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Shaky (4)
Child Started Coughing (2)
Cough (2)
Entire Body Shaking (2)
Blurriness (1)
Blurry Vision (1)
Raspy Throat (1)
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Berotec Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Vaginal Cancer, Infection, Dyspnoea, Renal Cancer, Fatigue (8359784-2)
on May 08, 2012 Female from BRAZIL , weighting 105.8 lb, was diagnosed with
  • bronchitis
and was treated with Berotec. Directly after, patient experienced the unwanted or unexpected Berotec side effects: vaginal cancer, infection, dyspnoea, renal cancer, fatigue. Berotec dosage: Twice Daily (when It Was Necessary).
Associated medications used:
  • Atrovent (Twice Daily (when It Was Necessary))
  • Simvastatin (Half Tablet At Morning And Half Tablet At Night)
  • Formoterol Fumarate (Foraseq 12/400 Mcg 60/60 Twice A Day)
  • Cortisone Acetate (Unk Ukn, Unk)
Patient was hospitalized.

Pneumonia (8337599-9)
Patient was taking Berotec. Patient felt the following Berotec side effects: pneumonia on Apr 26, 2012 from BRAZIL Additional patient health information: Female , 62 years of age, weighting 169.8 lb, was diagnosed with
  • asthma
and. Berotec dosage: Prn.
Multiple prescriptions taken:
  • Symbicort (320/9 Mcg Two Time A Day)
Patient was hospitalized.

Dyspnoea, Epilepsy (7949442-8)
Adverse event was reported on Nov 17, 2011 by a Male taking Berotec (Dosage: N/A) was diagnosed with
  • bronchitis
and. Location: BRAZIL , weighting 154.3 lb, After Berotec was administered, patient encountered several Berotec side effects: dyspnoea, epilepsy.
Multiple concurrent drugs taken:
  • Albuterol


Product Quality Issue, Respiratory Failure (7611569-8)
on Jul 07, 2011 Male from BRAZIL , weighting 154.3 lb, was treated with Berotec. Directly after, patient experienced the unwanted or unexpected Berotec side effects: product quality issue, respiratory failure. Berotec dosage: 5drop Per Day.
Associated medications used:
  • Seretide



Respiratory Failure, Product Quality Issue (7563383-X)
on Jun 14, 2011 Male from BRAZIL , weighting 154.3 lb, was treated with Berotec. Patient felt the following Berotec side effects: respiratory failure, product quality issue. Berotec dosage: 5drop Per Day.
Multiple prescriptions taken:
  • Seretide


Bedridden, Decreased Appetite (7518254-1)
Patient was taking Berotec (fenoterol Hydrobromide) (fenoterol Hydrobromide). After Berotec was administered, patient encountered several Berotec side effects: bedridden, decreased appetite on May 12, 2011 from GERMANY Additional patient health information: Female , 84 years of age, weighting 127.9 lb, . Berotec (fenoterol Hydrobromide) (fenoterol Hydrobromide) dosage: N/A.
Multiple concurrent drugs taken:
  • Onbrez (indacaterol) (indacaterol)
  • Roflumilast (roflumilast) (tablets) (500 Mcg (500 Mcg, 1 In 1 D))
  • Euphylong (theophylline) (theophylline)
  • Decortin (prednisone) (prednisone)
  • Serevent (salmeterol) (salmeterol)


Depression, Withdrawal Syndrome (7417871-7)
Adverse event was reported on Apr 04, 2011 by a Male taking Berotec (Dosage: N/A) . Location: GERMANY , weighting 154.3 lb, Directly after, patient experienced the unwanted or unexpected Berotec side effects: depression, withdrawal syndrome.
Associated medications used:
  • Palexia Retard
  • Tilidine
  • Palexia Retard


Withdrawal Syndrome, Depression (7367068-4)
on Mar 09, 2011 Male from GERMANY , weighting 154.3 lb, was treated with Berotec. Patient felt the following Berotec side effects: withdrawal syndrome, depression. Berotec dosage: N/A.
Multiple prescriptions taken:
  • Tilidine
  • Palexia Retard


Urticaria (7357902-6)
on Jan 04, 2010 Female from GERMANY , 42 years of age, weighting 154.3 lb, was treated with Berotec. After Berotec was administered, patient encountered several Berotec side effects: urticaria. Berotec dosage: N/A.
Multiple concurrent drugs taken:
  • Mirtazapin
  • Prolastin (4 Gm; 1x; Iv)


Atrial Flutter (7320685-X)
Patient was taking Berotec. Directly after, patient experienced the unwanted or unexpected Berotec side effects: atrial flutter on Feb 24, 2011 from GERMANY Additional patient health information: Male , weighting 176.4 lb, was diagnosed with
  • chronic obstructive pulmonary disease
and. Berotec dosage: Prn.
Associated medications used:
  • Salmeterol (100 Mcg)
  • Torem (20 Mg)
  • Tiotropium Bromide (18 Mcg)
  • Viani (Form.: Dpi; Str.: 50/150mcg, D. Dose: 100/300 Mcg)
Patient was hospitalized.

Pneumonia (7120938-4)
Adverse event was reported on Nov 17, 2010 by a Female taking Berotec (Dosage: N/A) was diagnosed with
  • asthma
  • pneumonia
and. Location: , 69 years of age, Patient felt the following Berotec side effects: pneumonia.
Multiple prescriptions taken:
  • Spiriva (18 Mcg)
  • Combivent (45 Drops As Nebulization Daily)
  • Symbicort
  • Lexotanil
  • Rivotril (0.5 Mg)
  • Lotrial (20 Mg)
Patient was hospitalized.

