hospitalizations: 4

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