Tachycardia (6706986-4)
on Apr 23, 2010 Female from , 59 years of age, weighting 154.3 lb, was diagnosed with
  • chronic obstructive pulmonary disease
and was treated with Berotec. After Berotec was administered, patient encountered several Berotec side effects: tachycardia. Berotec dosage: 100 Mcg.
Multiple concurrent drugs taken:
  • Spiriva (2 Anz)
  • Norvasc (1 Anz)
  • Acc 200 (3 Anz)
  • Atacand (2 Anz)
  • Pantozol (1 Anz)
Patient was hospitalized.

Erythema, Lip Discolouration, Oxygen Saturation Decreased, Pupillary Disorder, Tremor (6264607-1)
on Jul 08, 2009 Female from , child 8 years of age, was diagnosed with
  • bronchospasm
and was treated with Berotec. Directly after, patient experienced the unwanted or unexpected Berotec side effects: erythema, lip discolouration, oxygen saturation decreased, pupillary disorder, tremor. Berotec dosage: N/A.
Associated medications used:
  • Atrovent
  • Busonid Aerossol
  • Cortisone
  • Sodium Chloride 0.9%
  • Bricanyl
Patient was hospitalized.

Overdose, Tachycardia (6192620-1)
Patient was taking Berotec. Patient felt the following Berotec side effects: overdose, tachycardia on May 12, 2009 from Additional patient health information: Female , 59 years of age, was diagnosed with
  • chronic obstructive pulmonary disease
and. Berotec dosage: 100mcg.
Multiple prescriptions taken:
  • Spiriva (2anz)
  • Acc 200 (3anz)
  • Atacand (2anz)
  • Norvasc (1anz)
  • Pantozol (1anz)
Patient was hospitalized.

Cataract, Dyspnoea, Hallucination, Tremor (6135786-1)
Adverse event was reported on Mar 24, 2009 by a Female taking Berotec (Dosage: See Narrative) was diagnosed with
  • dyspnoea
and. Location: , 71 years of age, weighting 110.2 lb, After Berotec was administered, patient encountered several Berotec side effects: cataract, dyspnoea, hallucination, tremor. Patient was hospitalized.

Diarrhoea, Influenza, Nasopharyngitis, Overdose, Therapeutic Response Decreased (5960984-7)
on Nov 18, 2008 Female from , 58 years of age, was diagnosed with
  • chronic obstructive pulmonary disease
and was treated with Berotec. Directly after, patient experienced the unwanted or unexpected Berotec side effects: diarrhoea, influenza, nasopharyngitis, overdose, therapeutic response decreased. Berotec dosage: 8mg.
Associated medications used:
  • Atrovent (1.25mg)
  • Combivent
  • Spiriva (18mcg)
  • Foraseq
Patient was hospitalized.

Diarrhoea, Influenza, Nasopharyngitis, Overdose, Therapeutic Response Decreased (5953331-8)
on Nov 11, 2008 Female from , 58 years of age, was diagnosed with
  • chronic obstructive pulmonary disease
and was treated with Berotec Drops. Patient felt the following Berotec side effects: diarrhoea, influenza, nasopharyngitis, overdose, therapeutic response decreased. Berotec Drops dosage: 8mg.
Multiple prescriptions taken:
  • Atrovent (1.25mg)
  • Combivent
  • Spiriva (18mcg)
  • Foraseq
Patient was hospitalized.

Dyspnoea, Movement Disorder, Suffocation Feeling, Tremor (5872202-9)
Patient was taking Berotec. After Berotec was administered, patient encountered several Berotec side effects: dyspnoea, movement disorder, suffocation feeling, tremor on Sep 05, 2008 from Additional patient health information: Male , 54 years of age, was diagnosed with
  • respiratory failure
and. Berotec dosage: N/A.
Multiple concurrent drugs taken:
  • Atrovent
  • Formoterol Fumarate
Patient was hospitalized.

Back Pain, Fatigue, Headache, Insomnia, Muscle Spasms, Pruritus, Rash Macular, Renal Colic (5301912-7)
Adverse event was reported on Apr 09, 2007 by a Male taking Berotec (Dosage: 8 Drops/day) . Location: BRAZIL , 61 years of age, weighting 136.7 lb, Directly after, patient experienced the unwanted or unexpected Berotec side effects: back pain, fatigue, headache, insomnia, muscle spasms, pruritus, rash macular, renal colic.
Associated medications used:
  • Atrovent (16 Drops/day)
  • Salbutamol (100 Ml, Qid)
  • Foradil (1 Df, Q12h)
  • Talofilina


Blood Pressure Increased, Incorrect Dose Administered, Treatment Noncompliance (5177559-2)
on Dec 08, 2006 Female from BRAZIL , 64 years of age, was diagnosed with
  • ill-defined disorder
  • dyspnoea
  • bronchitis
and was treated with Berotec. Patient felt the following Berotec side effects: blood pressure increased, incorrect dose administered, treatment noncompliance. Berotec dosage: N/A.

Blood Pressure Increased (5176948-X)
on Dec 08, 2006 Female from BRAZIL , 64 years of age, was diagnosed with
  • ill-defined disorder
  • dyspnoea
  • bronchitis
and was treated with Berotec. After Berotec was administered, patient encountered several Berotec side effects: blood pressure increased. Berotec dosage: N/A.

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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.

Berotec Information

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Side Effects reported to FDA: 21. View Berotec Adverse Reports

Berotec safety alerts: No

Reported deaths: 1

Reported hospitalizations: 10

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